DE202017006939U1 - Cartridge for pacifier with inhalation device - Google Patents

Abstract

A cartridge for loading a pacifier with active agent, comprising: - a cartridge wall enclosing a cavity, - at least one opening in the cartridge wall connecting the cavity to an outside space around the cartridge, and - a removable closure liquid-tightly sealing the at least one opening (in particular hermetically), wherein the cartridge is designed so that it can be releasably connected to a pacifier, and wherein the cartridge is designed as a disposable cartridge.

Description

TECHNICAL AREA

The present disclosure relates to nipple and pacifier cartridges for use in the treatment of discomfort, typically in the upper respiratory tract of infants and young children, and generally for the targeted local delivery of drugs to infants and toddlers. Embodiments further relate to the dosage forms, comprising the correspondingly provided active ingredients, and in particular also their physical nature.

BACKGROUND OF THE INVENTION

In the first two years of life, infants or young children (that is, children aged 0 to 2) have a number of problems. So they are often caught cold due to the not yet fully developed immune system. Respiratory diseases, such as sore throats, cause them especially in the evening before falling asleep, as well as considerable difficulties at night. As a rule, this also has an immediate effect on the well-being of the parents. If home remedies, such as frequent drinking or calf wrap, as well as homeopathic treatments, such as the use of globules to combat the aforementioned problems are no longer sufficient, (school) medical help may be useful.

According to conventional medicine, juices (eg cough syrup), suppositories (eg paracetamol suppositories) as well as inhalation solutions (eg NaCl solution) are used for the medical treatment of respiratory diseases, depending on the indication, using specially developed inhalation devices (eg Pari Boy SX ) used. Lozenges, such as halves, are indicated for use in children at the earliest from the age of about 3 to 4 years. The reason for this is that infants and very young children easily swallow such lozenges, which can lead to severe coughing fits or, in the worst case, to a refractory cardiovascular arrest.

In view of the above, there is a need for the present invention.

SUMMARY OF THE INVENTION

The present invention relates to a nipple for a pacifier, and a pacifier, according to the claims.

In one aspect, a nipple comprising a rubbery material is provided for a pacifier. The nipple comprises a central cavity for receiving a first active agent, and at least a portion of its outer surface (wall, body wall) a plurality of passages connecting the cavity with an external space around the pacifier so that the passages in use of the pacifier the cavity connect with the mouth of a child (infant or infant).

According to a further aspect, a pacifier is proposed, which comprises a nipple according to the first aspect, and a flat shield, to which the nipple is attached.

According to another aspect, a pacifier is proposed. It comprises a nipple, optionally according to the first aspect, and a flat shield to which the nipple is attached, and a replaceable cartridge having an active substance, with at least one opening through which the active substance can be dispensed. A holding element serves to receive the cartridge, wherein the holding element is attached to the suction side facing away from the shield and is designed so that the at least one opening of the cartridge in the use of the pacifier exposed to the nose of the child (infant or small child) out is aligned so that the drug can be delivered in the direction of the nose.

According to a further aspect, a pacifier is proposed which comprises a drug-loadable nipple, optionally according to the first aspect, and a liquid-erodible dosage form. The drug form is provided in the form of a suitable for sucking dosage form, and comprises a first active ingredient. The dosage form is configured to be introduced into the nipple as a refillable element, and further preferably is a composition for use in the treatment of diseases of infants and infants, particularly for the topical treatment of upper respiratory tract disorders of infants and infants.

In another aspect, the use of a dosage form in a pacifier according to the present invention is proposed. In particular, the dosage form is used as a refillable element.

In another aspect, a dosage form for use in the treatment of diseases of infants and infants is proposed. The dosage form comprises at least one active substance. The drug form is erodible with the aid of liquid, and is in a suitable for sucking, solid, single-dose dosage form.

In another aspect, a pacifier is proposed for generating an aerosol. The pacifier comprises a nipple and a nebulizer unit configured to nebulize a liquid, preferably an aqueous liquid.

According to a further aspect, a cartridge for loading a pacifier with active ingredient is proposed. The cartridge includes a cartridge wall enclosing a cavity and at least one opening in the cartridge wall connecting the cavity to an exterior space around the cartridge. The cartridge is adapted to be releasably connected to a pacifier, the cartridge opening after connecting the cartridge to the pacifier being oriented to close to the nostrils of the baby during use of the pacifier is located and aligned to this.

Further features and advantages of the present invention are presented in the following detailed description of preferred embodiments of the system.

list of figures

• 1 zeigt schematisch eine perspektivische Ansicht eines Saugers gemäß Ausführungsformen, für einen Schnuller gemäß Ausführungsformen, sowie eine Detailvergrößerung eines der Durchlässe in dem Sauger;
• 2 zeigt den Sauger der 1 in einer Frontansicht;
• 3 zeigt in einer rückwärtigen Ansicht den Sauger der 1 und 2;
• 4 zeigt eine perspektivische Ansicht eines Schnullers gemäß Ausführungsformen;
• 5 zeigt perspektivisch eine Explosionsdarstellung eines Schnullers gemäß weiteren Ausführungsformen;
• 6 zeigt eine andere perspektivische Ansicht der Explosionsdarstellung der 5;
• 7 zeigt eine auswechselbare Kartusche für bzw. aus einem Schnuller gemäß Ausführungsformen;
• 8 zeigt einen Schnuller mit einer Zerstäubereinheit gemäß Ausführungsformen;
• 9 zeigt eine Explosionsdarstellung des Schnullers der 8.

Other features and advantages of the present invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the appended drawings. Showing:

• 1 schematically shows a perspective view of a nipple according to embodiments, for a pacifier according to embodiments, as well as an enlarged detail of one of the passages in the nipple;
• 2 shows the sucker the 1 in a front view;
• 3 shows in a rear view the sucker of 1 and 2 ;
• 4 shows a perspective view of a pacifier according to embodiments;
• 5 shows in perspective an exploded view of a pacifier according to further embodiments;
• 6 shows another perspective view of the exploded view of 5 ;
• 7 shows a replaceable cartridge for or from a pacifier according to embodiments;
• 8th shows a pacifier with a nebulizer unit according to embodiments;
• 9 shows an exploded view of the pacifier of 8th ,

DETAILED DESCRIPTION

Although preferred embodiments are described below, the scope of the invention is not limited to illustrated embodiments, but also includes embodiments obvious to those skilled in the art.

In the following, more detailed reference will be made to various embodiments of the invention, one or more examples of which are illustrated in the drawings. In the following, unless otherwise stated, the same reference numerals are used for identical and equivalent elements.

According to the present disclosure, a pacifier is a pacifier designed to satisfy the sucking needs of infants (especially infants and toddlers).

Sucker / pacifier with sucker

Generally, embodiments relate to suckers / mouthpieces for pacifiers, or pacifiers for infants (especially for infants and toddlers), with which applied in a novel way one or more active ingredients in / to the mouth, and / or throat, and / or nose area can be. For this purpose, a sucker made of a rubber-like, elastic material is provided, which has a central cavity. In a wall (outer surface, body wall) of the nipple, which simultaneously represents the wall or enclosure of the central cavity, a plurality of passages or perforations are provided. The passages provide a fluidic connection between the central cavity and the exterior around the pacifier.

If an active ingredient, for example in the form of a fruit gum, is present in the central cavity, it comes into contact with the saliva of the child through the passages. The saliva dissolves the active ingredient successively. Through the passages, the drug comes into contact with the mouth of the child through the return of the drug-enriched saliva. It is absorbed or swallowed via the oral mucosa. The instinctive, dynamic suction movement promotes the above process or salivation in both directions - in and out. If the passages are arranged in a targeted manner or in a focal point in certain regions of the nipple, for example in the area close to the palate, and / or a region facing the tongue, and / or the region close to the nasal cavity, it can be ensured that the active substance is focused in the region concerned and operates there. The cavity is thus configured to receive a first active substance. The cavity is further configured so that liquid can only pass through the passages into the cavity.

In embodiments, the passages are conical, that is, their outer opening has a significantly larger diameter than the inner opening facing the central cavity with the active agent. This allows for a given number and surface density (number of passages per unit area) of the passages to increase the contact surface with the oral mucosa. Depending on the active ingredient, its water solubility and the desired administered dose, this may be useful to achieve the application of the desired dose in an acceptable period of time at all. The conically shaped passages are particularly useful in solid forms of the drug, as they also prevent about fragments of the drug or drug body (dosage form), such as a tablet, undesirably get out of the cavity of the teat into the mouth of the child.

To introduce the active ingredient in the central cavity, the sucker has a kind of valve. This can be provided in the form of a passage passage, for example as a slot (preferably as a cross-slot), in a - remote from the mouth of the child during use - back wall of the teat. This reduces the risk that the drug form, or fragments of it, will not accidentally get into the child's mouth, which in extreme cases may lead to an unwanted swallowing with following respiratory disturbance. Especially with an opening for drug loading in a - during use the mouth of the child facing - area of the teat unwanted ingestion of at least fragments of the dosage form due to incorrect insertion of the dosage form and depending on the fragility of the dosage form is quite possible. A drug coating applied to the outer suction wall (ie, the suction wall facing the child's mouth during use) is even less suitable for the reasons given above because larger pieces of the coating detach themselves from the wall of the teat as a result of the suction movement and thus penetrate into the Can reach the child's mouth. In embodiments, the above-mentioned passage passage is designed as a purely structural modification of the (wall) material of the nipple. This facilitates the manufacture of the nipple, makes it less expensive, since no additional material has to be processed, and further prevents the occurrence of possible breakages (as might be the case with the use of a slider or a flap made of a different material). In addition, the special structure of the nipple, and in particular the remote from the child's mouth back wall (surface 45 ) with valve that the sucker forms a cavity that is surrounded only by suction walls. If you now fill this cavity with a solid drug form, this comes only with the walls of the cavity, but with no other pacifier component in contact, such as the shield, the pacifier cap oa .. Since the sucker - when used in a pacifier - preferably detachably detachable from it, it can be cleaned independently of all other pacifier components (for example, boiled and sterilized). During this time, the rest of the pacifier body, ie shield and cap can be used with another sucker, which can be used, for example. With another active ingredient. In short, the provision of a suction back wall 45 and the fact that the nipple from the shield is solvable to a synergistic effect: the remainders of saliva dissolving dosage form are only on the nipple (in the cavity 15 and the outer surface of the mouth), but no other dummy component. This "dirty" sucker can be removed from the rest of the pacifier and clean if necessary (boil and sterilize). The rest of the pacifier can be used independently of the "dirty" nipple with another nipple. This is especially helpful at night for stressed parents, as the cleaning, as well as the (urgently needed in infants) sterilizing the nipple can wait. You can comfortably use the pacifier if necessary. With another dosage form: Simply disassemble the "dirty" sucker and mount a new sucker. If remnants of the dosage form also come into contact with other parts, such as the pacifier cap, the entire pacifier must be cleaned and thus can not be reused.

