NON-TOBACCO ORAL NICOTINE POUCH COMPOSITION

Abstract

A non-tobacco oral nicotine pouch composition is provided, including water in an amount of at least 15% by weight of the pouch composition; nicotine; and at least one sugar alcohol, the pouch composition being free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. An oral pouched nicotine product is also provided, including a saliva-permeable pouch and the non-tobacco oral nicotine pouch composition enclosed in the saliva-permeable pouch.

Claims

1.-43. (canceled)

44. A non-tobacco oral nicotine pouch composition, comprising: water in an amount of at least 15% by weight of the pouch composition; nicotine; and at least one sugar alcohol, wherein the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol.

45. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition is further free of humectants consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

46. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises 0-0.4% by weight of humectants.

47. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition is free of humectants.

48. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises the at least one sugar alcohol in an amount of at least 1% by weight of the composition.

49. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol.

50. The non-tobacco oral nicotine pouch composition according to claim 44, wherein 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.

51. The non-tobacco oral nicotine pouch composition according to claim 49, wherein the non-directly compressible (non-DC) grade sugar alcohol(s) is provided as particles, which have not been subject to granulation or agglomeration steps.

52. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises the nicotine in an amount of at least 0.1% by weight.

53. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent binding, nicotine bound to zeolites, nicotine bound to cellulose, and mixtures thereof.

54. The non-tobacco oral nicotine pouch composition according to claim 44, further comprising a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition.

55. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin.

56. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin.

57. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight.

58. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the ion-exchange resin comprises one or more resins selected from the group consisting of: (i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups, (ii) a copolymer of methacrylic acid and divinylbenzene, the copolymer containing carboxylic functional groups, (iii) a polystyrene, strongly acidic type of resin containing sulphonic functional groups, (iv) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups, and (v) a combination thereof.

59. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the ion-exchange resin comprises polacrilex resin.

60. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises the water in an amount of 15%-65% by weight of the composition.

61. The non-tobacco oral nicotine pouch composition according to claim 44, further comprising at least one water-insoluble fiber.

62. The non-tobacco oral nicotine pouch composition according to claim 61, wherein the at least one water-insoluble fiber is a non-tobacco fiber.

63. The non-tobacco oral nicotine pouch composition according to claim 61, wherein the water-insoluble fiber is a plant fiber.

64. The non-tobacco oral nicotine pouch composition according to claim 44, further comprising a pH regulating agent.

65. An oral pouched nicotine product comprising a saliva-permeable pouch and the pouch composition of claim 44 enclosed in the saliva-permeable pouch.

Description

DETAILED DESCRIPTION

[0201] 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.

[0202] 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.

[0203] 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, hydroxypropyl cellulose, and glycerol. It is noted that when glycerol is included as a humectant, the glycerol is added as free glycerol and therefore liquid at room temperature. Further examples of humectants include triacetin, modified starch, pectin, xanthan gum, etc. The term humectant does not refer to sugar alcohols comprising 4 or more carbons. Also, the term humectant does not refer to fibers, such as water-insoluble fiber, such as wheat 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, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, and combinations thereof. Also, the term humectant does not include e.g. NaCl.

[0204] 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, or is free of tobacco fibers.

[0205] 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.

[0206] 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.

[0207] As used herein, the term “nicotine complexed with ion-exchange resin” refers to nicotine bound to an ion exchange resin.

[0208] 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.

[0209] 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.

[0210] 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.

[0211] 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.

[0212] 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.

[0213] 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.

[0214] 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.

[0215] 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.

[0216] As used herein the term “fast release rate” refers to the released nicotine per minute within the initial 2 minutes.

[0217] In an embodiment of the invention the pouch composition comprises high intensity sweetener.

[0218] 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.

[0219] In an embodiment of the invention, the pouch composition comprises bulk sweeteners including sugar and/or sugarless components.

[0220] 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.

[0221] The sweeteners may often support the flavor profile of the pouch composition.

[0222] 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.

[0223] 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.

[0224] 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.

[0225] The flavors can be natural or synthetic flavors.

[0226] 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.

[0227] 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.

[0228] 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.

[0229] According to an embodiment of the invention, the enhancer comprises one or more pH-regulating agent, such as a buffering agent.

[0230] 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.

[0231] 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.

[0232] 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.

[0233] 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.

[0234] 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.

