RU2832929C2 - Nicotine sachet composition and sachet containing thereof - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to a nicotine sachet composition, to an oral nicotine sachet product containing a nicotine sachet composition, as well as to a method for preparing such a sachet. Nicotine sachet composition for relieving nicotine cravings contains a mixture of nicotine in the form of a free base with a sugar alcohol, said sachet composition containing water of at least 15% by weight of said sachet composition, where nicotine in the form of a free base contains nicotine in the form of a free base, mixed with an ion-exchange resin in a weight ratio between nicotine in the form of a free base and ion-exchange resin from 0.1 to 2.0, where the nicotine sachet composition contains sugar alcohol in amount of 1–80% by weight of the sachet composition. Oral product in the form of a nicotine sachet for relieving cravings for nicotine contains a sachet and a certain amount of a nicotine sachet composition enclosed in said sachet. Method of producing an oral product in the form of a nicotine sachet involves the following steps: providing a nicotine sachet composition, providing the sachet, adding the sachet composition to said sachet and sealing the sachet.

EFFECT: use of the group of inventions provides the presence of stable nicotine in the form of a free base in the presence of a high water content in an amount of at least 15% by weight, facilitating the craving for smoking even after storage, fast release of nicotine and effective absorption, as well as providing a sustained release of nicotine in comparison with nicotine in the form of a free base, mixed with sugar alcohols, in addition, in comparison with a nicotine-ion-exchange resin complex, relatively fast release is achieved.

90 cl, 16 tbl, 4 ex

Description

FIELD OF INVENTION

The present invention relates to a nicotine pouch composition according to claim 1 and to an oral nicotine pouch product containing the nicotine pouch composition according to claim 83 and to a method for producing such a pouch according to claim 93.

LEVEL OF TECHNOLOGY

Delivery of nicotine through smoking has many well-known disadvantages, particularly health-related issues such as the inclusion of carcinogenic substances.

However, tobacco substitutes also have disadvantages, such as providing insufficient craving relief for smokers who are quitting.

The object of the present invention is to provide a nicotine-containing pouch, for example as a tobacco substitute, which can solve the above-described problems.

ESSENCE OF THE INVENTION

The invention relates to a nicotine sachet composition containing nicotine in the form of a free base and having a water content of at least 15% by weight of said sachet composition.

An advantage of the invention may be that a more desirable mouthfeel can be achieved for the same amount of nicotine compared to pouch compositions with a lower moisture content. Using free base nicotine, a recognizable burning sensation can be achieved, thereby better simulating tobacco-containing products.

A further advantage of the invention may be that a relatively rapid release of nicotine may be achieved, for example by avoiding any delays associated with the release of ionized nicotine bound to the carrier. The rapid release of nicotine advantageously provides rapid relief of nicotine cravings in consumers. Also, the high water content further contributes to the rapid release of nicotine, since the delay normally associated with the attraction of moisture into the pouch may be more or less avoided.

By providing nicotine as nicotine in free base form, a relatively high pH value in the final saliva of the user can be achieved due to the provision of nicotine as its free base form compared to, for example, nicotine bitartrate. In this way, either a higher pH value can be achieved or a reduction in the amount of pH-adjusting agent can be achieved to achieve the same pH value. A higher pH value promotes the absorption of nicotine through the oral mucosa.

It may also be an advantage of the invention that a relatively rapid release and ultimately relief from nicotine cravings can be achieved by combining the use of nicotine in the form of a non-ionized free base and the presence of a relatively high water content. Thus, the product in the form of a pouch can provide a relatively rapid release of nicotine into the saliva and subsequent rapid absorption of nicotine through the oral mucosa due to the high pH value in the oral cavity, thereby providing a rapid effect to the user.

Furthermore, the use of free base nicotine advantageously provides a pouch product having a desirable texture and mouth feel and provides relief from nicotine cravings. While any degradation of nicotine due to the presence of water may reduce the amount of nicotine available to the consumer to some extent, by providing nicotine as free base nicotine, a higher pH can be achieved, whereby any reduction in nicotine is offset both in terms of mouth feel and because the higher pH promotes higher nicotine absorption. At the same time, a high pH can increase shelf life by inhibiting unwanted microbial growth. Also, the water content and free base form of nicotine promote rapid nicotine absorption.

The pouch composition may also provide a desirable mouthfeel, such as a soft and sticky texture. The desirable texture and mouthfeel may be achieved while maintaining the ability to store the produced pouches together in a container, such as a tin can, etc., without excessively sticking together, causing the pouches to break upon removal. In some embodiments, the desirable mouthfeel may also include a tingling or burning sensation, reminiscent of the sensation of tobacco pouches, but without many of the undesirable effects associated with them, such as health, color change, etc.

A further advantage of the invention may be that the resulting nicotine pouch product containing the pouch composition has a relatively low tendency to release dust-like material through a permeable pouch wall, for example in a package such as a tin can. This is advantageous both in the sense that little expensive nicotine is lost and in the sense that any such lost material in tin cans is generally considered highly unattractive to consumers.

The inventors of the present invention have found that the pouch composition of the invention can provide unexpectedly acceptable stability of nicotine in free base form in the presence of a high water content of at least 15% by weight of water. In more detail, pouches containing the pouch composition provided relief of nicotine craving also after storage.

Producing nicotine with a relatively rapid release and efficient absorption is desirable because it provides a rapid effect for the user. Furthermore, this can be achieved by reducing the need for enhancers such as a pH adjusting agent due to the use of nicotine in the free base form, whereby production can be simplified.

In a preferred embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin and/or a water soluble composition such as a sugar alcohol or a water soluble fiber.

An advantage of the above embodiment may be that a relatively rapid release of nicotine can be achieved compared to, for example, using a nicotine-ion exchange resin complex such as nicotine-polacrilex resin.

In one embodiment of the invention, the free base nicotine consists of free base nicotine mixed with an ion exchange resin and/or a water soluble composition such as a sugar alcohol or a water soluble fiber.

In a preferred embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin.

One advantage of the embodiment described above may be to provide a slow release of nicotine compared to, for example, free base nicotine mixed with water-soluble compositions such as sugar alcohols. At the same time, the release of nicotine is not too slow, which provides the user with the desired craving-reducing effect. Thus, compared to, for example, using a nicotine-ion exchange resin complex, a relatively fast release can be achieved.

Another advantage of the embodiment described above may be that it provides a relatively cost-effective solution.

At the same time, a relatively high pH value can be achieved during application compared to the amounts of pH-regulating agents used.

In one embodiment, the freebase nicotine comprises freebase nicotine mixed with an ion exchange resin.

In a preferred embodiment of the invention, the free base nicotine comprises free base nicotine mixed with polyacrylex resin.

In one embodiment, the free base nicotine comprises free base nicotine mixed with polyacrylex resin.

In one embodiment of the invention, the free base nicotine comprises nicotine mixed with an ion exchange resin, such as polacrilex resin, the nicotine pouch composition further comprises nicotine bound to the ion exchange resin, i.e. a nicotine-ion exchange resin complex. Thus, the nicotine may be nicotine mixed with polacrilex resin, wherein a portion of the nicotine is bound to the ion exchange resin, while a portion of the nicotine remains unbound as free base nicotine.

In a preferred embodiment of the invention, the freebase nicotine comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of from 0.1 to 2.0, preferably from 0.5 to 2.0, and most preferably from about 0.67 to 1.0.

In a preferred embodiment of the invention, the freebase nicotine comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of from 1:1 to about 1:10, preferably from 1:2 to 1:6, and most preferably about 1:4-1:5.

In this case, the mass ratio refers to the mass of the first component divided by the mass of the second component. The term "mixing ratio" may also be used.

Thus, in the above-described embodiment, the freebase nicotine comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of from 0.1 to about 1, preferably from 0.17 to 0.5, and most preferably about 0.2-0.25.

In a preferred embodiment of the invention, the free base nicotine comprises free base nicotine mixed with a water-soluble composition such as a sugar alcohol or a water-soluble fiber.

An advantage of the described embodiment may be that a relatively rapid release of nicotine can be achieved compared to, for example, using a nicotine-ion exchange resin complex such as nicotine-polacrilex resin.

At the same time, a relatively high pH value can be achieved during application compared to the amounts of pH-regulating agents used.

In one embodiment, the free base nicotine comprises free base nicotine mixed with a water soluble composition such as a sugar alcohol or a water soluble fiber.

In a preferred embodiment of the invention, the sachet composition comprises a water-soluble composition, such as a sugar alcohol or a water-soluble fiber, in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition.

When free base nicotine is mixed with a water-soluble composition such as a sugar alcohol or a water-soluble fiber, the amount of the water-soluble composition such as the sugar alcohol or the water-soluble fiber may typically be at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition. When using a higher concentration of free base nicotine in the pouch composition, it may be advantageous to increase the amount of the water-soluble composition such as the sugar alcohol or the water-soluble fiber used in the mixture with the free base nicotine. Likewise, for lower amounts of free base nicotine, the need for the water-soluble composition such as the sugar alcohol or the water-soluble fiber may be reduced. The additional water-soluble composition, in particular the sugar alcohol, may be used, for example, as a bulk sweetener, filler, etc.

In a preferred embodiment of the invention, free base nicotine comprises free base nicotine mixed with a sugar alcohol.

In one embodiment, the freebase nicotine comprises freebase nicotine mixed with a sugar alcohol.

In a preferred embodiment of the invention, said sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof.

In one embodiment of the invention, the sugar alcohol is provided as a direct compression (DC) sugar alcohol. An advantage of this embodiment may be that an increase in flowability may be achieved.

In a preferred embodiment of the invention, the free base nicotine comprises free base nicotine mixed with a water soluble fiber.

In one embodiment, the freebase nicotine comprises freebase nicotine mixed with a water-soluble fiber.

In a preferred embodiment of the invention, said water-soluble fiber is selected from the list comprising inulin, polydextrose, including refined polydextrose, dextrin, maltodextrin and mixtures thereof.

In a preferred embodiment of the invention, nicotine in free base form mixed with an ion exchange resin further comprises water.

Thus, in the embodiments described above, the mixture of nicotine with an ion exchange resin further comprises water. This mixture containing water is then added to other ingredients, which may typically contain water, to obtain a water content of at least 15% by weight of the pouch composition.

In an advantageous embodiment of the invention, the pouch composition comprises a combination of free base nicotine mixed with a first composition and free base nicotine mixed with a second, different composition.

It is understood that the first and second compositions are different. One example is free base nicotine mixed with an ion exchange resin in combination with free base nicotine mixed with a water soluble composition such as a sugar alcohol or a water soluble fiber. Another example is a combination of free base nicotine mixed with a sugar alcohol and free base nicotine mixed with a water soluble fiber. Another example is a combination of free base nicotine mixed with one type of ion exchange resin and free base nicotine mixed with another type of ion exchange resin, or a combination of free base nicotine mixed with one type of water soluble fiber and free base nicotine mixed with another type of water soluble fiber, or a combination of free base nicotine mixed with one type of sugar alcohol and free base nicotine mixed with another type of sugar alcohol.

In a preferred embodiment of the invention, the free base nicotine comprises a combination of free base nicotine mixed with a water-soluble composition and free base nicotine mixed with a water-insoluble composition.

An advantage of the embodiment described above may be that a nicotine release profile can be achieved that contains both a fast release component and a slow release component, which may be desirable for consumers of nicotine pouch products.

Examples of suitable water-insoluble compositions may include, for example, water-insoluble fibers such as plant fibers, bran fibers, and cellulose fibers, hereinafter microcrystalline cellulose (MCC).

In a preferred embodiment of the invention, the free base nicotine comprises a combination of free base nicotine mixed with an ion exchange resin and free base nicotine mixed with a water soluble composition.

An advantage of the embodiment described above may be that a nicotine release profile can be achieved that contains both a fast release component and a slow release component, which may be desirable for consumers of nicotine pouch products.

In a preferred embodiment of the invention, nicotine in free base form is granulated with a water-soluble composition or ion exchange resin.

In an advantageous embodiment of the invention, the sachet composition further comprises a pH-regulating agent, such as a basic pH-regulating agent, such as a basic buffering agent.

An advantage of the embodiment described above may be that more efficient absorption of nicotine can be achieved.

Another advantage of the embodiment described above may be that a desired mouth feel can be achieved during use.

In one embodiment of the invention, the sachet composition further comprises a combination of at least two pH-regulating agents, such as a combination of at least two basic pH-regulating agents, such as a combination of at least two basic buffering agents, such as a basic buffer pair.

While in some embodiments lower amounts of pH adjusting agent may be used, for example by avoiding the use of nicotine salts such as nicotine bitartrate, it may still be desirable to further increase the pH by adding a pH adjusting agent.

In one embodiment of the invention, the sachet composition comprises a pH-regulating agent, for example in an amount of from 0.01 to 15% by weight of the sachet composition.

In a preferred embodiment of the invention, the sachet composition comprises a pH-regulating agent in an amount of from 0.01 to 15% by weight of the sachet composition, such as from 0.5 to 10% by weight of the sachet composition, such as from 1 to 10% by weight of the sachet composition, such as from 5 to 10% by weight of the sachet composition.

In an advantageous embodiment of the invention, the composition of the sachet is adapted to achieve a pH of at least 8.0.

In one embodiment of the invention, the sachet composition is adapted to achieve a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 grams of the sachet composition is added to 20 ml of 0.02 M potassium dihydrogen phosphate buffer (adjusted to pH 7.4).

In one embodiment of the invention, the composition of the sachet is adapted to achieve a pH of at least 8.0 during use after placement in the oral cavity.

An advantage of the embodiment described above may be that relatively efficient absorption of nicotine is ensured due to the high pH value.

A further advantage of the embodiment described above may be that the need for a preservative may be reduced or even eliminated, and that low amounts of such preservatives may be used, or even absent.

