NICOTINE POUCH COMPOSITION AND POUCH COMPRISING SUCH

Abstract

A nicotine pouch composition is disclosed, the pouch composition comprising free-base nicotine and having a water content of at least 15% by weight of said pouch composition. Furthermore, an oral nicotine pouch product comprising the pouch composition and a method for manufacturing the oral nicotine pouch product is disclosed.

Claims

1. A nicotine pouch composition comprising a free-base nicotine mixture, and sugar alcohol, said pouch composition having a water content of at least 15% by weight of said pouch composition, wherein the free-base nicotine mixture comprises at least one selected from the group consisting of free-base nicotine mixed with ion exchange resin, free-base nicotine mixed with a water-soluble substance, and combinations thereof.

2. The nicotine pouch composition according to claim 1, wherein said sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, and any combination thereof.

3. The nicotine pouch composition according to claim 1, wherein the pouch composition comprises sugar alcohol in an amount of 5-70% by weight of the pouch composition.

4. The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises a pH-regulating agent.

5. The nicotine pouch composition according to claim 4, wherein the pouch composition comprises pH-regulating agent in an amount of between 0.01 and 15% by weight of the pouch composition

6. The nicotine pouch composition according to claim 4, wherein the pH regulating agent is a basic pH regulating agent.

7. The nicotine pouch composition according to claim 4, wherein the pH regulating agent is selected from the group consisting of Sodium carbonate, Sodium bicarbonate, Potassium carbonate, Potassium bicarbonate, Magnesium carbonate, and combinations thereof.

8. The nicotine pouch composition according to claim 4, wherein the nicotine pouch composition comprises an acidic pH regulating agent.

9. The nicotine pouch composition according to claim 8, wherein the nicotine pouch composition further comprises an alkaline pH regulating agent and wherein the pouch composition is adapted to give a pH of at least 8.0

10. The nicotine pouch composition according to claim 8, wherein the acidic pH regulating is selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-δ-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Carbonic acid, Benzoic acid, and salts thereof.

11. The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises a humectant.

12. The nicotine pouch composition according to claim 1, wherein the pouch composition is free of silicon dioxide.

13. The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises a water-insoluble composition in an amount of between 5 and 50% by weight of the pouch composition.

14. The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises an amount of a water-insoluble composition, wherein the water-insoluble composition comprises or consists of water-insoluble fiber.

15. The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber is selected from the group consisting of wheat fibers, oat fibers, pea fibers, rice fiber, maize fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fiber, powdered cellulose, bamboo fibers, bran fibers and combinations thereof.

16. The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber comprises microcrystalline cellulose.

17. The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber comprises powdered cellulose.

18. The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber comprises at least two different types of fibers.

19. The nicotine pouch composition according to claim 18, wherein the water-insoluble fiber comprises powdered cellulose

20. The nicotine pouch composition according to claim 1, wherein the pouch composition has a water content of 15 to 70% by weight of said pouch composition.

21. The nicotine pouch composition according to claim 1, wherein the pouch composition comprises nicotine in an amount corresponding to 0.5 to 20 mg per pouch.

22. The nicotine pouch composition according to claim 1, wherein the pouch composition is free of tobacco, tobacco fibers and fibers derived from tobacco.

23. The nicotine pouch composition according to claim 1, wherein the composition comprises flavor.

24. An oral nicotine pouch product comprising a pouch and an amount of the nicotine pouch composition according to claim 1 enclosed in said pouch.

25. The oral nicotine pouch product according to claim 24, wherein the pouch composition is a non-tobacco pouch composition, wherein the nicotine pouch composition comprises sugar alcohol in an amount of 10-60% by weight of the pouch composition, said sugar alcohol being selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, and combinations thereof, wherein the pouch composition comprises pH regulating agent in an amount of 0.01 and 15% by weight of the pouch composition, and wherein the pouch composition comprises water-insoluble fiber in an amount of 10-50% by weight of the pouch composition.

26. A nicotine pouch composition comprising free-base nicotine and sugar alcohol, said pouch composition having a water content of at least 15% by weight of said pouch composition.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0259] As used herein the term “nicotine pouch composition” refers to the composition for use in an oral nicotine pouch, i.e. in pouches for oral use comprising nicotine. Also, the terms “nicotine pouch composition” and “pouch composition” is used interchangeably.

[0260] As used herein the term “free-base nicotine” refers to non-protonated form of nicotine, and therefore does not include nicotine salts and 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.

[0261] 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.

[0262] 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.

[0263] As used herein the term “humectant” is understood as a moistening agent used to attract moisture or water in the form of saliva. Humectants may typically include suitably hygroscopic compositions. In some cases, humectants may also be described as moistening agents, due to their role in attraction of moisture. Examples of humectants include glycerol, propylene glycol, alginate, triacetin modified starch, hydroxypropyl cellulose, pectin, xanthan gum, etc.

[0264] As used herein the term “water-soluble” refers to a relatively high water-solubility, for example a water-solubility of more than 5 gram of water-soluble composition or substance per 100 mL of water measured at 25 degrees Celsius and pH of 7.0. When referring to a “soluble” composition or substance, water-soluble is meant, unless otherwise stated.

[0265] 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 and pH of 7.0. When referring to “insoluble”, water-insoluble is meant unless otherwise stated.

[0266] 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. NaCl, Citric acid, ammonium chloride etc.

[0267] 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.

[0268] 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.

[0269] As used herein “release rate” describes the average release of nicotine per minute within a given period, for example if a pouch in the period from 2 minutes to 10 minutes further releases 16% of the nicotine dose, the release rate is 2% per minute within this given period. Alternatively, if a pouch in the period from 2 minutes to 10 minutes further releases 2 mg of nicotine, the release rate is 0.25 mg per minute within this given period. The release rate is determined only from the release data at the outer time points of the time period.

