A NICOTINE POUCH COMPOSITION
A nicotine pouch composition is disclosed, the composition comprising nicotine, water-insoluble fibers, and a particulate inert filler, wherein the pouch composition comprises said inert filler in an amount of at least 5% by weight of the pouch composition, wherein the pouch composition further comprises at least 10% by weight of water. Also, a pouched product is disclosed.
The invention relates to a nicotine pouched product according to the claims, in particular to non-tobacco nicotine pouched products.
BACKGROUNDIn the latest years a wide range of nicotine products having a reduced tobacco content or without tobacco has been seen, also within the field of pouched products or pouches.
Yet for pouched products, it remains a desire to provide a faster nicotine release in order to give the user an improved experience by means of faster craving relief.
SUMMARYThe invention relates to a nicotine pouch composition comprising nicotine, water-insoluble fibers, and a particulate inert filler,
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- wherein the pouch composition comprises said inert filler in an amount of at least 5% by weight of the pouch composition,
- wherein the pouch composition further comprises at least 10% by weight of water.
An advantage of the invention may be a fast release of nicotine, which in turn facilitates fast nicotine craving relief. The present inventors surprisingly found that by including an amount of the inert filler, the release of nicotine was significantly improved in the sense that the nicotine release was substantially faster.
At the same time, the texture and mouthfeel were kept at a desirable level. Thus, the addition of the inert filler helped to ensure that the texture and mouthfeel was not compromised. The present inventors have found that having the claimed water content contributed significantly to the desirable texture and mouthfeel, in part due to interaction with the water-insoluble fiber as a filler material. However, adding the inert filler with a low or negligible water-retention capacity was found not to compromise the texture and mouthfeel, whereas the release of nicotine was improved.
Also, the present inventors found that keeping an amount of water instead of exchanging the water, which does not in itself contribute to taste, for the inert filler still enabled the desirable taste and mouthfeel even if this left less room for compounds such as sweeteners and flavors. However, due to an improved release, including e.g. also of sweetener and flavor, having reduced amounts of such compounds did not lead to the taste being compromised. Thus, when having a combination of water with e.g. sweetener and flavor, a very desirable taste and mouthfeel was obtained while at the same time having the desirable fast nicotine release due to the presence of the inert filler.
In the present context, the term “inert filler” refers to a filler, which may be referred to as non-absorbing due to a limited affinity for absorbing in particular water and nicotine. Also, the inert filler may be water-insoluble or comprise water-insoluble components. In one embodiment, the inert filler is non-absorbing with respect to water and thus characterized by having a low water retention capacity. In another embodiment, the inert filler is non-absorbing with respect to nicotine and thus characterized by having a lower nicotine absorbance (i.e. a low retention capacity with respect to nicotine).
In the present context, the term “particulate” refers to any kind of particles, powders granules, beads, pellets and the like. The particulate inert filler may therefore be characterized by a particle size. In an embodiment of the invention, the particulate inert filler has an average particle size of 0.02 mm to 2.0 mm. The particulate inert filler is therefore not a single solid matrix.
In an advantageous embodiment of the invention, the inert filler has a water retention capacity of no more than 20% by weight of the inert filler, such as no more than 10% by weight of the inert filler, such as no more than 5% by weight of the inert filler, such as no more than 2% by weight of the inert filler, such as no more than 1% by weight of the inert filler, such as no more than 0.5% by weight of the inert filler, such as no more than 0.2% by weight of the inert filler.
As used herein the term “water retention capacity” refers to a material that is capable to absorb and withheld moisture from the surroundings. The water retention capacity can be determined by weighing the material after absorbance of moisture, followed by weighing the material after a dehydration. Hence, the difference in weight between the two states refers to a water retention capacity. In an embodiment of the invention, the material is soaked in water for a predetermined time to allow full absorbance of water, e.g. 24 hours. Water retention capacity may also be referred to as water binding capacity.
In an advantageous embodiment of the invention, the inert filler has an average particle size of at least 0.02 mm, such as at least 0.05 mm, such as at least 0.1 mm, such as at least 0.2 mm, such as at least 0.5 mm, such as at least 1.0 mm.
According to an embodiment of the invention, the average particles size was measured by means of sieving.
According to an embodiment of the invention, the average particles size was measured by means of laser diffraction (laser granulometry).
In an advantageous embodiment of the invention, the inert filler has an average particle size of at least 0.1 mm, such as at least 0.2 mm, such as at least 0.5 mm, such as at least 1.0 mm.
In an advantageous embodiment of the invention, the inert filler has an average particle size of 0.02 mm to 2.0 mm, such as 0.05 mm to 1.5 mm, such as 0.1 mm to 1.0 mm, such as 0.2 mm to 0.8 mm.
In an advantageous embodiment of the invention, the pouch composition comprises said inert filler in an amount of at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition, such as at least 25% by weight of the pouch composition, such as at least 30% by weight of the pouch composition.
In an advantageous embodiment of the invention, the pouch composition comprises said inert filler in an amount of no more than 80% by weight of the pouch composition, such as no more than 70% by weight of the pouch composition, such as no more than 60% by weight of the pouch composition, such as no more than 50% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises said inert filler in an amount of 5-80% by weight of the pouch composition, such as 10-80% by weight of the pouch composition, such as 15-80% by weight of the pouch composition, such as 20-70% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises said inert filler in an amount of 30-70% by weight of the pouch composition, such as 40-70% by weight of the pouch composition, such as 50-70% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises said inert filler in an amount of 10-70% by weight of the pouch composition, such as 15-60% by weight of the pouch composition, such as 20-40% by weight of the pouch composition.
In an advantageous embodiment of the invention, the inert filler comprises a polymeric material.
In an embodiment of the invention, the inert filler is a polymeric material.
In an advantageous embodiment of the invention, the inert filler comprises gum base.
In an advantageous embodiment of the invention, the inert filler comprises gum base in an amount of at least 25% by weight of the inert filler, such as at least at least 50% by weight of the inert filler, such as at least 75% by weight of the inert filler.
According to an embodiment of the invention, the inert filler comprises gum base in an amount of 25-100% by weight of the inert filler, such as 50-99% by weight of the inert filler, such as 75-99% by weight of the inert filler.
In an advantageous embodiment of the invention, the inert filler consists of gum base.
In an advantageous embodiment of the invention, the inert filler comprises chewing gum composition.
In an advantageous embodiment of the invention, the inert filler comprises chewing gum composition in an amount of at least 25% by weight of the inert filler, such as at least at least 50% by weight of the inert filler, such as at least 75% by weight of the inert filler.
According to an embodiment of the invention, the inert filler comprises chewing gum composition in an amount of 25-100% by weight of the inert filler, such as 50-99% by weight of the inert filler, such as 75-99% by weight of the inert filler.
In an advantageous embodiment of the invention, the inert filler consists of chewing gum composition.
According to an embodiment of the invention, the inert filler comprises gum base or chewing gum composition in an amount of at least 25% by weight of the inert filler, such as at least at least 50% by weight of the inert filler, such as at least 75% by weight of the inert filler.
According to an embodiment of the invention, the inert filler comprises gum base or chewing gum composition in an amount of 25-100% by weight of the inert filler, such as 50-99% by weight of the inert filler, such as 75-99% by weight of the inert filler.
According to an embodiment of the invention, the inert filler consists of gum base or chewing gum composition.
In an advantageous embodiment of the invention, the gum base comprises one or more gum base polymers.
In an embodiment of the invention, the gum base consists of one or more gum base polymers.
In an advantageous embodiment of the invention, the inert filler comprises one or more gum base polymers.
In an embodiment of the invention, the inert filler consists of one or more gum base polymers.
In an advantageous embodiment of the invention, the one or more gum base polymers comprise one or more gum base polymer selected from the group consisting of polyvinyl acetate, vinyl acetate-vinyl laurate (VA-VL) copolymers, styrene-butadiene copolymers (SBR), polyisobutylene, isobutylene-isoprene copolymers, polyethylene, polyurethane or any combination thereof.
