WO2025056698A1

WO2025056698A1 - Permeable pouch comprising a moist non-tobacco composition

Info

Publication number: WO2025056698A1
Application number: PCT/EP2024/075528
Authority: WO
Inventors: Peter Spetz
Original assignee: Lewa Of Sweden Ab
Priority date: 2023-09-13
Filing date: 2024-09-12
Publication date: 2025-03-20

Abstract

The present disclosure relates to the field of oral pouched products for delivering active substances and/or for providing a pleasant oral experience. More specifically, the present disclosure relates to a saliva-permeable pouch comprising a moist non-tobacco composition for oral use, said moist non-tobacco composition comprising: i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) caffeine; and iii) nicotine, wherein caffeine and nicotine are provided in specific amounts in said composition.

Description

PERMEABLE POUCH COMPRISING A MOIST NON-TOBACCO COMPOSITION

TECHNICAL FIELD

The present disclosure relates to the field of oral pouched products for delivering active substances and/or for providing a pleasant oral experience. It relates to oral products that, similar to snuff products, are provided in small pouches for easy adaption in the oral cavity, such as under the lip of a user. The products are tobacco free and are intended to provide positive effects to the user.

BACKGROUND

As of today, there are many products on the market for providing a pleasant oral experience, such as a taste experience, and for delivering active substances, such as nicotine.

Smokeless tobacco products for oral use, such as snuff, are very common in some countries, particularly Sweden. These products are available in loose form or as portion-packed in a soft material formed from a small pouch. The pouch is typically used by the user by placing the pouch containing the snuff product in the mouth, such as between the upper or lower gum and the lip, or in the cheek and then maintaining it there for a while until the contents of the product has been released into the mouth. Accordingly, the pouch material is permeable and releases parts of the snuff products continuously when placed in the mouth of the user. The pouch material holds the snuff product in place and should be formed from a material convenient and/or comfortable for the user to have positioned against the sensitive mucous membrane in the mouth.

Smokeless tobacco products are associated with a general odour that is not pleasant for the user or to the surroundings of the user. More importantly, snuff products provide damage to the gum of the long-term user.

Further, energy drinks are widely used today. There is always a need to find new alternatives to energy drinks and in particular products that provide beneficial effects in addition to an energizing effect of an energy drink.

Taking the above into account, there is still a need in the art to identify products for delivering active substances and/or for providing a pleasant experience which will also lessen the need for other products having similar effects but being associated with disadvantages affecting the health of the users and thereby the society. There is also a need to complement and replace energy drinks for active and aware people. Finally, there is a general need for new products within this area that will provide both similar effects to existing products, but which also provides additional beneficial effects to the user. SUMMARY OF THE DISCLOSURE

The present disclosure relates to a saliva-permeable pouch comprising a moist non-tobacco composition for oral use, said moist non-tobacco composition comprising: i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) caffeine; and iii) nicotine, wherein the amount of nicotine is from about 6 mg to about 25 mg per g of moist non- tobacco composition, such as from about 6 mg to about 15 mg, such as from about 7 mg to 12 mg, such as about 8 mg or about 10 mg, and wherein the amount of caffeine is from about 10 mg to about 60 mg per g of moist non- tobacco composition, such as from about 20 mg to about 50 mg, such as from about 25 mg to about 45 mg, such as about 30 mg or about 40 mg.

The present disclosure also relates to the non-medical use of the pouch as described herein for losing weight.

The present disclosure also relates to the non-medical use of the pouch as described herein to improve stamina and/or endurance.

The present disclosure also relates to the non-medical use of the pouch as described herein for improving cognitive ability.

DEFINITIONS

All words and terms used herein shall be considered to have the same meaning usually given to them by the person skilled in the art unless another meaning is apparent from the context.

The singular “a” and “an” shall be construed as including also the plural.

Compositions “comprising” one or more recited elements may also include other elements not specifically recited.

A “moist non-tobacco composition” may also be referred to herein, in short, as “a composition”, “a non-tobacco-composition” or the like.