The passage allows passage of an active substance, such as a fruit gum, in the teat or its central cavity. At the same time, the passage passage prevents the escape of liquid, ie saliva or active ingredient or a mixture of both, from the nipple or through the shield in the rear part of the pacifier.

The nipple, ie the mouthpiece of the pacifier, is typically connected to a label (releasably) in use. The sucker can thus be separable from the shield so that it can be cleaned individually, e.g. by decoction. Also, it can be replaced as a single item. Furthermore, it is conceivable to provide different, replaceable pacifiers for a pacifier in order to achieve the greatest possible flexibility in the treatment of various diseases. Preferably, a nose attached to the nipple prevents the nipple from rotating relative to the shield (tongue and groove principle). The sign should also prevent the swallowing of the mouth part. The shield may according to embodiments have any known in the prior art forms. For example, the shield may have a butterfly-like shape. The shield may have at least two through holes, which is beneficial for ventilation.

According to the present invention, the nipple may be made of latex and / or silicone and / or a rubber-like material. In principle, the mouthpiece of the nipple may have any shape. Thus, for example, the mouthpiece may have a round cherry shape, or the anteriorly beveled, the oral cavity adapted palate shape.

In embodiments, the pacifier is provided with a retainer or retainer for a replaceable cartridge. The retaining element is mounted on the opposite side of the sucker of the shield. The cartridge is designed to receive a (preferably) liquid (second) active substance. On one side, the cartridge has at least one opening, which is aligned after insertion of the cartridge in the holding element so that it is located near the nostrils of the child and is aligned therewith. If a cover or a closure is removed, the second active ingredient evaporates at room temperature through the at least one opening and is discharged in the direction of the nose. In this way, volatile compounds, e.g. an essential oil for the relief of cold symptoms. The cartridge can be fixed in place by means of a cap which is placed on the holding element. The cap may also be releasably connectable to the retaining element by means of a locking mechanism which requires a combination of at least two simultaneous or sequential movements. For example, the cap can be releasably connected to the holding element by means of a push-turn closure. In particular, the cap can be fastened to the holding element by means of a rotatably detachable bayonet closure, which can not be opened by small children. This is a parental control against accidental loosening / opening and prevents injury from loose parts or their ingestion.

The suckers according to embodiments are similar in shape and design to commercial pacifier suckers. Accordingly, according to embodiments, the nipples may have an axial extent of from about 1.5 to about 3.5 cm, typically from about 2.5 to 3.2 cm (measured from the nipple tip to the shield). The nipple has a transverse axis, which is perpendicular to the longitudinal or axial axis of the nipple, and in the use state of the pacifier parallel to a connecting line of the mouth angle of the wearer of the pacifier. In the direction of the transverse axis, the nipple can have a width of 1.5 cm to about 2.8 cm, typically 1.8 to 2.3 cm, at its widest point, which is usually in use in the mouth during use. An applying child thus sees little or no difference to his usual pacifier. Through the controlled, relatively slow (sustained release) delivery of both the first active ingredient 17 Through the nipple or the second active ingredient on the cartridge longer lasting (prolonged and / or retarded) drug delivery is possible, for example, over several minutes / hours. Thus, no waking up of the child is usually necessary to perform a pacifier exchange, because an active ingredient is consumed.

1 shows a sucker 10 according to embodiments for a pacifier 1 , The nipple comprises a rubbery material, such as silicone, rubber, latex, or similar materials. The nipple has a central cavity 15 for receiving a first active substance 17 on. In at least part of its outer surface 25 (Sucker wall) it has a plurality of passages 30 on. These provide a fluidic connection of the cavity 15 with an outdoor space 35 around the nipple dar. In use state of the nipple 10 or a pacifier equipped with it connect the passages 30 the cavity 15 with the mouth of a child (especially baby or baby).

To the sucker 10 with a first active ingredient 17 To load, the sucker points to a in use state with the palate, tongue and lips of the child not coming into contact surface 45 (Wall) a passage passage 50 on. For example, the teat may be attached to a surface 45 (wall 45 ) a passage passage 50 exhibit. The sucker 10 However, it is also possible, for example, to pass through a passage 45 located in the mouth during use 50 have, wherein the area 45 in use does not come into contact with the palate, tongue and lips. The area 45 thus represents a kind of inner wall of the nipple and is preferably constructed of the same material as the rest of the nipple. The area 45 is (in both alternatives mentioned above) liquid-tight in the normal state and can by mechanical pressure from the outside - for example, by a manually pressed against it tablet with the first active ingredient 17 - be opened temporarily. The first active ingredient 17 is typically performed generally as part of a solid dosage form, such as a lozenge. The dosage form with the first active substance 17 is doing manually through the passage passage 50 in the cavity 15 introduced. Typically, the passage is passage 50 as a purely structural modification of the rubbery material of the nipple 10 executed. This can be about a slot as in 1 sketched, (and in particular a Phillips). The slot (or cross slot) can be designed with partially overlapping walls, which increases the tightness. Passage passage 50 typically has an extension (length) of 0.5 cm to 1.5 cm, more typically from 0.7 cm to 1.2 cm. As a result, a solid dosage form can be conveniently and easily brought into the central cavity.

In 2 is a front view of the nipple of the 1 shown with passages 30 at a top and bottom of the mouthpiece 60 of the teat 10 , 3 shows a passage passage 50 in a plane 45 of (preferably round) tail 55 is provided. The tail 55 used for attachment to a sign 20 , The part of the teat at least partially in the mouth of a child during use 10 is the mouthpiece 60 , In certain embodiments, the passages 30 may only be in certain areas of the mouthpiece 60 , or focused or reinforced in certain areas of the mouthpiece 60 be provided. It is between an upper area 61 which rests on the palate in use, and a lower portion 62 , which rests mainly on the tongue in use, distinguished. Because of the usually asymmetrical in at least two dimensions design of the mouthpiece 60 the following can be considered as a distinction between the two areas mentioned above: one passage 30 belongs to the upper area 61 if the normal vector 63 the outer surface 25 at the position of the passage 30 a component in the direction of the lower area 62 (tongue-near) to the upper area 61 (palate-close) has. On the other hand, there is a passage 30 to the lower area 62 if the normal vector 63 the outer surface 25 at the position of the passage 30 a component towards the top 61 (near the palate) to the lower area 62 (tongue-near) has. An example of such a normal vector 63 for a passage 30 in the upper area 61 is in 2 shown.

As an alternative to the above-mentioned geometric definition, depending on the specific case, the purely functional distinction may also be expedient, according to which the following assignment applies: Is an aperture 30 In the typical usage mode palate-facing or in contact, he belongs by definition to the upper area 61 , is a passage 30 tongue-facing in typical usage mode or in contact with it, it belongs by definition to the lower area 62 , passages 30 at the throat-side end and the tip of the teat 10 may suitably be assigned according to the above geometric definition, since in use they have neither contact with the palate nor the tongue or can not be unambiguously assigned to it.

The central cavity 15 of the teat 10 is thus defined as that space which is limited by a) the inside (ie the side facing away from the palate or tongue) of the wall of the mouthpiece 60 and b) the inside (ie, in the direction of use pharynx facing side) of the wall of the surface 45. Will the drug form with the first active ingredient 17 through the passage passage 50 in the cavity 15 introduced, the dosage form is freely movable within the central cavity, that is, that the dosage form does not cover the entire space of the central cavity 15 occupies. This promotes the play instinct of the child, stimulates the production of saliva and thereby increases the fluid removal from the mouth and throat, which is beneficial for colds, for example.

In embodiments, the nipple 10 a total of three to one hundred and fifty ( 3 to 150 ), typically four to a hundred ( 4 to 100 ), typically ten to eighty ( 10 to 80 ), more typically twenty to sixty ( 20 to 60 ) Have passages 30. Thus, the present nipple is not suitable for liquid dosage forms, as they are delivered too quickly in the mouth and throat, which in extreme cases can lead to an unwanted ingestion with the following breath disorder. Nor is a teat with only one or two passages basically not suitable for solid dosage forms (eg lozenges or similar). First, it would take too long to dissolve the dosage form, on the other hand, the release of active ingredient through only one or two openings is not effective in the local treatment of oral and pharyngeal diseases. The passages 30 can typically be both in the upper range 61 (ie in the typical use mode palate-facing) as well as in the lower area 62 (that is tongue-facing in typical usage mode). Typically, in the upper area 61 as many passages 30 are provided as in the lower area 62 , so each area typically two to fifty ( 2 to 50 ), more typically five to forty ( 5 to 40 ), more typically ten to thirty ( 10 to 30 ). Alternatively, the upper area 61 and the lower area 62 but also different numbers of passages 30 depending on the active ingredient used and indication. The provision of passages both in the upper and in the lower area allows a defined drug release of the first drug 17 from the dosage form, as well as an evenly distributed throughout the mouth and throat area drug delivery, and thus an optimized effect of the first drug 17 at the site of action. In particular, passages in the upper and lower portions of the teat allow saliva to flow from opposite teat sides into the central lumen and, due to the suction motion of the child, completely wet the dosage form. This regularly leads to a defined dissolution of the dosage form, and thus to a defined release of active ingredient of the first active ingredient 17 from his drug form. At the same time, the reflux of the drug-enriched saliva over both areas 61 and 62 carried out, resulting in the above-mentioned evenly distributed drug delivery throughout the mouth and throat area. As a theoretical example, an erodible dosage form (such as. A throat tablet or a fruit gum) is mentioned, which is washed with saliva from all sides, which due to the defined contact surface between saliva and drug form to a uniform erosion of the dosage form and thereby to a defined drug release in leads the central cavity. The reflux of the drug-enriched saliva occurs over both areas 61 and 62 and thus ensures a uniformly distributed drug delivery throughout the mouth and throat area. One would only have the passages on one of the two areas 61 or 62 provide, it would - either using the same drug concentration - less active ingredient per unit time in the central cavity are released (risk of underdose), or you would have to increase the drug concentration in the drug form, which can cause problems in the preparation on one hand (eg lower dimensional stability, etc.), but may also result in an altered composition of the dosage form. For example, a higher level of masking agent may be required to adequately mask the taste of the drug. Furthermore, the reflux of the drug-enriched saliva would only be via one of the two areas 61 and 62 take place, which leads adversely to the fact that the active ingredient is released either exclusively on the tongue side or exclusively on the palate side.