[0270] 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 an water-insoluble composition, inside the pouch during use.

[0271] 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.

[0272] 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.

[0273] 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.

[0274] 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.

[0275] According to an embodiment of the invention, the pouch composition may further comprise one or more enhancers.

[0276] In an embodiment of the invention, said enhancers are selected from the group consisting of bile salts, cetomacrogols, chelating agents, citrates, cyclodextrins, detergents, enamine derivatives, fatty acids, labrasol, lecithins, phospholipids, syntetic and natural surfactants, nonionic surfactants, cell envelope disordering compounds, solvents, steroidal detergents, chelators, solubilization agents, charge modifying agents, pH regulating agents, degradative enzyme inhibitors, mucolytic or mucus clearing agents, membrane penetration-enhancing agents, modulatory agents of epithelial junction physiology, vasodilator agents, selective transport-enhancing agents, or any combination thereof. pH regulating agents include buffers.

[0277] In an embodiment of the invention, said enhancers are selected from the group consisting of cetylpyridinium chloride (CPC), benzalkonium chloride, sodium lauryl sulfate, polysorbate 80, Polysorbate 20, cetyltrimethylammonium bromide, laureth 9, sodium salicylate, sodium EDTA, EDTA, aprotinin, sodium taurocholate, saponins, bile salt derivatives, fatty acids, sucrose esters, azone emulsion, dextran sulphate, linoleic acid, labrafil, transcutol, urea, azone, nonionic surfactants, sulfoxides, sauric acid/PG, POE 23 lauryl ether, methoxysalicylate, dextran sulfate, methanol, ethanol, sodium cholate, Sodium taurocholate, Lysophosphatidyl choline, Alkylglycosides, polysorbates, Sorbitan esters, Poloxamer block copolymers, PEG-35 castor oil, PEG-40 hydrogenated castor oil, Caprocaproyl macrogol-8 glycerides, PEG-8 caprylic/capric, glycerides, Dioctyl sulfosuccinate, Polyethylene lauryl ether, Ethoxydiglycol, Propylene glycol, mono-di-caprylate, Glycerol monocaprylate, Glyceryl fatty acids (C.sub.8-C.sub.18) ethoxylated Oleic acid, Linoleic acid, Glyceryl caprylate/caprate, Glyceryl monooleate, Glyceryl monolaurate, Capryliccapric triglycerides, Ethoxylated nonylphenols, PEG-(8-50) stearates, Olive oil PEG-6, esters, Triolein PEG-6 esters, Lecithin, d-alpha tocopherol polyethylene glycol 1,000 succinate, Citric acid, Sodium citrate, BRIJ, Sodium laurate, 5-methoxysalicylic acid, Bile salts, Acetyl salicylate, ZOT, Docosahexaenoic acid, Alkylglycosides, Sodium glycocholate (GC-Na), Sodium taurocholate (TC-Na), EDTA, Choline salicylate, Sodium caprate (Cap-Na), N-lauryl-beta-D-maltopyranoside (LM), Diethyl maleate, Labrasol, Sodium salicylate, Mentol, Alkali metal alkyl sulphate, Sodium lauryl sulphate, Glycerin, Bile acid, Lecithin, phosphatidylcholine, phosphatidylserine, sphingomyelin, phophatidylethanolamine, cephalin, lysolecithin, Hyaluronic acid: alkalimetal salts, sodium, alkaline earth and aluminum, Octylphenoxypolyethoxyethanol, Glycolic acid, Lactic acid, Chamomile extract, Cucumber extract, Borage oil, Evening primrose oil, Polyglycerin, Lysine, Polylysine, Triolein, Monoolein, Monooleates, Monolaurates, Polydocanol alkyl ethers, Chenodeoxycholate, Deoxycholate, Glycocholic acid, Taurocholic acid, Glycodeoxycholic acid, Taurodeoxycholic acid, Sodium glycocholate, Phosphatidylcholine, Phosphatidylserine, Sphingomyelin, Phosphatidylethanolamine, Cephalin, Lysolecithin, Alkali metal hyaluronates, Chitosan, Poly-L-arginine, Alkyl glucoside, Saccharide alkyl ester, Fusidic acid derivatives, Sodium taurdihydrofusidate (STDHF), L-α-phosphatidylcholine Didecanoyl (DDPC), Nitroglycerine, nitropruside, N005 [3-(2-hydroxy-I-(methyl-ethyl)-2-nitrosohydrazino)-I-propanamine], NOC12 [iV-ethyl-2-(I-ethyl-hydroxy-2-nitrosohydrazino)-ethanamine, SNAP [S-nitroso-N-acetyl-DL-penicillamine, NORI, NOR4, deacylmethyl sulfoxide, azone, salicylamide, glyceryl-I,3-diacetoacetate,I,2-isopropylideneglycerine-3-acetoacetate), Amino acids, Amino acid salts, monoaminocarboxlic acids, Glycine, alanine, phenylalanine, proline, hydroxyproline, hydroxyamino acids, serine, acidic amino acids, aspartic acid, Glutamic acid, Basic amino acids, Lysine, N-acetylamino acids, N-acetylalanine, N-acetylphenylalanine, TM-acetylserine, N-acetylglycine, N-acetyllysine, N-acetylglutamic acid, N-acetylproline, N-acetylhydroxyproline, lactic acid, malic acid and citric acid and alkali metal salts thereof, pyrrolidonecarboxylic acids, alkylpyrrolidonecarboxylic acid esters, N-alkylpyrrolidones, proline acyl esters, sodium lauryl phosphate, sodium lauryl sulphate, sodium oleyl phosphate, sodium myristyl sulphate, polyoxyethylene alkyl ethers, polyoxyethylene alkyl esters, and caproic acid, alkylsaccharide, fusidic acid, polyethylene glycol, cetyl alcohol, polyvinylpyrolidone, Polyvinyl alcohol, Lanolin alcohol, Sorbitan monooleate, Ethylene glycol tetraacetic acid, Bile acid conjugate with taurine, Cholanic acid and salts, Cyclodextran, Cyclodextrin, Cyclodextrin (beta), Hydroxypropyl-β-cyclodetran, Sulfobutylether-β-cyclodextran, Methyl-β-cyclodextrin, Chitosan glutamate, Chitosan acetate, Chitosan hydrochloride, Chitosan hydrolactate, 1-O-alkyl-2-hydroxy-sn-glycero-3-phosphocholine, 3-O-alkyl-2-acetoyl-sn-glycero-1-phosphocholine,1-O-alkyl-2-O-acetyl-sn-glycero-3-phospho(N,N,N-trimethyl)hexanolamine, Propylene glycol, Tetradecylmaltoside (TDM), Sucrose dedecanoate.