In an advantageous embodiment of the invention, the one or more gum base polymers comprise elastomer.
In an embodiment of the invention, the one or more gum base polymers consists of elastomer.
In an advantageous embodiment of the invention, the one or more gum base polymers comprise a natural elastomer.
In an embodiment of the invention, the one or more gum base polymers consists of a natural elastomer.
In an advantageous embodiment of the invention, the one or more gum base polymers comprise a natural elastomer selected from the group of chicle gum, natural rubber, crown gum, nispero, rosidinha, jelutong, perillo, niger gutta, tunu, balata, guttapercha, lechi capsi, sorva, gutta kay, and any mixtures thereof.
In an embodiment of the invention, the one or more gum base polymers consist of a natural elastomer selected from the group of chicle gum, natural rubber, crown gum, nispero, rosidinha, jelutong, perillo, niger gutta, tunu, balata, guttapercha, lechi capsi, sorva, gutta kay, and any mixtures thereof.
In an advantageous embodiment of the invention, the one or more gum base polymers comprise chicle.
In an embodiment of the invention, the one or more gum base polymers consists of chicle.
In an advantageous embodiment of the invention, the one or more gum base polymers comprise a synthetic elastomer selected from the group consisting of styrene-butadiene copolymers (SBR), polyisobutylene, isobutylene-isoprene copolymers, polyethylene, polyvinyl acetate and any mixtures thereof.
In an embodiment of the invention, the one or more gum base polymers consists of a synthetic elastomer selected from the group consisting of styrene-butadiene copolymers (SBR), polyisobutylene, isobutylene-isoprene copolymers, polyethylene, polyvinyl acetate and any mixtures thereof.
In an embodiment of the invention, the one or more gum base polymers comprise styrene-butadiene copolymers (SBR).
In an embodiment of the invention, the one or more gum base polymers consists of styrene-butadiene copolymers (SBR).
In an embodiment of the invention, the one or more gum base polymers comprise polyisobutylene.
In an embodiment of the invention, the one or more gum base polymers consists of polyisobutylene.
In an embodiment of the invention, the one or more gum base polymers comprise an isobutylene-isoprene copolymer.
In an embodiment of the invention, the one or more gum base polymers consists of an isobutylene-isoprene copolymer.
In an embodiment of the invention, the one or more gum base polymers comprise polyethylene.
In an embodiment of the invention, the one or more gum base polymers consists of polyethylene.
In an embodiment of the invention, the one or more gum base polymers comprise polyvinyl acetate.
In an embodiment of the invention, the one or more gum base polymers consists of polyvinyl acetate.
In an advantageous embodiment of the invention, the gum base comprises resin.
In an advantageous embodiment of the invention, the gum base comprises natural resin.
In an advantageous embodiment of the invention, the gum base comprises natural resin selected from the polyterpenes derived from terpenes of natural origin or resinous compounds derived from gum rosin, wood rosin, or tall-oil rosin.
In an embodiment of the invention, the gum base is free of natural resin.
The term “natural resin”, as used herein, means resinous compounds being either polyterpenes derived from terpenes of natural origin or resinous compounds derived from gum rosin, wood rosin or tall-oil rosin.
In an advantageous embodiment of the invention, the inert filler comprises a synthetic component.
In an advantageous embodiment of the invention, the inert filler comprises glass particles.
In an advantageous embodiment of the invention, said inert filler comprises silica.
In an embodiment of the invention, said silica is provided in the form of sand.
In an embodiment of the invention, said silica is provided in the form of glass.
In an embodiment of the invention, said silica comprise silica crystals.
In an embodiment of the invention, said silica comprise crystalline silica.
In an advantageous embodiment of the invention, the inert filler comprises clay particles.
In an advantageous embodiment of the invention, the inert filler comprises cork particles.
In an advantageous embodiment of the invention, the inert filler comprises pectin particles.
In an embodiment of the invention, the inert filler is free of pectin particles.
In an advantageous embodiment of the invention, the inert filler comprises flavor-containing particles.
In the present context the flavor-containing particles are particles, including beads, which contain flavor, and which are susceptible to breakage upon mastication. Thus, the flavor may be released upon mastication to give an extra flavor burst.
In an embodiment of the invention, the inert filler comprises flavor-containing particles.
In an advantageous embodiment of the invention, the inert filler comprises one or more selected from the group consisting of magnesium carbonate, calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, and any combination thereof.
In an advantageous embodiment of the invention, the inert filler is free of glass particles.
In an advantageous embodiment of the invention, the inert filler is free of clay particles.
In an advantageous embodiment of the invention, the inert filler is free of cork particles.
In an advantageous embodiment of the invention, the inert filler is free of natural material.
In an advantageous embodiment of the invention, the inert filler is free of cellulose and derivatives thereof.
In an advantageous embodiment of the invention, the inert filler is free of cellulose derivatives.
In an advantageous embodiment of the invention the inert filler is free of cellulose derivatives selected from the list consisting of ethylcellulose (EC), methylcellulose (MC), hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), carboxymethylcellulose (CMC), cellulose acetate (CA), hydroxyethyl cellulose (HEC), cellulose gum, cellulose triacetate (CTA), sodium carboxymethyl cellulose (Na-CMC), ethyl hydroxyethyl cellulose (EHEC), carboxymethyl hydroxyethyl cellulose (CMHEC), cellulose sulfate, cellulose acetate propionate (CAP), cellulose acetate butyrate (CAB), nitrocellulose, cellulose sulfate, and any combinations thereof.
In an advantageous embodiment of the invention the inert filler is free of microcrystalline cellulose (MCC).
In an advantageous embodiment of the invention, the pouch composition is free of cellulose derivatives.
In an advantageous embodiment of the invention, the pouch composition is free of cellulose derivatives selected from the list consisting of ethylcellulose (EC), methylcellulose (MC), hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), carboxymethylcellulose (CMC), cellulose acetate (CA), hydroxyethyl cellulose (HEC), cellulose gum, cellulose triacetate (CTA), sodium carboxymethyl cellulose (Na-CMC), ethyl hydroxyethyl cellulose (EHEC), carboxymethyl hydroxyethyl cellulose (CMHEC), cellulose sulfate, cellulose acetate propionate (CAP), cellulose acetate butyrate (CAB), nitrocellulose, cellulose sulfate, and any combinations thereof.
In an advantageous embodiment of the invention the pouch composition is free of microcrystalline cellulose (MCC).
In the present context, the term “natural material” is intended to denote materials that may be present in nature.
In an advantageous embodiment of the invention, the inert filler comprises a natural material.
In an advantageous embodiment of the invention, the inert filler consists of one or more natural materials.
In an advantageous embodiment of the invention, the inert filler comprises an inorganic material.
In an embodiment of the invention, the inorganic material comprises silica.
In an embodiment of the invention, the inorganic material comprises filler, such as calcium carbonate.
In an embodiment of the invention, the pouch composition comprises gum base in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition, such as at least 30% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises gum base in an amount of 5-80% by weight of the pouch composition, such as 10-80% by weight of the pouch composition, such as 15-80% by weight of the pouch composition, such as 20-70% by weight of the pouch composition, such as 20-50% by weight of the pouch composition, such as 20-40% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises chewing gum composition in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition, such as at least 30% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises chewing gum composition in an amount of 5-80% by weight of the pouch composition, such as 10-80% by weight of the pouch composition, such as 15-80% by weight of the pouch composition, such as 20-70% by weight of the pouch composition, such as 20-50% by weight of the pouch composition, such as 20-40% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises glass particles in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition, such as at least 30% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises glass particles in an amount of 5-80% by weight of the pouch composition, such as 10-80% by weight of the pouch composition, such as 15-80% by weight of the pouch composition, such as 20-70% by weight of the pouch composition, such as 20-50% by weight of the pouch composition, such as 20-40% by weight of the pouch composition.
In an embodiment of the invention, the water-insoluble fiber comprises a non-tobacco fiber.
In an advantageous embodiment of the invention, the water-insoluble fiber is a non-tobacco fiber.