Also, the high pH value obtained may advantageously provide a tingling sensation in the mouth, which may be perceived as a desirable mouthfeel, for example due to the similarity to tobacco-based pouch products.

In an advantageous embodiment of the invention, the pH-regulating agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide or any combination thereof.

In a preferred embodiment of the invention, the pH-adjusting agent is a basic pH-adjusting agent, such as a basic buffering agent, such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

In an advantageous embodiment of the invention, the sachet composition further comprises a wetting agent.

A humectant can attract and retain water in the oral cavity during use. However, a humectant can also delay the release of nicotine, for example by providing a delayed release of nicotine.

In an advantageous embodiment of the invention, the sachet composition further comprises a wetting agent in an amount of from 0.5 to 10% by weight of the sachet composition, such as from 0.5 to 5% by weight of the sachet composition, such as 1-3% by weight of the sachet composition.

In a preferred embodiment of the invention, the wetting agent comprises one or more of the following: glycerin, propylene glycol, alginate, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

In a preferred embodiment of the invention, the composition of the sachet additionally contains alginate.

In one embodiment of the invention, the sachet composition further comprises glycerin.

In one embodiment of the invention, the sachet composition further comprises modified starch.

In one embodiment of the invention, the sachet composition further comprises hydroxypropyl cellulose (HPC).

An advantage of the embodiment described above may be that the pouch composition provides a desirable soft texture during use. The alginate may be provided, for example, as a wetting agent and thus attract and retain water in the oral cavity during use. However, the alginate may additionally inhibit the release of nicotine, for example by providing a delayed release of nicotine.

In a preferred embodiment of the invention, the sachet composition further comprises alginate in an amount of 0.5 to 5% by weight of the sachet composition, such as 1-3% by weight of the sachet composition.

In a preferred embodiment of the invention, the sachet composition additionally contains xanthan gum.

An advantage of the embodiment described above may be that the composition of the sachet provides a desirable soft texture during use. Xanthan gum may be provided, for example, as a humectant and thus attract and retain water in the oral cavity during use.

In a preferred embodiment of the invention, the composition of the sachet additionally contains silicon dioxide.

An advantage of the embodiment described above may be that a higher flowability of the sachet composition is achieved. Thus, silicon dioxide can be provided as a glidant. Alternative glidants may also be used in embodiments in which glidants are used.

In one embodiment of the invention, the sachet composition further comprises silicon dioxide in an amount of from 0.5 to 5% by weight of the sachet composition, such as 1-3% by weight of the sachet composition.

In an advantageous embodiment of the invention, the composition of the sachet contains a flavor additive, for example, in an amount of from 0.01 to 20% by weight of the composition of the sachet, for example, in an amount of from 0.01 to 15% by weight of the composition of the sachet.

In one embodiment of the invention, the sachet composition comprises a flavor additive in an amount of from 0.01 to 15% by weight of the sachet composition, such as from 0.1 to 15% by weight of the sachet composition, such as from 1 to 10% by weight of the sachet composition, such as from 3 to 10% by weight of the sachet composition.

In a preferred embodiment of the invention, the flavoring agent comprises a liquid flavoring agent.

The properties of the water-insoluble component may influence the release of the flavor additive from the sachet composition and, thereby, may influence the consumer's perception of taste.

In one embodiment of the invention, the water-insoluble fiber may elicit a more pronounced or less pronounced taste sensation in the consumer.

In one embodiment of the invention, the sachet composition comprises a flavor additive in an amount of no more than 10% by weight of the sachet composition, such as no more than 8% by weight of the sachet composition, such as no more than 5% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises a flavor additive in an amount of 0.01-10% by weight of the sachet composition, such as 0.01-8% by weight of the sachet composition, such as 0.01-5% by weight of the sachet composition.

In a preferred embodiment of the invention, the sachet composition contains water-insoluble fibers selected from pea fibers, powdered cellulose and combinations thereof, and a flavor additive in an amount of no more than 10% by weight of the sachet composition.

Cellulose obtained by processing alpha-cellulose obtained as pulp from materials of fibrous plant varieties can be obtained, for example, from wood pulp.

In one embodiment of the invention, the sachet composition comprises water-insoluble fibres selected from pea fibres and powdered cellulose or a combination thereof, and a flavouring additive in an amount of 0.01-10% by weight of the sachet composition.

In a preferred embodiment of the invention, the composition of the sachet is substantially homogeneous.

For example, by mixing at least 90% by weight of the total amount of dry ingredients before adding nicotine and then water, such as before adding nicotine and then water and liquid flavor additives, if any, a more uniform pouch composition having a uniform distribution of nicotine can be obtained.

In an advantageous embodiment of the invention, the nicotine content in a series of at least 10 oral sachets containing such a sachet composition maintains a relative standard deviation (RSD) of below 10%, preferably below 8%, more preferably no more than 6%, even more preferably no more than 4%, most preferably no more than 2%.

In one embodiment of the invention, the nicotine content in a series of at least 10 oral sachets containing said sachet composition maintains a relative standard deviation (RSD) of 0.1-10%, preferably 0.1-8%, more preferably 0.1-6%, even more preferably 0.1-4% and most preferably 0.1-2%.

The homogeneity of the composition of a sachet can be assessed by assessing the distribution of the individual components of the composition between individual sachets.

For example, the standard deviation of the nicotine content can be measured as described in Example 3J. The content, i.e. the uniformity of the content (CU) of nicotine, relates to the uniformity of the pouch composition. Pouches obtained from the same pouch composition and having a low standard deviation of the nicotine content have a high uniformity of the pouch composition, while pouches obtained from the same pouch composition and having a high standard deviation of the nicotine content have a low uniformity of the pouch composition.

In a preferred embodiment of the invention, the pouch composition is prepared by mixing the dry ingredients before adding nicotine, water and liquid flavorings, if any.

An advantage of the embodiment described above may be that increased homogeneity of the composition of the sachet can be achieved.

In a preferred embodiment of the invention, the sachet composition is prepared by mixing at least 90% by weight of the total amount of dry ingredients before adding water, for example before adding water and liquid flavorings, if any.

An advantage of the embodiment described above may be that increased homogeneity of the composition of the sachet can be achieved.

In a preferred embodiment of the invention, the sachet composition additionally contains a certain amount of a water-insoluble composition.

An advantage of the embodiment described above may be that the residue remains even after using a nicotine pouch containing the pouch composition. This may result in a pleasant sensation for the user of the nicotine pouch, for example due to the similarity to tobacco-containing products.

In a preferred embodiment of the invention, the water-insoluble composition comprises at least a composition selected from dibasic calcium phosphate, calcium carbonate, mono-, diglyceride powder, hydrogenated vegetable oil, and combinations thereof.

In a preferred embodiment of the invention, said amount of said water-insoluble composition is from 5 to 50% by weight of the composition of the sachet, such as from 10 to 30% by weight of the composition of the sachet.

In an advantageous embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble plant fiber, such as wheat fiber, oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, cellulose fiber, powdered cellulose, bamboo fiber, bran fiber, or combinations thereof.

Within the scope of the invention, powdered cellulose means cellulose obtained by processing alpha-cellulose obtained as pulp from materials of fibrous plant varieties, such as wood pulp.

In one embodiment of the invention, the water-soluble fiber comprises or consists of cereal fiber.

In one embodiment of the invention, the water-soluble fiber comprises or consists of fruit and/or plant fibers.

In a preferred embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble plant fiber, such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

In a preferred embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble plant fiber, such as wheat fiber, oat fiber, pea fiber, or combinations thereof.

In a preferred embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble plant fiber, such as wheat fiber, oat fiber, or combinations thereof.

Non-limiting examples of suitable plant fibers include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel L00, Vitacel Erbsenfaser EF 150, Vitacel bamboo fiberbaf 90, Vitacel HF 600, Vitacel Cellulose L700G, Vitacel PF200, Vitacel potatofiber KF200, Vitacel bamboo fiberhaf BAF40, Vitacel Haferfaser/oat fiber HF-401-30 US.

Non-limiting examples of suitable powdered cellulose include Vitacel L 00, Vitacel Cellulose L700G, Vitacel LC1000, Vitacel L600-20, Vitacel L600, etc.

In one embodiment, the powdered cellulose is chemically unmodified. Thus, the powdered cellulose may be chemically unmodified cellulose fibers that do not include, for example, microcrystalline cellulose (MCC).

In an advantageous embodiment of the invention, the water-insoluble fiber has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

An advantage of the embodiment described above may be that the high water binding capacity provides sachet compositions having a high water content.

Furthermore, sachets having a high water content have been found to have the desired consistency and mouthfeel, yet may still be able to be stored together in containers such as cans, etc., without excessively sticking together, causing the sachets to rupture upon removal.

In one embodiment of the invention, the water-insoluble fiber has a water binding capacity of from 200% to 1500%, such as from 300 to 1300%, such as from 200 to 800%, such as from 300 to 800%, such as from 400 to 600%.

In one embodiment of the invention, the water-insoluble fiber has a water binding capacity of from 200 to 1500%, such as from 300 to 1300%, such as from 300 to 900%, such as from 300 to 700%, such as from 400 to 700%.

In one embodiment of the invention, the water-insoluble fiber has a water binding capacity of from 200 to 1500%, such as from 400 to 1500%, such as from 500 to 1500%, such as from 500 to 1200%, such as from 500 to 1000%.

In one embodiment of the invention, the water-insoluble fiber has a swelling capacity of at least 5.0 ml/g, such as 5.0-20 ml/g.

The advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without deteriorating the mouthfeel during consumption. If some of the water-insoluble fiber is replaced by a water-soluble component, the swelling of the water-insoluble fiber during consumption will counteract the dissolution of the water-soluble component, so that the consumer will not perceive any decrease in the contents of the sachet during consumption.

In a preferred embodiment of the invention, the water-insoluble composition comprises or consists of water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition and has a water content of 15 to 70% by weight of said sachet composition.

In a preferred embodiment of the invention, the water-insoluble fibers are selected from pea fibers, powdered cellulose, and combinations thereof, and wherein the sachet composition contains a flavor additive in an amount of no more than 10% by weight of the sachet composition.

The composition of the pouch according to the embodiment described above may also provide a desirable mouthfeel, such as a soft and sticky consistency. The desirable consistency and mouthfeel may be achieved while maintaining the ability to store the pouches together in a container, such as a tin, etc., without excessively sticking together, causing the pouches to break upon removal. In some embodiments, the desirable mouthfeel may also include a tingling sensation reminiscent of tobacco pouches, but without many of the undesirable effects associated with them, such as health, color change, etc.

In one embodiment of the invention, the sachet composition comprises water-insoluble fiber in an amount of 5-50% by weight of the sachet composition, such as 10-40% by weight of the sachet composition.

In an advantageous embodiment of the invention, the sachet composition has a water content of at least 20% by weight of said sachet composition, such as at least 25% by weight of said sachet composition, such as at least 30% by weight of said sachet composition, such as at least 40% by weight of said sachet composition.

Water may be added as a separate component or may be mixed in whole or in part with other components such as fibres. For example, when freebase nicotine is added as a mixture of freebase nicotine with an ion exchange resin and water, a significant amount of the water in the final pouch composition may come from the freebase nicotine-ion exchange resin-water premix. For example, if the final amount of the pouch composition contains 5% of the water from the freebase nicotine-ion exchange resin-water premix, then up to one third of the water in the pouch composition comes from the freebase nicotine-ion exchange resin-water premix.

In an advantageous embodiment of the invention, the sachet composition has a water content of from 15 to 70% by weight of said sachet composition, such as from 15 to 65% by weight of said sachet composition, such as from 15 to 50% by weight of said sachet composition, such as from 25 to 50% by weight of said sachet composition, such as from 30 to 40% by weight of said sachet composition.

In an advantageous embodiment of the invention, the sachet composition has a water content of from 15 to 70% by weight of said sachet composition, such as from 15 to 50% by weight of said sachet composition, such as from 15 to 40% by weight of said sachet composition, such as from 15 to 30% by weight of said sachet composition, such as from 15 to 25% by weight of said sachet composition.

In a preferred embodiment of the invention, the composition has a bulk density of no more than 0.8 g/ ^cm3 , such as a bulk density of no more than 0.7 g/ ^cm3 , such as no more than 0.6 g/ ^cm3 , such as no more than 0.5 g/ ^cm3 .

The use of a composition according to the invention having a relatively low bulk density will provide not only a good mouthfeel but also an effective release from the sachet due to the fact that the relatively low bulk density promotes effective wetting with saliva and thus the release of water-soluble ingredients of the composition. In particular, it should be noted that a low bulk density in combination with the stated water content is attractive when improved consumer perception is desired.

At the same time, low density mainly reduces the need for raw materials and thus reduces production costs.

An advantage of the embodiment described above may be that a composition with a low density can be obtained. Surprisingly, the combination of water and sugar alcohols did not result in a very dense, compressed and unprocessable composition, but provided a relatively light and low-density composition.

In a preferred embodiment of the invention, the composition has a bulk density of from 0.2 g/ ^cm3 to 0.8 g/ ^cm3 , such as from 0.3 g/ ^cm3 to 0.7 g/ ^cm3 , such as from 0.3 g/ ^cm3 to 0.6 g/ ^cm3 , such as from 0.4 to 0.5 g/ ^cm3 .

In one embodiment of the invention, the composition has a bulk density of from 0.2 g/ ^cm3 to 0.8 g/ ^cm3 , such as from 0.2 g/ ^cm3 to 0.7 g/ ^cm3 , such as from 0.2 g/ ^cm3 to 0.6 g/ ^cm3 , such as from 0.2 to 0.5 g/ ^cm3 .