[0278] According to an embodiment of the invention, the enhancer comprises one or more pH-regulating agent, such as a buffering agent.

[0279] 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, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.

[0280] According to various embodiments of the invention, one or more sugar alcohols may be included in the pouch as part of the pouch composition, e.g. as a carrier or part thereof, as a humectant, or as a sweetener. Suitable sugar alcohols include sugar alcohols selected from the group of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, or any combination thereof.

[0281] In an embodiment of the invention the pouch composition comprises high intensity sweetener.

[0282] 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.

[0283] In an embodiment of the invention, the pouch composition comprises bulk sweeteners including sugar and/or sugarless components.

[0284] 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. Bulk sweeteners may function both as a sweetener and also as a humectant. In some embodiments, inclusion of certain ingredients may limit the about amounts of bulk sweetener further.

[0285] The sweeteners may often support the flavor profile of the pouch composition.

[0286] 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. These sugar sweeteners may also be included as a humectant.

[0287] The 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, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination. These sugarless sweeteners may also be included as a humectant.

[0288] 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.

[0289] 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.

[0290] In various embodiments of the invention, the pouch composition comprises a release controlling composition for controlling the release of the pouch composition and/or parts thereof, especially the nicotine.

[0291] The release controlling composition may, according to various embodiments, be selected group consisting of metallic stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, silicates dioxide, talc, magnesium stearates, calcium stearates, fumed silica, powdered hydrogenated cottonseed oils, hydrogenated vegetable oils, hydrogenated soya oil, emulsifiers, triglycerides, and mixtures thereof. Particularly, metallic stearates, such as magnesium stearate, may be advantageous.

[0292] The release controlling composition may be added to the pouch composition in various ways.

[0293] For example, the release controlling composition may be added by full powder mixture during the last few minutes of the final mixing.

[0294] Alternatively, the release controlling composition may be added after granulation steps on a granulation premix.

[0295] Still further, the release controlling composition may be added only as a fraction of the pouch composition so two different release profiles of nicotine is achieved. Even further two or more fractions of the matrix composition may comprise different amounts of the release controlling composition, if any, thereby providing a more complex and tailored release profile of nicotine.

[0296] The release controlling composition, such as magnesium stearate, may have a sealing effect and can be used to control the release of the nicotine and the solubility of the pouch.

[0297] According to an embodiment of the invention, the pouch composition comprises polyvinylpyrrolidone (PVP). The pouch composition may also be free of PVP.

[0298] One advantage of the above embodiment may be that a more uniform composition may be obtained.

EXAMPLES

Example 1A—Preparation of Pouches Designed for Administration of Nicotine

[0299] The 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.

[0300] The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 1B—Preparation of Pouches Designed for Administration of Nicotine

[0301] The 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.

[0302] The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 2A—Nicotine Premix I—Resin

[0303] A Stephan mixer (vacuum premixing) was charged with water, and nicotine was weighed and added, the mixer was closed and stirred for 5 minutes. Then ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred for 10-60 minutes.

[0304] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 1.

TABLE-US-00001 TABLE 1 Ingredients used to manufacture nicotine premix I. Constituent Amount (kg) Amount (%) Nicotine 1.0 5.7 Water 12.5 71.4 Resin 4.0 22.9 Total 17.5 100.0 Nicotine:resin ratio: 1:4 (0.25) % water in obtained nicotine-resin composition: 71.4

Example 2B—Nicotine Premix II—Resin

[0305] A 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.

[0306] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 2.

TABLE-US-00002 TABLE 2 Ingredients used to manufacture nicotine premix II. Constituent Amount (kg) Amount (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100.0 Nicotine:resin ratio: 1:4 (0.25) % water in obtained nicotine-resin composition: 34.1 The total process time was 20 minutes.

Example 2C—Nicotine Premix III—Resin

[0307] A 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.

[0308] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 3.

TABLE-US-00003 TABLE 3 Ingredients used to manufacture nicotine premix III. Constituent Amount (kg) Amount (%) Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100.0 Nicotine:resin ratio: 1:4 (0.25) % water in obtained nicotine-resin composition: 7.5 The total process time was 20 minutes.

Example 2D—Nicotine Premix IV—Resin

[0309] A 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.

[0310] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 4.

TABLE-US-00004 TABLE 4 Ingredients used to manufacture nicotine premix IV. Constituent Amount (kg) Amount (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100.0 Nicotine:resin ratio: 1:4 (0.25) % water in obtained nicotine-resin composition: 50.0 The total process time was 20 minutes.

Example 2E—Nicotine Premix V—Resin

[0311] A 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.