[0235] 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 Nicotine

[0236] 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.

[0237] 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

[0238] 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.

[0239] The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 2: Preparation of Nicotine Premixes

[0240] 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. The total process time was 20 minutes.

[0241] Thereby, mixtures of nicotine and cation exchange resin were produced from the constituents stated in the below tables.

Premix I:

[0242]

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

Premix II:

[0243]

TABLE-US-00002 TABLE 2 Ingredients used to manufacture nicotine premix II (13.2% nicotine). % water in obtained nicotine-resin composition: 34.1. Constituent Amount (kg) Amount (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100.0

Premix III:

[0244]

TABLE-US-00003 TABLE 3 Ingredients used to manufacture nicotine premix III (18.5% nicotine). % water in obtained nicotine-resin composition: 7.5. Constituent Amount (kg) Amount (%) Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100.0

Premix IV:

[0245]

TABLE-US-00004 TABLE 4 Ingredients used to manufacture nicotine premix IV (10% nicotine). % water in obtained nicotine-resin composition: 50.0. Constituent Amount (kg) Amount (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100.0

Premix V:

[0246]

TABLE-US-00005 TABLE 5 Ingredients used to manufacture nicotine premix V (20% nicotine). % water in obtained nicotine-resin composition: 31.5. Constituent Amount (kg) Amount (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100.0

Premix VI:

[0247]

TABLE-US-00006 TABLE 6 Ingredients used to manufacture nicotine premix VI (30% nicotine). % water in obtained nicotine-resin composition: 27.5. Constituent Amount (kg) Amount (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100.0

Premix VII

[0248]

TABLE-US-00007 TABLE 7 Ingredients used to manufacture nicotine premix VII (35% nicotine). % water in obtained nicotine-resin composition: 25.6. Constituent Amount (kg) Amount (%) Nicotine 3.83 35.0 Water 2.80 25.6 Resin 4.32 39.4 Total 10.95 100.0

Premix VIII:

[0249]

TABLE-US-00008 TABLE 8 Ingredients used to manufacture nicotine premix VIII (42% nicotine). % water in obtained nicotine-resin composition: 22.8. Constituent Amount (kg) Amount (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100.0

Example 3: Preparation of Pouch Compositions

[0250] Pouches are prepared comprising powdered compositions as outlined in table 9-21. The pouches are made as follows.

[0251] 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.

Example 4: Preparation of Filled Pouches

[0252] The 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: Pouches

[0253] The pouch compositions are prepared from the ingredients in table 9 using preparation method described in example 3.

[0254] 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).

TABLE-US-00009 TABLE 9 Pouch compositions. Pouches P01 P02 P03 P04 C1 C2 C3 C4 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 25 20 15 10 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 Non-DC 18.9 20.9 30.9 40.9 45.9 16.9 16.9 16.9 xylitol Purified 27 25 20 15 10 27 27 27 water Wheat fiber 25 25 20 15 15 25 25 25 Sodium — — — — — 2.0 — — alginate Glycerol — — — — — — 2.0 — Hydroxy- — — — — — — — 2.0 propyl cellulose Sodium 5.0 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 8.9 High 1.0 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 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

[0255] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0256] 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.

[0257] 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.

[0258] 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.

[0259] 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.

[0260] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0261] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5B: Pouches

[0262] The pouch compositions are prepared from the ingredients in table 10 using preparation method described in example 3.

[0263] 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).

TABLE-US-00010 TABLE 10 Pouches P10 P11 P12 P13 C5 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 27 25 20 15 10 Raw material Content in weight percent Premix VI 6.4 6.4 6.4 6.4 6.4 Non-DC xylitol 26.6 28.6 38.6 48.6 53.6 Purified water 25 23 18 13 8 Wheat fiber 25 25 20 15 15 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Flavor 8.9 8.9 8.9 8.9 8.9 High intensity 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

[0264] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0265] 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.

[0266] 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.

[0267] 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.

[0268] 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.

[0269] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0270] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5C: Pouches

[0271] The pouch compositions are prepared from the ingredients in table 11 using preparation method described in example 3.

[0272] 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).