In one embodiment of the invention, the composition has a bulk density of from 0.2 g/ ^cm3 to 0.8 g/ ^cm3 , such as from 0.3 g/ ^cm3 to 0.8 g/ ^cm3 , such as from 0.4 g/ ^cm3 to 0.8 g/ ^cm3 , such as from 0.5 to 0.8 g/ ^cm3 .

In a preferred embodiment of the invention, the sachet composition comprises water and water-insoluble fiber in a weight ratio of no more than 3.0, such as no more than 2.5, such as no more than 2.0, such as no more than 1.5, such as no more than 1.0.

In one embodiment, the sachet composition comprises water and water-insoluble fiber in a weight ratio of from 3.0 to 0.2, such as from 2.0 to 0.2, such as from 2.0 to 1.0, or such as from 1.5 to 0.5.

Thus, the mass ratio given above has in the numerator the water content as a percentage by weight of the sachet composition, and in the denominator the water-insoluble fiber content as a percentage by weight of the sachet composition.

In particular, the inventors found that too low a water content resulted in incomplete wetting of the pouch composition. This typically resulted in a dry, lumpy composition, i.e., an undesirable mouthfeel. Furthermore, it could result in a slow release of nicotine due to the time delay before the pouch composition is wetted by saliva. On the other hand, it was found that too high a water content could result in a composition with an excessively heavy feel, including undesirable flowability. The inclusion of a glidant, such as silicon dioxide, can at least partially eliminate the undesirable flowability and thus provide a higher water content.

The presence of water content in the volume of the present invention may facilitate rapid release in the initial rapid release period, for example, during the first 120 seconds, since the sachet is already wetted or partially wetted with water from the beginning of use.

On the other hand, the water content should not be too high. Too high a water content can affect the diffusion of liquid into and out of the pouch. A fully wetted pouch may have lower liquid diffusion both into and out of the pouch during consumption, while a partially wetted pouch may have higher liquid diffusion both into and out of the pouch. Thus, a pouch with low liquid diffusion may have lower nicotine release, for example, after 10 minutes.

In an advantageous embodiment of the invention, the sachet composition has a water content of no more than 60% by weight of said sachet composition, such as no more than 50% by weight of said sachet composition, such as no more than 40% by weight of said sachet composition, such as no more than 30% by weight of said sachet composition.

In a preferred embodiment of the invention, the sachet composition is a powder composition.

In a preferred embodiment of the invention, the sachet composition has an average particle size of from 1 to 1200 micrometers, such as from 10 to 500 micrometers.

In one embodiment of the invention, the sachet composition has an average particle size of less than 1200 micrometers.

In one embodiment of the invention, the sachet composition has an average particle size greater than 1 micrometer, such as greater than 10 micrometers, such as greater than 50 micrometers.

In one embodiment of the invention, all ingredients are sifted through a sieve having a size of 1400 micrometers.

In one embodiment of the invention, all ingredients are sifted through a sieve having a size of 800 micrometers.

In a preferred embodiment of the invention, at least 50% by weight of the sachet composition is provided in particles having a size greater than 10 micrometers, such as from 10 to 500 micrometers.

A nicotine release profile can be achieved that includes both a rapid release period and a sustained release period.

In one embodiment, the rapid release period refers to the initial 120 seconds of the nicotine release profile, while the sustained release period may refer to a subsequent period of the release profile until the end of the experiment or until the end of use, such as a period from 2 minutes to 30 minutes after the start of use.

In an advantageous embodiment of the invention, the pouch composition is adapted to release at least 15% by weight of nicotine in free base form over a period of 120 seconds in contact with oral saliva, such as at least 20% by weight of nicotine in free base form, such as at least 30% by weight of nicotine in free base form, such as at least 40% by weight of nicotine in free base form, when provided in a pouch and the release is measured as described in Example 3K.

In an advantageous embodiment of the invention, the pouch composition is designed to release at least 50% by weight of nicotine in free base form over a period of 120 seconds in contact with oral saliva when provided in the pouch. Preferably, the release is measured as described in Example 3K.

In one embodiment of the invention, the pouch composition is adapted to release at least 15% by weight of free base nicotine over a period of 120 seconds, such as at least 20% by weight of free base nicotine, such as at least 30% by weight of free base nicotine, when provided in a pouch and subjected to the in vitro release experiment described in Example 3L.

In an advantageous embodiment of the invention, the pouch composition is adapted to release at least 30% by weight of nicotine in free base form over a period of 10 minutes upon contact with saliva in the oral cavity, such as at least 40% by weight of nicotine in free base form, such as at least 50% by weight of nicotine in free base form, such as at least 60% by weight of nicotine in free base form, when provided in a pouch and the release is measured as described in Example 3K.

In one embodiment of the invention, the pouch composition is adapted to release at least 30% by weight of free base nicotine over a period of 10 minutes, such as at least 40% by weight of free base nicotine, such as at least 50% by weight of free base nicotine, such as at least 60% by weight of free base nicotine, when provided in a pouch and subjected to the in vitro release experiment described in Example 3L.

The release rate describes the average release of nicotine per minute over a given period.

In one embodiment of the invention, the pouch composition provided in the pouch into the oral cavity has a nicotine release rate of at least 0.2% per minute over a release period of 2 to 10 minutes, such as at least 0.3% per minute over a release period of 2 to 10 minutes, such as at least 0.4% per minute over a release period of 2 to 10 minutes, such as at least 0.5% per minute over a release period of 2 to 10 minutes.

In one embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.2% per minute over a release period of 2 to 60 minutes, such as at least 0.3% per minute over a release period of 2 to 60 minutes, such as at least 0.4% per minute over a release period of 2 to 60 minutes, such as at least 0.5% per minute over a release period of 2 to 60 minutes.

In one embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.2% per minute over a release period of 2 to 30 minutes, such as at least 0.3% per minute over a release period of 2 to 30 minutes, such as at least 0.4% per minute over a release period of 2 to 30 minutes, such as at least 0.5% per minute over a release period of 2 to 30 minutes.

In an advantageous embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.2% per minute over a release period of 2 to 10 minutes, such as at least 0.3% per minute over a release period of 2 to 10 minutes, such as at least 0.4% per minute over a release period of 2 to 10 minutes, such as at least 0.5% per minute over a release period of 2 to 10 minutes.

In one embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.1 mg per minute over a release period of 2 to 60 minutes, such as at least 0.2 mg per minute over a release period of 2 to 60 minutes.

In one embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.4 mg per minute over a release period of 2 to 10 minutes.

In an advantageous embodiment of the invention, the pouch composition additionally contains nicotine as a nicotine salt and/or as a complex with an ion exchange resin, such as polacrilex resin.

In an advantageous embodiment of the invention, the composition of the sachet additionally contains nicotine as a nicotine salt.

In one embodiment of the invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, nicotine chloride (e.g., nicotine hydrochloride and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine gensitate, nicotine lactate, nicotine mucate, nicotine laurate, nicotine levulinate, nicotine malate, nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine zinc chloride, nicotine sulfate, nicotine tosylate and hydrates thereof (e.g., nicotine zinc chloride monohydrate).

In one embodiment of the invention, the nicotine salt comprises or consists of nicotine bitartrate.

In an advantageous embodiment of the invention, the pouch composition further comprises nicotine as a complex with an ion exchange resin, such as polacrilex resin.

An advantage of the embodiment described above may be that a desired nicotine release profile can be achieved having both a relatively rapid release nicotine release component due to the free base nicotine and a delayed release component due to the nicotine-ion exchange resin complex.

In one embodiment of the invention, the pouch composition comprises nicotine in free base form mixed with an ion exchange resin, in combination with nicotine as a complex with an ion exchange resin, such as polacrilex resin.

In one embodiment of the invention, the pouch composition comprises nicotine in free base form mixed with a water-soluble composition such as a sugar alcohol or a water-soluble fiber, in combination with nicotine as a complex with an ion exchange resin such as polacrilex resin.

In one embodiment of the invention, the polacrilex resin is Amberlite®IRP64.

In a preferred embodiment of the invention, the composition of the sachet additionally contains a preservative.

A preservative can help prevent unwanted growth of microorganisms in the sachet composition.

In a preferred embodiment of the invention, the sachet composition further comprises a preservative in an amount of from 0.05 to 0.5% by weight of the sachet composition, such as from 0.1 to 0.2% by weight of the sachet composition.

Non-limiting examples of suitable preservatives within the scope of the invention include sorbic acid (E200) and its salts (e.g. sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and its salts (e.g. sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213)).

In a preferred embodiment of the invention, the sachet composition contains less than 0.1% by weight of preservatives, such as less than 0.05% by weight of preservatives.

Thus, the pouch composition may contain preservatives in an amount of 0 to 0.1% by weight of preservatives, such as an amount of 0 to 0.05% by weight of preservatives. This includes zero preservatives, i.e. the pouch composition is free of preservatives. A low amount or even no preservative may be achieved by providing a relatively alkaline environment, in particular by using nicotine in the form of a free base.

In a preferred embodiment of the invention, the composition of the sachet is free of preservatives.

Low or even no preservative can be achieved by providing a relatively alkaline environment, particularly by using nicotine in its free base form.

In one embodiment of the invention, the sachet composition comprises an antioxidant.

An advantage of the embodiment described above may be that nicotine may have a lower degree of degradation.

In one embodiment of the invention, the antioxidant is selected from butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherol, and combinations thereof. Other antioxidants may also be used.

In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.2% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1.0% by weight of the pouch composition.

In a preferred embodiment of the invention, the pouch composition contains nicotine in an amount of no more than 20% by weight of the pouch composition, such as no more than 10% by weight of the pouch composition, such as no more than 5% by weight of the pouch composition.

In one embodiment of the invention, the pouch composition comprises nicotine in an amount of from 0.1 to 20% by weight of the pouch composition, such as in an amount of from 0.2 to 20% by weight of the pouch composition, such as in an amount of from 0.5 to 10% by weight of the pouch composition.

In a preferred embodiment of the invention, the pouch composition contains nicotine in an amount corresponding to from 0.5 to 20 mg per pouch, such as from 1.0 to 20 mg per pouch, such as from 5.0 to 15 mg per pouch.

In an advantageous embodiment of the invention, the sachet composition further comprises a release-controlling composition.

In an advantageous embodiment of the invention, said release-controlling composition is selected from the list consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, silicon dioxide, talc, magnesium stearate, calcium stearate, colloidal silicon dioxide, powdered hydrogenated cottonseed oil, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides and mixtures thereof.

In one embodiment of the invention, the sachet composition is free of triglycerides.

In a preferred embodiment of the invention, the release-controlling composition is hydrophobic.

In an advantageous embodiment of the invention, said release-controlling composition comprises one or more metal stearates, such as magnesium stearate and/or calcium stearate.

In one embodiment of the invention, said controlled release composition comprises magnesium stearate.

In one embodiment of the invention, said controlled release composition comprises calcium stearate.

In a preferred embodiment of the invention, the sachet composition comprises said release-controlling composition in an amount of from 1 to 20 percent by weight of said sachet composition.

In one embodiment of the invention, the controlled release composition comprises or is a solubilizer, such as a solubilizer selected from the list of monoglycerides, diglycerides, polysorbate (e.g., Tween XX), sucrose ester, and combinations thereof.

Anionic, cationic, amphoteric or nonionic solubilizers can be used. Suitable solubilizers include lecithins, polyoxyethylene stearate, polyoxyethylene sorbitan fatty acid esters, fatty acid salts, mono- and diacetyl tartaric acid esters of mono- and diglycerides of edible fatty acids, citric acid esters of mono- and diglycerides of edible fatty acids, sucrose esters of fatty acids, polyglycerol esters of fatty acids, polyglycerol esters of transesterified castor oil acid (E476), sodium stearoyl lactylate, sodium lauryl sulfate and sorbitan esters of fatty acids and polyoxyethylated hydrogenated castor oil (e.g. the product sold under the trade name CREMOPHOR), block copolymers of ethylene oxide and propylene oxide (e.g. the products sold under the trade names PLURONIC and POLOXAMER), polyoxyethylene ethers fatty alcohols, polyoxyethylene sorbitan fatty acid esters, sorbitan fatty acid esters and polyoxyethylene stearic acid esters.

Particularly suitable solubilizers are polyoxyethylene stearates, such as, for example, polyoxyethylene (8) stearate and polyoxyethylene (40) stearate, polyoxyethylene sorbitan esters of fatty acids sold under the trade name TWEEN, such as TWEEN 20 (monolaurate), TWEEN 80 (monooleate), TWEEN 40 (monopalmitate), TWEEN 60 (monostearate) or TWEEN 65 (tristearate), esters of mono- and diacetyl tartaric acid and mono- and diglycerides of edible fatty acids, citric acid esters of mono- and diglycerides of edible fatty acids, sodium stearoyl lactylate, sodium lauryl sulfate, polyoxyethylene hydrogenated castor oil, block copolymers of ethylene oxide and propylene oxide with a fatty alcohol ether. and polyoxyethylene. The solubilizer may be either a single compound or a combination of several compounds. The term "solubilizer" is used in this text to describe both possibilities; the solubilizer used must be suitable for use in food and/or medicine.

In an advantageous embodiment of the invention, the composition of the sachet is free of tobacco, tobacco fibres and fibres originating from tobacco.

In some alternative embodiments, the pouch composition may contain small amounts of tobacco. Any nicotine provided as part of the tobacco, such as powdered tobacco, is in addition to the free base nicotine. Such tobacco may be included, for example, to provide tobacco flavor.

In one embodiment, the pouch composition may comprise tobacco, tobacco fibers, or fibers derived from tobacco in an amount of 0.1 to 5.0% by weight of the pouch composition, such as in an amount of 0.1 to 3.0% by weight of the pouch composition. Thus, while in some embodiments the pouch composition may comprise small amounts of tobacco, this is in addition to the free base nicotine, and thus the pouch composition is not tobacco based.