[0312] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 4B.

TABLE-US-00005 TABLE 4B Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100.0 Nicotine:resin ratio: 1:2.43 (0.41) % water in obtained nicotine-resin composition: 31.5 The total process time was 20 minutes.

Example 2F—Nicotine Premix VI—Resin

[0313] A 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.

[0314] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 4C.

TABLE-US-00006 TABLE 4C Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100.0 Nicotine:resin ratio: 1:1.4 (0.71) % water in obtained nicotine-resin composition: 27.5 The total process time was 20 minutes.

Example 2G—Nicotine Premix VII—Resin

[0315] A 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.

[0316] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 4A.

TABLE-US-00007 TABLE 4D Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100.0 Nicotine:resin ratio: 1.19:1 (1.19) % water in obtained nicotine-resin composition: 22.8 The total process time was 20 minutes.

Example 2H—Nicotine Premix VIII—Resin

[0317] A 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.

[0318] Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 4A.

TABLE-US-00008 TABLE 4E Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 5.15 39.8 Water 2.80 21.6 Resin 4.32 33.4 Pea fiber 0.67 5.2 Total 12.94 100.0 Nicotine:resin ratio: 1.19:1 (1.19) % water in obtained nicotine-resin composition: 21.6 The total process time was 20 minutes.

Example 3A—Pouches

[0319] Comparative pouches containing nicotine polacrilex resin (NPR) or nicotine bitartrate (NBT) are prepared comprising powdered compositions as outlined in table 5. The pouches are made as follows.

[0320] 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 Nicotine bitartrate xH2O (NBT, nicotine content of 32.5%) or nicotine polacrilex resin (NPR, nicotine content of 15.9%) as applicable (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.

[0321] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing.

[0322] The 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.

[0323] The pouch material of example 1B may also be used.

[0324] The powder is filled into pouches and is maintained in the pouch by a sealing.

[0325] Pouches PPC1-PPC5 containing nicotine premix are prepared comprising powdered compositions as outlined in table 5. The pouches are made as follows.

[0326] Fibers and water are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: Nicotine premix (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

[0327] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing.

[0328] The 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.

[0329] The pouch material of example 1B may also be used.

[0330] The powder is filled into pouches and is maintained in the pouch by a sealing.

TABLE-US-00009 TABLE 5 Comp. Comp. PPC NBT NPR PPC1 PPC2 PPC3 PPC4 PPC5 Amount of 9.6 9.6 9.6 9.6 9.6 9.6 9.6 nicotine mg mg mg mg mg mg mg Water 30 30 30 25 15 10 40 content [wt %] Raw material Content in weight percent NPR — 12.1 — — — — — NBT 5.9 — — — — — — Nicotine — — 14.6 14.6 14.6 14.6 14.6 premix II Xylitol DC 15.0 8.8 11.3 16.3 26.3 31.3 1.3 Purified water 30 30 25 20 10 5 35 Wheat fiber 30 30 30 30 30 30 30 Sodium 2.0 2.0 2.0 2.0 2.0 2.0 2.0 alginate Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 NaCl 0.1 0.1 0.1 0.1 0.1 0.1 0.1 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 The nicotine premix II (example 2B) comprises 34.1 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g The Xylitol DC applied is e.g. trade name “Xylitab 200”.

[0331] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber.

[0332] For 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.

[0333] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0334] 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.

[0335] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0336] Acesulfame potassium 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.

[0337] Pouches PPC1-PPC3, PPC5 show that different pouches having a water content of at least 15% by weight of the pouch composition can be made using free-base nicotine. Pouch PPC4 has a lower water content outside the scope of the invention. Comparative pouches Comp. NBT and Comp. NPR have a similar water content as PPC1, but uses nicotine salt and nicotine in complex with an ion exchange resin.

Example 3B—Pouches

[0338] Pouches PPC11-PPC15 are made similarly to pouches PPC1-PPC5 of example 3A. Pouches PPC11-PPC15 containing nicotine premix are prepared comprising powdered compositions as outlined in table 5. The pouches are made as follows.

[0339] Fibers and powder ingredients (except glidants) are mixed using a planetary Bear Varimixer mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. Water is then added and mixed for 5 minutes followed by liquid flavor (if any—mixed for 1 minute) and glidant (if any—mixed for 1 minute). The total mixing time is 9-11 minutes.

TABLE-US-00010 TABLE 6 Comp. PPC PPC11 PPC12 PPC13 PPC14 PPC15 2 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 30 25 15 10 35 5 content [wt %] Raw material Content in weight percent Nicotine 14.6 14.6 14.6 14.6 14.6 14.6 premix II Isomalt DC 11.3 22.3 44.3 55.3 0.3 60.3 Purified 25 20 10 5 30 0 water Wheat fiber 30 24 12 6 36 6 Sodium 2.0 2.0 2.0 2.0 2.0 2.0 alginate Sodium 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 9.0 9.0 9.0 9.0 9.0 9.0 High 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total. The applied Isomalt DC e.g. GalenIQ 720.

[0340] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fiber, bamboo fibers, and cellulose fiber.

[0341] For 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.

[0342] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0343] 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.

[0344] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0345] Acesulfame potassium 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.

[0346] Pouches PPC11-PPC13, PPC15 shows varying water content of at least 15% by weight of the pouch composition. The water content varies, but the ratio between the amount of added purified water and the amount of fibers remain constant.

[0347] Pouches PPC14 has a water content outside the scope of the invention and is used for comparative purposes.

Example 3C—Pouches

[0348] Pouches PPC21-PPC25 are made similarly to pouches PPC11-PPC15 of example 3B.