In an advantageous embodiment of the invention, the pouch composition comprises non-tobacco water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
Thus, the pouch composition of the above embodiment may comprise substantial amounts of non-tobacco water-insoluble fiber and in such cases may be a non-tobacco pouch composition or a low tobacco pouch composition.
In an embodiment of the invention, the pouch composition comprises non-tobacco water-insoluble fiber in an amount of 5-60% by weight of the pouch composition, such as at least 10-50% by weight of the pouch composition, such as at least 15-40% by weight of the pouch composition.
In an advantageous embodiment of the invention, the water-insoluble fibers are free of tobacco fibers.
Thus, in the above embodiment the water-insoluble fibers do not comprise any tobacco fibers or any fibers derived from tobacco, i.e. the water-insoluble fiber is a non-tobacco fiber. Whereas nicotine may be derived from tobacco or from other sources, the water-insoluble fibers do not comprise any tobacco fibers in the above embodiment.
In an advantageous embodiment of the invention, the pouch composition is free of tobacco fibers.
Thus, in the above embodiment the pouch composition does not comprise any tobacco fibers or any fibers derived from tobacco. Whereas nicotine may be derived from tobacco or from other sources, the pouch composition does not comprise any tobacco fibers in the above embodiment.
In an advantageous embodiment of the invention, the pouch composition is a non-tobacco pouch composition.
In an advantageous embodiment of the invention, the pouch composition is a powdered composition.
In an advantageous embodiment of the invention, the pouch composition comprises at least one sugar alcohol.
In an embodiment of the invention, the pouch has a maximum dimension of no more than 30 mm, such as no more than 25 mm, such as no more than 20 mm.
In an advantageous embodiment of the invention, the pouch composition comprises said at least one sugar alcohol in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
An advantage of the above embodiment may be that a desirable sweetness is provided, e.g. for support of the flavor profile, and while retaining an attractive texture.
In an advantageous embodiment of the invention, the pouch composition comprises said at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition, such as 15 to 40% by weight of the composition, such as 15 to 30% by weight of the composition.
In an embodiment of the invention, the pouch composition comprises said at least one sugar alcohol in an amount of 5 to 70% by weight of the composition, such as 10 to 70% by weight of the composition, such as 15 to 70% by weight of the composition, such as 20 to 70% by weight of the composition, such as 20 to 60% by weight of the composition, such as 20 to 50% by weight of the composition, such as 20 to 40% by weight of the composition.
In an advantageous embodiment of the invention, said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combinations thereof.
An advantage of the above embodiment may be that a desirable sweetness is provided, e.g. for support of the flavor profile, and while retaining an attractive texture. In particular, by utilizing sugar alcohols with desirable characteristics with respect to e.g. melting point—e.g. being solid at ambient temperature of 25 degrees Celsius—a desirable texture is facilitated.
Thus, in the above embodiment, the at least one sugar alcohol may include mixtures of different types of sugar alcohols, such as e.g. hydrogenated starch hydrolysates, which comprises a mixture of primarily maltitol, sorbitol and further sugar alcohols.
In an embodiment of the invention, said at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combinations thereof.
In an advantageous embodiment of the invention, said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combinations thereof.
In an embodiment of the invention, said at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combinations thereof.
In an embodiment of the invention, the pouch composition comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combinations thereof in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
In an embodiment of the invention, the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combinations thereof in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combinations thereof in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
In an embodiment of the invention, the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combinations thereof in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
In an advantageous embodiment of the invention, said at least one sugar alcohol comprises at least one non directly compressible (non-DC) grade sugar alcohol.
In an embodiment of the invention, the pouch composition comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
In an embodiment of the invention, the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.
In an embodiment of the invention, the pouch the at least one further sugar alcohol comprises directly compressible (DC) grade sugar alcohol.
Thus, in some embodiments, the pouch composition comprises a combination of DC grade sugar alcohol(s) and non-DC grade sugar alcohol(s).
In an embodiment of the invention, the pouch composition is free of xanthan gum.
In an embodiment of the invention, the inert filler is free of xanthan gum.
In an embodiment of the invention, the pouch composition is free of ethyl cellulose.
In an embodiment of the invention, the inert filler is free of ethyl cellulose.
In an embodiment of the invention, the pouch composition comprises glidant, such as silicon dioxide.
In an advantageous embodiment of the invention, the pouch composition comprises said water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
An advantage of the above embodiment may be that a desirable texture is facilitated e.g. by the ability of the water-insoluble fiber to hold substantial amounts of water.
In an embodiment of the invention, the pouch composition comprises said water-insoluble fiber in an amount of 5 to 60% by weight of the pouch composition, such as 10 to 45% by weight of the pouch composition, such as 15 to 40% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises said water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 5 to 45% by weight of the pouch composition, such as 5 to 40% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises said water-insoluble fiber in an amount of 10 to 60% by weight of the pouch composition, such as 10 to 50% by weight of the pouch composition, such as 15 to 50% by weight of the pouch composition.
In an advantageous embodiment of the invention, the water-insoluble fiber comprises one or more selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof.
In an embodiment of the invention, the water-insoluble fiber is selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof.
In an embodiment of the invention, the water-insoluble fiber is free of microcrystalline cellulose.
In an embodiment of the invention, the water-insoluble fiber has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.
In an embodiment of the invention, the water-insoluble fiber has a density of 50 to 500 gram per Liter, such as 100 to 400 gram per Liter, such as 200 to 300 gram per Liter.
In an embodiment of the invention, the pouch composition comprises water-insoluble fiber selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
In an advantageous embodiment of the invention, the pouch composition comprises tobacco in an amount of no more than 5% by weight of the pouch composition, such as no more than 2% by weight of the pouch composition, such as no more than 1% by weight of the pouch composition, such as no more than 0.5% by weight of the pouch composition, such as no more than 0.1% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises tobacco in an amount of 0.001-5% by weight of the pouch composition, such as 0.01-5% by weight of the pouch composition, such as 0.05-2% by weight of the pouch composition, such as 0.1-1% by weight of the pouch composition, such as 0.2-0.5% by weight of the pouch composition.
In one embodiment of the invention, the pouch composition comprises water in an amount of no more than 20% by weight of the pouch composition, such as no more than 15% by weight of the pouch composition.
In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition.
An advantage of the above embodiment may be that a desirable and soft texture of the pouched product is facilitated. Also, by including substantial amounts of water, release of nicotine may be facilitated. If the water content of the pouch composition is low, the pouch composition may absorb saliva for an undesirably long period, whereas a sufficiently wet pouch composition may facilitate fast release of nicotine.
In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of no more than 65% by weight of the composition, such as no more than 60% by weight of the composition, such as no more than 50% by weight of the composition, such as no more than 40% by weight of the composition.
In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of 10-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.
In an embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 20-65% by weight of the composition, such as 25-65% by weight of the composition.
In an embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 15-40% by weight of the composition.
In an embodiment of the invention, the pouch composition comprises water in an amount of 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 15-40% by weight of the composition, such as 15-30% by weight of the composition.
In an embodiment of the invention, the pouch composition comprises water in an amount of 15-40% by weight of the composition.
In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.25% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1.0% by weight of the pouch composition, such as at least 2.0% by weight of the pouch compositions.
In an embodiment of the invention, the pouch composition comprises nicotine in an amount of no more than 15% by weight of the pouch composition, such as no more than 10% by weight of the pouch composition, such as no more than 5% by weight of the pouch composition, such as no more than 2.0% by weight of the pouch composition, such as no more than 1.0% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises nicotine in an amount of between 0.25% and 15.0% by weight of the pouch composition, such as between 0.5% and 10.0% by weight of the pouch composition, such as between 1.0% and 8.0% by weight of the pouch composition, such as between 2.0% and 5.0 by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises nicotine in an amount of 0.25% and 15.0% by weight of the pouch composition, such as 0.5% and 10.0% by weight of the pouch composition, such as 1.0% and 8.0% by weight of the pouch composition, such as 2.0% and 5.0 by weight of the pouch compositions.