In embodiments, the passages 30 typically arranged at a generally uniform distance from one another. The passages 30 may typically have a generally circular cross-section. This show the passages 30 typically a uniform cross-sectional size, that is, all the passages have the same cross section. Alternatively, however, different cross-sectional sizes may be used, for example, depending on their location on the outer surface 25 are selected. The passages 30 can in principle have any shape. For example, they may be cylindrical, conical, cuboidal, cube-shaped, or combinations thereof (as a non-limiting enumeration). Furthermore, the passages may have a uniform shape, but alternatively, different shapes may be used. In particular embodiments, at least a portion of the passages 30 be cylindrically shaped. For example, all the passages 30 be cylindrically shaped. This simplifies the production of the nipple and thereby reduces the production costs. Alternatively, at least a portion of the passages 30 be conically shaped. For example, all the passages 30 be conical, or only a portion of the passages 30 conical and the rest of the passages 30 be cylindrically shaped. Conically shaped passages 30 mean that the proximal to the cavity 15 of the teat 10 located inner opening 31 the conically shaped passages 30 have a diameter d1 which is less than the diameter d2 of the distal to the cavity 15 of the teat 10 (ie outside) located outer opening 32 , see enlarged illustration in the 1 , The inner opening 31 the conical passages 30 has at least one 30 Percent smaller diameter d1 than diameter d2 the outside opening 32 , more typical at least one 50 Percent smaller diameter. The diameter d2 is typically 0.1 mm to 1 mm, more typical 0.2 mm to 0.8 mm, more typically 0.3 mm to 0.6 mm. The conical shaped passages allow to increase the contact surface with the oral mucosa. Depending on the active ingredient, its water solubility and the desired administered dose, this may be useful to achieve the application of the desired dose in an acceptable period of time at all. On the other hand, the conically shaped passages prevent - despite the large contact area with the oral mucus - too large fragments of the drug form, such as a tablet, undesirably get out of the cavity of the nipple into the child's mouth, resulting in an unwanted swallowing in extreme cases with the following breath disorder. This is particularly useful for those solid dosage forms that form particularly hard and sharp fragments during erosion, which is why even very small fragments of it can be a danger to the child. Typically, cylindrically shaped passages have a cross-sectional diameter of from 0.1 mm to 1 mm, more typically from 0.2 mm to 0.8 mm, more typically from 0.3 mm to 0.6 mm.

In embodiments, the passages 30 be arranged in a variety of patterns. So can the passages 30 for example - without prejudice to their provision both in the upper range 61 as well as in the lower area 62 - in some parts of the outer surface 25 amplified, while in other parts of the outer surface no passages 30 available. In a particular embodiment, the sucker 10 in the part which rests on the so-called lip bow of the child, no passages 30. This prevents the active ingredient from being delivered to the lips of the sucking child, which, depending on the active substance, could lead to irritation, but at least loss of active substance to areas of the mouth which should not be treated at all. In a further particular embodiment, which can be combined with the aforementioned embodiment, the sucker 10 for example, a plurality of passages 30 at the throat-side end and the tip of the teat 10 on. That is, the passages 30 are located only on the throat-side end and the tip of the teat 10 while the rest of the nipple has none, or alternatively, fewer passages 30 having. In the latter case, therefore, at the atrial end or at the tip of the nipple 10 a larger number of passages 30 per outer surface unit of the nipple 10 provided as in the remaining part of the nipple 10 , This leads to an increased release of active ingredient in the back of the oral cavity, that is in the transition from the hard palate to the soft palate or in the throat. These sections of the upper respiratory tract, for example, are affected by a so-called "acute pharyngitis" and can thus be treated efficiently and specifically. As an alternative to the aforementioned embodiments, the sucker 10 only in the part of the teat 10 , which rests on the so-called dental arch, a plurality of passages 30 exhibit. This can be used to bring appropriate active ingredients (such as the local anesthetic lidocaine) specifically to the so-called teething caused by gingivitis, without coming into contact with other areas in the mouth and throat.

Through a targeted combination of parameters such as size, shape, position, total number and area density of the culverts 30 on the outside surface 25 of the teat 10 can better control the drug release of the first drug 17 be reached in the mouth and throat area. Thus, depending on the position and area density of the passages 30 in certain parts of the teat the first active ingredient 17 targeted and concentrated at the desired site of action are delivered. So this is a kind of local "drug-targeting". One benefit of this is that those areas of the mouth and throat that are healthy and need no treatment do not even come into contact with the drug to cause any damage. On the other hand, the "diseased" areas of the mouth and throat (ie those areas that are reddened, swollen, attacked by bacteria, inflamed, etc.) are targeted and concentrated (ie treated with a high concentration of active ingredient at the site of action). The size and shape of the passages 30 On the other hand, it influences, among other things, the dissolution rate of the (solid) pharmaceutical form and thus indirectly also the release of active ingredient of the first active substance 17 from his drug form. For example, using passages 30 of generally circular cross-section having smaller diameters (eg, 0.1 mm), less saliva per unit time enters the central cavity of the nipple 10 , resulting in a slower dissolution of the (solid) dosage form and thus a delayed release of active ingredient of the first active ingredient 17 from his drug form leads. At the same time, the reflux of drug-enriched saliva is slowed down by such "narrower" passages, which in turn results in delayed drug delivery to the site of action. The interaction of the aforementioned parameters thus allows a tailor-made treatment of diseases of the upper respiratory tract of infants (preferably of infants and young children), depending on the active ingredient, dosage form, indication, etc.

In a particular embodiment, the nipple may typically be an end piece 55 for attachment to a shield, as well as a mouthpiece 60 include. The mouthpiece typically represents that part of the teat which is designed for the mouth of the child, which is therefore completely enclosed in the use state of the teat by the mouth (including the lips). In this particular embodiment, the mouthpiece may typically include a nipple neck and a nipple body. Of the Nipple body is that part of the mouthpiece which, in use, is substantially enclosed by the oral cavity and the dental arch of the child. The nipple neck is that part of the mouthpiece which, in use, is substantially enclosed by the child's lips. The nipple neck thus provides the connection between the tail 55 and nipple body. Typically, in this particular embodiment, the nipple has the face (back wall). 45 not (as in 1 and 3 shown and described above) in the end piece 55, but in the nipple neck on. As a result, less active substance is "lost" on the suction inner walls, which leads to greater dosing accuracy. The surface (back wall) 45 structurally corresponds to surface 45 as described above. So it has a valve in the form of a passage passage 50 which is designed so that it is liquid-tight in the normal state, and through which the active ingredient 17 as part of a solid dosage form in the cavity 15 , In particular, can be introduced as a refillable element. Typically, the passage passage is thereby a purely structural modification of the rubber-like material of the nipple 10 executed. In this particular embodiment, the passages are typically provided only in the region of the nipple body. As a result, the active ingredient only reaches the oral mucosa (palate and tongue) but not the lips. The end piece (which is preferably a round end piece) in the use state of the nipple is typically connected to a shield, preferably releasably detachable. The nipple can thus be separated from the shield, so that it can be cleaned individually, for example by boiling. Also, it can be replaced as a single item. Furthermore, it is conceivable to provide different, replaceable pacifiers for a pacifier in order to achieve the greatest possible flexibility in the treatment of various diseases.

In embodiments of a pacifier 1 can the sucker 10 according to embodiments with a shield 20 be combined, as in 4 shown. At the flat sign 20 which may have openings for better ventilation of the skin is the sucker 10 attached.

Pacifier with cartouche / cartridge

In other embodiments, a pacifier (preferably the above pacifier 1 of the 4 ) provided with a replaceable cartridge 70 is provided. This is schematically as an exploded view in 5 shown, with the cartridge 70 here as an example two openings 71 having. The cartouche 70 comprises a second active ingredient 18 that has at least one opening 71 can be delivered. The cartridge is in a holding element 75 held or provided, which s.der the sucker 10 opposite side of the shield 20 is appropriate. The holding element 75 is designed so that the opening (s) 71 of the cartridge 70 in use state of the pacifier 1 exposed to the nose of the toddler (infant or infant). For this purpose, the holding element may have a recess on a part of its circumference as in 6 shown. In this way, located in the cartridge second active ingredient 18 , as evidenced by evaporation or evaporation in the direction of the nose. The cartouche 70 in embodiments has a closure to be removed prior to use 72 the openings 71 on, which may be designed as a tear-off foil (non-limiting), or as a cap as in 5 shown schematically. Other possible closure forms are known to those skilled in the art and are considered to be within the scope of the disclosure. Furthermore, the opening (s) can (can) 71 the cartouche 70 be designed so that no liquid can escape from the cartridge (ie can escape in liquid form). This may typically be achieved by a corresponding orifice size (eg, a corresponding diameter for a circular opening cross-section) at which the liquid is retained by the surface tension. Alternatively, a polymer can be used to "seal" the opening (s) 71 be provided, which is gas permeable and liquid impermeable. Such polymers are known to those skilled in the art and are considered to be part of the disclosure.

As in 5 and 6 illustrated, includes the pacifier 1 in embodiments a preferably cap-shaped conclusion 80 , This is for interacting with the retaining element 75 designed so that the cartridge 70 is kept stable between. In particular, the degree may 80 a fixing mechanism on the cartridge 70 produce. This is the conclusion 80 typically for engagement with the retaining element 75 designed. The conclusion 80 can with the holding element 75 through a bayonet lock 85 be releasably connectable. The bayonet lock 85 is typically occlusable and releasable by rotation through an angle of a few degrees, say 5 degrees to 30 degrees. To stabilize the closure, in the cap-shaped closure 80 a feather 90 and a pressure ring 95 be provided. These generate a compressive force that causes a twist of the conclusion 80 inhibits. This also reduces the risk of unintentional release. In addition, the closure is not operable by infants and babies and thus represents a child safety.

