Non-tobacco oral nicotine pouch composition

Abstract

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

Description

[Technical Field]

[0001] The present invention relates to the claimed non-tobacco oral nicotine pouch compositions and oral pouch nicotine products. [Background technology]

[0002] Delivery of nicotine through smoking has many well-known drawbacks, particularly health-related issues such as the presence of carcinogens.

[0003] However, tobacco substitutes can also have drawbacks, such as insufficient relief of cravings in users.

[0004] A further problem in the prior art is that the desired nicotine release must be appealing to the user of the pouch from a user perspective.

[0005] Furthermore, a further problem associated with the prior art is that pouches as a delivery vehicle for nicotine are somewhat costly, which places limitations on how the pouches can be designed to keep manufacturing costs down.

[0006] An object of one embodiment of the present invention is to provide a nicotine-containing pouch, for example as an alternative to cigarettes, which may solve the above-mentioned problems. Summary of the Invention

[0007] The present invention provides Water in an amount of at least 15% by weight of the pouch composition; Nicotine and at least one sugar alcohol, The present invention relates to a non-tobacco oral nicotine pouch composition, wherein the pouch composition does not include a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol.

[0008] An advantage of the present invention is that a combination of high nicotine release rate is obtained along with the desired mouthfeel, softness and moistness herein.

[0009] A further advantage of the present invention is the desirable flavor perception facilitated by the combination of improved flavor release and desirable mouthfeel, softness and moistness herein.

[0010] The advantages of the present invention can be improved nicotine release without compromising the moist mouthfeel, improved flavor release, and improved flavor sensation.

[0011] Yet another advantage of the present invention is that the combination of sugar alcohol and water not only provides an appealing mouthfeel, but also a very appealing taste profile.

[0012] Conventionally, a moisture retaining agent may be added to protect the product from drying out, and may also have a preservative effect.

[0013] High moisture content can make the product vulnerable to microbial growth, such as yeast, mold, and bacterial growth. This not only compromises health safety, but can also lead to a significantly reduced user experience due to visual and taste changes and deterioration of the product. Surprisingly, the inventors have found that the pouch composition according to the present invention has desirable taste and mouthfeel, such as softness and moistness, even after being stored for a considerable period of time.

[0014] Another advantage of the present invention is that it can retain moisture surprisingly effectively. Typically, moisture retention is achieved by including a humectant such as alginate, propylene glycol, hydroxypropyl cellulose, or glycerol. However, the pouch composition of the present invention can advantageously retain moisture effectively without including these substances as humectants.

[0015] In one embodiment of the present invention, the pouch composition does not include a humectant in the form of a sugar alcohol containing 3 or fewer carbons. Examples of sugar alcohols containing 3 or fewer carbons include glycerol, propylene glycol, and ethylene glycol.

[0016] In an advantageous embodiment of the present invention, the pouch composition is further free of humectants consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

[0017] Thus, in the above embodiment, the pouch composition does not include the humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, glycerol, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

[0018] In an advantageous embodiment of the invention, the pouch composition comprises 0 to 0.4% by weight of a moisture retention agent.

[0019] Thus, in the above embodiment, the pouch composition does not include a humectant or includes a humectant in an amount of up to 0.4% by weight of the pouch composition.

[0020] In an advantageous embodiment of the present invention, the pouch composition does not contain a humectant.

[0021] Thus, in the above embodiment, the pouch composition is completely free of any humectants, both alginates, sugar alcohols containing 3 carbons or less, hydroxypropyl cellulose, modified starch, triacetin, polyethylene glycol (PEG), pectin, xanthan gum and other humectants.

[0022] In one embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, for example at least 5% by weight of the composition, such as at least 10% by weight of the composition, for example at least 15% by weight of the composition.

[0023] In one embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, for example 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, for example 15 to 50% by weight of the composition.

[0024] In an advantageous embodiment of the invention, the pouch composition comprises at least one sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, for example at least 5% by weight of the composition, such as at least 10% by weight of the composition, for example at least 15% by weight of the composition.

[0025] In an advantageous embodiment of the invention, the pouch composition comprises at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, for example 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, for example 15 to 50% by weight of the composition.

[0026] In one embodiment of the present invention, the at least one sugar alcohol comprises a sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, hydrogenated starch hydrolysates, and any mixture thereof.

[0027] As an exemplary embodiment, a hydrogenated starch hydrolysate containing primarily maltitol, sorbitol, and a mixture of additional sugar alcohols may be used.

[0028] In one advantageous embodiment of the invention, the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol.

[0029] Traditionally, directly compressible ingredients are used to enhance the flowability of powder compositions. Typically, when handling powder compositions, flowability is used as a measure of processability. However, when a significant amount of water is added to a sugar alcohol-containing composition, the composition tends to clump, significantly reducing flowability, sometimes to a level that cannot be measured by conventional methods. Surprisingly, the inventors have found that pouch compositions of the present invention containing non-DC sugar alcohols can still be processed into individual pouches using a filling machine. Thus, the present invention facilitates efficient processing and, thereby, cost-effective setup by enabling the use of non-DC sugar alcohols and avoiding the need to fill pouches, for example, by hand or using highly complex, specially designed filling machines.