In one embodiment of the invention, the pouch composition comprises less than 5.0% by weight of tobacco, such as less than 3.0% by weight of the pouch composition, such as less than 1.0% by weight of the pouch composition, such as less than 0.5% by weight of the pouch composition, such as less than 0.1% by weight of the pouch composition, such as being free of tobacco.

In an advantageous embodiment of the invention, the water-insoluble composition does not contain tobacco, tobacco fibers, or fibers originating from tobacco. Thus, in this embodiment, the water-insoluble fibers are non-tobacco fibers, i.e., do not contain tobacco, tobacco fibers, or fibers originating from tobacco.

In an advantageous embodiment of the invention, the sachet composition is free of microcrystalline cellulose (MCC), such as free of cellulose.

In one embodiment of the invention, the sachet composition comprises cellulose and is free of microcrystalline cellulose (MCC).

In an advantageous embodiment of the invention, said composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, and wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, and wherein said composition further comprises water-insoluble fibre in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, and wherein the water-insoluble composition comprises or consists of water-insoluble fiber, such as wheat fiber, oat fiber, pea fiber, powdered cellulose or combinations thereof.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said composition further comprises a water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, wherein the water-insoluble composition comprises or consists of a water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose or a combination thereof, and wherein the sachet composition comprises a flavor additive in an amount of 0.01 to 15% by weight of the composition of the sachet, such as from 0.1 to 15% by weight of the composition of the sachet, such as from 1 to 10% by weight of the composition of the sachet, such as from 3 to 10% by weight of the composition of the sachet.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said composition further comprises a water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, wherein the water-insoluble composition comprises or consists of a water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose or a combination thereof, and wherein the sachet composition comprises a flavor additive in an amount of 0.01 to 15% by weight of the sachet composition, such as from 0.1 to 15% by weight of the sachet composition, such as from 1 to 10% by weight of the sachet composition, such as from 3 to 10% by weight of the sachet composition, and wherein the flavoring agent has an oil base.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said composition further comprises water-insoluble fibre in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, and wherein the sachet composition comprises a pH-regulating agent selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, and wherein the sachet composition comprises a pH-regulating agent, which is a basic pH-regulating agent, such as a basic buffering agent and/or such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate or any combination thereof.

Furthermore, the invention relates to an oral product in the form of a nicotine sachet, comprising a sachet and a certain amount of the nicotine sachet composition according to the invention or any of its embodiments, enclosed in said sachet.

In a preferred embodiment of the invention, said sachet product comprises said sachet composition in an amount of from 50 to 1000 mg, such as from 100 to 700 mg, such as from 300 to 600 mg.

In a preferred embodiment of the invention, said sachet product contains nicotine in an amount of from 0.5 to 20 mg, such as from 1.0 to 20 mg, such as from 5.0 to 15 mg.

In an advantageous embodiment of the invention, the sachet comprises a water-permeable membrane comprising, for example, a woven or non-woven material.

Typically, the sachet membrane comprises openings, where the characteristic size of the opening is adapted to the characteristic size of the sachet composition to retain the sachet composition within the sachet prior to use and/or to retain a portion of the sachet composition, such as a water-insoluble composition, within the sachet during use.

In order to obtain a sachet membrane having suitable aperture sizes taking into account the sachet composition used, the material of the sachet membrane can be selected accordingly, including, for example, a woven and/or non-woven material.

In other words, according to various embodiments, the membrane of the pouch allows the passage of saliva and prevents or inhibits the passage of undissolved composition and water-insoluble fibers. The membrane of the pouch can be of any suitable material, such as a woven or non-woven material (e.g. cotton, fleece, etc.), a heat-sealable non-woven cellulose such as long-fiber paper, or other polymeric materials such as synthetic, semi-synthetic or natural polymeric materials. An example of a suitable material for the membrane of the pouch is paper made from pulp and a small amount of a moisture-resistant agent. The material suitable for use should provide a semi-permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. Suitable materials are also materials that do not have a significant effect on the release of nicotine from the pouch.

In more detail with respect to the material, the sachet membrane may be a natural, synthetic, semi-synthetic hydrophilic or hydrophobic membrane. It may be made of one or more biocompatible and physiologically acceptable polymeric materials. Examples of suitable materials for the sachet membrane are cellulose acetate and their derivatives, carboxymethyl cellulose, polycellulose ester, other cellulose derivatives including ethyl cellulose, propyl cellulose, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinyl acetate, methacrylate and acrylates polymers, natural rubber, polycarbonate, polyethylene terephthalate, polyester, polyamide and nylon. Other suitable materials are mentioned in the present description above.

It is also possible to use rayon fibres (i.e. regenerated cellulose), such as viscose rayon fibres, for example in combination with an acrylic polymer, which acts as a binder component in the non-woven material and ensures the heat-sealing of the bag membrane during its production. Other binders, such as one or more copolymers of vinyl acetate ester and acrylic acid, can be used.

Suitable sachet membranes are available under the trade names "taboka", CatchDry, Ettan, General, Granit, Goteborgs Rape, GrovSnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf, TreAnkrare, Camel Snus Original, Camel Snus Frost and Camel Snus Spice. The sachet membrane provides a liquid-permeable container of a type that may be considered similar in nature to the honeycomb type material used to make tea bags. The components of the nicotine composition whose release is desired diffuse through the sachet membrane into the oral cavity of the consumer.

The pouch membrane materials may be in the form of a mesh, a sieve, a perforated paper, a perforated fabric, and the like. For example, a pouch material made of honeycomb rice paper or perforated rice paper may dissolve in the consumer's mouth. In some exemplary embodiments, the pouch membrane materials may be made using water-dispersible film-forming materials (e.g., binders such as alginates, carboxymethyl cellulose, xanthan gum, pullulan, and the like), as well as these materials in combination with materials such as ground cellulosic materials (e.g., finely divided wood pulp). Preferred pouch materials, although water-dispersible or soluble, may be designed and manufactured such that, under conditions of normal use, a significant amount of the nicotinine content passes through the pouch material before the physical integrity of the pouch is lost. If desired, flavoring ingredients, disintegrating agents and other desired components may be included in or applied to the sachet material.

Examples of different types of sachet membrane materials are given in US Patent No. 5,167,244 issued to Kjerstad. Fleece materials for use as sachet membranes are described, for example, in WO 2008/152469, GB 673587 and EP 2692254.

In one embodiment of the invention, the membrane comprises a water-insoluble fiber of a different origin than the water-insoluble fiber contained in the pouch product.

In one embodiment of the invention, both the water-insoluble membrane fiber and the water-insoluble fiber of the sachet composition comprise natural fiber.

In one embodiment of the invention, both the water-insoluble membrane fibers and the water-insoluble sachet composition fibers are natural fibers.

In an advantageous embodiment of the invention, the sachet product comprises said sachet in an amount of up to 20 percent by weight of said sachet product, for example in an amount of up to 15 percent by weight of said sachet product.

In a preferred embodiment of the invention, the sachet product comprises said sachet in an amount of 3-20 percent by weight of said sachet product, for example, in an amount of 5-15 percent by weight of said sachet product.

In an advantageous embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin in a weight ratio of free base nicotine to ion exchange resin of 0.1 to 2.0, wherein the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble plant fiber, such as wheat fiber, oat fiber, pea fiber, rice fiber, corn fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, cellulose fiber, bamboo fiber, powdered cellulose, bran fiber, or combinations thereof, wherein the pouch composition comprises a sugar alcohol in an amount of 1-80% by weight of the pouch composition, and the pouch composition comprises a pH-regulating agent in an amount of 0.01 to 15%. by the weight of the composition of the bag.

The invention further relates to a method for producing an oral product in the form of a nicotine sachet according to the invention or any of its embodiments, the method comprising the steps

- providing a nicotine pouch composition according to the invention or any of its embodiments,

- providing a bag,

- adding the composition of the sachet to the specified sachet, and

- sealing the bag.

DETAILED DESCRIPTION

As used herein, the term "nicotine pouch composition" refers to a composition for use in an oral nicotine pouch, i.e., in pouches for oral use containing nicotine. Also, the terms "nicotine pouch composition" and "pouch composition" are used interchangeably.

As used herein, the term "free base nicotine" refers to the unprotonated form of nicotine, and thus does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin. However, free base nicotine may be mixed with some amount of an ion exchange resin or water soluble compositions such as sugar alcohols or water soluble fibers. While free base nicotine includes both free base nicotine extracted from tobacco and synthetically produced free base nicotine, free base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free base nicotine is provided as a liquid.

As used herein, the term "sachet" is a container, typically formed by a web of fibrous material, defining a cavity. The sachet is a pouch intended for introducing an active ingredient into the oral cavity and is thus adapted for oral use, it is non-toxic and insoluble in water. The fibrous material may form, for example, a woven or non-woven web or sheet. The sachet may be sealed, for example, by gluing two corresponding pieces of the web or sheet together along their edges to form a cavity for nicotine and a water-insoluble composition. For the release of nicotine, the sachet is made so that it is permeable to water to allow saliva from the oral cavity to pass through the sachet and penetrate into the cavity, where the saliva can come into contact with nicotine, whereby the nicotine is released from the oral sachet.

As used herein, the term "powder composition" refers to a composition in powder form, i.e., as a particulate material having a relatively small particle size, such as 1 to 1200 micrometers. In particular, a powder composition does not include powdered tobacco.

As used herein, the term "humectant" refers to a humectant used to attract moisture or water in the form of saliva. Humectants typically may suitably include hygroscopic compositions. In some cases, humectants may also be described as humectants due to their role in attracting moisture. Examples of humectants include glycerin, propylene glycol, alginate, triacetin, modified starch, hydroxypropyl cellulose, pectin, xanthan gum, etc.

As used herein, the term "water-soluble" refers to a relatively high solubility in water, such as a solubility in water of greater than 5 grams of a water-soluble composition or substance per 100 ml of water, measured at 25 degrees Celsius and a pH of 7.0. When referring to a composition or substance as "soluble," it is meant to be soluble in water unless otherwise indicated.

As used herein, the term "water-insoluble" refers to a relatively low solubility in water, such as a water solubility of less than 0.1 grams of a water-soluble composition or substance per 100 ml of water, measured at 25 degrees Celsius and pH 7.0. Whenever reference is made to "insoluble," it is meant to be insoluble in water unless otherwise specified.

As used in the context of the invention, the term "flavoring agent" is understood to have its usual meaning in the art. Flavoring agent includes liquid and powdered flavoring agents. Thus, flavoring agents certainly do not include sweeteners (such as sugar, sugar alcohols and high-intensity sweeteners) or acids that provide exclusively acidity/sour taste, as well as compounds that provide exclusively salty taste (e.g. NaCl) or exclusively bitter taste. Flavor enhancers include substances that provide only salty taste, bitter taste or sour taste. Thus, flavor enhancers include, for example, NaCl, citric acid, ammonium chloride, etc.

The pouches according to the invention provide for the release of nicotine into the oral cavity. A nicotine release profile can be achieved that includes both a rapid release period and a sustained release period.

As used herein, the term "rapid release" or "rapid release period" may refer to the initial 2 minutes of the nicotine release profile, while the term "sustained release period" refers to the subsequent period of the release profile until the end of the experiment or end of use.

As used herein, "release rate" describes the average release of nicotine per minute during a given period, for example, if a pouch releases an additional 16% of the nicotine dose during a period of 2 minutes to 10 minutes, the release rate is 2% per minute during that given period. Alternatively, if a pouch releases an additional 2 mg of nicotine during a period of 2 minutes to 10 minutes, the release rate is 0.25 mg per minute during that given period. The release rate is determined only from the data for the extreme times of that time period.

Typically, the sachets contain openings, wherein the characteristic size of the opening is adapted to the characteristic size of the matrix composition, in order to retain the matrix composition within the sachet prior to use and/or to retain a portion of the matrix composition, such as a water-insoluble composition, within the sachet during use.

In order to obtain a sachet having suitable aperture sizes taking into account the matrix composition used, the material of the sachet can be selected accordingly, for example including, for example, a woven and/or non-woven material.

In other words, according to various embodiments, the pouch forms a membrane that allows the passage of saliva and prevents or inhibits the passage of said matrix composition. The membrane of the pouch can be of any suitable material, such as a woven or non-woven material (e.g. cotton, fleece, etc.), heat-sealed non-woven cellulose or other polymeric materials, such as a synthetic, semi-synthetic or natural polymeric material. An example of a suitable pouch material is paper made of pulp and a small amount of a moisture-resistant agent. The material suitable for use should provide a semi-permeable membrane layer to prevent the powder or composition from escaping from the pouch or sachet during use. Suitable materials are materials that do not significantly affect the release of nicotine from the pouch.

The pouch composition is filled into the pouches and retained in the pouch by sealing. The ideal pouch is chemically and physically stable, it is pharmaceutically acceptable, it is insoluble in water, it is easy to fill with powder and seal, and it provides a semipermeable membrane layer that prevents the powder from leaving the pouch but allows saliva and dissolved or sufficiently small suspended components of the pouch composition in the pouch, such as nicotine, to pass through said pouch.

The pouch can be placed in the mouth by the consumer. Saliva then penetrates the pouch and the nicotine and other components that are soluble in saliva begin to dissolve and are transported with saliva from the pouch into the mouth where the nicotine can be absorbed.

According to one embodiment of the invention, the sachet composition may further comprise one or more enhancers.

In one embodiment of the invention, said enhancers are selected from the group consisting of bile salts, cetomacrogols, chelating agents, citrates, cyclodextrins, detergents, enamine derivatives, fatty acids, labrasol, lecithins, phospholipids, synthetic and natural surfactants, nonionic surfactants, cell wall disrupting compounds, solvents, steroid detergents, chelators, solubilizing agents, charge modifying agents, pH adjusting agents, degradative enzyme inhibitors, mucolytic or mucus removing agents, membrane penetration enhancing agents, epithelial junction physiology modulating agents, vasodilators, selective transport enhancing agents, or any combination thereof. pH adjusting agents include buffers.