According to embodiments, the pacifier 1 with a sucker 10 , as in 1 f , shown, equipped, as well as with the cartridge 70 as described above. In other embodiments, a pacifier with a conventional nipple, that is, without passages 30, may be associated with the cartridge 70 and the holding system. In other embodiments, such as in 5 shown, the sucker are the 1 and the cartridge or its holding system combined.

For use with the nipple 10 of the 1 Thus, a solid drug form is typically provided, which is a first active ingredient 17 includes. The dosage form is typically provided in a lozenge-like dosage form. It thus serves as refillable element with a first active ingredient 17 that in a sucker 10 for a pacifier 1 can be used, such as in 1 shown. The second active ingredient 18 is for use in the cartridge 70 (see also 7 ) intended. He is chosen to achieve a soothing effect for cold symptoms of the nose by evaporation. Typical would be here about essential oils. For example, in the case of infants and toddlers, fungal oil (Nigella sativa), camomile oil (matricaria chamomilla), pine needle oil (picea abies), angelica (angelica archangelica) and eucalyptus oil (oleum eucalypti) are used. For example, a commercially available oil mixture for infants and toddlers is Babix®, a blend of pine needle and eucalyptus oil.

The cartridge according to the invention 70 can be refillable, or typically designed as a replaceable disposable cartridge. The cartridge is preferred 70 designed as a replaceable disposable cartridge. This is because: The use of essential oils in infants and toddlers is not without controversy. Thus, not every essential oil is suitable for every age and every child. For example, the use of 1.8 cineol (for example in eucalyptus oil) in infants is less 6 Months controversial, as this ingredient triggers the tough mucus of the respiratory tract, infants under 6 Months but can not reliably cough up. In addition, due to hyperemia, the sensitive bronchial mucosa of infants may swell, which can lead to a life-threatening respiratory distress, depending on the "sensitivity" of the infant.

For the above reasons, there is a great deal of uncertainty among many parents as to which essential oils are suitable in which concentration and duration of use, for which age groups and which indication. Therefore, the use of essential oils is often completely dispensed with. Even those parents who are open to treatment with essential oils often do not know what dosage of a given oil will fit which age group. Commercially available oil mixtures can not provide any assistance, since they usually give no such recommendations. Even if parents were advised on the correct dosage of a particular oil mixture (with medical help, etc.), the dripping of the oil on a carrier medium, for example, the child's clothing with many disadvantages. So it can happen, especially at night, and under stress, that despite advice wrong dosage. In addition, the clothing of the child is dirty, or it requires an additional carrier medium for the oil, for example. A Wattebauschs. After opening the bottle, the oil has only a limited shelf life. The child's clothing and pacifier components in contact with the oil must be cleaned in one additional step. These and other disadvantages are eliminated by providing a replaceable disposable cartridge.

Thus, in another aspect, there is provided the use of a disposable replaceable cartridge in a pacifier, optionally in a pacifier according to the present invention. After consumption of the second active ingredient 18 in the cartouche 70 can the cartridge 70 thus against a new, filled cartridge 70 be replaced. This has, among other things, the advantage that - for certain indications and age groups - tailored single doses can be provided.

The change of the cartridge 70 can, for example, through the bayonet lock 85 , be made even if the pacifier 1 is in the child's mouth. A twist lock with safety stopper is an alternative push-turn closure and is considered to be part of the disclosure. Other types of closure or variants of the holder of the cartridge 70 are also possible and are considered to be part of the revelation. It should be noted, however, that, for example, the bayonet lock is a parental lock, as it is in principle not possible for infants and toddlers to perform the relatively complicated pressure and rotational movement. This also applies mutatis mutandis to the screw cap with safety stopper. In contrast to the aforementioned closure variants would be a simple screw between the cap-shaped closure 80 and the holding element 75 pose a risk. For example, infants of nearly 2 years could easily open such a screw cap. The reliability of a screw cap depends heavily on the force and angle at which the thread is twisted. Especially at night, and under stress, it may happen that the screw cap is twisted incorrectly (ie with too little force or a slightly offset angle). This could lead to an opening of the closure by the child, whereby items of the closure or the cartridge itself could get into the child's mouth and be swallowed. It is important to avoid this.

In embodiments, therefore, a cartridge is provided. The cartridge is typically configured to load a pacifier with drug. The cartridge includes: a cartridge wall enclosing a cavity and at least one opening in the cartridge wall which typically connects the cavity to an exterior space around the cartridge. The cartridge is typically configured to be releasably connected to a pacifier. The opening of the cartridge, after connecting the cartridge to the pacifier, is typically oriented so that, in use, the pacifier is in proximity to and aligned with the child's nostrils.

The cavity of the cartridge may contain a composition that is typically a semi-solid or liquid composition. The composition may contain at least one lipophilic, typically volatile mixture. The mixture of substances may be an essential oil. When filled to the maximum with the composition, the cartridge has a weight of 1g to 7g , prefers 2g to 6g , more preferably 2.5g to 5g on. For cartridges with a larger than imminent weight compliance is very bad, as the total weight of the loaded pacifier reaches a limit that is no longer accepted by the children. Lower weight cartridges may not contain enough fluid for proper therapy. Typically, the oily liquid may comprise at least one therapeutic agent which may be delivered via the at least one port and, in the use state of the pacifier, via the nose into the respiratory tract of the infant. The essential oil may typically be selected from the group consisting of tincture oil (Nigella sativa), chamomile oil (Matricaria chamomilla), pine needle oil (Picea abies), angelica (Angelica archangelica) eucalyptus oil (Oleum eucalypti) and combinations thereof.

As described above, the at least one opening of the cartridge is typically designed such that no liquid can escape from the cartridge. Furthermore, the cartridge may comprise a removable closure which closes the at least one opening in a liquid-tight (in particular hermetic) manner.

The cartridge according to the invention has a maximum spatial extent, which is characterized in that the cartridge can be completely enclosed by an imaginary hollow sphere with a radius of 1.5 cm. Typically, there is no point of contact and / or intersection between the sphere surface and the cartridge. Cartridges that transcend the impending spatial expansion are perceived by the child as sterically disturbing and "pacifier-alien". In addition, such oversized cartridges interfere with the child's vision and affect the weight of the loaded pacifier (see above). The cavity of the cartridge typically has a volume of 0.5 ml to 3 ml, preferably 1 ml to 2 ml. The cartridge wall contains plastic or aluminum. Typically, the plastic is selected from PE, PET, PVC, PS, PP, PA and / or PC, preferably PE and / or PET. The cartridge wall may be made of plastic, preferably made of PE and / or PET, or of aluminum, or may consist of the aforementioned materials.

Thus, in light of the above, embodiments pertain to the use of a pacifier to deliver upper respiratory tract (typically mouth, throat and nose) to infants and toddlers (children aged 0 to 2 years). In other words, embodiments relate to a pacifier for use in the treatment of upper respiratory tract (typically the mouth, throat and nose) disorders of infants and infants (children aged 0 to 2 years). The pacifier according to the invention makes it possible to deliver active substances both to the nose and to the mouth / throat. This can be done simultaneously or sequentially as needed.

Dosage Form (Drug Composition)

Further, embodiments relate to a liquid form (ie, saliva) erodible (ie, dissolvable) dosage form typically configured for a pacifier comprising a drug-loadable nipple. The dosage form is provided in the form of a dosage form suitable for sucking (for example in the form of a lozenge), and comprises a first active substance 17 , The drug form is designed so that it can be introduced as a refillable element in the nipple. That is, the dosage form has the required dimensions and properties to enter the teat of the Pacifier to be introduced. The required dimensions and properties of the drug form depend essentially on the particular configuration of the nipple, and in particular of the respective mechanism for introducing the pharmaceutical form. For example, in the nipple of the present invention, the passage passage 50 the course, whether a dosage form in the teat 10 can be introduced or not. The dosage form is also typically a composition for use in the treatment of diseases of infants and infants, and more particularly for topical (local) treatment of upper respiratory tract disorders in infants and infants. Typically, the dosage form is a solid dosage form such as a lozenge, chewable tablet, sublingual tablet, buccal tablet, dragee, capsule, candy, fruit gum, gum candy, jellybean, marshmallow candy, gumdrop and combination thereof. Typically, the dosage form is not in the form of homeopathic globules or as a coating on the teat wall.

Thus, embodiments of the present invention also relate to a dosage form (drug composition) in a suitable form for sucking, typically for use in the treatment of diseases of infants and infants, in particular for the topical (local) treatment of upper respiratory tract disorders in infants and infants. The dosage form is typically a solid (preferably single dose) solid dosage form (typically liquid, especially saliva), especially for prolonged oral cavity residence time for use in the treatment of infants and infants. In other words, the dosage form according to the invention is a dosage form which can be dissolved by sucking (with the aid of saliva). Typically, the dosage form is therefore for the treatment of children in the 1 , and 2 , Year (ie for the treatment of children up to and including 2 years). By "length of stay in the oral cavity" is meant the time required to completely dissolve the dosage form in the oral cavity, typically by sucking with the aid of saliva. Typically, the time to completely dissolve the dosage form of the invention in the oral cavity is about 1 to about 30 minutes, more typically about 2 to about 25 minutes, even more typically about 5 to about 15 minutes. The residence time in the oral cavity can be determined by reference to corresponding dissolution tests described in pharmacopoeias.

The dosage form according to the invention is intended for use in the treatment of diseases of infants and young children. Typically, the dosage form according to the invention is a dosage form suitable for the topical treatment of diseases of the upper respiratory tract. Upper respiratory tract disorders are typically cough, catarrh, mucosal irritation in the upper airways, and / or inflammatory diseases of the oropharynx, i. Oral and pharyngeal inflammation, such as sore throat, throat scratching, hoarseness, dry throat and / or gingivitis. These diseases often occur as a concomitant of cold and flu infections, but also as independent diseases. Non-limiting examples of such inflammatory diseases of the cervical area are throat inflammation, especially angina, laryngitis, pharyngitis, and tonsillitis. Such diseases of the throat / throat are often accompanied by dysphagia. Also inflammations in the area of the oral cavity, such as Stomatitis, gingivitis, oral mucosal lesions, inflammation caused by teething and the like, have a very unpleasant symptoms for children and are included in the invention. Typically, the dosage form has a weight of from 200 mg to 1000 mg, preferably from 300 mg to 700 mg.