By “water content” is in the context of the present disclosure intended water added during the production of a composition of the present disclosure and water provided by water-containing ingredients added to the composition of the present disclosure, such as aromas. Further moisture may be provided to the composition by for example moisturizers such as propylene glycol.

A “pouch” according to the present disclosure is a form of a small, soft, sealed but permeable bag for keeping a moist non-tobacco composition of the present disclosure. The pouch is saliva-permeable. The permeability allows saliva to enter the moist non-tobacco composition and substances from the moist non-tobacco composition to travel through the material for release into the oral cavity of the user. The pouch is made from a material that is comfortable for the user to position under the lip. Typically, the pouch is made from or comprises a cellulosic material. The pouch may also be freely positioned elsewhere in the mouth, i.e. , other than under the lip of a user.

A “cellulose pouch” as referred to herein means that the material for the pouch includes cellulose, but it may also include other constituents suitable for the purpose of the pouch. Suitable sizes for the pouch are further described herein.

“Saliva-permeable”, in the context of a pouch as described herein, relates to that said pouch is permeable in the sense that once the pouch is positioned in the mouth of a user, saliva is allowed to travel through the pouch material into the composition of the present disclosure positioned inside the pouch so as to provide further moisture to the composition but also to ensure that substances present in the composition can travel through the pouch material and into the mouth of the user. This is particularly important so that the active substance can reach the oral cavity of the user and provide the effect.

Herein “wt%”, “weight %” or “% by weight” refers to weight percent of an ingredient based on the total weight of the composition disclosed herein.

An “active substance” according to the present disclosure is a substance that exert an effect on the body when taken up by the body. The effect for example be an invigorating and/or a stimulating effect. Non-limiting examples of active substances as referred to herein comprise caffeine, nicotine and taurine.

A “carrier material” according to the present disclosure, is a material that carries the active substances and/or ingredients and allows or facilitates release thereof when positioned in the mouth of a user.

DETAILED DESCRIPTION OF THE DISCLOSURE The present disclosure provides oral moist non-tobacco products which may be used to experience positive effects on the body and that also have an appealable taste and mouth feel. The oral moist non-tobacco products of the present disclosure are smokeless.

According to the present disclosure, active substances are administered to the oral mucus membrane in the form of saliva-permeable pouches comprising a moist non-tobacco composition that are placed in the oral cavity, preferably under the lip, and in contact with the oral mucous membrane. This surprisingly results in a rapid uptake of the active substances and therefore a more rapid on-set of the positive effects of the active substances. The active substances may therefore be directly taken up by the oral mucosa when delivered via the saliva-permeable pouches comprising a moist non-tobacco composition of the present disclosure. The user of a product of the present disclosure therefore experiences the positive effects of the active substances quicker than if the active substances, e.g., would be delivered by eating or drinking a product containing them whereby the active substances would have to be absorbed in the gastrointestinal tract.

Oral moist tobacco-containing products and white nicotine products (i.e., smokeless products containing nicotine but no tobacco) contain nicotine and other substances that may not be healthy for the user. Therefore, it would be advantageous to be able to lower the amount of nicotine and/or to be able to increase the effect of nicotine without having to increase the amount of it in an oral moist non-tobacco product. In accordance with the present disclosure, this is achieved by combining nicotine with caffeine. Thereby, the effects of the nicotine may be enhanced by the caffeine. The amount of nicotine in the oral moist non-tobacco composition can thereby be lowered compared to earlier products or the effect of the nicotine may be enhanced without having to increase the amount of it in the product. Further, the nicotine in the oral moist non-tobacco composition may enhance the effects of the caffeine, thereby providing a caffeine-containing product that provides the desirable effects of caffeine with a lower amount of caffeine or that provides a stronger effect of the caffeine without having to increase its amount in the product. Such a product may for example be used as an alternative to caffeine containing energy drinks or as an alternative to drinking coffee. Further, the combined effects of the nicotine and the caffeine in a product of the present disclosure provides the user of it with the positive effects of both nicotine and caffeine.