In one embodiment of the invention, said enhancers are selected from the group consisting of cetylpyridinium chloride (CPC), benzalkonium chloride, sodium lauryl sulfate, polysorbate 80, polysorbate 20, cetyltrimethylammonium bromide, laureth 9, sodium salicylate, sodium EDTA, EDTA, aprotinin, sodium taurocholate, saponins, bile salt derivatives, fatty acids, sucrose esters, azone emulsion, dextran sulfate, linoleic acid, labrafil, transacutol, urea, azone, nonionic surfactants, sulfoxides, sauric acid/PG, POE 23 lauryl ether, methoxysalicylate, dextran sulfate, methanol, ethanol, sodium cholate, taurocholate sodium, lysophosphatidylcholine, alkyl glycosides, polysorbates, sorbitan esters, poloxamer block copolymers, PEG-35 castor oil, PEG-40 hydrogenated castor oil, caprocaproyl macrogol-8 glycerides, PEG-8 caprylic/capric glycerides, dioctyl sulfosuccinate, polyethylene lauryl ether, ethoxydiglycol, propylene glycol, mono-di-caprylate, glyceryl monocaprylate, glyceryl fatty acids (C ₈ -C ₁₈ ), ethoxylated oleic acid, linoleic acid, glyceryl caprylate/caprate, glyceryl monooleate, glyceryl monolaurate, caprylic/capric triglycerides, ethoxylated nonylphenols, PEG-(8-50) stearates, olive oil esters of PEG-6, triolein esters of PEG-6, lecithin, d-alpha-tocopherol polyethyleneglycol 1000 succinate, citric acid, sodium citrate, BRIJ, sodium laurate, 5-methoxysalicylic acid, bile salts, acetylsalicylate, ZOT, docosahexaenoic acid, alkyl glycosides, sodium glycocholate (GC-Na), sodium taurocholate (TC-Na), EDTA, choline salicylate, sodium caprate (Cap-Na), N-lauryl beta-D-maltopyranoside (LM), diethyl maleate, labrasol, sodium salicylate, menthol, alkali metal alkyl sulfate, sodium lauryl sulfate, glycerin, bile acid, lecithin, Phosphatidylcholine, Phosphatidylserine, Sphingomyelin, Phosphatidylethanolamine, Cephalin, Lysolecithin, Hyaluronic Acid: Salts of Alkali Metals, Sodium, Alkaline Earth Metals and Aluminum, Octylphenoxypolyethoxyethanol, Glycolic Acid, Lactic Acid, Chamomile Extract, Cucumber Extract, Borage Oil, Evening Primrose Oil, Polyglycerin, Lysine, Polylysine, Triolein, Monoolein, Monooleates, Monolaurates, Alkyl Esters of Polidocanol, Chenodeoxycholate, Deoxycholate, Glycocholic Acid, Taurocholic Acid, Glycodeoxycholic Acid, Taurodeoxycholic Acid, Sodium Glycocholate, Phosphatidylcholine, Phosphatidylserine, Sphingomyelin, Phosphatidylethanolamine, Cephalin, Lysolecithin, Hyaluronates alkali metals, chitosan, poly-L-arginine, alkyl glucoside, alkyl ester of saccharide, fusidic acid derivatives, sodium taurodihydrofusidate (STDHF), didecanoyl L-α-phosphatidylcholine (DDPC), nitroglycerin, nitroprusside, NOC5 [3-(2-hydroxy-1-(methylethyl)-2-nitrosohydrazino)-1-propanamine], NOC12 [IV-ethyl-2-(1-ethylhydroxy-2-nitrosohydrazino)ethanamine, SNAP [S-nitroso-N-acetyl-DL-penicillamine], NORI, NOR4, deacyl methyl sulfoxide, azone, salicylamide, glyceryl 1,3-diacetoacetate, 1,2-isopropylideneglycerol-3-acetoacetate, amino acids, amino acid salts, monoaminocarboxylic acids, glycine, alanine, phenylalanine, proline, hydroxyproline, hydroxyamino acids, serine, acidic amino acids, aspartic acid, glutamic acid, basic amino acids, lysine, N-acetylamino acids, N-acetylalanine, N-acetylphenylalanine, TM-acetylserine, N-acetylglycine, N-acetyllysine, N-acetylglutamic acid, N-acetylproline, N-acetylhydroxyproline, lactic acid, malic acid and citric acid and their alkali metal salts, pyrrolidonecarboxylic acids, alkylpyrrolidonecarboxylic acid esters, N-alkylpyrrolidones, acyl esters of proline, sodium lauryl phosphate, sodium lauryl sulfate, sodium oleyl phosphate, sodium myristyl sulfate, polyoxyethylene alkyl ethers, polyoxyethylene alkyl esters and caproic acid, alkyl saccharide, fusidic acid, polyethylene glycol, cetyl alcohol, polyvinylpyrrolidone, polyvinyl alcohol, lanolin alcohol, sorbitan monooleate, ethylene glycol tetraacetic acid, bile acid conjugate with taurine, cholanic acid and salts, cyclodextran, cyclodextrin, cyclodextrin (beta), hydroxypropyl-β-cyclodextran, sulfobutyl ether-β-cyclodextran, methyl-β-cyclodextrin, chitosan glutamate, chitosan acetate, chitosan hydrochloride, chitosan hydrolactate, 1-O-alkyl-2-hydroxy-sn-glycero-3-phosphocholine, 3-O-alkyl-2-acetoyl-sn-glycero-1-phosphocholine, 1-O-alkyl-2-O-acetyl-sn-glycero-3-phospho(N,N,N-trimethyl)hexanolamine, propylene glycol, tetradecyl maltoside (TDM), sucrose dedecanoate.

According to one embodiment of the invention, the enhancer comprises one or more pH-adjusting agents, such as a buffering agent.

In one embodiment of the invention, said pH-regulating agents are selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

According to various embodiments of the invention, one or more sugar alcohols may be included in the sachet as part of the composition of the sachet, such as as a carrier or part thereof, as a humectant, or as a sweetener. Suitable sugar alcohols include sugar alcohols selected from the group of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof.

In one embodiment of the invention, the sachet composition comprises a high intensity sweetener.

Preferred high intensity sweeteners include, but are not limited to, sucrose, aspartame, acesulfame salts such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside, and the like, alone or in combination.

In one embodiment of the invention, the sachet composition comprises bulk sweeteners including sugar and/or sugar-free components.

In one embodiment of the invention, the composition of the sachet comprises a bulk sweetener in an amount of from 1.0 to about 80% by weight of the composition of the sachet, more particularly in an amount of from 5 to about 70% by weight of the composition of the sachet, and more often from 10 to 60% by weight of the composition of the sachet or 10-50% by weight of the composition of the sachet. Bulk sweeteners can serve as both a sweetener and a humectant. In some embodiments, the inclusion of certain ingredients can further limit the amounts of bulk sweetener.

Sweeteners can often contribute to the flavor profile of a sachet composition.

Sugar sweeteners generally include, but are not limited to, saccharide-containing components well known in the sachet art, such as sucrose, dextrose, maltose, beet sugar, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination. These sugar sweeteners may also be included as wetting agents.

The sweetener may be used in combination with sugar-free sweeteners. Sugar-free sweeteners typically include components with sweetening characteristics but which are devoid of commonly known sugars and include, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt, erythritol, lactitol, etc., alone or in combination. These sugar-free sweeteners may also be included as humectants.

In one embodiment of the invention, the composition of the sachet comprises a flavor additive. The flavor additive may typically be present in amounts of from 0.01 to 15% by weight of the total composition of the sachet, such as from 0.01 to 5% by weight of the total composition.

Non-exhaustive examples of flavor additives useful in embodiments of the present invention are coconut, coffee, chocolate, vanilla, grapefruit, orange, lime, menthol, licorice, caramel flavor, honey flavor, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus and mint, fruit essence such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple and plum. Essential oils include peppermint oil, spearmint oil, menthol, eucalyptus oil, clove oil, bay oil, anise oil, thyme oil, cedar leaf oil, nutmeg oil and oils from the fruits mentioned above.

In various embodiments of the invention, the pouch composition comprises a release-controlling composition for controlling the release of the pouch composition and/or portions thereof, especially nicotine.

The release-controlling composition may be selected, according to various embodiments, from the group consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, silicon dioxide, talc, magnesium stearates, calcium stearates, colloidal silicon dioxide, hydrogenated cottonseed oil powders, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides and mixtures thereof. In particular, metal stearates such as magnesium stearate may be advantageous.

The release controlling composition can be added to the sachet composition in a variety of ways.

For example, the release-controlling composition may be added via the complete powder blend during the last few minutes of final mixing.

Alternatively, the release controlling composition may be added after the granulation steps of the granulation premix.

In addition, the release-controlling composition may be added only as part of the pouch composition, so that two different nicotine release profiles are achieved. Moreover, two or more fractions of the matrix composition may contain different amounts of the release-controlling composition, if any, thereby providing a more complex and optimized nicotine release profile.

A release controlling composition such as magnesium stearate may have a sequestering effect and may be used to control the release of nicotine and the solubility of the pouch.

According to one embodiment of the invention, the composition of the sachet comprises polyvinylpyrrolidone (PVP). The composition of the sachet may also be free of PVP.

One advantage of the embodiment described above may be that a more homogeneous composition can be obtained.

EXAMPLES

Example 1A - Production of pouches intended for nicotine administration

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

The powder is filled into sachets and held in the sachet by sealing.

Example 1B - Production of pouches intended for nicotine administration

The material of the bags is made using rayon fibers such as viscose staple rayon fibers. The membrane of the bag is heat-sealed along its edges except for an opening at one end to form an internal cavity with the membrane of the bag.

The powder is filled into sachets and held in the sachet by sealing.

Example 2A - Nicotine Premix I - Resin

Water was added to the Stephan mixer (vacuum premix) and nicotine was weighed and added, the mixer was closed and mixed for 5 minutes. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed and mixed for 10-60 minutes.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 1 below.

Component Quantity (kg) Quantity (%) Nicotine 1.0 5.7 Water 12.5 71.4 Resin 4.0 22.9 Total 17.5 100,0

Table 1. Ingredients used to prepare Nicotine Premix I.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 71.4.

Example 2B - Nicotine Premix II - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 2 below.

Component Quantity (kg) Quantity (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100,0

Table 2. Ingredients used to prepare Nicotine Premix II.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 34.1

The total process time was 20 minutes.

Example 2C - Nicotine Premix III - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 3 below.

Component Quantity (kg) Quantity (%) Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100,0

Table 3. Ingredients used to prepare Nicotine Premix III.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 7.5

The total process time was 20 minutes.

Example 2D - Nicotine Premix IV - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 4 below.

Component Quantity (kg) Quantity (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100,0

Table 4. Ingredients used to prepare Nicotine Premix IV.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 50.0

The total process time was 20 minutes.

Example 2E - Nicotine Premix V - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4B below.

Component Quantity (kg) Quantity (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100,0

Table 4B. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1:2.43 (0.41)

% water in the resulting nicotine-resin composition: 31.5

The total process time was 20 minutes.

Example 2F - Nicotine Premix VI - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4C below.

Component Quantity (kg) Quantity (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100,0

Table 4C. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1:1.4 (0.71)

% water in the resulting nicotine-resin composition: 27.5.

The total process time was 20 minutes.

Example 2G - Nicotine Premix VII - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4A below.

Component Quantity (kg) Quantity (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100,0

Table 4D. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1.19:1 (1.19)

% water in the resulting nicotine-resin composition: 22.8

The total process time was 20 minutes.

Example 2H - Nicotine Premix VIII - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4A below.

Component Quantity (kg) Quantity (%) Nicotine 5.15 39.8 Water 2.80 21.6 Resin 4.32 33.4 Pea fiber 0.67 5.2 Total 12.94 100,0

Table 4E. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1.19:1 (1.19)

% water in the resulting nicotine-resin composition: 21.6

The total process time was 20 minutes.

Example 3A - Sachets

Comparative pouches containing nicotine polacrilex resin (NPR) or nicotine bitartrate (NBT) containing powder compositions were prepared as described in Table 5. The pouches were prepared as follows.

The fibres and water are mixed using a Bear Varimixer for 5 minutes. The following ingredients are then added sequentially while constantly mixing: first nicotine bitartrate xH2O (NBT, nicotine content 32.5%) or nicotine polacrilex resin (NPR, nicotine content 15.9%) as applicable (mixed for 2 minutes), then the remaining ingredients except liquid flavour and glidant, if any (mixed for 2 minutes), then liquid flavour, if any (mixed for 1 minute), then glidant, if any (mixed for 1 minute). Total mixing time is 9-11 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1A, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

You can also use the bag material from Example 1B.

The powder is filled into sachets and held in the sachet by sealing.

Sachets PPC1-PPC5 with nicotine premix containing powder compositions as indicated in Table 5 are obtained. The sachets are manufactured as follows.

The fibers and water are mixed using a Bear Varimixer for 5 minutes. The following ingredients are then added in sequence while constantly mixing: nicotine premix (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant, if any (mixed for 2 minutes), then liquid flavor, if any (mixed for 1 minute), then glidant, if any (mixed for 1 minute). Total mixing time is 9-11 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1A, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

You can also use the bag material from Example 1B.

The powder is filled into sachets and held in the sachet by sealing.