The dosage form according to the invention typically contains a first active ingredient 17 , The first active ingredient 17 is typically selected from the group consisting of topical antibiotics, topical anesthetics, antiseptics, expectorants, anticariogenic agents, mucous drugs and their extracts, tanning drugs or their extracts, and combinations thereof. Other possible drug classes for the drug are antitussives, anti-inflammatory drugs, analgesics, and glucocorticoids. An exemplary local antibiotic is tyrotricin, preferably used in combination with lactoferrin and lysozyme. Non-limiting examples of local anesthetics are benzocaine or lidocaine. Non-limiting examples of local antiseptics are octenidine, chlorhexidine, triclosan, dequalinium chloride, cetylpyridinium chloride, hexamidine diisethionate, amylmetacresol, 2,4-dichlorobenzyl alcohol, benzalkonium chloride. Expectorants are medicines that liquefy the mucus in diseases with tough mucus formation, promote the removal of the mucus or facilitate expectoration. Non-limiting examples of expectorants are bromhexine and its metabolites ambroxol, acetlycysteine carbocysteine, and / or guaifenesin. Non-limiting examples of mucous drugs are ribwort plantain (Plantago lanceolata L), Icelandic moss (Lichen islandicus), marshmallow (Althaea officinalis L.), mallow (Malva sylvestris L. and M. neglecta TRUE), boxhorn clover (Trigonella foenumgraecum L.), Salep and quince (Cydonia oblonga MILL.) and their combinations, preferably plantain (Plantago lanceolata L.). Non-limiting examples of tannin drugs are pelargonium, blackberry (Rubus fructiosus), Oak (Quercus rubor and / or Quercus petraea), goose fingerwort (Potentilla anserina), cloves (Szygium aromaticum), blueberry (Vaccinium myrtillus), myrrh (Commiphora molmol), ratanhia (Krameria triandra), sage (Salvia triloba), blackthorn (Prunus spinosa), nettle (Lamium album), tormentil (Potentilla erecta), strawberry (Fragaria vesca), ormening herb (Agrimonia eupatoria), lady's mantle (Alchemilla xanthochlora), rose (Rosa gallica), meadow button (Sanguisorba officinalis) and their combinations. Also, the ingredients of drug drugs such as ivy, peppermint, thyme, primrose, fennel, anise, ginger, or combination thereof may be used as the active ingredient.

The concentration of the first active substance 17 in the dosage form according to the invention can vary within wide ranges, depending on the active ingredient and age of the child. In general, the dosage form according to the invention contains the first active ingredient 17 in a therapeutically effective amount, in particular from 0.05 to 30% by weight, typically from 0.1 to 20% by weight, more typically from 0.2 to 10% by weight, more typically from 0.5 to 5% by weight. -%, based on the total weight of the dosage form. Nevertheless, depending on the application, it may be advantageous or necessary to deviate from the aforementioned quantities. The respective amounts of a particular active ingredient are those skilled in the art, for example from relevant textbooks (such as Dietmar Wigger et al., Pediatrics, Elsevier Urban and Fischer, Munich 4th edition, 2013 ) known.

The dosage form according to the invention typically comprises a matrix. The active substance is typically embedded in the matrix according to the invention in the dosage form. In particular, the matrix is a solid, in particular when sucking and / or saliva dissolvable matrix. The matrix is in the dosage form according to the invention typically in amounts of 70 to 99.05 wt .-%, more typically 80 to 99.9 wt .-%, still typistically 90 to 99.8 wt .-%, more typically 95 to 99.9 Wt .-%, based on the total weight of the dosage form.

In particular embodiments, the matrix comprises a hydrocolloid, especially those selected from the group consisting of starch, cellulose, pectins, gum arabic, galactomannans, carubin, agar, carrageenan, alginates, gelatin, caseinates, xanthan, dextrans, scleroglucan, and combinations thereof.

In particular embodiments, the dosage form according to the invention has elastic and / or plastic properties. In this case, the dosage form generally has elastic properties when they change their shape under the action of force and can return to the original form when the acting force ceases. The dosage form has plastic properties if it is irreversibly deformed when force is applied after exceeding a yield point and this shape is retained after exposure. Typically, the dosage form may exhibit nonlinear elastic behavior, in particular rubber elasticity.

In particularly preferred embodiments, the dosage form has a Shore A hardness of 1 to 30 , more typical of 2 to 25 , more typical of 5 to 15 on. The Shore hardness A is typically determined according to DIN ISO 7619-1 standard. Since the active ingredient has no significant influence on the Shore hardness A, it can also be said that the matrix has a Shore A hardness of 1 to 30 , more typical of 2 to 25 , more typical of 5 to 15 having. If the Shore A hardness is too small, the cohesion of the dosage form is not guaranteed and causes the drug form loses its shape instantaneously under pressure (chewing movements) and dissolves too quickly (as for example with pure gelatin). Too high a shore hardness A leads to a bad "mouthfeel", and ultimately to the rejection of the dosage form by the child. The abovementioned hydrocolloids may in principle impart to the dosage form their typical characteristic properties, for example their rubber-elastic consistency (and in particular the low Shore A hardness). In addition, however, plasticizers can also be added in order to achieve the rubber-elastic behavior (and in particular the Shore hardness A).

Due to their elastic and / or plastic properties, and in particular due to their low Shore hardness A, the dosage form according to the invention is optimally suitable for use in a teat of a pacifier which can be loaded with active substance. Thus, the drug form according to the invention can optimally compensate for the pressure caused by the sucking and chewing movement of the child without it having a disturbing effect on the child. This is particularly advantageous, for example in comparison to conventional lozenges (such as Dolo-Dobendan® throat tablets) and neck pastilles with a higher Shore A hardness (such as "Ipalat®) mild", which are rigid and therefore disturbing foreign bodies during the suction movement be perceived. Such "harder" dosage forms (eg harder lozenges) are not or only very poorly accepted by babies. In other words, the compliance for "harder", "rigid" dosage forms for use in the nipple cavity is very poor (See Example 4 below). Since babies can not appeal to their reason, the gift of "harder" dosage forms endangers seriously the therapy. The optimized elastic and / or plastic properties of the dosage form according to the invention with a correspondingly low Shore hardness therefore represent an essential feature of the dosage form according to the invention. Through the sucking and chewing movement of the child, the dosage form dissolves slowly with the help of saliva and thus gives the Active substance from the oral cavity. The dosage form according to the invention differs on the basis of its matrix from commercially available tablets for babies, such as vitamin D3 tablets, etc., which are intended to dissolve on contact with liquid within a few seconds. But it also differs from conventional fruit gums, etc. in that it is tailor-made for infants and toddlers. Thus, the dosage forms of the invention have the age-appropriate drug dose for each indication and can be used by the parents stress-free and without extensive research regarding. Dosage / application, etc. The dosage forms according to the invention represent a heretofore unknown form of administration in that they are tailor-made for children up to 2 years. To date, to the knowledge of the inventors, there are no comparable drug forms for this particular group of patients, as drug forms are indicated in a suitable for sucking dosage form for children earliest from an age of well over two years (for example, at least 4 years) (see, for example, Isla® Moss for children from 4 years). The reason for this is that infants and very young children easily swallow such lozenges, which in the worst case can lead to a reflec- tive cardiovascular arrest. However, it is often difficult for parents to estimate when their child has the ability to hold a tablet or similar. to suck, without swallowing. Furthermore, approved and commercially available dosage forms for older children (eg for children from the age of 4) may contain concentrations of active substance that are not compatible with children up to 2 years of age. This uncertainty leads to the fact that drug forms for sucking are generally not administered to children ≤ 2 years. The present invention overcomes this technical prejudice.

In addition to the active ingredient in the appropriate dosage, the dosage form can also contain customary auxiliaries (fillers, masking agents, etc.), depending on the type of dosage form. These are widely known to those skilled in the pharmaceutical art and can be suitably used. For example, in a fruit gum in addition to active ingredient and hydrocolloid sweeteners, acids, fruit and vegetable extracts, flavors, water, plasticizers, and sequestering agents may be included. For example, sugars, glucose syrup, fructose and sugar alcohols are used as sweeteners. Typically, the dosage form has no disintegrant.

In embodiments, the drug form according to the invention can be used in particular as a refillable element in a drug-loadable nipple of a pacifier. In this case, the pacifier may be a pacifier according to the present invention, or any other drug-loadable pacifier, that is, each pacifier is configured to temporarily integrate a (solid) dosage form such that in the use state of the pacifier an active substance to the oral cavity of the child can deliver.

The pharmaceutical form according to the invention can be provided in a variety of child-friendly forms, for example as animal figures, and can furthermore be packaged as a single dose.

Exemplary embodiments of the dosage form according to the invention:

Exemplary embodiment 1: The exemplary embodiment 1 relates to a medicament form according to the invention in the form of fruit gums with the active compounds 2,4-diclorobenzyl alcohol and amylmetacresol, and their preparation.

Starting materials:

Table 1: kind Amount in mg glucose syrup 420.0 granulated sugar 420.0 modified starch 124 pectin 30.4 citric acid 2.0 2,4-Diclorbenzylalkohol 2.4 amylmetacresol 1.2 Total 1000.0

The starting materials glucose syrup, sugar, modified starch and pectin are boiled with the addition of water. Then citric acid and, if necessary, flavors and coloring fruit and vegetable extracts are added and mixed. Thereafter, the hot mass is cooled to about 60 ° C and the antiseptic active ingredients 2,4-diclorobenzyl alcohol and amylmetacresol homogeneously stirred therein. The still warm mass is poured into powder-filled and embossed molds. The fruit gum mass solidifies by cooling, whereby the dosage form according to the invention arises. The solidified Fruchtgummikörper be formed and in an air-conditioned room at a drying temperature between 45 and 55 ° C over a drying period of 36 to 96 Hours dried. Then the fruit gums are freed from adhering powder thickness, surrounded with a thin film of a release agent and packed in single doses.

Exemplary embodiment 2: The exemplary embodiment 2 relates to a dosage form according to the invention in the form of gum drops with the active ingredient "ivy dry extract" (5-7.5: 1), extracting agent: ethanol 30% (m / m) (35 mg per 5 ml) , and their production.