TABLE-US-00011 TABLE 11 Pouch compositions. Pouches P20 P21 P22 P23 C6 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 27 25 20 15 10 Raw material Content in weight percent Premix II 14.6 14.6 14.6 14.6 14.6 Non-DC xylitol 21.4 23.4 33.4 43.4 48.4 Purified water 22 20 15 10 5 Wheat fiber 25 25 20 15 15 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Flavor 8.9 8.9 8.9 8.9 8.9 High intensity 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

[0273] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0274] 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.

[0275] 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.

[0276] 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.

[0277] 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.

[0278] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0279] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5D: Pouches

[0280] The pouch compositions are prepared from the ingredients in table 12 using preparation method described in example 3.

[0281] 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).

TABLE-US-00012 TABLE 12 Pouch compositions. Pouches P30 P31 P32 P33 P34 P35 P36 P37 P38 Amount of 9.6 mg 9.6 mg 9.6 mg 4.8 mg 7.2 mg 12.0 mg 4.8 mg 7.2 mg 12.0 mg nicotine Water 27 27 27 27 27 27 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 — — 6.1 9.0 15.1 — — — Premix II — 14.6 — — — — — — — Premix VI — — 6.4 — — — 3.2 4.8 8.0 Non-DC 18.9 21.4 26.6 24.9 22.0 15.9 28.6 27.5 25.2 xylitol Purified 27 22 25 27 27 27 26.2 25.7 24.8 water Wheat fiber 25 25 25 25 25 25 25 25 25 Sodium 5.0 5.0 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 9.0 9.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100

[0282] Pouch content: 500 mg total.

[0283] 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.

[0284] 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.

[0285] 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.

[0286] 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.

[0287] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5E: Pouches

[0288] The pouch compositions are prepared from the ingredients in table 13 using preparation method described in example 3.

[0289] 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).

TABLE-US-00013 TABLE 13 Pouch compositions. Pouches P40 P41 P42 P43 P44 P45 P46 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 4.8 mg 7.2 mg 12.0 mg nicotine Water 27 27 27 27 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) — 7.0 — — — — — NBT 5.9 2.3 2.3 2.3 — — — Premix II — — 8.5 — 7.3 10.9 18.2 Premix VI — — — 3.7 — — — Non-DC 25.1 21.7 23.1 26.0 26.2 23.8 19.0 xylitol Purified 27 27 24.1 26.0 24.5 23.3 20.8 water Wheat fiber 25 25 25 25 25 25 25 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 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

[0290] Pouch content: 500 mg total.

[0291] 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.

[0292] 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.

[0293] 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.

[0294] 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.

[0295] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0296] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5F: Pouches

[0297] The pouch compositions are prepared from the ingredients in table 14 using preparation method described in example 3.

[0298] 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).

TABLE-US-00014 TABLE 14 Pouch compositions. Pouches P50 P51 P52 P53 P54 P55 P56 P57 P58 C14 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 30 30 30 30 30 30 30 30 30 35 content [wt %] Raw material Content in weight percent Premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 Non-DC 5.0 — 5.0 — — 7.0 5.0 5.0 — xylitol Xylitol DC — — — — — — 5.0 — — — Non-DC — 21.6 — — — — — — — — Isomalt Isomalt DC — — — — — — — 16.6 — — Sorbitol — — 16.6 — — — — — — — Mannitol DC — — — — — — — — 16.6 — Non-DC — — — 21.6 — — — — — — Mannitol Non-DC — — — — 21.6 — — — — — Maltitol Non-DC 16.6 — — — — 14.6 16.6 — — — Erythritol Purified 28 28 28 28 28 28 28 28 28 33 water Wheat fiber 27 27 27 27 27 27 27 27 27 43.6 Sodium 5.0 5.0 5.0 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 8.9 8.9 8.9 High 1.0 1.0 1.0 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 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100 100

[0299] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0300] 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.

[0301] 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.

[0302] 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.

[0303] 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.

[0304] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0305] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5G: Pouches

[0306] The pouch compositions are prepared from the ingredients in table 15 using preparation method described in example 3.

[0307] 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).