PPC Comparative NBT NPR Comparative PPC1 PPC2 PPC3 PPC4 PPC5 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 25 15 10 40 Source material Content in percent by weight NPR - 12.1 - - - - - NBT 5.9 - - - - - - Nicotine Premix II - - 14.6 14.6 14.6 14.6 14.6 Xylitol DC 15.0 8.8 11.3 16.3 26.3 31.3 1.3 Purified water 30 30 25 20 10 5 35 Wheat fiber 30 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 8.9 8.9 8.9 8.9 8.9 8.9 8.9 NaCl 0,1 0,1 0,1 0,1 0,1 0,1 0,1 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

Table 5. Nicotine Premix II (Example 2B) contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: 500 mg in total, i.e. nicotine concentration 19.2 mg/g.

The xylitol DC used is xylitol, for example under the trade name "Xylitab 200".

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bran fiber, bamboo fiber and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

Pouches PPC1-PPC3, PPC5 show that it is possible to manufacture various pouches having a water content of at least 15% by weight of the pouch composition using nicotine in free base form. Pouch PPC4 has a lower water content, which is outside the scope of the invention. Comparative pouches "comparative NBT" and "comparative NPR" have a similar water content to PPC1, but they use nicotine salt and nicotine in a complex with an ion exchange resin.

Example 3B - sachets

The PPC11-PPC15 pouches are manufactured in a manner similar to the PPC1-PPC5 pouches described in Example 3A. The PPC11-PPC15 pouches are obtained containing a nicotine premix comprising the compositions as indicated in Table 5. The pouches are manufactured as follows.

The fiber and powder ingredients (excluding glide) are mixed using a Bear Varimixer for 2 minutes. The nicotine premix is then added and mixed for 2 minutes. The water is then added and mixed for 5 minutes, followed by the liquid flavor (if present, mixed for 1 minute) and glide (if present, mixed for 1 minute). The total mixing time is 9-11 minutes.

PPC PPC11 PPC12 PPC13 PPC14 PPC15 Comparative 2 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 25 15 10 35 5 Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 14.6 14.6 14.6 Isomalt DC 11.3 22.3 44.3 55.3 0.3 60.3 Purified water 25 20 10 5 30 0 Wheat fiber 30 24 12 6 36 6 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

Table 6. Nicotine Premix II contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

The isomalt DC used is, for example, GalenIQ 720.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

Sachets PPC11-PPC13, PPC15 show different water content of at least 15% by weight of the sachet composition. The water content varies, but the ratio between the amount of added water and the amount of fibers remains constant.

PPC14 sachets have a water content that is not within the scope of the invention and are used for comparative purposes.

Example 3C - Sachets

PPC21-PPC25 sachets are manufactured in the same manner as PPC11-PPC15 sachets according to Example 3B.

PPC PPC21 PPC22 PPC23 PPC24 PPC25 PPC26 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix II 14.6 7.3 14.6 14.6 14.6 14.6 Liquid nicotine* - 1.0 - - - - Xylitol DC 11.3 15.1 16.3 13.3 11.4 9.4 Purified water 25 27.5 25 25 25 25 MCC (Avicel 102) 30 - - - - - Wheat fiber - 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 - 3.0 5.0 7.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 - - Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

Table 7. *Liquid nicotine is added as a premix to the nicotine-sugar alcohol in powder form. Nicotine premix II contains 34.1% by weight of water and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC21 sachet demonstrates the use of, for example, microcrystalline cellulose (MCC) instead of wheat fibre.

The PPC22 pouch features a combination of nicotine ion exchange resin premix and nicotine sugar alcohol premix.

Sachets PPC23-PPC26 demonstrate the use of different amounts of buffer (in this case sodium carbonate). For the high amounts of basic buffers, which provide a more alkaline environment, the need for preservative (in this case potassium sorbate) is less, so it is excluded from PPC25-PPC26, which have the highest amounts of alkaline buffers.

Example 3D - bags

Pouches PPC31-PPC32 are prepared similarly to pouches PPC1-PPC5 of Example 3A, but using nicotine premix I and III, respectively.

PPC31-PPC35 bags are manufactured as described below.

The nicotine and sugar alcohol (xylitol, sorbitol, maltitol or other) are weighed. The nicotine is slowly added to the sugar alcohol powder while stirring (Kitchenaid mixer running at approximately 30 rpm for approximately 30 minutes). The resulting granulate is sifted and placed on a tray. The resulting powder is dried at ambient temperature overnight and then sifted to form a nicotine-sugar alcohol premix. It is also possible to add some water to the nicotine before mixing with the sugar alcohol. Any such water is then evaporated during the drying process.

The fibers and water are mixed using a Bear Varimixer for 5 minutes. The following ingredients are then added sequentially while constantly mixing: powdered ingredients other than the nicotine premix (mixed for 2 minutes), nicotine-sugar alcohol premix (mixed for 2 minutes), then liquid flavor, if present (mixed for 1 minute), and finally glide, if present (mixed for 1 minute). Total mixing time is 9-11 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1A, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

You can also use the bag material from Example 1B.

The powder is filled into sachets and held in the sachet by sealing.

PPC PPC31 PPC32 PPC33 PPC34 PPC35 PPC36 PPC37 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix I 33.7 - - - - - - Nicotine Premix III - 10.4 - - - - - Liquid nicotine* - - 1.9 1.9 1.9 1.9 1.9 Isomalt DC 11.2 11.3 19.0 - - - - Sorbitol DC - - - 19.0 - - - Maltitol DC - - - - 19.0 - - Inulin - - - - - 19.0 - Polydextrose - - - - - - 19.0 Purified water 6 29.2 30 30 30 30 30 Wheat fiber 30 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

Table 8. *Liquid nicotine is added as a nicotine-sugar alcohol premix or as a nicotine-water-soluble fiber premix in powder form. Nicotine premix I contains 71.4% by weight of water and thus contributes to the total water content. Nicotine premix II contains 34.1% by weight of water and thus contributes to the total water content. Nicotine premix III contains 7.5% by weight of water and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC31-PPC32 pouches demonstrate the use of different nicotine pre-mixes.

PPC33-PPC35 pouches demonstrate the use of nicotine pre-mixed with various sugar alcohols.

PPC36-PPC37 pouches demonstrate the use of nicotine pre-mixed with various water-soluble fibres.

Example 3E - sachets

Sachets PPC41-PPC45 are obtained similarly to sachets PPC1-PPC5 according to Example 3A.

PPC PPC41 PPC42 PPC43 PPC44 PPC45 PPC46 Amount of nicotine 4.8 mg 7.2 mg 9.6 mg 12 mg 9.6 mg 9.6 mg Water content [wt.%] 27.5 28.3 30 31.2 30 30 Source material Content in percent by weight Nicotine Premix II 7.3 9.7 14.6 18.3 14.6 14.6 Xylitol DC 18.6 16.2 11.3 7.6 13.3 5 Erythritol - - - - - 6.3 Purified water 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 - 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 8.9 NaCl - - - - - 0,1 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

Table 9. Nicotine Premix II contains 34.1% water by weight and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC41-PPC44 pouches demonstrate the use of different nicotine doses from 4.8 mg to 12 mg.

The PPC45 sachet shows a sachet without alginate, otherwise comparable to the PPC43 sachet.

Example 3F - bags

PPC51-PPC53 sachets are obtained as follows.

The fiber and powder ingredients (excluding nicotine containing powders and glidants) are mixed for 1 minute using a Bear Varimixer. Then the NPR and NBT are added and mixed for 2 minutes (if needed). Then the nicotine premix is added and mixed for 2 minutes. Then the water is added and mixed for 5 minutes, followed by the liquid flavor (if present, mixed for 1 minute) and the glidant (if present, mixed for 1 minute). The total mixing time is 9-11 minutes.

PPC PPC51 PPC52 PPC53 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 Source material Content in percent by weight NPR - 6.0 3.0 NBT 2.9 - 1.5 Nicotine Premix II 7.3 7.3 7.3 Isomalt DC 15.2 12.1 13.6 Purified water 27.5 27.5 27.5 Wheat fiber 30 30 30 Sodium carbonate 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100

Table 10. Nicotine Premix II contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: total 500 mg

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC51 pouch demonstrates a pouch using a pre-mixed nicotine ion exchange resin in combination with nicotine bitartrate (NBT).

The PPC52 pouch demonstrates a pouch using a pre-blended nicotine ion exchange resin in combination with nicotine polacrilex resin (NPR).

The PPC53 pouch demonstrates a pouch using a pre-mixed nicotine ion exchange resin in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

Example 3G - Packets

PPC61-PPC65 nicotine premix pouches containing powder compositions as described in Table 11 are obtained. The pouches are manufactured as follows.

Fibers and powder ingredients (except glide agents) are mixed using a mixer for 2 minutes. Then add the nicotine premix and mix for 2 minutes. Then add water to the running mixer for 15 minutes, followed by liquid flavor (if any, mix for 15 minutes) and glidant (if any, mix for 1 minute). Total mixing time is 19-35 minutes.

PPC PPC61 PPC62 PPC63 PPC64 PPC65 PPC66 PPC67 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 Xylitol 5 18.3 18.3 18.3 5 5 5 Erythritol 13.5 - - - 13.5 13.5 13.5 Purified water 28 28 28 28 28 28 28 Wheat fiber 30 30 20 40 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 - - Glycerol - - - - - 2.0 - Hydroxypropyl cellulose - - - - - - 2.0 Sodium carbonate 5.0 3.0 3.0 3.0 3.0 3.0 3.0 Sodium bicarbonate - 2.0 2.0 2.0 2.0 2.0 2.0 Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

Table 11. Nicotine Premix VI contains 27.5% by weight water and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bamboo fiber, bran fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as wetting agents. Other wetting agents as described herein can also be used in combination with sodium alginate, glycerin, or HPC or as an alternative.

Sodium carbonate and sodium bicarbonate are used as the alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Acesulfame potassium and/or sucralose may be used as high intensity sweeteners. Other suitable high intensity sweeteners may be used in combination with or instead of acesulfame potassium and/or sucralose.

Sachets PPC61-PPC62 demonstrate the use of different combinations of sweetener and buffer.

PPC63-PPC64 sachets show sachets with different fibre content.

PPC65-PPC67 sachets demonstrate various wetting agents.

Example 3H - bags

PPC71-PPC76 nicotine premix pouches containing powder compositions as described in Table 12 are obtained. The pouches are manufactured as follows.

Fibers and powder ingredients (except glide agents) are mixed using a mixer for 2 minutes. Then add the nicotine premix and mix for 2 minutes. Then add water to the running mixer for 15 minutes, followed by liquid flavor (if any, mix for 15 minutes) and glidant (if any, mix for 1 minute). Total mixing time is 19-35 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material according to Example 1A, made of long-fiber paper, is used. The powder is filled into sachets and retained in the sachet by sealing. The sachet material according to Example 1B can also be used.

PPC PPC
71 PPC
72 PPC
73 PPC
74 PPC
75 PPC 76 PPC 77 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix IV 19.2 - - - - - Nicotine Premix V - 9.6 - - - - Nicotine Premix VI - - - - 6.4 6.4 6.4 Nicotine Premix VII - - 4.6 - - - Nicotine Premix VIII - - - 4.8 - - Purified water 21 27 29 29 28 28 28 Wheat fiber 30 30 30 29.75 - - - Oat fiber - - - - 30 - - Pea fiber - - - 0.25 - 30 - Powdered cellulose - - - - - - 30 Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 7.7 11.3 14.3 14.1 13.5 13.5 13.5 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

Table 12. Nicotine premixes contain water in varying amounts and thus contribute to the total water content.

Nicotine Premix VIII contains pea fiber.

Contents of the sachet: 500 mg in total, i.e. nicotine concentration 19.2 mg/g.

Wheat fiber, trade name "Vitacel 600 WF plus".

Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

Oat fiber, trade name "Vitacel HF 600".

Pea fiber, trade name "Vitacel EF150".

Other fibers may also be used, such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, powdered cellulose, bamboo fiber, bran fiber, and cellulose fiber.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as wetting agents. Other wetting agents as described herein can also be used in combination with sodium alginate, glycerin, or HPC or as an alternative.

Sodium carbonate and sodium bicarbonate are used as the alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners that may be used include, for example, acesulfame potassium and/or sucralose. Other suitable high intensity sweeteners may be used in combination with or instead of acesulfame potassium and/or sucralose.

Pouches PPC71-PPC74 demonstrate the use of different nicotine pre-mixes.

PPC75-PPC77 sachets demonstrate the use of various fibers.

Example 3I-I - bags

Nicotine premix pouches PPC81-PPC94 are obtained containing powder compositions as specified in Tables 13I and 13II. The pouches are manufactured as follows.

Fibers and powder ingredients (except glide agents) are mixed using a mixer for 2 minutes. Then add the nicotine premix and mix for 2 minutes. Then add water to the running mixer for 15 minutes, followed by liquid flavor (if any, mix for 15 minutes) and glidant (if any, mix for 1 minute). Total mixing time is 19-35 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material according to Example 1A, made of long-fiber paper, is used. The powder is filled into sachets and retained in the sachet by sealing. The sachet material according to Example 1B can also be used.

PPC PPC 81 PPC 82 PPC 83 PPC 84 PPC 85 PPC 86 PPC 87 PPC88 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 14.6 - - - Nicotine Premix VI - - - - 6.4 6.4 6.4 6.4 Purified water 25 25 25 25 28 28 28 28 Wheat fiber 30 - - - - - - 15 Oat fiber - 30 - - 15 - - - Pea fiber - - 30 - - 15 - - Powdered cellulose - - - 30 - - 15 - Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 8.3 8.3 8.3 8.3 28.5 28.5 28.5 28.5 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 100

Table 13 I/II.

PPC PPC 89 PPC 90 PPC 91 PPC 92 PPC 93 PPC 94 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 14.6 Nicotine Premix VI - - - - 6.4 6.4 Purified water 25 25 25 25 28 28 Wheat fiber 15 - - - 15 15 Oat fiber - 15 - - - - Pea fiber - - 15 - - - Powdered cellulose - - - 15 - - Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 23.3 23.3 23.3 23.3 28.5 20.5 Sodium alginate 2.0 2.0 2.0 2.0 NaCl - - - - - 10 Sodium carbonate 5.0 5.0 5.0 5.0 3.5 5.0 Sodium bicarbonate - - - - 3.5 - Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

Table 13 II/II

Nicotine premixes contain water in varying amounts and thus contribute to the overall water content.