Starting materials:

Table 2 kind Amount in mg fruit juice 630 gelatin powder 130 lemon juice 150 sugar 37.5 Ivy leaves dry extract 52.5 Total: 1000.0

The starting materials of fruit juice and gelatine are combined and allowed to stand for about 5-10 minutes. Lemon juice and sugar are added. The mixture is heated under moderate heat (about 40 ° C) for about 10 min. stirred. Subsequently, the ivy dry extract is added with uniform stirring. The still warm mass is poured into powder-filled and embossed molds. The Gummidropmasse solidifies by cooling, wherein the dosage form according to the invention is formed. The solidified rubber drops are molded and placed in an air conditioned room at a drying temperature of between 45 and 55 ° C over a drying period of 36 to 96 Hours dried. Subsequently, the rubber drops are freed from adhering powder thickness, surrounded with a thin film of a release agent and packaged in single doses.

Exemplary embodiment 3: The exemplary embodiment 3 relates to a dosage form according to the invention in the form of gumdrops (gelatin-free) with the active ingredient ambroxol hydrochloride, and their preparation.

Starting materials:

Table 3 kind Amount in mg fruit juice 650 honey 30 Aniseed fennel extract 50 Agar Agar 100 Strength 45 lemon juice 50 sugar 40 NaCl 5 ambroxol hydrochloride 30 Total: 1000.0

The agar-agar powder and the starch are mixed in the fruit juice, followed by adding honey, aniseed fennel extract, sugar and salt. The mixture is heated under moderate heat (about 40 ° C) for about 10 min. stirred and then boiled briefly with stirring until a viscous mass has resulted. Thereafter, the hot mass is cooled to about 60 ° C, and lemon juice and ambroxol hydrochloride stirred homogeneously therein. The still warm mass is poured into powder-filled and embossed molds. The gum candy solidifies by cooling to form the dosage form according to the invention. The solidified gumdrops are molded and placed in an air conditioned room at a drying temperature between 45 and 55 ° C over a drying period of 36 to 96 Hours dried. Then the gumdrops are freed from adhering powder, surrounded with a thin film of a release agent and packed in single doses.

Exemplary Embodiment 4 In Embodiment 4, the Shore Hardness A of dosage forms A1 according to the invention (fruit gum according to Embodiment 1), A2 (gum drop according to Embodiment 2) and A3 (gum base according to Exemplary Embodiment 3) and the Shore Hardness A of a commercially available sucking paste ( "Ipalat®) mild" according to DIN ISO 7619-1 standard (depending 5 Tests per dosage form). Furthermore, a "compliance" test with comparable dosage forms of dosage forms A1-A3 (without active ingredient) and "Ipalat® mild" (the size of "Ipalat® mild" was adapted accordingly) was added in a pacifier according to the invention 5 Children aged about 1.5 years. It was each of the 5 Children are given only one dosage form per day, so after a total 4 Every child had tested all dosage forms A1-A3 (without active ingredient) and "Ipalat® mild". The results (the Shore A hardness averages and the Compliance score) are shown in Table 4 below. Table 4 A1 A2 A3 Ipalat® mild Shore hardness A Ø 8th 27 14 33 compliance ◯◯ ◯ ◯◯ X 00: Sucker with drug form is accepted by all children, dosage form is completely taken. 0: Sucker with dosage form is accepted by 3 children, dosage form is completely taken. For the other two children, the teat was removed after max. Spent 2 minutes and no longer accepted. X: Sucker is spat out after a short time (a few seconds) and no longer accepted. Dosage form can not be used.

Pacifier with atomizer

8th shows a pacifier 1 according to further embodiments, which is designed to generate an aerosol. The pacifier 1 includes a nipple 10 in accordance with the prior art, or according to other embodiments described herein, such as those described with reference to FIGS 1 to 5 described, can be designed. The pacifier 1 has an atomizer unit 100 configured to atomize a liquid 18b. The liquid 18b may typically comprise an aqueous or low viscosity oily liquid. Preferably, the liquid 18b may comprise an aqueous liquid, typically an aqueous solution.

In the liquid 18b, a therapeutic agent can be dissolved, which can be delivered via the nose into the respiratory tract of the infant. So can preferentially as therapeutic active substance in the Liquid 18b NaCl (sodium chloride) to be dissolved. Other examples of therapeutic agents dissolved in the fluid 18b include agents from the group of bronchodilators (for example, formoterol) and steroids (for example, glucocorticoids such as budesonide).

The atomizer unit 100 typically has at least one opening 105 on, in the use state of the pacifier 1 is oriented so that an aerosol generated in the atomizer unit can be delivered in the direction of the nose of the infant.

As in 8th illustrated, the atomizer unit 100 via a holding element 75 on a flat sign 20 of the pacifier 1 be attached, on which also the sucker 10 is attached. In this case, the atomizer unit 100 or the holding element 75 at the sucker 10 opposite side of the shield 20 appropriate. The atomizer unit 100 is located between the holding element 75 and a, preferably cap-shaped, conclusion 80 , This is for engagement with the holding element 75 executed, so that the atomizer 100 between the holding element 75 and graduation 80 is held. The conclusion 80 typically has a recess through which the aerosol from the opening 105 coming from the atomizer unit 100, can escape.

The conclusion 80 can with the retaining element 75 through a locking mechanism 85 which requires a combination of at least two simultaneous or sequential movements, be releasably connectable. Preference is given to the cap-shaped closure 80 a feather 90 and a pressure ring 95 provided (not shown, see, for example 5 ).

In 9 is an exploded view of a non-limiting example of the construction of a nebulizer unit 100 shown according to embodiments. The atomizer unit 100 typically includes a piezo-atomizer 110 , The liquid 18b to be atomized is typically in a cartridge 125 or basically stored in a container. Typically, the atomizer unit 100 is configured such that the cartridge 125 can be changed quickly and easily or with a few simple steps, for example, after consumption of the liquid 18b, or to switch to another liquid 18b, for example with another solvent or another dissolved active ingredient.

A control electronics 115 is operative with the piezo atomizer 110 coupled. It draws energy from a power source 120 , such as a battery or a battery, as in 9 shown, structurally with the control electronics 115 can be combined. Depending on the design of the atomizer unit can optionally be a wick unit 140 be provided, which is the transport of the liquid 18 b from the cartridge 125 to the piezo atomizer 110 guaranteed. In this case, for example, a wick (not shown) made of natural or synthetic material may be provided, which via the capillary action and / or by gravity, the liquid 18b from the cartridge 125 to the diaphragm of the piezo atomizer 110 passes. The piezo-side end of the wick touches a surface of the diaphragm of the piezoelectric atomizer. The liquid 18b is thus transported past the membrane of the piezo atomizer, where it is atomized by the high-frequency movement of the membrane. Typical frequencies for operation of the piezoelectric atomizer are several tens of kHz to several hundreds of kHz, for example, from 30 kHz to 400 kHz, more typically from 50 kHz to 300 kHz. To adjust the sputtering power, an adjuster, such as a potentiometer (not shown) may be provided, which is connected to the control electronics 115 acts. Typically, there is also an on / off switch for activating and deactivating the piezo atomizer 110 or the atomizing unit 100 is provided. This may be through a recess or a rubber-like section in the conclusion 80 be accessible. Likewise, it may be provided that the piezo atomizer 110 when mounting the degree 80 is activated by an integrated pressure switch or deactivated after removal.

In the example of 9 are the above-described elements of the atomizer unit 100 each formed as separate assemblies. They are at a body 130 attached and form with this the atomizer unit 100 , Each form a separate module: the control electronics 115 including the power source 120 ; the piezo atomizer 110 ; the wick unit 140 ; and the cartouche 125 for the liquid 18b.

The assemblies may be configured as follows to facilitate assembly or disassembly of the nebulizer unit 100 to achieve. The wick unit 140 is configured to the body 130 to be infectious. After that, the cartouche 125 in a recess in the control electronics 115 pushed. The control electronics 115 is placed on the body and can be screwed. The wick unit is between control electronics 115 and the body 130 fixed. The piezo atomizer 110 is typically to the control electronics 115 plugged and / or screwed.

In embodiments, the control of the nebulizer unit 100 may be implemented as described above via a switch or button integrated therein, or by remote control. A remote control can be designed as a per se known radio remote control with a hand control unit or wireless control by an information technology device. This can in particular be a mobile device such as a smartphone or a tablet computer, or else a mobile or stationary PC, in particular in the form of a portable netbook or notebook computer.

In exemplary embodiments, the remote control can take place approximately (non-limiting) via the wireless standards WLAN or Bluetooth. In this case, the control electronics in the atomizer unit includes 100 typically an integrated circuit with antenna, which allows the control via WLAN or Bluetooth. On the part of the information technology device, the operation can be done via a browser interface, or typically via its own application software for the respective operating system. In the case of smartphones or tablet computers, this can be, in particular, a mobile application (app) which is usually downloadable or made available there from an Internet-based App Store.

In the case of using the WLAN standard, the connection between the information technology device and the atomizer unit 100 be designed as a direct connection in ad-hoc mode. Typically, however, both devices are part of a common WLAN (wireless network) with a common WLAN access point, typically a WLAN router. In embodiments, also several pacifiers with atomizer unit 100 operated together in a WLAN, and jointly controlled by one (or more) information technology device. In this way, in a nursery or in a clinical setting, for example, a plurality of pacifiers according to embodiments may be applied and commonly controlled by an operator, either with a mobile device or via a stationary PC connected to the WLAN.

The remotely controllable functions of the atomizer unit 100 may typically include switching the piezoelectric fogger on / off. Furthermore, the intensity of the nebulization in stages or steplessly controllable. This directly influences the amount of mist released per unit of time and thus also how long a filling of a cartridge holds. Likewise, an interval nebulization may be adjustable, e.g. a fixed duration of nebulization, followed by a break with a duration also defined after which the nebulization begins again. Also, a fixed duration may be programmable remotely, such that the nebulizer - e.g. at night - after a period of time completely off.

In embodiments, therefore, a cartridge is also provided which can typically be used in a pacifier with atomizer. The cartridge is typically configured to load the pacifier with drug. The cartridge includes: a cartridge wall enclosing a cavity and at least one opening in the cartridge wall which typically, after loading the pacifier, forms a fluidic connection with the pacifier. The cartridge is typically configured to be releasably connected to the pacifier.