The present disclosure relates to a saliva-permeable pouch comprising a moist non-tobacco composition for oral use, said moist non-tobacco composition comprising: i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) caffeine; and iii) nicotine.

The amounts of nicotine are from about 6 mg to about 25 mg per g of moist non-tobacco composition, such as from about 6 mg to about 15 mg, such as from about 7 mg to about 13 mg, such as about 8 mg or about 10 mg, per g of moist non-tobacco composition. Suitable amounts of caffeine are from about 10 mg to about 60 mg per g of moist non-tobacco composition, such as from about 20 mg to about 50 mg, such as from about 25 mg to about 45 mg, such as from about 40 mg to about 60 mg, such as about 30 mg or about 40 mg, per g of moist non-tobacco composition.

Any combination of the above-mentioned ranges of nicotine and caffeine may be used in a moist non-tobacco composition of the present disclosure. An exemplary product containing both nicotine and caffeine may contain from about 7 mg to about 13 mg of nicotine and from about 25 mg to about 45 mg of caffeine, per g of moist non-tobacco composition, such as about 8 mg of nicotine and 30 mg of caffeine or 10 mg of nicotine and 40 mg of caffeine, per g of moist non-tobacco composition.

As a further alternative there is also provided herein a moist non-tobacco composition that contains an amount of nicotine of from about 6 mg to about 25 mg per g of moist non- tobacco composition, such as from about 20 mg to about 25 mg, such as from about 10 mg to about 15 mg per g of moist non-tobacco composition, and an amount of caffeine of from about 150 mg to about 250 mg per g of moist non-tobacco composition, such as about 170 mg of caffeine per g of moist non-tobacco composition. An exemplary product may contain from about 10 mg to about 25 mg of nicotine and from about 170 mg to about 250 mg of caffeine per g of moist non-tobacco composition. A saliva-permeable pouch comprising such a combination of caffeine and nicotine may provide an additional boost in effect to the user in view of the increased concentration of caffeine in such a composition. Such a combination is also applicable to the other aspects of the disclosure as presented herein.

One example of a plant-based fiber as referred to herein is a cellulosic fiber material, or a derivative thereof. Cellulose fibers are fibers made with ethers or esters of cellulose. These can e.g., be obtained from the bark, wood or leaves of plants, or from other plant-based material. The cellulosic fiber material may also contain hemicellulose and lignin, with different percentages of these components altering the mechanical properties of the fibers. Examples of suitable cellulosic materials, or derivatives thereof, are carboxymethyl cellulose (CMC) and microcrystalline cellulose (MCC). The plant-based fiber is however not intended to be limited thereto.

The carrier material comprising a plant-based fiber may be present in an amount of from about 400 mg to about 500 mg per g of moist non-tobacco composition, such as from about 450 mg to 550 mg per g of moist non-tobacco composition, such as about 400 mg, 425 mg, 450 mg, 475 mg, 500 mg, 525 mg or 550 mg per g of moist non-tobacco composition. The amount is however not limited thereto.

Sometimes, alternatives to plant-based fibers may also be used.

Said moist non-tobacco composition may further comprise a composition comprising an extract of Lippia citriodora, and an extract of Hibiscus sabdariffa L. Such extracts contain plant polyphenols. The extract of lemon verbena (Lippia citriodora) and hibiscus flower (Hibiscus sabdariffa L.) may be as disclosed in W02013004856A1. These extracts have been shown to work synergistically on the activation of AMPK (enzyme (EC 2.7.11.31) that plays a role in cellular energy homeostasis, largely to activate glucose and fatty acid uptake and oxidation) and promote optimal metabolic efficiency through the modulation of fat metabolism. The extracts and their preparation are also described in Nutrients. 2018 Sep; 10(9): 1204., Young-Sil Lee, et al, (Metabolaid® Combination of Lemon Verbena and Hibiscus Flower Extract Prevents High-Fat Diet-Induced Obesity through AMP-Activated Protein Kinase Activation), incorporated herein for reference. Lippia citriodora extract and Hibiscus sabdariffa L. extract were prepared by hydroalcoholic extraction, centrifuged, concentrated under reduced pressure using a rotary evaporator, and then filtered. A composition comprising an extract of Lippia citriodora, and an extract of Hibiscus sabdariffa L. was prepared by mixing Lippia citriodora, and Hibiscus sabdariffa L extracts at a weight ratio (w/w) of 65:35. The four compounds, delphinidin-3-o-sambubioside, cyanidin-3-o- sambubioside, verbascoside, and isoverbascoside were identified as the main active compounds of the composition.