Contents of the sachet: 500 mg in total, i.e. nicotine concentration 19.2 mg/g.

Wheat fiber, trade name "Vitacel 600 WF plus" or "Vitacel 200WF".

Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

Oat fiber, trade name "Vitacel HF 600".

Pea fiber, trade name "Vitacel EF150".

Other fibers may also be used, such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, powdered cellulose, cellulose fiber, apple fiber, coconut fiber, bamboo fiber, bran fiber and cellulose fiber.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as wetting agents. Other wetting agents as described herein can also be used in combination with sodium alginate, glycerin, or HPC or as an alternative.

Sodium carbonate and sodium bicarbonate are used as the alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners that may be used include, for example, acesulfame potassium and/or sucralose. Other suitable high intensity sweeteners may be used in combination with or instead of acesulfame potassium and/or sucralose.

Pouches PPC81-PPC92 demonstrate the use of different fibers in different quantities and with different nicotine pre-mixes.

Sachets PPC93-PPC94 demonstrate the use of a pair of buffers and a higher amount of salt, respectively.

Example 3I-II - Sachets

Nicotine premix pouches PPC111-PPC117 are prepared containing powder compositions as described in Table 13III. The pouches are manufactured as follows.

The powdered ingredients, including the powdered flavor (if any), are mixed using a Bear Varimixer for 2 minutes. The nicotine is then added and mixed for 2 minutes. Water is then slowly added to the running mixer, followed by the liquid flavor. Finally, the silicon dioxide is added and mixed for approximately 1 minute. The total mixing time is approximately 30 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

The powder is filled into sachets and held in the sachet by sealing.

PPC PPC
111 PPC
112 PPC
113 PPC
114 PPC
115 PPC
116 PPC
117 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 15 30 45 30 30 30 30 Density (grams per liter) 256 303 578 N.D. N.D. N.D. N.D. Hausner relation 1.25 1.22 1.11 N.D. N.D. N.D. N.D. Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 14.6 14.6 14.6 14.6 Sugar alcohol(s) 12.3 12.3 12.3 12.4 12.7 12.1 11.9 Purified water 10 25 40 25 25 25 25 Wheat fiber 45 30 15 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 4.0 4.0 4.0 4.0 4.0 4.0 4.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0.01 0.05 0.2 0.5 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

Table 13III. Nicotine premix II contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: total 500 mg, i.e. nicotine concentration 19.2 mg/g.

The sugar alcohol(s) may be xylitol, such as trade name "Xylitab 200", and/or isomalt, such as trade name "GalenIQ 720".

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as wetting agents. Other wetting agents as described herein can also be used in combination with sodium alginate, glycerin, or HPC or as an alternative.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as an alternative.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

Sachets PPC111-PPC113 show sachets having different water and water-insoluble fiber contents.

PPC114-117 show varying amounts of preservative.

Example 3J Determination of homogeneity of content

The content uniformity (CU) of a pouch sample was determined by analyzing 10 replicate sub-samples. Each sub-sample of approximately 500 mg was determined for nicotine content using standard HPLC methods. The nicotine content of the sub-sample was expressed as a percentage of the normal nicotine content of the sample (i.e., % declared content). For example, a pouch sample with a nominal nicotine content of 20 mg/g that was determined to have an actual content of 19 mg/g would have a nicotine content of 95% of the declared content.

The homogeneity of the content in the sample was then determined as the relative standard deviation (RSD) of the individual assay of the relative nicotine content in 10 replicates.

Example 3K - Release Test ( in vivo )

The release properties of the sachets were assessed by a panel of assessors, preferably at least 8 assessors. Each assessor was given a sachet to place in the oral cavity, in particular behind the upper lip.

The sachet was removed from the assessing individual's mouth after 2 min, 5 min, 10 min, 30 min, or 60 min.

The amount of nicotine remaining in the pouches was determined using standard HPLC methods.

For each time point, two pouches were tested. The average of the results obtained for each time point was used to obtain nicotine content profiles of the pouches over time.

The amount of nicotine released could then be obtained by subtracting the remaining amount of nicotine in the pouch from the initial dose of nicotine in the test pouch.

Example 3L - Release Test ( in vitro )

The release properties of the sachets were tested in an in vitro experiment.

Individual sachets were placed in reaction tubes approximately 2 cm in diameter containing 10 ml of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4) and heated to 37 degrees Celsius.

No stirring or shaking was used during the release experiment.

The pouches were removed from the buffer after 2 min, 5 min, 10 min, 30 min or 60 min. Excess buffer was removed and the amount of residual nicotine was determined using standard HPLC.

For each time point, two pouches were tested. The average of the results obtained for each time point was used to obtain nicotine content profiles of the pouches over time.

The amount of nicotine released can then be obtained by subtracting the residual amount of nicotine in the pouch from the original nicotine dosage in the pouch being tested.

Example 3M - Release Results

The sachets were subjected to the in vitro release experiment described in Example 3L.

PPC Fiber Residual nicotine in the pouch after 2 minutes Residual nicotine in the pouch after 10 min. Release rate over time: 2-10 min
(% per min) PPC82 Oatmeal (HF 600) 74.7% 67.9% 0.85 PPC81 Wheat (WF600) 80.0% 71.6% 1.05 PPC84 Cellulose L00 66.6% 62% 0.58 PPC83 Pea fiber 78% 62.0% 2.00 PPC81 Wheat (WF200) 85.2% 63.6% 2.70 PPC89 Wheat (WF 200) N.D. 64.5% N.D. PPC92 Cellulose L00 N.D. 64.6% N.D. PPC91 Pea fiber N.D. 64.5% N.D. PPC84 Cellulose L700G N.D. 47.3% N.D. PPC89 Wheat (WF 600) 79% 72% 0.88

Table 14: ND=not defined.

The release results show increased nicotine release after 10 min for pouches containing fibres with relatively high water binding capacity such as pea fibre, L700G cellulose and wheat fibre (WF200).

Example 3N - Release Results

The resulting sachets with sachet compositions similar to PPC46 but using the wetting agent described below were subjected to the in vitro release experiment described in Example 3L.

Wetting agent Residual nicotine in the pouch after 10 min. Modified starch 68% Glycerol 71% Alginate (PPC46) 79%

Table 15: Various wetting agents.

Example 3O - Release Results

The sachets were subjected to the in vitro release experiment described in Example 3L.

PPC Mass.% fiber Nicotine premix Residual nicotine in the pouch after 10 min. PPC81 30 wt.% wheat (WF600) II 71.6% PPC61 30 wt.% wheat (WF600) VI 66.6% PPC88 15 wt.% wheat (WF600) VI 43.6% PPC89 15 wt.% wheat (WF600) II 54.4% PPC93 15 wt.% wheat (WF600) VI 34.6% PPC94 15 wt.% wheat (WF600) VI 43.7% PPC76 30% pea fiber VI 58.2% PPC83 30% pea fiber II 62.0%

Table 16: Release results. ND=not determined.

The results demonstrate that the release after 10 min is improved by using nicotine premix VI. The release can be further improved by including a buffer system, i.e. 3.5% sodium carbonate and 3.5% sodium bicarbonate (PPC93).

Also, the addition of 10% NaCl appears to increase the release achieved after 10 min (PPC94).

Example 4 - Evaluation

The pouches produced according to the invention were evaluated and found to be highly suitable as nicotine delivery vehicles in that they provide a favourable nicotine release and at the same time are pleasant for the user, for example with regard to the desirable sticky consistency. In particular, the pouches according to the invention do not require any wetting before use, in contrast to conventional low-moisture nicotine pouches, which may initially feel dry upon use.

The PPC1 pouch product was compared with the NPR comparator pouch in terms of the perceived nicotine effect and the burning (tingling) sensation.

The perceived effect of nicotine and the sensation of burning (tingling) were assessed as described below.

The perceived effect of nicotine and the sensation of burning (tingling) were assessed by a testing panel of 4 trained assessors. Each assessor assessed all samples twice. The average ratings were evaluated.

The PPC1 pouch product was rated as having a rapid onset of action and a higher perceived nicotine effect by all four evaluators compared to the NPR comparison pouch. Also, all four evaluators rated the PPC1 pouch product as having a higher burning (tingling) sensation compared to the NPR comparison pouch.

Similarly, the PPC1 pouch product was compared to the NBT comparative pouch for perceived nicotine effect in the same manner as described above. The PPC1 pouch product was rated as having a higher perceived nicotine effect by all raters compared to the NBT comparative pouch.

Claims (97)