In an advantageous embodiment of the invention, the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, a nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites; nicotine bound to cellulose, such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.
In an advantageous embodiment of the invention, the nicotine comprises non-salt nicotine.
In an advantageous embodiment of the invention, the nicotine comprises nicotine free base.
In an advantageous embodiment of the invention, the nicotine comprises nicotine mixed with ion exchange resin.
In an advantageous embodiment of the invention, the nicotine comprises free-base nicotine mixed with ion exchange resin in a weight ratio between the free-base nicotine and the ion exchange resin of 0.1 to 2.0, preferably from 0.5 to 2.0, and most preferred about 0.67 to 1.0.
In an advantageous embodiment of the invention, the nicotine comprises a nicotine salt.
In an embodiment of the invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, nicotine chloride (e.g., nicotine hydrochloride and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine gensitate, nicotine lactate, nicotine mucate, nicotine laurate, nicotine levulinate, nicotine malate nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine zinc chloride, nicotine sulfate, nicotine tosylate and hydrates thereof (e.g., nicotine zinc chloride monohydrate).
In an advantageous embodiment of the invention, the nicotine salt comprises nicotine bitartrate.
According to an embodiment of the invention, the nicotine salt is nicotine bitartrate.
In an advantageous embodiment of the invention, the nicotine comprises nicotine bound to an ion exchange resin.
In an advantageous embodiment of the invention, the nicotine comprises synthetic nicotine.
In an advantageous embodiment of the invention, the nicotine pouch composition is adapted to release more than 50% of the nicotine content within a period of 30 minutes, such as more than 60% of the nicotine content within a period of 30 minutes, such as more than 70% of the nicotine content within a period of 30 minutes, such as more than 80% of the nicotine content within a period of 30 minutes, such as more than 90% of the nicotine content within a period of 30 minutes.
In an embodiment of the invention, the nicotine pouch composition is adapted to release more than 80% of the nicotine content within a period of no more than 30 minutes, such as within a period of no more than 25 minutes, such as within a period of no more than 20 minutes, such as within a period of no more than 15 minutes, such as within a period of no more than 10 minutes, such as within a period of no more than 5 minutes.
In an embodiment of the invention, the nicotine pouch composition is adapted to release no more than 99.9% of the nicotine content within a period of 30 minutes, such as no more than 99.5% of the nicotine content within a period of 30 minutes, such as no more than 99% of the nicotine content within a period of 30 minutes, such as no more than 98% of the nicotine content within a period of 30 minutes, such as no more than 95% of the nicotine content within a period of 30 minutes.
In an embodiment of the invention, the nicotine pouch composition is adapted to 50 to 100% of the nicotine content within a period 30 minutes, such as 50-99.9% of the nicotine content within a period of 30 minutes, such as 60-99.5% of the nicotine content within a period of 30 minutes, such as 70-99% of the nicotine content within a period of 30 minutes, such as 80-98% of the nicotine content within a period of 30 minutes, such as 90-95% of the nicotine content within a period of 30 minutes.
According to an embodiment of the invention, the nicotine pouch composition release is measured in vitro.
According to an embodiment of the invention, the nicotine pouch composition release is measured in vitro by the following steps of:
-
- providing a chewing buffer, wherein said chewing buffer comprises a volume of 10 L and a pH of 7.4, and wherein said chewing buffer is degassed and heated to 38 degrees Celsius with a dissolution media preparation station,
- transferring 900 mL of said chewing buffer to a vessel in a dissolution apparatus, wherein said dissolution apparatus is a USP Dissolution Apparatus 1,
- adjusting said chewing buffer to 37 degrees Celsius,
- weighing a nicotine pouch,
- transferring said pouch to a basket in said vessel in said dissolution apparatus,
- setting a rotational speed to 100 rpm,
- collecting said nicotine pouch after a specified time period,
- determining release by filtering and analyzing said chewing buffer using standard HPLC.
In an advantageous embodiment of the invention, the pouch composition comprises a pH regulating agent.
An advantage of the above embodiment may be that a more efficient absorption of nicotine through the oral mucosa may be facilitated.
In an embodiment of the invention, the pouch composition comprises pH regulating agent in an amount of at least 0.01% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 3% by weight of the pouch composition, such as at least 4% by weight of the pouch composition, such as at least 5% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises pH regulating agent in an amount of no more than 15% by weight of the pouch composition, such as no more than 10% by weight of the pouch composition, such as no more than 8% by weight of the pouch composition, such as no more than 5% by weight of the pouch compositions.
In an advantageous embodiment of the invention, the pouch composition comprises pH regulating agent in an amount of 0.01 to 15% by weight of the pouch composition, such as in an amount of 0.5 to 10% by weight of the pouch composition, such as in an amount of 1 to 10% by weight of the pouch composition, such as in an amount of 2 to 10% by weight of the pouch composition, such as in an amount of 3 to 8% by weight of the pouch composition.
In an advantageous embodiment of the invention, the pH regulating agent is a basic pH regulating agent, such as a basic buffering agent.
In an advantageous embodiment of the invention, the pH regulating agent is a buffering agent, such as a basic buffering agent.
In an advantageous embodiment of the invention, the pH regulating agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, trometamol, phosphate buffer, or any combination thereof.
In the present context the term trometamol refers to (tris(hydroxymethyl)aminomethane), also sometimes referred to as tris buffer.
In an advantageous embodiment of the invention, the pouch composition comprises flavor.
In an embodiment of the invention, the pouch composition comprises flavor in an amount of 0.01-15% by weight of the pouch composition.
In an embodiment of the invention, the flavor comprises liquid flavor.
In an embodiment of the invention, the flavor comprises powdered flavor.
In an embodiment of the invention, the flavor comprises liquid flavor and powdered flavor.
In an embodiment of the invention, the pouched product has a Surface Area to Volume (SAV) ratio of at least 0.6, such as at least 0.65, such as at least 0.7.
An advantage of the above embodiment may be that a high SAV ratio facilitates a fast release, e.g. due to more efficient interaction with saliva in the oral cavity.
In a further embodiment of the invention, the SAV ratio of the pouched product is at least 0.75, such as at least 0.8, such as at least 0.85, such as at least 0.9.
The term Surface Area to Volume ratio (SAV ratio) as used herein is a dimensionless ratio defined as the total surface area (SA) of the pouched product measured in mm2 multiplied by 1 mm and divided by the volume (V) of the same pouched product measured in mm3.
In an embodiment of the invention, the SAV ratio of the pouched product is no more than 3, such as no more than 2, such as no more than 1.
In an embodiment of the invention, the pouched product has a shortest dimension and a longest dimension with a ratio between said shortest dimension and said longest dimension of no more than 1:10.
In the present context it should be understood that the shortest dimension of the pouched product is the shortest distance passing through the center of the pouched product. Typically, the shortest dimension may thus be the thickness through the center or referred to as the maximum thickness. Similarly, the longest dimension is understood as the longest distance passing through the center of the pouched product. Thus, the longest dimension is a diagonal length of a rectangular shaped pouched product.
In an embodiment of the invention, the pouched product has a rectangular shape with a maximum thickness and a maximum length, and wherein a ratio between the maximum thickness and the maximum length is no more than 1:2, such as no more than 1:4, such as no more than 1:5, such as no more than 1:8, such as 1:10.
In an embodiment of the invention, the pouch product has a thickness of no more than mm, such as no more than 4 mm, such as no more than 3 mm, such as no more than 2 mm.
In an embodiment of the invention, the pouch has a maximum inner pouch volume and wherein the pouched product comprises said pouch composition in an amount of no more than 60% of said maximum inner pouch volume, such as no more than 55% of said maximum inner pouch volume, such as no more than 50% of said maximum inner pouch volume, such as 45% of said maximum inner pouch volume, such as in an amount of no more than 40% of said maximum inner pouch volume, such as in an amount of no more than 35% of said maximum inner pouch volume, such as in an amount of no more than 30% of said maximum inner pouch volume.