TABLE-US-00011 TABLE 7 PPC PPC21 PPC22 PPC23 PPC24 PPC25 PPC26 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water content 30 30 30 30 30 30 [wt %] Raw material Content in weight percent Nicotine premix 14.6 7.3 14.6 14.6 14.6 14.6 II Liquid nicotine* — 1.0 — — — — Xylitol DC 11.3 15.1 16.3 13.3 11.4 9.4 Purified water 25 27.5 25 25 25 25 MCC (Avicel 30 — — — — — 102) Wheat fiber — 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 Sodium 5.0 5.0 — 3.0 5.0 7.0 carbonate Flavor 9.0 9.0 9.0 9.0 9.0 9.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 — — sorbate Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 *Liquid nicotine is added as a nicotine-sugar alcohol premix in powder form. The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total.

[0349] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fiber, bamboo fibers, and cellulose fiber.

[0350] For 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.

[0351] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0352] 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.

[0353] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0354] Acesulfame potassium 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.

[0355] Pouch PPC21 shows the use of e.g. microcrystalline cellulose (MCC) instead of wheat fibers.

[0356] Pouch PPC22 shows the use of a combination of nicotine-ion exchange resin premix and nicotine-sugar alcohol premix.

[0357] Pouches PPC23-PPC26 shows the use of different amounts of buffering agent (here sodium carbonate). For high amounts of basic buffering agents, achieving a more alkaline environment, there is less need for a preservative (here potassium sorbate), therefore it is omitted in PPC25-PPC26, having the highest amounts of alkaline buffering agents.

Example 3D—Pouches

[0358] Pouches PPC31-PPC32 are made similarly to pouches PPC1-PPC5 of example 3A, but using nicotine premix I and III, respectively.

[0359] Pouches PPC31-PPC35 are made as described below.

[0360] The nicotine and sugar alcohol (xylitol, sorbitol, maltitol or other) are weighed. The nicotine is slowly added to the sugar alcohol powder under stirring (Kitchenaid mixer operated at about 30 RPM in about 30 minutes). The resulting granulate is sieved and placed on a tray. The resulting powder is dried at ambient temperature overnight and is thereafter sieved to obtain a nicotine-sugar alcohol premix. It is also possible to add an amount of water to the nicotine before mixing with the sugar alcohol. Any such water will then be evaporated during the drying.

[0361] Fibers and water are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: Powder ingredients other than nicotine premix (mixed for 2 minutes), nicotine-sugar alcohol premix (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute) and finally glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

[0362] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing.

[0363] The 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.

[0364] The pouch material of example 1B may also be used.

[0365] The powder is filled into pouches and is maintained in the pouch by a sealing.

TABLE-US-00012 TABLE 8 PPC PPC PPC PPC PPC PPC PPC PPC 31 32 33 34 35 36 37 Amount of 9.6 9.6 9.6 9.6 9.6 9.6 9.6 nicotine mg mg mg mg mg mg mg Water 30 30 30 30 30 30 30 content [wt %] Raw material Content in weight percent Nicotine 33.7 — — — — — — premix I Nicotine — 10.4 — — — — — premix III Liquid — — 1.9 1.9 1.9 1.9 1.9 nicotine* Isomalt DC 11.2 11.3 19.0 — — — — Sorbitol DC — — — 19.0 — — — Maltitol DC — — — — 19.0 — — Inulin — — — — — 19.0 — Polydextrose — — — — — — 19.0 Purified water 6 29.2 30 30 30 30 30 Wheat fiber 30 30 30 30 30 30 30 Sodium 2.0 2.0 2.0 2.0 2.0 2.0 2.0 alginate Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 9.0 9.0 9.0 9.0 9.0 9.0 9.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 * Liquid nicotine is added as a nicotine-sugar alcohol premix or as a nicotine-water-soluble fiber premix in powder form. The nicotine premix I comprises 71.4 wt % water, thereby contributing to the total water content. The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. The nicotine premix III comprises 7.5 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total.

[0366] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

[0367] For 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.

[0368] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0369] 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.

[0370] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0371] Acesulfame potassium 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.

[0372] Pouches PPC31-PPC32 show use of other nicotine premixes.

[0373] Pouches PPC33-PPC35 show use of nicotine pre-mixed with different sugar alcohol.

[0374] Pouches PPC36-PPC37 show use of nicotine pre-mixed with different water-soluble fibers.

Example 3E—Pouches

[0375] Pouches PPC41-PPC45 are made similarly to pouches PPC1-PPC5 of example 3A.

TABLE-US-00013 TABLE 9 PPC PPC PPC PPC PPC PPC PPC 41 42 43 44 45 46 Amount of nicotine 4.8 mg 7.2 mg 9.6 mg 12 mg 9.6 mg 9.6 mg Water content 27.5 28.3 30 31.2 30 30 [wt %] Raw material Content in weight percent Nicotine premix II 7.3 9.7 14.6 18.3 14.6 14.6 Xylitol DC 18.6 16.2 11.3 7.6 13.3 5 Erythritol — — — — — 6.3 Purified water 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 — 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 Flavor 9.0 9.0 9.0 9.0 9.0 8.9 NaCl — — — — — 0.1 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total.

[0376] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

[0377] For 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.

[0378] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0379] 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.

[0380] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0381] Acesulfame potassium 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.

[0382] Pouches PPC41-PPC44 show use of different doses of nicotine, from 4.8 mg to 12 mg.

[0383] Pouch PPC45 shows pouch without alginate, otherwise comparable to pouch PPC43.

Example 3F—Pouches

[0384] Pouches PPC51-PPC53 are made as follows.