Hence, a composition comprising an extract of Lippia citriodora and an extract of Hibiscus sabdariffa L as described herein may comprise a minimum of about 50 weight% of Lippia citriodora extract and a minimum of about 25 weight% of Hibiscus sabdariffa L extract.

More specifically, the composition may comprise about 65 weight% of Lippia citriodora extract and about 35 weight% of Hibiscus sabdariffa L extract. However, the composition of the extracts is not limited thereto and may comprise other ratios of extracts of Lippia citriodora and Hibiscus sabdariffa L.

As mentioned elsewhere herein, the extraction may be performed by hydroalcoholic extraction. As an example, the Lippia citriodora extract may be carried out using an aqueous alcohol solution with an alcohol content greater than 70% and up to 100% in volume of ethanol using two hours at a temperature between about 40°C and about 80°C. Other details of production of an extract of a composition as presented herein may be found in EP3695848, incorporated herein for reference. The blend of the extracts has been shown in several studies to maintain blood pressure within the normal range, significantly increase metabolic function and support healthy weight by decreasing appetite biomarkers. The presence of extracts of Lippia citriodora and Hibiscus sabdariffa in a moist non-tobacco composition of the present disclosure may therefore provide positive effects on the weight of a user of the product and may be used for losing weight, controlling blood sugar and/or controlling appetite. Extracts of Lippia citriodora and Hibiscus sabdariffa are for example sold under the tradename Metabolaid® as discussed elsewhere herein.

The amount of said composition comprising an extract of Lippia citriodora and an extract of Hibiscus sabdariffa L. may be from about 10 mg to about 30 mg per g of moist non-tobacco composition, such as from about 15 mg to about 25 mg per g of moist non-tobacco composition, such as from about 18 mg to about 23 mg, such as about 21 mg, per g of moist non-tobacco composition.

In addition to nicotine and caffeine, the moist non-tobacco composition may further comprise taurine. Taurine occurs naturally in foods with protein, such as meat or fish. The human body uses taurine for actions in cells. One example is that taurine is used for energy production. Taurine also helps the body process bile acid and balance fluids, salts and minerals, among other actions. A moist non-tobacco composition of the present document containing taurine may therefore provide the user with more power, energy, and/or endurance. Further positive effects of taurine that may be experienced are reduced tiredness and fatigue, positive effect on the testosterone levels, fertility and/or muscle function. The amount of taurine may be from about 15 mg to 35 mg per g of moist non-tobacco composition, such as from about 20 mg to about 30 mg, such as about 25 mg, per g of moist non-tobacco composition.

Magnesium may also be added to a moist non-tobacco composition of the present disclosure. Magnesium such as magnesium in the form om magnesium citrate, may be added to a moist non-tobacco composition of the present disclosure in an amount of from about 4.4 mg to about 5.2 mg, such as from about 4.4 mg to about 4.8 mg, such as about 4.6 mg, per g of moist non-tobacco composition. Magnesium plays a crucial role in muscle function, the nervous system and energy production and may also help maintaining blood sugar and blood pressure. Magnesium has also been shown to have positive effects on the mood and cognitive abilities, such as executive function, working memory, attention and episodic memory. Administration of magnesium in the form of magnesium L-threonate has been shown to support cognitive functions and brain health. Magnesium L-threonate is for example sold under the tradename Magtein®. In addition to nicotine and caffeine, the moist non-tobacco composition may thus further comprise magnesium L-threonate. The amount of said magnesium L-threonate may be from about 50 mg to about 130 mg per g of said moist non-tobacco composition, such as from about 70 mg to about 100 mg, such as about 80 mg to about 90 mg, such as about 83 mg, per g of moist non-tobacco composition.