The cartridge may further comprise an aqueous fluid. Typically, the aqueous liquid is an aqueous solution. When maximally filled with the aqueous liquid, the cartridge has a weight of 1 g to 7 g, preferably 2 g to 6 g, more preferably 2.5 g to 5 g. For cartridges with a larger than imminent weight compliance is very bad, as the total weight of the loaded pacifier reaches a limit that is no longer accepted by the children. Lower weight cartridges may not contain enough fluid for proper therapy. Typically, the aqueous fluid may comprise at least one therapeutic agent which, by atomizing the fluid in the use state of the pacifier, may be delivered via the nose into the respiratory tract of the infant. The therapeutic agent typically contains at least one of NaCl, bronchodilators, and steroids.

Furthermore, the cartridge may comprise a removable closure which seals the at least one opening in a liquid-tight manner. The cartridge according to the invention has a maximum spatial extent, which is characterized in that the cartridge can be completely enclosed by an imaginary hollow sphere with a radius of 1.5 cm. Typically, there is no point of contact and / or intersection between the sphere surface and the cartridge. Cartridges that transcend the impending spatial expansion are perceived by the child as sterically disturbing and "pacifier-alien". In addition, such oversized cartridges interfere with the child's vision and affect the weight of the loaded pacifier (see above). The cavity of the cartridge typically has a volume of 0.5 ml to 3 ml, preferably 1 ml to 2 ml. The cartridge wall contains plastic or aluminum. Type safe manner the plastic is selected from PE, PET, PVC, PS, PP, PA and / or PC, preferably PE and / or PET. The cartridge wall may be made of plastic, preferably made of PE and / or PET, or of aluminum, or may consist of the aforementioned materials.

Although the present invention has been described above by means of typical embodiments, it is not limited thereto, but modifiable in many ways. Also, the invention is not limited to the applications mentioned.

Hereinafter, particularly preferred aspects of the present invention are listed:

Aspect I: Sucker for a pacifier / pacifier with nipple

• A nipple for a pacifier, comprising a rubbery material, the nipple having a central cavity for receiving a first active ingredient, and the nipple having in at least a part of its outer surface a plurality of passages connecting the cavity with an external space around the pacifier so that the passages in the use state of the pacifier connect the cavity with the mouth of a child.
• 2. Vacuum cleaner by aspect 1 wherein the sucker on a in use state with the palate, tongue and lips of the child not coming into contact surface, in particular on a surface in use outside of the mouth, a passage passage through which the first active ingredient as part of a solid dosage form in the cavity , In particular, can be introduced as a refillable element.
• 3. A sucker according to one of the preceding aspects, wherein the passage passage is designed such that it is liquid-tight in the normal state.
• 4. Sucker according to one of the preceding aspects, wherein the passage passage is designed as a purely structural modification of the rubber-like material of the nipple.
• A nipple according to any one of the preceding aspects, wherein the nipple comprises a (particularly round) end piece for detachable attachment to a shield and a mouthpiece, and wherein the passage passage is typically formed as a slot in a face of the round tail ,
• 6. A teat according to any one of the preceding aspects, having an axial extent of from about 2.5 to about 3.2 cm (measured from the teat tip to the shield).
• A nipple according to any one of the preceding aspects, wherein the nipple has a transverse axis perpendicular to the longitudinal or axial axis of the nipple, and in use of the pacifier parallel to a connecting line of the mouth of the wearer of the pacifier, and wherein the nipple in Direction of the transverse axis at its widest point, which is usually in use in the mouth, has a width of 1.5 cm to about 2.8 cm.
• Suckler according to any one of the preceding aspects, comprising three to one hundred and fifty ( 3 to 150 ), typically four to a hundred ( 4 to 100 ) Passages.
• Sucker according to one of the preceding aspects, wherein at least a part of the passages is conically shaped, and wherein in each case the proximal to the cavity of the nipple located inner opening of the at least a part of the passages has a smaller diameter d1 has as the outer diameter d2 the outside (distal) opening.
• A nipple for a pacifier, comprising a tail for attachment to a shield, and a mouthpiece, the mouthpiece comprising an upper portion which, in use, abuts substantially (substantially) on the palate of the child, and comprises a lower portion which, in use, rests mainly (substantially) on the tongue of the child, wherein the mouthpiece has a plurality of passages in at least part of its wall, wherein the passages are positioned substantially in the upper region and the lower region, wherein a passage belongs to the upper region when the normal vector of the outer surface at the position of the passageway is a component in the direction from the lower region (near the tongue) to the upper region (palate-near), and wherein a passage belongs to the lower area when the normal vector of the outer surface at the position of the passage has a component in the direction from the upper area (near the palate) to the lower area (near the tongue).
• A sucker configured for a pacifier, comprising: a body having a cross-sectional shape extending along a longitudinal axis of the nipple, the body having a rubber-like body wall, and the body comprising a mouthpiece and an endpiece, the rubbery body wall of the mouthpiece having a mouthpiece central cavity for receiving a first active substance is formed, and the rubbery body wall of the tail is designed such that it can be connected to a shield, wherein the rubbery body wall of the mouthpiece has a plurality of passages connecting the cavity with an outside space around the pacifier in that the passages in the use state of the pacifier connect the cavity with the mouth of a child, and wherein the body wall of the mouthpiece and / or the end piece on a non-coming in contact with the palate, tongue and lips of the child surface (wall) a Passage passage having such ge staltet is that it is liquid-tight in the normal state, and can be introduced by the first active ingredient as part of a solid dosage form in the cavity, in particular as a refillable element.
• 12. pacifier comprising a nipple according to one of the preceding aspects.
• 13. Pacifier comprising:
  • a nipple comprising a rubber-like material, the nipple having a central cavity for receiving a drug, and having in at least part of its outer surface a plurality of passages connecting the cavity to an outside space around the pacifier, such that the passages are in use the pacifier connect the cavity with the mouth of a child, wherein the teat in a state of use outside the mouth and facing away from the child's mouth rear wall of the teat has a valve in the form of a passage passage which is designed such that it is liquid-tight in the normal state , And through which the active ingredient can be introduced as part of a solid dosage form in the cavity, in particular as a refillable element, and wherein the passage passage as a purely structural modification of the rubber-like material of the nipple, and optional
  • - A flat plate with which the sucker is detachably connected.
• 14. Pacifier comprising:
  • a nipple comprising a rubber-like material, the nipple having a central cavity for receiving a drug, and having in at least part of its outer surface a plurality of passages connecting the cavity to an outside space around the pacifier, such that the passages are in use of the pacifier connect the cavity with the mouth of a child, wherein the nipple in the use state of the pacifier in a non - palatal, tongue and lips surface (wall) has a valve in the form of a passage passage which is designed so that Normal state is liquid-tight, and through which the active ingredient can be introduced as part of a solid dosage form in the cavity, in particular as a refillable element, and wherein the passage passage is typically carried out as a purely structural modification of the rubber-like material of the nipple, and optionally
  • - A flat plate with which the sucker is detachably connected.
• 15. Pacifier comprising:
  • a sucker comprising a rubbery material, the sucker having a central cavity for receiving a first active agent, and the sucker having in at least a part of its outer surface a plurality of passages connecting the cavity to an outside space around the soother Passages in the use state of the pacifier connect the cavity with the mouth of a child, the nipple comprises an end piece for attachment to a shield, and a mouthpiece, the mouthpiece comprises a nipple neck and a nipple body, wherein the nipple neck represents the connection between the tail and nipple body wherein the nipple neck comprises an inner partition which has a valve in the form of a passage which is designed to be liquid-tight in the normal state and through which the active ingredient is introduced as part of a solid dosage form into the cavity, in particular as a refillable element n, wherein the passage passage is typically designed as a purely structural modification of the rubber-like material of the nipple, and wherein the passages are typically provided only in the region of the nipple body, and optionally
  • - A flat plate with which the sucker is detachably connected.

Aspect II: Pacifier with replaceable cartridge

• 16. Pacifier, comprising:
  • - a sucker,
  • a flat plate to which the sucker is attached,
  • - An exchangeable cartridge having an active substance, with at least one opening through which the active ingredient can be discharged; and
  • a holding element for receiving the cartridge,
  wherein the holding element is attached to the side facing away from the sucker of the shield and is designed so that the at least one opening of the cartridge is exposed in the use state of the pacifier exposed to the nose of the child, so that the active ingredient can be delivered in the direction of the nose ,
• Pacifiers by aspect 16 , further comprising a, preferably cap-shaped, conclusion, which is designed to engage with the holding element, so that the cartridge between the holding element and completion is supported.
• 18. Pacifier by aspect 17 wherein the closure is releasably connectable to the support member by a closure mechanism which requires a combination of at least two simultaneous or sequential movements.
• 19. Pacifier by aspect 18 , wherein in the conclusion of a spring and a pressure ring are provided.
• Pacifier according to one of the preceding aspects 16 - 19 wherein the nipple is releasably secured to the shield, the cartridge typically having a removable closure of the opening (s) prior to use, and wherein the opening (s) of the cartridge are typically configured so that no liquid can escape from the cartridge.
• 21. Pacifier according to one of the preceding aspects 16 - 20 wherein the conclusion with the retaining element by a bayonet lock is detachably connectable.
• 22. Use of a replaceable cartridge in a pacifier, preferably in a pacifier according to one of the preceding aspects 16 - 21 ,