[0030] It should be noted that if the sugar alcohol composition is made from different sugar alcohols that have different properties with respect to storage, processability and / or taste, the different sugar alcohols may be applicable for taste and salivation purposes.

[0031] In an advantageous embodiment of the invention, the at least one non-direct compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

[0032] In one advantageous embodiment of the invention, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, for example at least 5% by weight of the composition, such as at least 10% by weight of the composition, for example at least 15% by weight of the composition.

[0033] In an advantageous embodiment of the invention, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, for example 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, for example 15 to 50% by weight of the composition.

[0034] In one embodiment of the pouch composition, the pouch comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, for example 5-60% by weight of the composition, for example 10-50% by weight of the composition, for example 15-50% by weight of the composition.

[0035] In one embodiment of the pouch composition, the pouch comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1-80% by weight of the composition, such as 10-70% by weight of the composition, for example 10-60% by weight of the composition, for example 15-60% by weight of the composition, such as 20-60% by weight of the composition, for example 20-50% by weight of the composition.

[0036] In one embodiment of the present invention, xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof are used as the at least one non-direct compressible (non-DC) grade sugar alcohol.

[0037] In one embodiment of the present invention, the at least one non-direct compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and combinations thereof.

[0038] In one embodiment of the invention, the pouch composition comprises at least one non-direct compressible (non-DC) grade sugar alcohol, such as at least two non-direct compressible (non-DC) grade sugar alcohols, such as at least three non-direct compressible (non-DC) grade sugar alcohols.

[0039] In one embodiment of the present invention, the at least two non-direct compressible (non-DC) grade sugar alcohols are selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and combinations thereof.

[0040] In one embodiment of the present invention, the at least three non-direct compressible (non-DC) grade sugar alcohols are selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and combinations thereof.

[0041] In one embodiment of the present invention, the at least one sugar alcohol comprises a directly compressible (DC) grade sugar alcohol.

[0042] In one embodiment of the present invention, the directly compressible (DC) grade sugar alcohol comprises a sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any mixture thereof.

[0043] The sorbitol is a naturally derived directly compressible (DC) grade.

[0044] In an advantageous embodiment of the invention, the pouch composition comprises at least one further sugar alcohol.

[0045] In an embodiment of the invention, the pouch composition comprises at least one further sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, for example at least 5% by weight of the composition, such as at least 10% by weight of the composition, for example at least 15% by weight of the composition.

[0046] In one embodiment of the invention, the pouch composition comprises at least one further sugar alcohol in an amount of 1 to 50% by weight of the composition, such as 2 to 70% by weight of the composition, for example 5 to 40% by weight of the composition, such as 10 to 50% by weight of the composition, for example 15 to 30% by weight of the composition.

[0047] In an advantageous embodiment of the invention, the at least one further sugar alcohol comprises a directly compressible (DC) grade sugar alcohol.

[0048] In one embodiment of the present invention, the at least one additional sugar alcohol is a directly compressible (DC) grade sugar alcohol.

[0049] In one embodiment of the invention, at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol and at least one further sugar alcohol comprises a directly compressible (DC) grade sugar alcohol.

[0050] In one embodiment of the present invention, the non-direct compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and combinations thereof.

[0051] The sugar alcohol can advantageously stimulate and induce salivation of the pouch composition, thereby releasing nicotine, e.g., nicotine from the pouch.

[0052] Sugar alcohols can be advantageously used to further increase the nicotine release from the pouch.

[0053] The use of sugar alcohols can also advantageously provide a desirable mouthfeel by increasing saliva production, thereby counteracting the sensation of local or oral dehydration experienced by users of the pouch.

[0054] In one embodiment of the pouch composition, the pouch comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, for example 5-60% by weight of the composition, for example 10-50% by weight of the composition, for example 15-50% by weight of the composition.

[0055] In one embodiment of the pouch composition, the pouch comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1-80% by weight of the composition, such as 10-70% by weight of the composition, for example 10-60% by weight of the composition, for example 15-60% by weight of the composition, such as 20-60% by weight of the composition, for example 20-50% by weight of the composition.

[0056] In one embodiment of the present invention, the at least one sugar alcohol comprises a sugar alcohol selected from the list consisting of maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combination thereof.

[0057] In one embodiment of the present invention, the at least one sugar alcohol comprises a sugar alcohol selected from the list consisting of maltitol, mannitol, isomalt, sorbitol, lactitol, and any combination thereof.

[0058] In one embodiment of the present invention, the at least one sugar alcohol comprises a sugar alcohol selected from the list consisting of maltitol, mannitol, sorbitol, lactitol, and any combination thereof.

[0059] In one embodiment of the present invention, the pouch composition does not include DC grade xylitol.

[0060] In one embodiment of the present invention, the pouch composition does not include xylitol.

[0061] In one embodiment of the present invention, the pouch composition does not include DC grade sugar alcohols.