Zink may be added to a moist non-tobacco composition of the present disclosure to support the normal function of the immune system and/or metabolism of fatty acids.

Further effects of active substances that may be added to a moist non-tobacco composition of the present disclosure are shown in Table 1:

Table 1: Further optional ingredients of the moist non-tobacco composition of the present disclosure.

Thus, said moist non-tobacco composition may further comprise one or more of: iv) magnesium, such as in an amount of from about 4.4 mg to about 5.2 mg, such as about 4.2 mg, such as in the form of magnesium citrate; v) vitamin B1 , such as in an amount of from about 0.05 mg to about 0.15 mg, such as about 0.1 mg; vi) vitamin B2, such as in an amount of from about 0.05 mg to about 0.15 mg, such as about 0.1 mg; vii) vitamin B5, such as in an amount of from about 0.05 mg to about 0.15 mg, such as about 0.1 mg, or from about 0.35 mg to about 0.45 mg, such as about 0.42 mg; viii) vitamin B12, such as in an amount of from about 0.02 mg to about 0.45 mg per g, such as about 0.25 mg to about 0.45 mg per g, such as from about 0.30 mg to about 0.35 mg, such as about 0.31, 0.32, 0.33, 0.34, or 0.35 mg per g of said moist non-tobacco composition, or from about 0.02 mg to about 0.04 mg, such as about 0.033 mg; ix) zinc, such as in an amount of from about 0.66 mg to about 1.0 mg, such as about 0.83 mg for example in the form of zinc gluconate; and x) selenium, such as in an amount of from about 0.0036 mg to about 0.013 mg, such as about 0.0048 mg; per g of moist non-tobacco composition.

Magnesium may be added to the moist non-tobacco composition, wherein said magnesium is in the form of magnesium citrate, as mentioned elsewhere herein. The amount of magnesium citrate may be from about 30 mg to about 90 mg per g of said moist non-tobacco composition, such as from about 35 mg to about 80 mg, such as from about 40 mg to about 70 mg, such as about 45, 50, 55, 56, 57, 58 59, 60, 65 or 70 mg.

Vitamin B12 may be added to a moist non-tobacco composition of the present disclosure in the form of a powder of cyanocobalamin stabilized in a matrix of modified food starch with a 1% concentration of vitamin B12. Such a vitamin B12 containing powder of cyanocobalamin may be present in an amount of from about 25 mg to about 45 mg per g of said moist non- tobacco composition, such as from about 30 mg to about 35 mg, such as about 31, 32, 33, 34, or 35 mg per g of said moist non-tobacco composition. Vitamin B5 may be added to a moist non-tobacco composition of the present disclosure in the form of calcium pantothenate, more specifically calcium D-pantothenate, but is not limited thereto. This is a form commonly used in dietary supplements and animal feed. This form may be added to the composition in an amount of from about 0.05 mg to about 0.25 mg per g of said moist non-tobacco composition, such as from about 0.05 mg to about 0.15 mg, such as from about 0.05 mg to about 0.20 mg, such as about 0.1, 0.12, 0.13, 0.14 or 0.15 mg per g of said moist non-tobacco composition, but it is not intended to be limited thereto. Vitamin D in other useful forms are also envisaged in a composition of the present disclosure.

Salt is usually in the form of sodium chloride and may be present in an amount of from about 10 mg to about 30 mg per g of moist non-tobacco composition, such as from about 15 mg to 25 mg, such as about 16, 17, 18, 19. 20, 21, 22, 23, 24 or 25 mg per g of moist non-tobacco composition.

The moist non-tobacco composition of the present disclosure may also contain additional substances such as sweeteners, flavors and/or salt(s). Exemplary such sweeteners, flavors and salts are given in the specific recipes given elsewhere herein and may be used in any combination. Also, propylene glycol may be added as a moisturizer.