Aspect III: pacifier for generating an aerosol

• 23. A pacifier for generating an aerosol comprising:
  • a sucker; and
  • an atomizer unit configured to atomize a liquid.
• 24. Pacifier by aspect 23 wherein the atomizer unit has at least one opening, which is aligned in the use state of the pacifier so that the aerosol can be delivered in the direction of the nose.
• 25. Pacifier according to one of the preceding aspects 23 and 24 wherein the atomizer unit comprises a piezo atomizer.
• 26. Pacifier by aspect 25 wherein the atomizer unit further comprises:
  • a basic body;
  • - An electronic control unit, which is operatively coupled to the piezoelectric atomizer;
  • - a power source;
  • - a cartridge for receiving the liquid;
  • optionally a wick unit configured to transport the liquid from the cartridge to the piezo atomizer.
• 27. Pacifier by aspect 26 , wherein the following elements form the atomizer unit as separate assemblies together with the main body:
  • - Control electronics ( 115 ) with power source ( 120 );
  • - Piezo atomizer ( 110 );
  • - Cartridge ( 125 ) for the active substance ( 18b) ,
• 28. Pacifier according to one of the preceding aspects 23 - 27 , further comprising
  • - a flat sign ( 20 ), to which the sucker is attached, wherein the atomizer unit ( 100 ) on the sucker ( 10 ) facing away from the shield ( 20 ) is attached.
• 29. Pacifier according to one of the preceding aspects 23 - 28 , Further comprising a holding element for receiving the atomizer unit, wherein the holding element is attached to the side facing away from the sucker of the shield.
• 30. Pacifier by aspect 29 , further comprising a preferably cap-shaped end, which is designed to engage with the holding element, so that the atomizer unit is supported between the holding element and the end.
• 31. Pacifier by aspect 30 wherein the termination with the retaining element is releasably connectable by a locking mechanism which requires a combination of at least two simultaneous or sequential movements, and preferably in the cap-shaped end a spring and a pressure ring are provided.
• 32. Pacifier according to one of the preceding aspects 23 - 31 wherein the nipple has a central cavity for receiving a first active substance, and in at least part of its outer surface has a plurality of passages connecting the cavity with an external space around the pacifier, so that the passages in the use state of the pacifier, the cavity with the Mouth of a child connect, and the teat optionally has a passage located in a non-estrous surface in use state, which is designed to be liquid-tight in the normal state, and through which the first active ingredient as part of a solid dosage form in the cavity, in particular can be introduced as a refillable element, and wherein the passage passage is preferably carried out as a purely structural modification of the rubber-like material of the nipple.
• 33. Use of a nebulizer unit in a pacifier for generating an aerosol by nebulizing a liquid, preferably an aqueous liquid.
• 34. A process for producing an aerosol, comprising:
  • - Providing a pacifier according to one of the aspects 23 to 32 ;
  • - Providing the liquid in a cartridge;
  • - Activation of the atomizer unit by activation of the piezo atomizer.

Aspect IV: Drug Form (Drug Composition)

• 35. Pharmaceutical composition (drug composition) for use in the treatment of diseases of infants and infants, comprising at least one active ingredient, wherein the dosage form is erodible by means of liquid and is present in a suitable for sucking, solid, single-dose dosage form.
• 36. dosage form by aspect 35 The treatment includes topical treatment of diseases of infants and infants.
• 37. dosage form by aspect 35 or 36 wherein the dosage form is selected from the group consisting of soft candy, fruit gum, gum candy, jellybean, marshmallow candy, gumdrop and combination thereof.
• 38. Pharmaceutical form according to one of the preceding aspects 35 - 37 wherein the concentration of the active ingredient is from 0.05 to 30% by weight, typically 0.1 to 20% by weight, more typically 0.2 to 10% by weight, even more typically 0.5 to 5 Wt .-%, based on the total weight of the dosage form is.
• 39. Pharmaceutical form according to one of the preceding aspects 35 - 38 , for use in the treatment of the upper respiratory tract of infants and infants.
• 40. Pharmaceutical form according to one of the preceding aspects 35 - 39 , for use in the treatment of children aged 0 to 2 Years.
• 41. dosage form according to one of the preceding aspects 35 - 40 wherein the time to completely dissolve the dosage form in the oral cavity of the child is about 1 to about 30 minutes, more typically about 2 to about 25 minutes, even more typically about 5 to about 15 minutes.
• 42. Pharmaceutical form according to one of the preceding aspects 35 - 41 , wherein the drug is embedded in the drug form in a matrix.
• 43. dosage form by aspect 42 wherein the matrix comprises a hydrocolloid selected from the group consisting of starch, cellulose, pectins, gum arabic, galactomannans, carubin, agar, carrageenan, alginates, gelatin, caseinates, xanthan, dextrans, scleroglucan, and combinations thereof.
• 44. Pharmaceutical form according to one of the preceding aspects 35 - 43 , wherein the active ingredient is selected from the group consisting of local antibiotics, local anesthetics, antiseptics, expectorants, anticariogenic agents, mucous drugs and their extracts, tanning drugs or their extracts, and combinations thereof.
• 45. Pharmaceutical form according to one of the preceding aspects 35 - 44 , wherein the dosage form has a Shore A hardness, determined according to DIN ISO 7619-1 Norm, from 1 to 30 , more typical of 2 to 25 , still type-safe from 5 to 15 having.
• 46. Pharmaceutical form according to one of the preceding aspects 35 - 45 , wherein the dosage form has a weight of 200 mg to 1000 mg, preferably from 300 mg to 700 mg.
• 47. Kit comprising
  • - A dosage form according to one of the preceding aspects, and
  • a drug-loadable pacifier, which is typically a pacifier according to the present invention,
  • optionally a sucker, which is typically a sucker according to the present invention, and
  • optionally a cartridge, which is typically a cartridge according to the present invention.
• 48. Use of a dosage form according to one of the preceding aspects 35 - 46 in a nipple of a pacifier, preferably in a nipple and / or pacifier according to one of the preceding aspects.

Aspect V: Cartridge

• 49. A cartridge for loading a pacifier with active substance, comprising: a cartridge wall which encloses a cavity, and at least one opening in the cartridge wall, which connects the cavity with an outer space around the cartridge, wherein the cartridge is designed so that they detachable with can be connected to a pacifier, wherein the opening of the cartridge after connecting the cartridge with the pacifier is aligned so that it is in the use state of the pacifier, in the vicinity of the nostrils of the child and is aligned therewith.
• 50. Cartridge by aspect 49 wherein the cavity contains a composition, wherein the composition is typically a semi-solid or liquid composition.
• 51. Cartridge by aspect 50 , wherein the composition contains at least one lipophilic, typically volatile mixture.
• 52. Cartridge by aspect 51 , wherein the mixture of substances is an essential oil.
• 53. Cartridge according to one of the preceding aspects 50 - 52 wherein the cartridge, when filled to the maximum with the composition, weighs 1g to 7g , prefers 2g to 6g , more preferably 2.5g to 5g having.
• 54. Cartridge according to one of the preceding aspects 50 - 53 wherein the composition comprises at least one therapeutic agent which can be delivered via the at least one opening and, in the use state of the pacifier, via the nose into the respiratory tract of the infant.
• 55. Cartridge by aspect 52 wherein the essential oil is selected from the group consisting of tincture oil (Nigella sativa), chamomile oil (Matricaria chamomilla), pine needle oil (Picea abies), angelica (Angelica archangelica), eucalyptus oil (Oleum eucalypti), and combinations thereof.
• 56. Cartridge according to one of the preceding aspects 50 - 55 wherein the at least one opening of the cartridge is configured so that the composition can not escape from the cartridge in a liquid state.
• 57. Cartridge according to one of the preceding aspects 49 - 56 , further comprising a removable closure sealing the at least one orifice liquid tight (especially hermetic).
• 58. Cartridge according to one of the preceding aspects 49 - 57 , wherein the cartridge has a maximum spatial extent, characterized in that the cartridge can be completely enclosed by a sphere with a radius of 1.5 cm, typically without there being a point of contact and / or intersection between the spherical surface and the cartridge.
• 59. Cartridge according to one of the preceding aspects 49 - 58 , wherein the cavity of the cartridge has a volume of 0.5 ml to 3 ml, preferably 1 ml to 2 ml.
• 60. Cartridge according to one of the preceding aspects 49 - 59 in which the cartridge wall contains plastic (typically selected from PE, PET, PVC, PS, PP, PA and / or PC) or aluminum.
• 61. Cartridge according to the preceding aspect 60 , wherein the cartridge wall made of plastic, preferably made of PE and / or PET, or aluminum is constructed.
• 62. Cartridge according to one of the preceding aspects 49 - 61 , wherein the cartridge is designed as a replaceable cartridge, typically as a disposable cartridge.
• 63. Kit comprising
  • - A cartridge according to one of the preceding aspects, and
  • a drug-loadable pacifier, which is typically a pacifier according to the present invention,
  • optionally a sucker, which is typically a sucker according to the present invention, and
  • optionally a dosage form which is typically a dosage form according to the present invention.
• 64. Use of a cartridge, typically a cartridge according to any one of the preceding aspects, in a pacifier.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited non-patent literature

• Wigger et al., Pediatrics, Elsevier Urban and Fischer, Munich 4th Edition, 2013 [0056]
• DIN ISO 7619-1 [0090]

Claims (10)

A cartridge for loading a pacifier with active ingredient, comprising: a cartridge wall enclosing a cavity, - At least one opening in the cartridge wall, which connects the cavity with an outside space around the cartridge, and a detachable closure closing the at least one opening in a liquid-tight (in particular hermetic) manner, the cartridge being designed such that it can be detachably connected to a pacifier, and wherein the cartridge is designed as a disposable cartridge. Cartridge after Claim 1 in which, after the cartridge has been connected to the pacifier, the opening of the cartridge is oriented in such a way that, in the use state of the pacifier, it is located near and aligned with the nostrils of the baby. A cartridge according to any one of the preceding claims, wherein the cavity contains a composition, the composition typically being a semi-solid or liquid composition. Cartridge after Claim 3 , wherein the composition contains at least one lipophilic, typically volatile mixture. Cartridge after Claim 4 , wherein the mixture of substances is an essential oil. Cartridge after one of the previous ones Claims 3 - 5 wherein the composition comprises at least one therapeutic agent which can be delivered via the at least one opening and, in the use state of the pacifier, via the nose into the respiratory tract of the infant. Cartridge according to one of the preceding claims, wherein the at least one opening of the cartridge is designed so that the composition can not escape from the cartridge in a liquid state. A cartridge as claimed in any one of the preceding claims, wherein the cartridge has a maximum spatial extent characterized in that the cartridge can be completely enclosed by a sphere having a radius of 1.5 cm, typically without a point of contact and / or point of intersection between the sphere surface and the cartridge. Cartridge according to one of the preceding claims, wherein the cavity of the cartridge has a volume of 0.5 ml to 3 ml, preferably 1 ml to 2 ml. Cartridge according to one of the preceding claims, wherein the cartridge wall plastic (typically selected from PE, PET, PVC, PS, PP, PA and / or PC) or aluminum.

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