[0385] Fibers and powder ingredients (except nicotine containing powders and glidants) are mixed for 1 minute using a planetary Bear Varimixer mixer. Then, NPR and NBT is added and mixed for 2 minutes (if applicable). Nicotine premix is then added and mixed for 2 minutes. Subsequently, water is added and mixed for 5 minutes followed by liquid flavor (if any—mixed for 1 minute) and glidant (if any—mixed for 1 minute). The total mixing time is 9-11 minutes.

TABLE-US-00014 TABLE 10 PPC PPC51 PPC52 PPC53 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 30 30 Raw material Content in weight percent NPR — 6.0 3.0 NBT 2.9 — 1.5 Nicotine premix II 7.3 7.3 7.3 Isomalt DC 15.2 12.1 13.6 Purified water 27.5 27.5 27.5 Wheat fiber 30 30 30 Sodium carbonate 5.0 5.0 5.0 Flavor 9.0 9.0 9.0 High intensity 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100 The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total

[0386] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

[0387] For 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.

[0388] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0389] 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.

[0390] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0391] Acesulfame potassium 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.

[0392] Pouch PPC51 shows pouch using nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT).

[0393] Pouch PPC52 shows pouch using nicotine-ion exchange resin premix in combination with nicotine polacrilex resin (NPR).

[0394] Pouch PPC53 shows pouch using nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

Example 3G—Pouches

[0395] Pouches PPC61-PPC65 containing nicotine premix are prepared comprising powdered compositions as outlined in table 11. The pouches are made as follows.

[0396] Fibers and powder ingredients (except glidants) are mixed using a Lödige mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. With the mixer running, water is then added during a period of 15 minutes followed by liquid flavor (if any—mixed for 15 minutes) and glidant (if any—mixed for 1 minute). The total mixing time is 19-35 minutes.

TABLE-US-00015 TABLE 11 PPC PPC PPC PPC PPC PPC PPC PPC 61 62 63 64 65 66 67 Amount of 9.6 9.6 9.6 9.6 9.6 9.6 9.6 nicotine mg mg mg mg mg mg mg Water content 30 30 30 30 30 30 30 [wt %] Raw material Content in weight percent Nicotine 6.4 6.4 6.4 6.4 6.4 6.4 6.4 premix VI Xylitol 5 18.3 18.3 18.3 5 5 5 Erythritol 13.5 — — — 13.5 13.5 13.5 Purified 28 28 28 28 28 28 28 water Wheat fiber 30 30 20 40 30 30 30 Sodium 2.0 2.0 2.0 2.0 2.0 — — alginate Glycerol — — — — — 2.0 — Hydroxy- — — — — — — 2.0 propyl cellulose Sodium 5.0 3.0 3.0 3.0 3.0 3.0 3.0 carbonate Sodium — 2.0 2.0 2.0 2.0 2.0 2.0 bicarbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 The nicotine premix VI comprises 27.5 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total.

[0397] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bamboo fibers, bran fibers, and cellulose fiber.

[0398] For 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.

[0399] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0400] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

[0401] Sodium carbonate and sodium bicarbonate are used as alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

[0402] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0403] 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.

[0404] Pouches PPC61-PPC62 show use of different sweetener and buffer combinations.

[0405] Pouches PPC63-PPC64 show pouches with varying fiber content.

[0406] Pouches PPC65-PPC67 show use of different humectants.

Example 3H—Pouches

[0407] Pouches PPC71-PPC76 containing nicotine premix are prepared comprising powdered compositions as outlined in table 12. The pouches are made as follows.

[0408] Fibers and powder ingredients (except glidants) are mixed using a Lödige mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. With the mixer running, water is then added during a period of 15 minutes followed by liquid flavor (if any—mixed for 15 minutes) and glidant (if any—mixed for 1 minute). The total mixing time is 19-35 minutes.

[0409] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing. The pouch material of example 1B may also be used.

TABLE-US-00016 TABLE 12 PPC PPC PPC PPC PPC PPC PPC PPC 71 72 73 74 75 76 77 Amount of 9.6 9.6 9.6 9.6 9.6 9.6 9.6 nicotine mg mg mg mg mg mg mg Water content 30 30 30 30 30 30 30 [wt %] Raw material Content in weight percent Nicotine 19.2 — — — — — premix IV Nicotine — 9.6 — — — — premix V Nicotine — — — — 6.4 6.4 6.4 premix VI Nicotine — — 4.6 — — — premix VII Nicotine — — — 4.8 — — premix VIII Purified water 21 27 29 29 28 28 28 Wheat fiber 30 30 30 29.75 — — — Oat fiber — — — — 30 — — Pea fiber — — — 0.25 — 30 — Powdered — — — — — — 30 cellulose Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 7.7 11.3 14.3 14.1 13.5 13.5 13.5 Sodium 2.0 2.0 2.0 2.0 2.0 2.0 2.0 alginate Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 The nicotine premixes comprise water in varying amount, thereby contributing to the total water content. Nicotine premix VIII comprises peafiber. Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g Wheat fiber, trade name “Vitacel 600 WF plus”. Powdered cellulose, trade name “Vitacel L00” or “Vitacel L700G”. Oat fiber, trade name “Vitacel HF 600”. Pea fiber, trade name “Vitacel EF150”.

[0410] 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, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bamboo fibers, bran fibers, and cellulose fiber.

[0411] For 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.

[0412] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0413] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

[0414] Sodium carbonate and sodium bicarbonate are used as alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

[0415] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0416] 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.

[0417] Pouches PPC71-PPC74 show use of different nicotine premixes.

[0418] Pouches PPC75-PPC77 show use of different fibers.

Example 3I-I—Pouches

[0419] Pouches PPC81-PPC94 containing nicotine premix are prepared comprising powdered compositions as outlined in table 131 and 1311. The pouches are made as follows.