TABLE-US-00015 TABLE 15 Pouch compositions. Pouches P60 P61 P62 P63 P64 P65 P66 P67 P68 C15 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 27 27 27 27 27 27 35 content [wt %] Raw material Content in weight percent Premix II 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 Non-DC 5.0 — 5.0 — — 7.0 5.0 5.0 — xylitol Xylitol DC — — — — — — 5.0 — — — Non-DC — 19.4 — — — — — — — — Isomalt Isomalt DC — — — — — — — 14.4 — — Sorbitol — — 14.4 — — — — — — — Mannitol DC — — — — — — — — 14.4 — Non-DC — — — 19.4 — — — — — — Mannitol Non-DC — — — — 19.4 — — — — — Maltitol Non-DC 14.4 — — — — 12.4 14.4 — — — Erythritol Purified 22 22 22 22 22 22 22 22 22 33 water Wheat fiber 27 27 27 27 27 27 27 27 27 35.4 Sodium 5.0 5.0 5.0 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 8.9 8.9 8.9 High 1.0 1.0 1.0 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 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100 100

[0308] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0309] 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.

[0310] 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.

[0311] 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.

[0312] 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.

[0313] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0314] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 511: Pouches

[0315] The pouch compositions are prepared from the ingredients in table 16 using preparation method described in example 3.

[0316] 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).

TABLE-US-00016 TABLE 16 Pouch compositions. Pouches P70 P71 P72 P73 P74 P75 P76 P77 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 20 20 30 20 30 content [wt %] Raw material Content in weight percent Premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 Non-DC 26.5 26.5 26.5 50.5 30.5 — 30.5 — Xylitol Xylitol DC — — — — — 5.0 — 5.0 Non-DC — — — — — 28.5 — 20.5 Erythritol Purified 25 25 25 18 18 28 18 28 water Wheat fiber — — — 10 30 15 — 15 Oat fiber 27 — — — — — 30 — Pea Fiber — 27 — — — — — — Powdered — — 27 — — — — — Cellulose Sodium 5.0 5.0 5.0 5.0 5.0 3.5 5.0 5.0 carbonate Sodium — — — — — 3.5 — — hydrogen- carbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 NaCl — — — — — — — 10 High 1.0 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 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

[0317] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0318] 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.

[0319] Sodium carbonate and optionally sodium hydrogen carbonate are used as alkaline buffering agents. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

[0320] 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.

[0321] 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.

[0322] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0323] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5I: Pouches

[0324] The pouch compositions are prepared from the ingredients in table 17 using preparation method described in example 3.

[0325] 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).

TABLE-US-00017 TABLE 17 Pouch compositions. Pouches P80 P81 P82 P83 P84 P85 P86 P87 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 20 20 35 20 35 content [wt %] Raw material Content in weight percent Premix II 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 Non-DC 21.3 21.3 21.3 45.3 25.3 20.3 25.3 20.3 Xylitol Purified 22 22 22 15 15 30 15 30 water Wheat fiber — — — 10 30 20 — — Oat fiber 27 — — — — — 30 20 Pea Fiber — 27 — — — — — — Powdered — — 27 — — — — — Cellulose 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 1.0 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 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

[0326] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0327] Wheat fiber, trade name “Vitacel 600 WF plus” or “Vitacel 200WF”.

[0328] Oat fiber, trade name “Vitacel HF 600”.

[0329] Pea fiber, trade name “Vitacel EF150”.

[0330] 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.

[0331] 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.

[0332] 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.

[0333] 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.

[0334] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0335] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5J: Pouches

[0336] The pouch compositions are prepared from the ingredients in table 18 using preparation method described in example 3.

[0337] 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).

TABLE-US-00018 TABLE 18 Pouch compositions. Pouches P90 P91 P92 P93 P94 P95 P96 P97 P98 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 27 27 27 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 Non-DC 5.0 — 5.0 — — — 5.0 5.0 5.0 Xylitol Xylitol DC — — — — — 5.0 — — — Non-DC — 18.8 — — — — — — — Isomalt Isomalt DC — — — — — — — — — Sorbitol — — 13.8 — — — — — — Non-DC — — — 18.8 — — — — — Mannitol Mannitol DC — — — — — — — — — Non-DC — — — — 18.8 — — — — Maltitol Non-DC 13.8 — — — — 13.8 13.8 13.8 13.8 Erythritol Purified 27 27 27 27 27 27 27 27 27 water Wheat fiber 27 27 27 27 27 27 — — — Oat fiber — — — — — — 27 — — Pea Fiber — — — — — — — 27 — Powdered — — — — — — — — 27 Cellulose Sodium 5.0 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 7.0 High 1.0 1.0 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 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100

[0338] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0339] Wheat fiber, trade name “Vitacel 600 WF plus” or “Vitacel 200WF”.