In an embodiment of the invention, the pouch has a maximum inner pouch volume and wherein the pouched product comprises said pouch composition in an amount of 5-60% of said maximum inner pouch volume, such as in an amount of 5-55% of said maximum inner pouch volume, such as in an amount of 5-50% of said maximum inner pouch volume, such as 5-45% of said maximum inner pouch volume, such as in an amount of 10-40% of said maximum inner pouch volume, such as in an amount of 15-35% of said maximum inner pouch volume, such as in an amount of 20-30% of said maximum inner pouch volume.
In an embodiment, the maximum inner pouch volume is at least 0.25 mL, such as at least 0.35 mL, such as at least 0.5 mL, such as at least 1.0 mL, such as at least 2.0 mL, such as at least 3.0 mL.
In an embodiment, the maximum inner pouch volume is within a range of 0.25 mL to 5.0 mL, such as 0.35 to 4.5 mL, such as 0.5 to 4.0 mL, such as 1.0 to 3.0 mL.
In an embodiment, the maximum inner pouch volume is within a range of 1.0 mL to 5.0 mL, such as 2.0 to 4.5 mL, such as 3.0 to 4.0 mL.
In an embodiment, the maximum inner pouch volume is within a range of 0.5 mL to 3.0 mL, such as 1.0 to 2.0 mL.
In an advantageous embodiment of the invention, the pouch composition further comprises one or more humectant(s).
In an embodiment of the invention, the inert filler is free of cellulose and derivatives thereof.
In an advantageous embodiment of the invention, said gum base comprises gum base granules.
The invention further relates to a nicotine pouch composition according to the invention or any of its embodiments for use in alleviation of nicotine craving.
The invention further relates to a method of alleviation of nicotine craving, the method comprising the step of administering an effective amount of a nicotine pouch composition according to the invention or any of its embodiments to a subject in need thereof.
In an embodiment of the invention, the pouch composition comprises humectants in an amount of 0.5 to 10% by weight of the pouch composition, such as 0.5 to 5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition.
In an embodiment of the invention, the humectant(s) are selected from the group consisting of alginate, propylene glycol, hydroxypropyl cellulose, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.
In an embodiment of the invention, the humectant(s) are selected from the group consisting of alginate, propylene glycol, and hydroxypropyl cellulose.
In an embodiment of the invention, the pouch composition is free of humectants selected from the group consisting of alginate, propylene glycol, and hydroxypropyl cellulose.
In an embodiment of the invention, the pouch composition is substantially free of humectants selected from the group consisting of alginate, and propylene glycol, hydroxypropyl cellulose.
In an embodiment of the invention, the pouch composition is free of humectants selected from the group consisting of alginate, propylene glycol, hydroxypropyl cellulose, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.
In an embodiment of the invention, the pouch composition is substantially free of humectants.
In an embodiment of the invention, the pouch composition is free of humectants.
The invention further relates to a pouched product comprising the pouch composition according to the invention or any of its embodiments and a saliva-permeable pouch enclosing said pouch composition.
In an embodiment of the invention, the pouched product comprises said pouch composition in an amount of no more than 700 mg, such as no more than 600 mg, such as no more than 500 mg, such as no more than 400 mg, such as no more than 350 mg, such as no more than 300 mg, such as no more than 250 mg, such as no more than 200 mg.
In an advantageous embodiment of the invention, the pouched product comprises said pouch composition in an amount of 50-700 mg, such as 60-600 mg, such as 75-500 mg, such as 50-400 mg, such as 75-350 mg, such as 100-300 mg, such as 125-250 mg, such as 150-200 mg.
In an embodiment of the invention, the pouched product comprises said pouch composition in an amount of 100-700 mg, such as 150-600 mg, such as 200-500 mg, such as 300-400 mg.
In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 1 mg, such as at least 2 mg, such as at least 4 mg, such as at least 6 mg.
In an embodiment of the invention, the pouch composition comprises nicotine in an amount of 1 mg to 25 mg, such as 2 mg to 20 mg, such as 4 mg to 15, such as 6 mg to 10 mg.
The invention will now be described with reference to the figures, where
As used herein the term “pouch composition” refers to the composition for use in an oral pouch, i.e. in pouches for oral use. Also, the terms “pouch composition” and “nicotine pouch composition” is used interchangeably.
As used herein the term “pouch” is intended to mean a container typically formed by a web of a fibrous material enclosing a cavity. The pouch is pouch designed for administration of an active ingredient in the oral cavity, and thus it is adapted for oral use, it is non-toxic and not water-soluble. The fibrous material may e.g. form a woven or non-woven web or fabric. The pouch may for example be sealed by bonding two corresponding pieces of web or fabric to each other along their edges to form a cavity for the nicotine and the non-water-soluble composition. In order to release the nicotine, the pouch is made water-permeable so as to allow saliva from the oral cavity to penetrate the pouch and enter the cavity, where the saliva can come into contact with the nicotine, whereby the nicotine are released from the oral pouch.
As used herein the term “humectant” is understood as a moistening agent used to keep pouches moist, i.e. a humectant is added to the pouch composition with the purpose of keeping the pouch moist. Hence, the term humectant does not refer to substances added for other purposes, hereunder also hygroscopic substances added for other purposes, such as sugar alcohols, water-insoluble fibers and glycerol associated with ion-exchange resin in nicotine-ion exchange resin combinations, such as nicotine polacrilex. Examples of humectants include alginate, propylene glycol, and hydroxypropyl cellulose.
As used here, a non-tobacco pouch composition refers to a non-tobacco based composition. In an embodiment of the invention, the non-tobacco pouch composition comprises at most 2% tobacco fibers, such as at most 0.01% tobacco fibers or is free of tobacco fibers.
As used herein the term “nicotine” refers to nicotine used as a refined/isolated substance. Nicotine may be isolated from tobacco and added to pouch compositions. Particularly, nicotine does not refer to tobacco materials having a content of nicotine. Thus, when referring to nicotine amounts also to be understood as the nicotine dose, the amounts refers to the amount of pure nicotine. Nicotine also covers nicotine not obtained from tobacco, often referred to as synthetic nicotine.
As used herein, the term “nicotine-ion exchange resin combination” refer to a combination comprising nicotine complexed with ion exchange resin and/or nicotine mixed with ion exchange resin.
As used herein, the term “nicotine complexed with ion-exchange resin” refers to nicotine bound to an ion exchange resin.
In the present context the term “free-base nicotine mixed with ion exchange resin” refers to a mixture comprising free-base nicotine and ion exchange resin. It is noted that even if some embodiments comprise a combination of nicotine complexed with ion exchange resin and nicotine in its free-base form mixed with ion exchange resin, the term “free-base nicotine mixed with ion exchange resin” requires the presence of nicotine in its free-base form. In some embodiments, the mixture is an aqueous mixture. Free-base nicotine and water is mixed with ion-exchange resin, whereby a mixture comprising both free-base nicotine and ion exchange resin is obtained. Free-base nicotine mixed with ion exchange resin is referred to as “premix” in the examples.
As used herein the term “powder composition” refers to composition in the form of powder, i.e. as a particulate material having a relatively small particle size, for example between 1 and 1200 micrometer. Particularly, by powder composition is not meant a powdered tobacco.
As used herein the term “free-base nicotine” refers to non-protonated form of nicotine, and therefore does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin. Nevertheless, the free-base nicotine may be mixed with an amount of ion exchange resin or water-soluble compositions such as sugar alcohols or water-soluble fibers. While free-base nicotine includes both free-base nicotine extracted from tobacco as well as synthetically manufactured free-base nicotine, the free-base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free-base nicotine is provided as a liquid.
As used herein the term “water-insoluble” refers to relatively low water-solubility, for example a water-solubility of less than 0.1 gram of water-soluble composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH of 7.0. When referring to “insoluble”, water-insoluble is meant unless otherwise stated.
As used herein the term “effective release” refers to the total release of nicotine over the release period of the experiment or the use period.
As used herein, the term “dissolve” is the process where a solid substance enters a solvent (such as oral saliva or water within the pouch) to yield a solution.