[0420] Fibers and powder ingredients (except glidants) are mixed using a Lödige mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. With the mixer running, water is then added during a period of 15 minutes followed by liquid flavor (if any—mixed for 15 minutes) and glidant (if any—mixed for 1 minute). The total mixing time is 19-35 minutes.

[0421] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing. The pouch material of example 1B may also be used.

TABLE-US-00017 TABLE 13 I/II PPC PPC PPC PPC PPC PPC PPC PPC PPC 81 82 83 84 85 86 87 88 Amount of 9.6 9.6 9.6 9.6 9.6 9.6 9.6 9.6 nicotine mg mg mg mg mg mg mg mg Water 30 30 30 30 30 30 30 30 content [wt %] Raw material Content in weight percent Nicotine 14.6 14.6 14.6 14.6 — — — premix II Nicotine — — — — 6.4 6.4 6.4 6.4 premix VI Purified 25 25 25 25 28 28 28 28 water Wheat fiber 30 — — — — — — 15 Oat fiber — 30 — — 15 — — — Pea fiber — — 30 — — 15 — — Powdered — — — 30 — — 15 — cellulose Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 8.3 8.3 8.3 8.3 28.5 28.5 28.5 28.5 Sodium 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 alginate Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100

TABLE-US-00018 TABLE 13 II/II PPC PPC PPC PPC PPC PPC PPC 89 90 91 92 93 94 Amount of 9.6 9.6 9.6 9.6 96 9.6 nicotine mg mg mg mg mg mg Water 30 30 30 30 30 30 content [wt %] Raw material Content in weight percent Nicotine 14.6 14.6 14.6 14.6 premix II Nicotine — — — — 6.4 6.4 premix VI Purified 25 25 25 25 28 28 water Wheat fiber 15 — — — 15 15 Oat fiber — 15 — — — — Pea fiber — — 15 — — — Powdered — — — 15 — — cellulose Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 23.3 23.3 23.3 23.3 28.5 20.5 Sodium 2.0 2.0 2.0 2.0 alginate NaCl — — — — — 10 Sodium 5.0 5.0 5.0 5.0 3.5 5.0 carbonate Sodium — — — — 3.5 — bicarbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 High 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 The nicotine premixes comprise water in varying amount, thereby contributing to the total water content. Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g Wheat fiber, trade name “Vitacel 600 WF plus” or “Vitacel 200WF”. Powdered cellulose, trade name “Vitacel L00” or “Vitacel L700G”. Oat fiber, trade name “Vitacel HF 600”. Pea fiber, trade name “Vitacel EF150”.

[0422] 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, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, bran fibers, and cellulose fiber.

[0423] For 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.

[0424] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0425] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

[0426] Sodium carbonate and sodium bicarbonate are used as alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

[0427] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0428] 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.

[0429] Pouches PPC81-PPC92 shows the use of different fibers, in different amounts and with different nicotine premixes.

[0430] Pouches PPC93-PPC94 show use of buffer pair and higher amount of salt, respectively.

Example 3I-II Pouches

[0431] Pouches PPC111-PPC117 containing nicotine premix are prepared comprising powdered compositions as outlined in table 13111. The pouches are made as follows.

[0432] Powdered ingredients including powdered flavor (if any) are mixed using a planetary Bear Varimixer mixer for 2 minutes. Then, the nicotine is added and mixed for 2 minutes. Then water is slowly added while the mixer is running, followed by addition of liquid flavor. Finally, silicon dioxide is added and the mixed for about 1 minute. The total mixing time is about 30 minutes.

[0433] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing.

[0434] The 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.

[0435] The powder is filled into pouches and is maintained in the pouch by a sealing.

TABLE-US-00019 TABLE 13III PPC PPC PPC PPC PPC PPC PPC PPC 111 112 113 114 115 116 117 Amount of 9.6 9.6 9.6 9.6 9.6 9.6 9.6 nicotine mg mg mg mg mg mg mg Water content 15 45 30 30 30 30 30 [wt %] Density (gram 256 303 578 ND ND ND ND per Liter) Hausner ratio 1.25 1.22 1.11 ND ND ND ND Raw material Content in weight percent Nicotine 14.6 14.6 14.6 14.6 14.6 14.6 14.6 premix II Sugar 12.3 12.3 12.3 12.4 12.7 12.1 11.9 alcohol(s) Purified water 10 25 40 25 25 25 25 Wheat fiber 45 30 15 30 30 30 30 Sodium 2.0 2.0 2.0 2.0 2.0 2.0 2.0 alginate Sodium 4.0 4.0 4.0 4.0 4.0 4.0 4.0 carbonate Flavor 9.0 9.0 9.0 9.0 9.0 9.0 9.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.01 0.05 0.2 0.5 sorbate Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. Pouch content: 500 mg total, i.e. nicotine concentration 19.2 mg/g The sugar alcohol(s) may be Xylitol e.g. trade name “Xylitab 200” and/or Isomalt e.g. tradename “GalenIQ 720”.

[0436] 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, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, apple fibers, cocoa fibers, and cellulose fiber.

[0437] For 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.

[0438] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

[0439] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

[0440] 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.

[0441] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0442] Acesulfame potassium 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.

[0443] Pouches PPC111-PPC113 show pouches having different water and water-insoluble fiber contents.

[0444] PPC114-117 show varying amount of preservative.

Example 3J Content Uniformity Measurements

[0445] Content Uniformity (CU) of a pouch sample was determined by analysis of 10 replicate sub-samples. For each sub-sample of approx. 500 mg, the content of nicotine was determined using standard HPLC techniques. The nicotine content of a sub-sample was expressed as a percentage relative to the nominal content of nicotine in the sample (ie. % Label Claim). For example, a pouch sample with a nominal content of nicotine of 20 mg/g being analyzed to have an actual content of 19 mg/g would have a nicotine content of 95% Label Claim.