[0340] Oat fiber, trade name “Vitacel HF 600”.

[0341] Powdered cellulose, trade name “Vitacel LOO” or “Vitacel L700G”.

[0342] Pea fiber, trade name “Vitacel EF150”.

[0343] 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.

[0344] 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.

[0345] 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.

[0346] 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.

[0347] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0348] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5K: Pouches

[0349] The pouch compositions are prepared from the ingredients in table 19 using preparation method described in example 3.

[0350] 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).

TABLE-US-00019 TABLE 19 Pouch compositions. Pouches P 100 P 101 P 102 P 103 P 104 P 105 P 106 P 107 C16 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 27 27 27 27 27 35 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 12.1 12.1 12.1 12.1 — — — 12.1 Premix VI — — — — — 6.4 6.4 6.4 — Non-DC 16.9 19.4 11.9 14.9 14.9 27.6 20.6 20.6 — Xylitol Purified 27 27 27 27 27 27 27 27 35 water Wheat fiber 27 27 27 27 27 27 27 27 37.8 Sodium 5.0 2.5 10.0 3.5 — — 3.5 — 5.0 carbonate Sodium — — — 3.5 — — 3.5 — — hydrogen- carbonate Trometamol — — — — 7.0 — — 7.0 — Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 7.0 High 1.0 1.0 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 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100

[0351] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0352] 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.

[0353] 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.

[0354] 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.

[0355] 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.

[0356] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0357] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5L: Pouches

[0358] The pouch compositions are prepared from the ingredients in table 20 using preparation method described in example 3.

[0359] 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).

TABLE-US-00020 TABLE 20 Pouch compositions. Pouches P110 P111 P112 P113 P114 P115 P116 P117 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 30 30 30 30 30 30 30 27 content [wt %] Raw material Content in weight percent NPR (16%) — — — — 12.1 12.1 12.1 — Premix II 14.6 14.6 — — — — — 14.6 Premix VI — — 6.4 6.4 — — — — CaCl.sub.2 1.3 2.0 1.3 2.0 1.0 1.3 2.0 — Non-DC 12.1 11.4 17.3 16.6 9.9 9.6 9.9 7.0 Xylitol Non-DC — — — — — — — 16.3 Erythritol Purified 25 25 28 28 30 30 30 22 water Wheat fiber 30 30 30 30 30 30 30 27 Sodium 5.0 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 5.0 High 1.0 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 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

[0360] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0361] 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.

[0362] 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.

[0363] 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.

[0364] 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.

[0365] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0366] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5M: Pouches

[0367] The pouch compositions are prepared from the ingredients in table 21 using preparation method described in example 3.

[0368] 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).

TABLE-US-00021 TABLE 21 Pouch compositions. Pouches P120 P121 P122 P123 C17 C18 C19 C20 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 30 30 30 30 30 30 30 30 content [wt %] Raw material Content in weight percent Premix II 14.6 — 14.6 — 14.6 — 14.6 — Premix VI — 6.4 — 6.4 — 6.4 — 6.4 CaCl.sub.2 1.0 1.0 — — 1.0 1.0 — — Non-DC 12.4 17.6 13.4 18.6 10.4 15.6 9.4 14.6 Xylitol Purified 25 28 25 28 25 28 25 28 water Wheat fiber 30 30 30 30 30 30 30 30 Sodium — — — — 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 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 NaCl — — — — — — 2.0 2.0 High 1.0 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 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

[0369] Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

[0370] 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.

[0371] 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.

[0372] 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.

[0373] 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.

[0374] 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.

[0375] Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0376] Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 6A: Pouch Release Experiments (In Vitro)

[0377] The release properties of the pouches were tested in an in vitro experiment.

[0378] Reaction tubes having a diameter approx. 2 cm and containing 10 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to 7.4) were warmed to 37 degrees Celsius. One reaction tuber per timepoint was used.

[0379] A pouch was submerged in the buffer of the first reaction tube using tweezers. After a specified time period, the pouch was captured with the tweezer and gently swirled in the buffer before being removed from the first reaction tube and added to the next reaction tube, representing the next time point. The procedure was repeated until the desired number of time points had been tested.

[0380] The whole release experiment was performed at 37 degrees Celsius. No stirring or shaken was applied during the release experiment.

[0381] The amount of release nicotine was determined by analyzing the buffer samples at the different timepoints using standard HPLC.