The pouches of the invention provide a nicotine release into the oral cavity. A release profile of nicotine may be obtained which both comprises a fast release period and a sustained release period.
As used herein the term “fast release” or “fast release period” may refer to the initial 2 minutes of the nicotine release profile, whereas the term “sustained release period refers” to the subsequent period of the release profile until end of experiment or end of use.
As used herein the term “fast release rate” refers to the released nicotine per minute within the initial 2 minutes.
The inert filler may comprise or consist of gum base, or it may comprise or consist of a composition comprising gum base, such as a chewing gum composition.
By the terms “gum base” and “gum base matrix” is meant the mainly water-insoluble and hydrophobic gum base ingredients that are mixed together, typically before the bulk portion of the chewing gum is added. The “gum base” may contain gum base polymers and plasticizers, waxes, emulsifiers, fats and/or fillers. The gum base may thus designate the typical water-insoluble chewing gum components, which may be manufactured in a first step and subsequently mixed with the mainly water soluble portion in a second step. The term gum base may, evidently, also refer to the relevant gum base components fed into an extruder and forming part of the final chewing gum when mixed with the chewing gum components in the extruder.
According to an embodiment of the invention, components of gum base may include softeners, such as wax, fats, and/or emulsifiers.
Gum base polymers are water insoluble and include elastomers and other polymeric materials suitable for use in the gum base. Elastomers provide the rubbery, cohesive nature to a gum base and subsequent chewing gum composition, which varies depending on this ingredient's chemical structure and how it may be compounded with other ingredients. Elastomers suitable for use in the present invention may include natural or synthetic types.
Elastomer plasticizers vary the firmness of the gum base. Their specificity on elastomer inter-molecular interaction (plasticizing) along with their varying softening points cause varying degrees of finished firmness and compatibility with other ingredients. This may be important when one wants to provide more elastomeric chain exposure to the alkane chains of the waxes. The elastomer plasticizers may typically be resins, such as synthetic resins and/or natural resins.
The elastomers employed in the gum base and subsequent chewing gum composition may vary depending upon various factors such as the desired texture of the coherent residual (i.e. the gum base and subsequent chewing gum composition after mastication) and the other components used in the formulation to make the gum base and subsequent chewing gum composition. The elastomer may be any water-insoluble polymer known in the art. Illustrative examples of suitable polymers in the gum base and subsequent chewing gum composition include both natural and synthetic elastomers. For example, those polymers which are suitable in the gum base and subsequent chewing gum composition include, without limitation, natural substances (of vegetable origin) such as chicle gum, natural rubber, crown gum, nispero, rosidinha, jelutong, perillo, niger gutta, tunu, balata, guttapercha, lechi capsi, sorva, gutta kay, and the like, and mixtures thereof. Examples of synthetic elastomers include, without limitation, styrene-butadiene copolymers (SBR), polyisobutylene, isobutylene-isoprene copolymers (i.e. butyl rubber), polyethylene, and the like, and mixtures thereof.
Natural resins may be used according to the invention and may be natural rosin esters, including as examples glycerol esters of partially hydrogenated rosins, glycerol esters of polymerized rosins, glycerol esters of partially dimerized rosins, glycerol esters of tally oil rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins, pentaerythritol esters of rosins, synthetic resins such as terpene resins derived from alpha-pinene, beta-pinene, and/or d-limonene, and natural terpene resins.
In an embodiment of the invention, the resin comprises terpene resins, e.g. derived from alpha-pinene, beta-pinene, and/or d-limonene, natural terpene resins, glycerol esters of gum rosins, tall oil rosins, wood rosins or other derivatives thereof such as glycerol esters of partially hydrogenated rosins, glycerol esters of polymerized rosins, glycerol esters of partially dimerised rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins or pentaerythritol esters of rosins and combinations thereof.
In an embodiment of the invention a synthetic resin may include polyvinyl acetate (PVAc) and/or vinyl acetate-vinyl laurate (VA-VL) copolymers.
In preferred embodiments, the gum base comprise elastomers and resins, e.g. in an amount of at least 50% by weight of the gum base, such as at least 70% by weight of the gum base.
In some embodiments of the present invention, the gum base comprises for example
-
- elastomer in the range of 1-15% by weight of the gum base,
- natural and/or synthetic resin in the range of 5-35% by weight of the gum base, and
- further other organic water insoluble components in the range of 5-30% by weight of the gum base.
Chewing gum compositions may include components such as bulk sweetener, high intensity sweetener, one or more fillers, etc.
In chewing gum compositions, the gum base may comprise elastomers and resins in amounts of at least 6% by weight of the chewing gum composition, such as at least 15% by weight of the chewing gum composition, or such as 6-50% by weight of the chewing gum composition, such at 15-45% by weight of the chewing gum composition.
In some embodiments of the present invention, the chewing gum composition comprises natural resins in an amount of 0.1 to 30%, such as 1 to 25%, such as 3 to 25% or 5 to 25%, by weight of the chewing gum composition.
In embodiments of the present invention, the chewing gum composition comprises synthetic resins in an amount of 0.1 to 30%, such as 1 to 25%, such as 3 to 25% or 5 to 25%, by weight of the chewing gum composition.
Usable bulk sweeteners include both sugar and non-sugar sweeteners such as sugar alcohols.
A chewing gum composition may, if desired, include one or more fillers/texturisers including as examples, talc, titanium dioxide, mono-, di- and tri-calcium phosphates, calcium and magnesium carbonate, and combinations thereof.
The inert filler may be provided in the form of granules. The granules or some of the granules may for example consist or largely comprise or consist of gum base or chewing gum composition and such granules may be manufactured by means of extrusion and under-water pelletizing.
The size of such granules of gum base or chewing gum composition may be controlled by several factors such as opening sizes, the composition, temperature and pressure drop, if a die plate is used in the extruder. Due to an interaction between the pressurized composition, temperature and friction in the openings of the die device, the average diameter of the produced granules is normally larger than the diameters of the openings in the die device. The relation between the diameters of the openings in the die device and the average diameters of granules produced from a specific composition may be determined by the skilled person on basis of routine experiments.
According to the invention it is also possible to produce granules with different average diameters by making granules with one diameter, and subsequently mix the granules with different average diameters in desired proportions.
Although the openings of a die of an extruder device may have cross-sections of any desired shape, e.g. circular, oval, square etc., it is in some embodiments preferred that the die device comprises openings with substantially circular cross-section and diameters in the range of 0.1 to 1.3 mm. A first set of openings can e.g. have a first diameter in the range of 0.07 to 0.7 mm, such as in the range of 0.15 to 0.6 mm, and suitably in the range of 0.2 to 0.5 mm. A second set of openings can have a second diameter larger than said first diameter. The second diameter is conveniently in the range of 0.4 to 1.3 mm, such as in the range of 0.7 to 1.2 mm.
In some embodiments the granulating system further comprises a drying device. Powder sweetener or talk may be added to the granules in a final drying step. The drying device can be a conventional centrifugal dryer or another suitable dryer e.g. a fluid bed dryer. The drying device can, for example, include a mixer. The powder sweetener may in an embodiment be sorbitol, which is mixed to the dried or partially dried granules. Minor amounts of residual moisture on the surface of the granules, e.g. 2% Wt. based on the total weight of the granules, may contribute to the adherence of the sorbitol powder to the surface of the granules. It is possible to use a conventional anti-agglomerating agent as e.g. talc, but sorbitol powder can function as an anti-agglomerating agent, and at the same time serves as sweetener. Although sorbitol is found to be most suitable, other bulk sweeteners based on polyols may also be suitable, e.g. mannitol, xylitol, maltitol, isomalt, erythritol, and lactitol.
In one embodiment one or more sieves adapted for removing granules with an average diameter such as above 1.3 mm may be used.
According to an embodiment of the invention at least the extruder and/or the die device comprises means for controlling the temperature of the composition. The means for controlling temperature can be cooling or heating devices, and may serve to facilitate the flow of composition through the extruder and the die device. In an embodiment the extruder comprises delivering means for delivering sweetener and/or flavour to the composition in the extruder.