The herein mentioned active substances and/or ingredients may be provided in any combination in a moist non-tobacco composition of the present disclosure.

A moist non-tobacco composition of the present disclosure may comprise, in addition to nicotine and caffeine, magnesium and a composition comprising an extract of Lippia citriodora and an extract of Hibiscus sabdariffa L. and optionally Vitamin B1 and/or Vitamin B2,

A moist non-tobacco composition of the present disclosure may comprise, in addition to nicotine and caffeine, taurine, magnesium, zinc, and optionally Vitamin B5 and/or selenium.

A moist non-tobacco composition of the present disclosure may comprise, in addition to nicotine and caffeine and magnesium L-threonate and optionally Vitamin B5 and/or Vitamin B12.

The pH of the moist non-tobacco composition of the present disclosure is typically between 6.5 and 10. More specifically, the pH is typically between 6.5 and 8, such as from about 7 to about 8. The pH may be adjusted by the presence of a pH regulating agent in the moist non- tobacco composition. Examples of such pH regulating agents include, but are not limited to, carbonates, such a sodium carbonate, metal hydroxides, such as sodium hydroxide and potassium hydroxide, alkali metal salts of acids such as acetates, glycinates, gluconates, glycerophosphates, borates, weak organic acids, such as citric acid, and phosphates, which may be used alone or in combination of two or more such pH regulating substances.

The moist non-tobacco composition is enclosed by a saliva-permeable pouch, such as a cellulosic pouch. Typically, the width of the pouch is from about 5 to about 20 mm, such as from about 10 to about 18 mm, such as from about 12 to about 15 mm, such as about 14 mm. Typically the length of the pouch is from about 20 mm to about 40 mm, such as from about 25 to about 35 mm, such as about 30 mm. However, other dimensions or shapes of the pouch may also be used.

The texture of the moist non-tobacco composition and the softness of the cellulose material of the saliva-permeable pouch presents the user with an appealing combination for comfortable positioning in the mouth.

The saliva-permeable pouches comprising a moist non-tobacco composition of the present disclosure may be placed in a container or a soft small bag. The container or bag provides for keeping of the pouches for the user. The container or bag may be made from a soft or a hard plastic material. The container may have a round or square shape and be in the form of a hard plastic material. The container may be a small rectangular shaped soft plastic bag. The bag may be of a transparent material or not, or a combination thereof.

The amount of water added to said moist non-tobacco composition may be from about 200 mg to about 350 mg per g of moist non-tobacco composition, such as from about 220 mg to 310 mg, such as from about 240 mg to 300 mg, such as from about 250 mg to 290 mg, per g of moist non-tobacco composition. Further moisture may be provided to the moist non- tobacco composition by ingredients in fluid form. Examples of ingredients that may be provided in fluid form include nicotine, propylene glycol and aromas (flavors). Typically, the moisture content of the moist non-tobacco composition is from about 25 wt% to about 45 wt%, such as about 30 wt% to about 35 wt%, such as about 32 wt% based on the total weight of the moist non-tobacco composition excluding any contribution to the moisture content of any moisturizer but water.

The total weight of said moist non-tobacco composition in the saliva-permeable pouch may be from about 0.3 g to about 1.5 g, such as from about 0.5 g to about 1.0 g, such as from about 0.5 g to about 0.8 g, such as about 0.6 g.

The moist non-tobacco composition of the present disclosure does not contain any tobacco material, i.e. it is tobacco free. However, the source of nicotine for use in a moist non-tobacco composition of the present disclosure may come from tobacco. The term ’’tobacco free”, “non-tobacco” and the like as used in the context of the present disclosure does therefore not exclude that the nicotine is isolated from a tobacco material.

There is further provided herein the non-medical use of the saliva-permeable pouch comprising a moist non-tobacco composition for losing weight. Particularly, this is intended when the moist non-tobacco composition comprises a composition comprising an extract of Lippia citriodora and an extract of Hibiscus sabdariffa L.