1. A nicotine pouch composition for relieving nicotine cravings, comprising a mixture of nicotine in free base form with a sugar alcohol, said pouch composition comprising water at least 15% by weight of said pouch composition, wherein the freebase nicotine comprises freebase nicotine mixed with an ion exchange resin in a mass ratio of freebase nicotine to ion exchange resin of from 0.1 to 2.0, wherein the composition of the nicotine sachet contains sugar alcohol in an amount of 1-80% by weight of the composition of the sachet. 2. The composition of a nicotine sachet according to claim 1, wherein the ion exchange resin is a polyacrylex resin. 3. The nicotine pouch composition of claim 1, wherein the freebase nicotine mixture comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of from 0.5 to 2.0, and most preferably from 0.67 to 1.0. 4. A nicotine pouch composition according to any one of claims 1 to 3, wherein the freebase nicotine mixture comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of from 1:1 to 1:10, preferably from 1:2 to 1:6, and most preferably from 1:4 to 1:5. 5. The nicotine pouch composition of any one of claims 1 to 4, wherein the freebase nicotine mixture comprises freebase nicotine mixed with a water-soluble composition such as a sugar alcohol or a water-soluble fiber. 6. A nicotine pouch composition according to any one of claims 1 to 5, wherein the pouch composition comprises a water-soluble composition, such as a sugar alcohol or a water-soluble fiber, in an amount of 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition. 7. A nicotine pouch composition according to any one of claims 1 to 6, wherein the freebase nicotine mixture comprises freebase nicotine mixed with a sugar alcohol. 8. The nicotine sachet composition according to any one of claims 5-7, wherein said sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof. 9. A nicotine pouch composition according to any one of claims 1 to 8, wherein the freebase nicotine mixture comprises freebase nicotine mixed with a water-soluble fiber. 10. The nicotine pouch composition of any one of claims 1-9, wherein said water-soluble fiber is selected from inulin, polydextrose, including refined polydextrose, dextrin, maltodextrin, and mixtures thereof. 11. The nicotine pouch composition according to any one of claims 1-10, wherein the nicotine in free base form mixed with the ion exchange resin further comprises water. 12. The nicotine pouch composition of any one of claims 1-11, wherein the pouch composition comprises a combination of free base nicotine mixed with a first composition and free base nicotine mixed with a second, different composition. 13. The nicotine pouch composition of any one of claims 1 to 14, wherein the freebase nicotine mixture comprises a combination of freebase nicotine mixed with a water-soluble composition and freebase nicotine mixed with a water-insoluble fiber composition. 14. A nicotine pouch composition according to any one of claims 1 to 13, wherein the nicotine in free base form is granulated with a water-soluble composition or an ion exchange resin. 15. The nicotine pouch composition of any one of claims 1 to 14, wherein the pouch composition further comprises a pH-regulating agent, such as a pH-regulating agent, such as a basic buffering agent. 16. The nicotine pouch composition of any one of claims 1 to 15, wherein the pouch composition further comprises a pH-regulating agent in an amount of from 0.01 to 15% by weight of the pouch composition, such as from 0.5 to 10% by weight of the pouch composition, such as from 1 to 10% by weight of the pouch composition, such as from 2 to 10% by weight of the pouch composition. 17. A nicotine pouch composition according to any one of claims 1 to 16, wherein the pouch composition is adapted to provide a pH of at least 8.0. 18. The nicotine sachet composition of any one of claims 15 to 17, wherein the sachet composition comprises a pH-regulating agent and wherein the pH-regulating agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide or any combination thereof. 19. The nicotine pouch composition of any one of claims 15-18, wherein the pH adjusting agent is a basic pH adjusting agent, such as a basic buffering agent, such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof. 20. The composition of a nicotine pouch according to any one of claims 1-19, wherein the composition of the pouch additionally comprises a wetting agent. 21. The nicotine pouch composition of any one of claims 1-20, wherein the pouch composition further comprises a wetting agent in an amount of from 0.5 to 10% by weight of the pouch composition, such as from 0.5 to 5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition. 22. The nicotine pouch composition of claim 21, wherein the wetting agent comprises one or more of the following: glycerin, propylene glycol, alginate, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum. 23. The composition of a nicotine sachet according to any one of claims 1-22, wherein the composition of the sachet additionally contains alginate. 24. The nicotine pouch composition of any one of claims 1-23, wherein the pouch composition further comprises alginate in an amount of 0.5-5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition. 25. The composition of a nicotine pouch according to any one of claims 1-24, wherein the composition of the pouch additionally comprises xanthan gum. 26. The composition of a nicotine sachet according to any one of claims 1-25, wherein the composition of the sachet additionally contains silicon dioxide. 27. A nicotine pouch composition according to any one of claims 1-26, wherein the composition comprises a flavor additive. 28. A nicotine pouch composition according to any one of claims 1-27, wherein the composition comprises an oil-based flavor additive. 29. The composition of a nicotine pouch according to any one of claims 1 to 28, wherein the composition of the pouch comprises a flavour additive, for example in an amount of from 0.01 to 20% by weight of the composition of the pouch, for example in an amount of from 0.01 to 15% by weight of the composition of the pouch. 30. The nicotine pouch composition of any one of claims 1 to 29, wherein the pouch composition comprises a flavour additive in an amount of from 0.01 to 15% by weight of the pouch composition, such as from 0.1 to 15% by weight of the pouch composition, such as from 1 to 10% by weight of the pouch composition, such as from 3 to 10% by weight of the pouch composition. 31. The composition of a nicotine pouch according to any one of claims 1-30, wherein the flavor additive comprises a liquid flavor additive. 32. The composition of a nicotine pouch according to any one of claims 1 to 31, wherein the composition of the pouch is substantially homogeneous. 33. A nicotine pouch composition according to any one of claims 1 to 32, wherein the dosage of nicotine in free base form in a series of at least 10 oral pouches containing such pouch composition maintains a relative standard deviation (RSD) of below 10%, preferably below 8%, more preferably no more than 6%, even more preferably no more than 4%, most preferably no more than 2%. 34. A nicotine pouch composition according to any one of claims 1-35, wherein the pouch composition is obtained by mixing dry ingredients before adding nicotine, water and liquid flavor additives, if any. 35. A nicotine pouch composition according to any one of claims 1 to 34, wherein the pouch composition is prepared by mixing at least 90% by weight of the total amount of dry ingredients before adding water, for example before adding water and liquid flavor additives, if any. 36. A nicotine pouch composition according to any one of claims 1-35, wherein the pouch composition further comprises a certain amount of a water-insoluble composition. 37. The nicotine pouch composition of claim 36, wherein the water-insoluble composition comprises at least one component selected from dibasic calcium phosphate, calcium carbonate such as calcium carbonate DC, mono-, diglyceride powder, hydrogenated vegetable oil, and combinations thereof. 38. The nicotine sachet composition of claim 36 or 37, wherein said amount of said water-insoluble composition is from 5 to 50% by weight of the sachet composition, such as from 10 to 30% by weight of the sachet composition. 39. The nicotine pouch composition of any one of claims 1 to 38, wherein the pouch composition comprises wheat fiber, oat fiber, pea fiber, rice fiber, corn fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, cellulose fiber, powdered cellulose, bamboo fiber, bran fiber, or combinations thereof. 40. The nicotine pouch composition of any one of claims 1-39, wherein the pouch composition comprises wheat fibre, oat fibre, pea fibre, powdered cellulose or combinations thereof. 41. The nicotine pouch composition of any one of claims 1-40, the pouch composition comprising a water-insoluble fibre that has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%. 42. The nicotine pouch composition of any one of claims 1 to 41, wherein the pouch composition comprises water-insoluble fibre in an amount of 5 to 50% by weight of the pouch composition and has a water content of 15 to 70% by weight of said pouch composition. 43. The nicotine pouch composition of any one of claims 1 to 42, wherein the pouch composition comprises water and water-insoluble fibre in a weight ratio of not more than 3.0, such as not more than 2.5, such as not more than 2.0, such as not more than 1.5, such as not more than 1.0. 44. The nicotine pouch composition of any one of claims 1 to 43, wherein the pouch composition comprises water-insoluble fibres selected from pea fibres, powdered cellulose and combinations thereof, and wherein the pouch composition comprises a flavour additive in an amount of no more than 10% by weight of the pouch composition. 45. The nicotine pouch composition of any one of claims 1 to 44, wherein the pouch composition has a water content of at least 20% by weight of said pouch composition, such as at least 25% by weight of said pouch composition, such as at least 30% by weight of said pouch composition, such as at least 40% by weight of said pouch composition. 46. The nicotine pouch composition of any one of claims 1 to 45, wherein the pouch composition has a water content of from 15 to 70% by weight of said pouch composition, such as from 15 to 30% by weight of said pouch composition, such as from 15 to 25% by weight of said pouch composition, such as from 20 to 40% by weight of said pouch composition, such as from 25 to 70% by weight of said pouch composition, such as from 30 to 60% by weight of said pouch composition. 47. A nicotine pouch composition according to any one of claims 1-46, wherein the pouch composition is a powder composition. 48. A nicotine pouch composition according to any one of claims 1 to 47, wherein the pouch composition has an average particle size of from 1 to 1200 μm, such as from 10 to 500 μm. 49. The nicotine pouch composition of any one of claims 1 to 48, wherein at least 50% by weight of the pouch composition is provided in particles having a particle size greater than 10 μm, such as from 10 to 500 μm. 50. A nicotine pouch composition according to any one of claims 1 to 49, wherein the pouch composition is adapted to release at least 15% by weight of free base nicotine over a period of 120 s upon contact with oral saliva, such as at least 20% by weight of free base nicotine, such as at least 30% by weight of free base nicotine, such as at least 40% by weight of free base nicotine when provided in a pouch and the release is measured as described in Example 3K. 51. A nicotine pouch composition according to any one of claims 1 to 49, wherein the pouch composition is designed to release at least 50% by weight of nicotine in free base form over a period of 120 seconds upon contact with oral saliva when provided in a pouch. 52. A nicotine pouch composition according to any one of claims 1 to 51, wherein the pouch composition is adapted to release at least 30% by weight of freebase nicotine over a period of 10 minutes upon contact with oral saliva, such as at least 40% by weight of freebase nicotine, such as at least 50% by weight of freebase nicotine, such as at least 60% by weight of freebase nicotine, when provided in a pouch and subjected to a release measurement as described in Example 3K. 53. The nicotine pouch composition of any one of claims 1 to 52, wherein the pouch composition provided in the pouch and subjected to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.2% per minute over a release period of 2 to 10 minutes, such as at least 0.3% per minute over a release period of 2 to 10 minutes, such as at least 0.4% per minute over a release period of 2 to 10 minutes, such as at least 0.5% per minute over a release period of 2 to 10 minutes. 54. The nicotine pouch composition according to any one of claims 1 to 53, wherein the pouch composition further comprises nicotine as a nicotine salt and/or as a complex with an ion exchange resin, such as polacrilex resin. 55. A nicotine pouch composition according to any one of claims 1-54, wherein the pouch composition further comprises nicotine as a nicotine salt. 56. A nicotine pouch composition according to any one of claims 1 to 55, wherein the pouch composition further comprises nicotine as a complex with an ion exchange resin, such as polacrilex resin. 57. The composition of a nicotine pouch according to any one of claims 1-56, wherein the composition of the pouch additionally contains a preservative. 58. A nicotine pouch composition according to any one of claims 1 to 57, wherein the pouch composition further comprises a preservative in an amount of from 0.05 to 0.5% by weight of the pouch composition, such as from 0.1 to 0.2% by weight of the pouch composition. 59. A nicotine pouch composition according to any one of claims 1 to 58, wherein the pouch composition contains less than 0.1% by weight of preservatives, for example less than 0.05% by weight of preservatives. 60. The composition of a nicotine sachet according to any one of claims 1-59, wherein the composition of the sachet is free of preservatives. 61. The nicotine pouch composition of any one of claims 1 to 60, wherein the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.2% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1.0% by weight of the pouch composition. 62. A nicotine pouch composition according to any one of claims 1 to 61, wherein the pouch composition comprises nicotine in an amount of no more than 20% by weight of the pouch composition, such as no more than 10% by weight of the pouch composition, such as no more than 5% by weight of the pouch composition. 63. A nicotine pouch composition according to any one of claims 1 to 62, wherein the pouch composition comprises nicotine in an amount corresponding to from 0.5 to 20 mg per pouch, such as from 1.0 to 20 mg per pouch, such as from 5.0 to 15 mg per pouch. 64. A nicotine pouch composition according to any one of claims 1 to 63, wherein the pouch composition further comprises a release-controlling composition. 65. The nicotine pouch composition of claim 64, wherein said release-controlling composition is selected from the list consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, silicon dioxide, talc, magnesium stearate, calcium stearate, colloidal silicon dioxide, powdered hydrogenated cottonseed oil, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides and mixtures thereof. 66. The nicotine pouch composition of claim 64 or 65, wherein the release-controlling composition is hydrophobic. 67. The nicotine pouch composition of any one of claims 64-66, wherein said release-controlling composition comprises one or more metal stearates, such as magnesium stearate and/or calcium stearate. 68. A nicotine pouch composition according to any one of claims 64-67, wherein the pouch composition comprises said release-controlling composition in an amount of from 1 to 20% by weight of said pouch composition. 69. The nicotine pouch composition of any one of claims 64-68, wherein the release-controlling composition comprises or is a solubilizer, such as a solubilizer selected from the list of mono/diglycerides, polysorbate (e.g. Tween XX), sucrose ester, and combinations thereof. 70. The composition of a nicotine pouch according to any one of claims 1-69, wherein the composition of the pouch is free of tobacco, tobacco fibres and fibres originating from tobacco. 71. A nicotine pouch composition according to any one of claims 1 to 70, wherein the nicotine in free base form is mixed with a composition free of microcrystalline cellulose (MCC), such as free of cellulose. 72. The nicotine pouch composition of any one of claims 1 to 71, wherein the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, and wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition. 73. The nicotine pouch composition of any one of claims 1 to 72, wherein said pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the pouch composition comprises said sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition, and wherein said pouch composition further comprises water-insoluble fibres in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition. 74. The nicotine pouch composition of any one of claims 1 to 73, wherein said pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the pouch composition comprises said sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition, wherein said composition further comprises water-insoluble fibres in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition, and wherein the pouch composition comprises water-insoluble fibre such as wheat fibre, oat fibre, pea fibre, powdered cellulose or combinations thereof. 75. The composition of a nicotine sachet according to any one of claims 1-74, wherein said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the sachet composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said sachet composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, and wherein the sachet composition comprises water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose or combinations thereof, and wherein the sachet composition comprises a flavor additive in an amount of 0.01 to 15% by weight of the composition of the sachet, such as from 0.1 to 15% by weight of the composition of the sachet, such as from 1 to 10% by weight of the composition of the sachet, such as from 3 to 10% by weight of the composition of the sachet. 76. The composition of a nicotine sachet according to any one of claims 1-75, wherein said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the sachet composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said sachet composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, wherein the sachet composition comprises water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose or combinations thereof, and wherein the sachet composition comprises a flavor additive in an amount of 0.01 to 15% by weight of the sachet composition, such as from 0.1 to 15% by weight of the sachet composition, such as from 1 to 10% by weight of the sachet composition, such as from 3 to 10% by weight of the sachet composition, and wherein said flavoring additive has an oil base. 77. The composition of a nicotine sachet according to any one of claims 1-76, wherein said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the sachet composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said sachet composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, and wherein the sachet composition comprises a pH-adjusting agent selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof. 78. The composition of a nicotine sachet according to any one of claims 1-77, wherein said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, wherein the sachet composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition, wherein said sachet composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, such as 10 to 30% by weight of the sachet composition, and wherein the sachet composition comprises a pH-adjusting agent that is a basic pH-adjusting agent, such as a basic buffering agent and/or such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate or any combination thereof. 79. A nicotine pouch composition according to any one of claims 1 to 78, wherein the pouch composition is free of microcrystalline cellulose (MCC), such as free of cellulose. 80. An oral product in the form of a nicotine sachet for relieving nicotine cravings, comprising a sachet and a quantity of the nicotine sachet composition according to any one of claims 1 to 79, enclosed in said sachet. 81. An oral nicotine sachet product according to claim 80, wherein said sachet product contains said sachet composition in an amount of from 50 to 1000 mg, such as from 100 to 700 mg, such as from 300 to 600 mg. 82. An oral nicotine sachet product according to claim 80 or 81, wherein said sachet product contains nicotine in an amount of from 0.5 to 20 mg, such as from 1.0 to 20 mg, such as from 5.0 to 15 mg. 83. An oral product in the form of a nicotine sachet according to any one of claims 80-82, wherein the sachet comprises a water-permeable membrane comprising, for example, a woven or non-woven material. 84. A nicotine pouch product according to any one of claims 80 to 83, wherein the membrane of the pouch comprises a water-insoluble fibre of a different origin from the water-insoluble fibre contained in the pouch product. 85. A nicotine pouch product according to any one of claims 80 to 84, wherein the membrane of the pouch comprises water-insoluble fibre, wherein the composition of the pouch comprises water-insoluble fibre, and wherein both the water-soluble fibre and the water-insoluble fibre of the composition of the pouch comprise natural fibre. 86. A nicotine sachet product according to any one of claims 80-85, wherein the membrane of the sachet comprises water-insoluble fibre, wherein the composition of the sachet comprises water-insoluble fibre and wherein both the water-soluble fibre, the water-insoluble fibres of the membrane and the water-insoluble fibre of the composition of the sachet are natural fibre. 87. A nicotine sachet product according to any one of paragraphs 80-86, wherein the sachet product comprises said sachet in an amount of up to 20% by weight of said sachet product, for example in an amount of up to 15% by weight of said sachet product. 88. A nicotine sachet product according to any one of paragraphs 80-87, wherein the sachet product contains said sachet in an amount of 3-20% by weight of said sachet product, for example in an amount of 5-15% by weight of said sachet product. 89. A nicotine pouch product according to any one of paragraphs 80-88, wherein the freebase nicotine mixture comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of 0.1 to 2.0, wherein the sachet composition comprises wheat fibre, oat fibre, pea fibre, rice fibre, corn fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, coconut fibre, bamboo fibre, powdered cellulose, bran fibre or combinations thereof, wherein the sachet composition comprises a sugar alcohol in an amount of 1-80% by weight of the sachet composition and the sachet composition comprises a pH-regulating agent in an amount of 0.01 to 15% by weight of the sachet composition. 90. A method for producing an oral product in the form of a nicotine sachet according to any one of paragraphs 80-89, wherein the method comprises the steps providing a nicotine pouch composition according to any one of paragraphs 1-79, providing a bag, adding the composition of the sachet to the specified sachet and sealing the bag.