During extrusion of the composition the differential pressure between the composition in the extruder and the composition in the liquid filled chamber, i.e. over the die device is suitably above 10 bar, such as above 18 bar, such as in the range of 25 to 90 bar. The temperature of the composition in the extruder may for example be in the range of 40 to 125° C., suitably in the range 50 to 115° C. The temperature of the die device may for example be in the range of 60 to 250° C., suitably in the range 80 to 180° C. The temperature of the liquid in the liquid filled chamber is conveniently in the range of 8 to 40° C. The optimum for the pressures and temperatures in the method according to the invention may, however, may be determined by the skilled person as a matter of routine. The optimum values for specific compositions, varies of course, depending on the composition.
The quick cooling in the air filled or water-filled chamber may act to preserve possible fragile ingredients in the composition so that their qualities are better kept intact and conveyed into the granules included in the final product. This improved quality of the composition in the granules comprising the gum vase improves the general composition.
Granule fractions of different average weights may be produced with two different setups, each producing a batch of granules of a particular average weight, followed by a blending of the fractions. It is also possible to design a die means with die openings of at least two different sizes to simultaneously obtain granules with different average diameter. Thus, it is possible to obtain granules having different weights. More than two different average weights may be obtained, depending on the design of the die means in use. It is for instance possible to obtain granules with three, four or more different average weights.
The granules may be cut in a very large liquid-filled chamber, in which the granules are also cooled. In some embodiments the cooling is combined with transfer of the granules away from the chamber. This can be done e.g. by cooling the cut granules in water during transfer from the liquid filled chamber to a de-watering device. The transfer time from cutting to de-watering can be less than 6 s. The advantage of this is that water-soluble ingredients in the composition are not unnecessarily washed out of the granules. Optionally, the total time of contact between granules and cooling water can be further limited to less than 4 s.
Examples of gum bases applicable for use as inert filler or as a part thereof in embodiments of the present invention are described in the PCT/DK02/00461 and PCT/DK02/00462, hereby incorporated by reference.
In an embodiment of the invention the pouch composition comprises high intensity sweetener.
Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination.
In an embodiment of the invention, the pouch composition comprises bulk sweeteners including sugar and/or sugarless components.
In an embodiment of the invention, the pouch composition comprises bulk sweetener in the amount of 1.0 to about 80% by weight of the pouch composition, more typically constitute 5 to about 70% by weight of the pouch composition, and more commonly 10 to 60% by weight of the pouch composition or 10-50% by weight of the pouch composition. In some embodiments, inclusion of certain ingredients may limit the about amounts of bulk sweetener further.
The sweeteners may often support the flavor profile of the pouch composition.
Sugar sweeteners generally include, but are not limited to saccharide-containing components commonly known in the art of pouches, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.
The sugar sweetener can be used in combination with sugarless sweeteners.
Generally, sugarless sweeteners include components with sweetening characteristics, but which are devoid of the commonly known sugars and comprise, but are not limited to, sugar alcohols comprising 4 or more carbons, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.
As used herein the term “flavor” is understood as having its ordinary meaning within the art. Flavor includes liquid and powdered flavors. Thus, flavors do of course not include sweeteners (such as sugar, sugar alcohols and high intensity sweeteners), or acids providing pure acidity/sourness, nor compounds providing pure saltiness (e.g. NaCl) or pure bitterness. Flavor enhancers include substances that only provide saltiness, bitterness or sourness. Flavor enhancers thus include e.g. sodium chloride, Citric acid, ammonium chloride etc.
The flavors can be natural or synthetic flavors.
In an embodiment of the invention the pouch composition comprises flavor. Flavor may typically be present in amounts between 0.01 and 15% by weight of the total composition of the pouch, such as between 0.01 and 5% by weight of the total composition.
Non-exhaustive examples of flavors suitable in embodiments of the present invention are coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essence. The essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.
As used herein, the term “pH regulating agent” refers to agents, which active adjust and regulates the pH value of the solution to which they have been added or are to be added. Thus, pH regulating agents may be acids and bases, including acidic buffering agents and alkaline buffering agents. On the other hand, pH regulating agents does not including substances and compositions that can only affect the pH by dilution. Furthermore, pH regulating agents does not include e.g. flavoring, fillers, etc.
According to an embodiment of the invention, the pouch composition comprises one or more pH-regulating agent, such as a buffering agent.
In an embodiment of the invention, said pH-regulating agents are selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-δ-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potassium carbonate, or any combination thereof.
Typically, the pouches comprise openings, where the characteristic opening dimension is adapted to a characteristic dimension of the matrix composition so as to retain the matrix composition inside the pouch before use and/or to retain a part of the matrix composition, such as a water-insoluble composition, inside the pouch during use.
In order to obtain a pouch having suitable opening dimensions in view of the matrix composition to be used, the material for the pouch may be selected accordingly, e.g. comprising e.g. woven and/or non-woven fabric.
In other words, according to the various embodiments, the pouch forms a membrane allowing passage of saliva and prevents or inhibits passage of said matrix composition. The membrane of the pouch may be of any suitable material e.g. woven or non-woven fabric (e.g. cotton, fleece etc.), heat sealable non-woven cellulose or other polymeric materials such as a synthetic, semi-synthetic or natural polymeric material. An example of suitable pouch material is paper made of pulp and a small amount of wet strength agent. A material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. Suitable materials are also those that do not have a significant impact on the release of nicotine from the pouch.
The pouch composition is filled into pouches and is maintained in the pouch by a sealing. An ideal pouch is chemically and physically stable, it is pharmaceutically acceptable, it is insoluble in water, it is easy to fill with powder and seal, and it provides a semi-permeable membrane layer which prevent the powder from leaving the bag, but permit saliva and therein dissolved or sufficiently small suspended components from the pouch composition in the pouch, such as nicotine, to pass through said pouch.
The pouch may be placed in the oral cavity by the user. Saliva then enters into the pouch, and the nicotine and other components, which are soluble in saliva, start to dissolve and are transported with the saliva out of the pouch into the oral cavity, where the nicotine may be absorbed.
EXAMPLES Example 1A—Preparation of Pouches Designed for Administration of NicotineThe material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.
The powder is filled into pouches and is maintained in the pouch by a sealing.
Example 1B—Preparation of Pouches Designed for Administration of NicotineThe material of the pouches is manufactured using rayon fibers, such as viscose rayon staple fibers. The pouch membrane is heat sealed along its edges except for an opening in one end into an inner cavity formed by the pouch membrane.
The powder is filled into pouches and is maintained in the pouch by a sealing.
Example 2: Preparation of Nicotine PremixesA 60 liter planetary Bear Varimixer mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally the mixer was stirred for further 5 minutes at high speed. The total process time was 20 minutes.
Thereby, mixtures of nicotine and cation exchange resin were produced from the constituents stated in the below tables.
Premix I:
Pouches are prepared comprising pouch compositions as outlined in table 10-23. The pouch compositions are made as follows.
Fibers and water are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: first the nicotine (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.
For pouch compositions comprising no or low amounts of water, the pouch compositions may alternatively be made as follows.
Fibers and other dry ingredients are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: first the nicotine (mixed for 2 minutes), then the remaining liquid ingredients if any, except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.
Example 4: Preparation of Filled PouchesThe final pouch composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A or 1B may be used. The powder is filled into pouches and is maintained in the pouch by a sealing.
Example 5A: Gum BaseFour different gum bases, referred to as GB01-GB04, are provided below. The compositions are given in table 9A and the samples were prepared by the following process:
Elastomers and about ⅓ of the resin are mixed at 120° C. together with filler in a pre-heated mixer having horizontally placed Z-shaped arms for mixing. The fillers are talc. The mechanical action of the mixer causes shearing and grinding resulting in softening of the elastomers.
When the elastomers are softened, more resin is slowly added to the elastomer, resin and filler until the mixture becomes homogeneous. The remaining resin is then added to the mixer and mixed for 10-20 minutes. The softeners, i.e. emulsifier, wax and vegetable fat, are then added and mixed for 20-40 minutes until the whole mixture becomes homogeneous.