There is further provided herein the non-medical use of the pouch comprising a moist non- tobacco composition to improve stamina and/or endurance.

There is further provided herein the non-medical use of the pouch comprising a moist non- tobacco composition for improving cognitive ability.

A saliva-permeable pouch comprising a moist non-tobacco composition of the present disclosure may be prepared in the following exemplary manner. The ingredients of the composition are mixed to a homogenous blend followed by addition of liquid (such as water). By infusing the carrier material with all the ingredients in a specialized blender, all components of the composition are merged into one aggregate moist non-tobacco composition.

The specialized blender is a blender normally used for blending snuff products.

Preferably, the thereafter obtained non-tobacco composition is left to rest for about 12 to 24 h before packaging into saliva-permeable pouches.

The non-tobacco composition is thereafter run in a machine that portions it out into small soft saliva-permeable pouches made from a saliva-permeable material, such as a cellulose paper. The saliva permeable pouches are pouches commonly used for packaging snuff products.

When adding the moist non-tobacco composition to the portioning machine, the composition is evenly distributed in the pipe of the machine. The evenly distributed composition is thereafter covered by the pouch material, weighted up into portions and subsequently laminated in both ends before cutting the pouches according to the pre-installed size selected for the particular pouch product.

The saliva-permeable pouches may come in different sizes and thereby contain varying amounts of the non-tobacco composition, as disclosed elsewhere herein.

After storing the saliva-permeable pouches for some time, the products may be checked for any presence of bacterial growth. The present disclosure will now be illustrated by the following experimental section without intending to be limited thereto as it merely illustrates different ways of performing the disclosure.

EXPERIMENTAL SECTION

Example 1

Materials and methods

The ingredients of the non-tobacco composition of Tables 2 to 4 can easily be obtained from suitable manufacturers and are provided as dry ingredients, except for nicotine and the aromas which are provided as aqueous solutions. Propylene glycol is added as a moisturizer.

A composition comprising an extract of Lippia citriodora and an extract of Hibiscus sabdariffa L. in composition 1 is sold under the tradename Metabolaid®, (see e.g. Nutrients. 2018, as referred to elsewhere herein). The product of the tradename Magtein® of composition 2 comprises magnesium L-threonate.

The dry ingredients of the compositions are mixed to a homogenous blend followed by addition of liquid (water). By infusing the carrier material with all the ingredients in a specialized blender, all components of the composition are merged into one aggregate moist non-tobacco composition. The moisture content of the composition is about 32 wt%. Propylene glycol is not included in this moisture content.

The specialized blender is a blender normally used for blending snuff products.

Preferably, the thereafter obtained non-tobacco composition is left to rest for about 12 to 24 h before packaging into pouches.

The non-tobacco composition is thereafter run in a machine that portions it out into small soft pouches made from a saliva-permeable material, such as a cellulose paper. The pouches are pouches commonly used for packaging snuff products. The pouches may be made of different sizes of which one example is 14x30 mm.

When adding the non-tobacco blend to the machine, the blend is evenly distributed in the pipe of the machine. The evenly distributed blend is thereafter covered by the pouch material, weighted up into portions and subsequently laminated in both ends before cutting the pouches according to the pre-installed size selected for the particular pouch product.

The pouches may come in different sizes and thereby contain varying amounts of the non- tobacco composition. One example of a total weight of a pouch comprising a non-tobacco composition is about 600 mg (0.6 g). After storing the pouches for some time, the products are checked for any presence of bacterial growth.

The following non-tobacco compositions were prepared:

Composition 1

Table 2: Contents of a non-tobacco composition of the present disclosure.

* Microcrystalline cellulose (MCC)

** Metabolaid® comprises a composition comprising an extract of Lippia citriodora, and an extract of Hibiscus sabdariffa L.

Composition 2

Table 2: Contents of a non-tobacco composition of the present disclosure.

* Microcrystalline cellulose (MCC)

** Magtein® comprises magnesium L-threonate.

Composition 3

Table 3: Contents of a non-tobacco composition of the present disclosure.