[0446] The Content Uniformity of the sample is then determined as the Relative Standard Deviation (RSD) of the individual analyses of relative nicotine content in the 10 replicates.

Example 3K—Release Test (In Vivo)

[0447] The release properties of the pouches were evaluated by a panel of assessors, preferably at least 8 assessors. Each assessor was provided with a pouch to place in the oral cavity, specifically at the upper lip.

[0448] Pouch was removed from the oral cavity of the test person after 2 min., 5 min., 10 min., 30 min. or 60 min.

[0449] The amount of remaining nicotine in the pouches were determined using standard HPLC techniques.

[0450] Two pouches were tested for each timepoint. The average of the result obtained for each timepoint was used to make profiles of the nicotine content in the pouches over time.

[0451] The amount of released nicotine could thereafter be obtained by subtracting the remaining amount of nicotine in the pouch from the initial dosage of nicotine in the tested pouch.

Example 3L—Release Test (In Vitro)

[0452] The release properties of the pouches were tested in an in vitro experiment.

[0453] Individual pouches were put into reaction tubes having a diameter of approx. 2 cm and containing 10 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to 7.4) at warmed to 37 degrees Celsius.

[0454] No stirring or shaken was applied during the release experiment.

[0455] Pouches were removed from the buffer after 2 min., 5 min., 10 min., 30 min. or 60 min. Excess buffer was removed, and the amount of remaining nicotine were determined using standard HPLC.

[0456] Two pouches were tested for each timepoint. The average of the result obtained for each timepoint was used to make profiles of the nicotine content in the pouches over time.

[0457] The amount of released nicotine could thereafter be obtained by subtracting the remaining amount of nicotine in the pouch from the initial dosage of nicotine in the tested pouch.

Example 3M—Release Results

[0458] Pouches were exposed to the in vitro release experiment described in example 3L.

TABLE-US-00020 TABLE 14 Release Remaining Remaining rate in time nicotine in nicotine in period: pouch after pouch after 2-10 min PPC Fiber 2 min 10 min (% per min.) PPC82 Oat 74.7% 67.9% 0.85 (HF600) PPC81 Wheat 80.0% 71.6% 1.05 (WF600) PPC84 Cellulose 66.6%   62% 0.58 L00 PPC83 Pea fiber   78% 62.0% 2.00 PPC81 Wheat 85.2% 63.6% 2.70 (WF200) PPC89 Wheat ND 64.5% ND (WF200) PPC92 Cellulose ND 64.6% ND L00 PPC91 Pea fiber ND 64.5% ND PPC84 Cellulose ND 47.3% ND L700G PPC89 Wheat   79%   72% 0.88 (WF600) ND = not determined.

[0459] The release results show an increased release of nicotine after 10 min for pouches comprising fibers with a relative high water binding capacity, such as pea fibers, cellulose L700G and wheat fibers (WF200).

Example 3N—Release Results

[0460] Pouches with pouch compositions similar to PPC46 were made, however, using the below indicated humectant, were exposed to the in vitro release experiment described in example 3L.

TABLE-US-00021 TABLE 15 Different humectants. Remaining nicotine in pouch Humectant after 10 min Modified starch 68% Glycerol 71% Alginate (PPC46) 79%

Example 3O—Release Results

[0461] Pouches were exposed to the in vitro release experiment described in example 3L.

TABLE-US-00022 TABLE 16 Release results. Remaining Weight % Nicotine nicotine in pouch PPC Fiber premix after 10 min PPC81 30 wt % Wheat II 71.6% (WF600) PPC61 30 wt % Wheat VI 66.6% (WF600) PPC88 15 wt % Wheat VI 43.6% (WF600) PPC89 15 wt % Wheat II 54.4% (WF600) PPC93 15 wt % Wheat VI 34.6% (WF600) PPC94 15 wt % Wheat VI 43.7% (WF600) PPC76 30 wt % VI 58.2% peafiber PPC83 30 wt % II 62.0% peafiber ND = not determined.

[0462] Results demonstrate that release after 10 min is improved when using nicotine premix VI. The release can be further improved by including a buffer system, i.e. 3.5% sodium carbonate and 3.5% sodium bicarbonate (PPC93).

[0463] Also, the addition of 10% NaCl seems to improve the release obtained after 10 min (PPC94).

Example 4—Evaluation

[0464] The produced pouches of the invention were evaluated and found highly suitable as delivery vehicles of nicotine in that they provide a favorable release of nicotine and at the same time are pleasant to the user, e.g. with respect to a desirable sticky texture. In particular, the pouches of the invention did not need any wetting before use as opposed to conventional nicotine pouches with low moisture content which may feel dry initially in use.

[0465] The pouch product PPC1 was compared to the Comp. NPR pouch with respect to perceived effect from nicotine and with respect to burning (tingling) sensation.

[0466] Evaluation of perceived effect from nicotine and burning (tingling) sensation is performed as described in the following.

[0467] Perceived effect from nicotine and burning (tingling) sensation was evaluated by a test panel of 4 trained assessors. Each assessor evaluates all samples twice. Average evaluations are estimated.

[0468] The pouch product PPC1 was evaluated to have a faster onset of action and a higher perceived effect from nicotine by all four assessors, when comparing to the Comp. NPR pouch. Also, all four assessors evaluated the pouch product PPC1 to have a higher burning (tingling) sensation compared to the Comp. NPR pouch.

[0469] Similarly, the pouch product PPC1 was compared to the Comp. NBT pouch with respect to perceived effect from nicotine in the same way as described above. The pouch product PPC1 was evaluated to have a higher perceived effect from nicotine by all four assessors compared to the Comp. NBT pouch.