Example 6B: Release Experiment on Pouch P 120-123

[0382] The release experiment was performed as described in example 6A.

TABLE-US-00022 TABLE 22 Shows the percentage of nicotine released from nicotine pouches at different timepoints with and without CaCl.sub.2 and with or without alginate. Pouch C19 C17 C20 C18 P122 P120 P123 P121 Nicotine premix II II VI VI II II VI VI Humectant Alginate Alginate Alginate Alginate None None None None CaCl.sub.2 (wt %) — 1.0 — 1.0 — 1.0 — 1.0 Min. Released nicotine (%) 2 13.8 12.9 20.8 24.0 16.2 29.5 26.9 38.7 5 25.7 26.0 39.8 42.9 28.6 50.9 47.4 58.2 10 37.5 40.3 59.0 61.7 42.0 64.8 66.0 74.8 30 60.4 62.3 79.4 82.6 59.2 78.7 79.5 92.2

[0383] Evaluation: the results demonstrate increased release of nicotine from pouches not comprising sodium alginate.

[0384] Also, the result shows that the presence of CaCl.sub.2 increases the release of nicotine from pouches. The presence of CaCl.sub.2 increases both the initial release rate and seems to also increase the effective release of nicotine.

[0385] Furthermore, the results demonstrate that increasing the nicotine content of the premixes also increases the nicotine release from the pouches.

Example 7A: Weight-Loss Over Time

[0386] Pouch compositions with different humectants (comparative formulations) and without humectants were prepared and directly placed in open containers at 25 degrees Celsius and 60% RH (relative humidity).

TABLE-US-00023 TABLE 23 shows relative weight-loss in % from comparative pouch compositions with varying humectants and from pouch compositions without humectants. Time Pouch Humectant 1 week 2 weeks 3 weeks 4 weeks P1 — 0.68 1.14 1.37 2.51 C2 Alginate 0.96 1.53 2.11 3.64 C3 Glycerol 1.05 1.68 2.10 3.77 C4 Hydroxypropyl 1.15 2.08 2.54 4.39 cellulose

[0387] Evaluation: the results demonstrate a higher weight-loss from pouch compositions comprising humectants selected from alginate, glycerol, and hydroxypropyl cellulose.

Example 8A: User Evaluation

[0388] 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 mouthfeel such as a moist and moldable texture and a desirable taste.

Example 8B: User Evaluation

[0389] Pouches were evaluated by a test-panel of 4 trained assessors. Each assessor evaluated all samples twice. The test-panel evaluated the pouches on 2 different parameters over 15 min: overall taste and sweetness intensity.

[0390] The test was performed on pouches with two different flavors.

[0391] Pouch P117-1 corresponds to P117 with lemon and orange flavor.

[0392] Comparative P117-C1, which is based on P117, but with 2.0% alginate, 10.0% flavor (lemon and orange) and where the content of erythritol is adjusted to obtain a total of 100%.

[0393] Pouch P117-2 corresponds to P117 with raspberry and liquorice.

[0394] Comparative P117-C2, which is based on P117, but with 2.0% alginate, 10.0% flavor (raspberry and liquorice) and where the content of erythritol is adjusted to obtain a total of 100%.

TABLE-US-00024 TABLE 24 Overall taste Sweetness intensity Minutes P117-C1 P117-1 P117-C2 P117-2 P117-C1 P117-1 P117-C2 P117-2 0.5 3.5 4 3 4 3.5 4 3 4 1 3.5 4 3 4 3.5 4 3 4 3 3.5 4.5 3.5 4.5 4 4.5 3 4.5 5 4 4 3.5 4 4 4 3 4 10 4 4 3.5 4 4 4 3 4 15 4 4 3.5 3.5 4 4 3 3.5

[0395] Evaluation: the test panel found that pouches P117-1 and P117-2 without alginate and a lower amount of flavor scored similarly or even higher on overall taste and sweetness intensity during the test period when compared to pouches P117-C1 and P117-C2 with alginate and a higher amount flavor.

[0396] Surprisingly, the inventive pouches P117-1 and P117-2 were found to score higher on both overall taste and sweetness during the initial time of use, i.e. use up to 5 min. Also, the inventive pouches P117-1 and P117-2 were found to score similarly or higher in the period from 5 to 15 min of use, despite the lower amount of flavor in the inventive pouches P117-1 and P117-2 tested.