* Microcrystalline cellulose (MCC)

Claims

1 . A saliva-permeable pouch comprising a moist non-tobacco composition for oral use, said moist non-tobacco composition comprising: i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) caffeine; and iii) nicotine, wherein the amount of nicotine is from about 6 mg to about 25 mg per g of moist non- tobacco composition, such as from about 6 mg to about 15 mg, such as from about 7 mg to about 12 mg, such as about 8 mg or about 10 mg, and wherein the amount of caffeine is from about 10 mg to about 60 mg per g of moist non-tobacco composition, such as from about 20 mg to about 50 mg, such as from about 25 mg to about 45 mg, such as about 30 mg or about 40 mg.

2. The saliva-permeable pouch of claim 1 , wherein the amount of nicotine is from about 7 mg to about 13 mg and the amount of caffeine is from about 25 mg to about 45 mg, per g of moist non-tobacco composition, such as about 8 mg of nicotine and 30 mg of caffeine or 10 mg of nicotine and 40 mg of caffeine.

3. The saliva-permeable pouch of claim 1 or 2, wherein said moist non-tobacco composition further comprises a composition comprising an extract of Lippia citriodora and an extract of Hibiscus sabdariffa L.

4. The saliva-permeable pouch of claim 3, wherein the amount of said composition comprising an extract of Lippia citriodora and an extract of Hibiscus sabdariffa L. is from about 10 mg to about 30 mg per g of moist non-tobacco composition, such as from about 15 mg to about 25 mg, such as from about 18 mg to about 23 mg, such as about 21 mg.

5. The saliva-permeable pouch of any one of the preceding claims, wherein said moist non-tobacco composition further comprises taurine.

6. The saliva-permeable pouch of claim 5, wherein said amount of taurine is from about 15 mg to 35 mg per g of moist non-tobacco composition, such as from about 20 mg to about 30 mg, such as about 25 mg.

7. The saliva-permeable pouch of any one of the preceding claims, wherein said moist non-tobacco composition further comprises magnesium L-threonate.

8. The saliva-permeable pouch of claim 7, wherein the amount of said magnesium L- threonate is from about 50 mg to about 130 mg per g of said moist non-tobacco composition, such as from about 70 mg to about 100 mg, such as about 80 mg to about 90 mg, such as about 83 mg.

9. The saliva-permeable pouch of any one of the preceding claims, wherein said moist non-tobacco composition further comprises one or more of: iv) magnesium, such as in an amount of from about 4.4 mg to about 5.2 mg, such as about 4.6 mg; v) vitamin B1 , such as in an amount of from about 0.05 mg to about 0.15 mg, such as about 0.1 mg; vi) vitamin B2, such as in an amount of from about 0.05 mg to about 0.15 mg, such as about 0.1 mg; vii) vitamin B5, such as in an amount of from about 0.05 mg to about 0.15 mg, such as about 0.1 mg, or from about 0.35 mg to about 0.45 mg, such as about 0.42 mg; viii) vitamin B12, such as in an amount of from about 0.02 mg to about 0.45 mg per g, such as from about 0.30 mg to about 0.35 mg, such as about 0.33 mg, or such as from about 0.02 mg to about 0.04 mg, such as about 0.033 mg; ix) zinc, such as in an amount of from about 0.66 mg to about 1.0 mg, such as about 0.83 mg; and x) selenium, such as in an amount of from about 0.0036 mg to about 0.013 mg, such as about 0.0048 mg; per g of moist non-tobacco composition.

10. The saliva-permeable pouch of any one of the preceding claims, wherein the total weight of said moist non-tobacco composition in said pouch is from about 0.3 g to about 1.5 g, such as about 0.6 g.

11. Non-medical use of the saliva-permeable pouch of any one of claims 3 to 4 and 9 to 10 for losing weight.

12. Non-medical use of the saliva-permeable pouch of any one of claims 5 to 6 and 9 to 10 to improve stamina and/or endurance.

13. Non-medical use of the saliva-permeable pouch of any one of claims 7 to 10 for improving cognitive ability.