After a total mixing time of about 45-60 minutes, the mixture is subjected to pelletizing in a standard under water pelletizing (UWP) unit resulting in coherent granules with an average diameter of approximately 1 mm. Flavor may be added to the composition just before pelletizing.
The applied polyisobutylene may e.g. be Oppanol B12, polyvinyl acetate (PVAc) may e.g. be Vinnapas B 1.5 sp, VA-VL copolymers (vinyl acetate-vinyl laurate copolymers) may e.g. be Vinnapas B 500/20 VL, natural resin may e.g. be Staybelite 5E or Piccolyte C85, softener may e.g. be hydrogenated vegetable fat such as hydrogenated sunflower oil. Flavor may e.g. be menthol crystals. It is stressed that the specifically mentioned components are of course a non-limiting disclosure intended to assist a skilled person in reproducing the present invention.
Chewing gum compositions CG01 and CG02, respectively, were prepared as follows: Gum base and filler are mixed in a mixing kettle having horizontally placed Z-shaped arms for mixing. The kettle was preheated to a temperature of up to approximately 50° C.
When the content of the kettle is homogeneous, the other ingredients are added according to a specified time schedule. After mixing to ensure homogeneity of the final chewing gum, the chewing gum mass is poured into open trays and allowed to cool to room temperature. Then, the chewing gum is further cooled and milled to obtain chewing gum granules using standard milling techniques.
The chewing gum compositions were as displayed in table 9B here below, the amounts given corresponding to percentages by weight:
The pouch compositions are prepared from the ingredients in table 10 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 13.6 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 0.5 mm were used as inert filler. Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6B: PouchesThe pouch compositions are prepared from the ingredients in table 11 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 11.2 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 0.5 mm were used as inert filler. Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6C: PouchesThe pouch compositions are prepared from the ingredients in table 12 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 1.0 mm were used as inert filler. Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6D: PouchesThe pouch compositions are prepared from the ingredients in table 13 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied)
Pouch content: 500 mg total.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 1.0 mm were used as inert filler. Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6E: PouchesThe pouch compositions are prepared from the ingredients in table 14 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 13.4 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 0.5 mm were used as inert filler. Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6F: PouchesThe pouch compositions are prepared from the ingredients in table 15 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 13.4 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus” or “Vitacel 200WF”.
Oat fiber, trade name “Vitacel HF 600”.
Pea fiber, trade name “Vitacel EF150”.
Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, powdered cellulose, apple fibers, cocoa fibers, bamboo fibers, and bran fibers.
Gum base granules with an average particle size of 1.0 mm were used as inert filler. Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6G: PouchesThe pouch compositions are prepared from the ingredients in table 16 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 13.4 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 0.5 mm were used as inert filler. Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 61: PouchesThe pouch compositions are prepared from the ingredients in table 18 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 13.4 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 0.5 mm were used as inert filler. Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6J: Pouches with Gum Base as Inert FillerThe pouch compositions are prepared from the ingredients in table 19 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Gum base granules with an average particle size of 1.0 mm were used as inert filler. Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6K: Pouches with Chewing Gum Composition as Inert FillerThe pouch compositions are prepared from the ingredients in table 20 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Chewing gum granules with an average particle size of 0.5 mm were used as inert filler.
Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6L: Pouches with Clay as Inert FillerThe pouch compositions are prepared from the ingredients in table 21 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Clay particles with an average particle size of 0.5 mm were used as inert filler.
Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6M: Pouches with Cork as Inert FillerThe pouch compositions are prepared from the ingredients in table 22 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Cork particles with an average particle size of 1.0 mm were used as inert filler.
Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 6N: Pouches with Glass Spheres as Inert FillerThe pouch compositions are prepared from the ingredients in table 23 using preparation method described in example 3.
The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
Pouch content: 500 mg total, i.e. nicotine conc 16.0 mg/g.
Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
Glass spheres (spherical beads) with varying diameters were used as inert filler in accordance with table 23.
Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
Optionally, acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 7: Release of NicotinePouches PIC130-131, PIC133-134 and C130 and were subjected to tests to measure nicotine release.
Test Method10 L chewing buffer pH 7.4 was degassed and heated to 38° C. with a Dissolution Media Preparation Station.
900 mL chewing buffer pH 7.4 was transferred to each vessel in the USP Dissolution Apparatus 1. Inside the vessels, the chewing buffer pH 7.4 was adjusted to 37° C.
Weight measured pouches were transferred to baskets and the dissolution apparatus was started.
Sampling times of buffer were set to different times, occasionally covering the time span of different times such as 2, 6, 12, 20, 30 and 60 min. Rotational speed was set to 100 rpm.
Release samples after 2 min were taken manually with cannulas. Release samples at all time points were taken automatically with the dissolution apparatus.
All samples were filtered and prepared for HPLC analysis.
For each sample release measurements were repeated for 6 individual pouches.
ResultsThe measured nicotine release profiles are shown in tables 24-28 and illustrated in
The results of table 24 are illustrated in
The results of table 25 are illustrated in
The results of table 26 are illustrated in
The results of table 27 are illustrated in
Claims
1. A nicotine pouch composition comprising nicotine, water-insoluble fibers, and a particulate inert filler,
- wherein the pouch composition comprises said inert filler in an amount of at least 5% by weight of the pouch composition,
- wherein the pouch composition further comprises at least 10% by weight of water.
2. The nicotine pouch composition according to claim 1, wherein the inert filler has a water retention capacity of no more than 20% by weight of the inert filler.
3. The nicotine pouch composition according to claim 1, wherein the inert filler has an average particle size of at least 0.02 mm.
4-5. (canceled)
6. The nicotine pouch composition according to claim 1, wherein the pouch composition comprises said inert filler in an amount of at least 10% by weight of the pouch composition.
7. (canceled)
8. The nicotine pouch composition according to claim 1, wherein the inert filler comprises a polymeric material.
9. The nicotine pouch composition according to claim 1, wherein the inert filler comprises gum base.
10-11. (canceled)
12. The nicotine pouch composition according to claim 1, wherein the inert filler comprises chewing gum composition.
13-15. (canceled)
16. The nicotine pouch composition according to claim 1, wherein the inert filler comprises one or more gum base polymers.
17-26. (canceled)
27. The nicotine pouch composition according to claim 1, wherein the inert filler comprises glass particles.
28. The nicotine pouch composition according to claim 1, wherein said inert filler comprises silica.
29. (canceled)
30. The nicotine pouch composition according to claim 1, wherein the inert filler comprises clay particles.
31-33. (canceled)
34. The nicotine pouch composition according to claim 1, wherein the inert filler comprises one or more selected from the group consisting of magnesium carbonate, calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, and any combination thereof.
35-40. (canceled)
41. The nicotine pouch composition according to claim 1, wherein the inert filler is free of microcrystalline cellulose (MCC).
42-43. (canceled)
44. The nicotine pouch composition according to claim 1, wherein the inert filler comprises an inorganic material.
45. The nicotine pouch composition according to claim 1, wherein the water-insoluble fiber is a non-tobacco fiber.
46-49. (canceled)
50. The nicotine pouch composition according to claim 1, wherein the pouch composition is a powdered composition.
51. The nicotine pouch composition according to claim 1, wherein the pouch composition comprises at least one sugar alcohol.
52-56. (canceled)
57. The nicotine pouch composition according to claim 1, wherein the pouch composition comprises said water-insoluble fiber in an amount of at least 5% by weight of the pouch composition.
58. The nicotine pouch composition according to claim 1, wherein the water-insoluble fiber comprises one or more selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof.
59-83. (canceled)
84. A pouched product comprising the pouch composition according to claim 1 and a saliva-permeable pouch enclosing said pouch composition.
85-86. (canceled)
Type: Application
Filed: Feb 2, 2024
Publication Date: Aug 6, 2026
Applicant: Fertin Pharma A/S (Vejle)
Inventor: Kent Albin Nielsen (Vejle)
Application Number: 19/149,503