[0062] In one embodiment of the present invention, the pouch composition comprises sugar alcohol in an amount of at least 14.0% by weight of the pouch composition.

[0063] In one embodiment of the present invention, the pouch composition comprises at least one non-wheat fiber.

[0064] In one embodiment of the present invention, the pouch composition comprises at least one non-sodium carbonate pH adjusting agent.

[0065] In one embodiment of the present invention, the pouch composition comprises a pH adjuster in an amount greater than 5.5% by weight of the pouch composition.

[0066] In one embodiment of the present invention, the pouch composition comprises sodium chloride.

[0067] One embodiment of the pouch composition comprises at least two non-direct compressible (non-DC) grade sugar alcohols selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

[0068] In an advantageous embodiment of the present invention, the non-directly compressible (non-DC) grade sugar alcohol is provided as particles, which have not been subjected to a granulation or agglomeration step.

[0069] The term directly compressible is well known in the art of tableting, i.e., the compression of particles into tablets that are assembled and compressed. Many manufacturers of such particles routinely refer to directly compressible as DC.

[0070] In one embodiment of the present invention, the at least one non-directly compressible (non-DC) grade sugar alcohol is defined as non-DC grade by reference to the compressibility index according to the European Pharmacopoeia 6.0, and particles comprised of the non-DC grade sugar alcohol have a compressibility index of greater than 21%.

[0071] In one embodiment of the present invention, at least one non-directly compressible (non-DC) grade sugar alcohol is defined as non-DC by reference to a compressibility index according to the European Pharmacopoeia 6.0, and particles comprised of non-DC grade sugar alcohols have a compressibility index greater than 21% and less than 37%.

[0072] In one embodiment of the present invention, the pouch composition comprises an additional sugar alcohol, wherein said additional sugar alcohol is directly compressible (DC).

[0073] In one embodiment of the invention, the further sugar alcohol is defined as DC with reference to the compressibility index according to the European Pharmacopoeia 6.0, and particles consisting of the further sugar alcohol have a compressibility index of less than 21%, such as less than 15%, for example less than 10%.

[0074] In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.1%, such as at least 0.2% by weight of the pouch composition.

[0075] In one embodiment of the present invention, the pouch composition comprises nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, for example 1.0 to 2.0% by weight of the pouch composition.

[0076] In one advantageous embodiment of the invention, the pouch composition comprises nicotine selected from the group consisting of nicotine salts, nicotine free base, nicotine-ion exchange resin combinations, nicotine-containing complexes or any non-covalently bound nicotine, nicotine bound to zeolites, nicotine bound to cellulose or starch microspheres, e.g., microcrystalline cellulose, and mixtures thereof.

[0077] In an advantageous embodiment of the invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition.

[0078] In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine complexed with an ion exchange resin.

[0079] In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination is nicotine complexed with an ion exchange resin.

[0080] Thus, in the above embodiment, the nicotine-ion exchange resin combination consists of nicotine complexed with an ion exchange resin.

[0081] In an advantageous embodiment of the present invention, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin.

[0082] One advantage of the above embodiment is that it can provide a sustained release of nicotine, while at the same time the rate of release of nicotine is not too slow to alleviate the cravings desired by the user.

[0083] In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of 5 to 50% by weight.

[0084] In one embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine complexed with an ion exchange resin, the nicotine comprising an amount of 5-50% by weight of the nicotine-ion exchange resin combination.

[0085] In one embodiment of the invention, the nicotine-ion exchange resin combination consists of nicotine complexed with an ion exchange resin, wherein the nicotine comprises an amount of 10 to 50% by weight of the nicotine-ion exchange resin combination, such as 10 to 40% by weight of the nicotine-ion exchange resin combination, for example 10 to 30% by weight of the nicotine-ion exchange resin combination, such as 10 to 25% by weight of the nicotine-ion exchange resin combination.

[0086] In one embodiment of the invention, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, the nicotine comprising an amount of 5-50% by weight of the nicotine-ion exchange resin combination.

[0087] In one embodiment of the invention, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, wherein the nicotine comprises an amount of 5 to 50% by weight of the nicotine-ion exchange resin combination, such as 10 to 50% by weight of the nicotine-ion exchange resin combination, for example 20 to 50% by weight of the nicotine-ion exchange resin combination, such as 25 to 50% by weight of the nicotine-ion exchange resin combination, for example 25 to 45% by weight of the nicotine-ion exchange resin combination.

[0088] In one embodiment of the invention, the nicotine-ion exchange resin combination comprises free base nicotine mixed with the ion exchange resin, wherein the nicotine comprises an amount of 5 to 40% by weight of the nicotine-ion exchange resin combination, such as 10 to 40% by weight of the nicotine-ion exchange resin combination, for example 10 to 35% by weight of the nicotine-ion exchange resin combination, such as 10 to 25% by weight of the nicotine-ion exchange resin combination, for example 10 to 15% by weight of the nicotine-ion exchange resin combination.

[0089] In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of 5-50% by weight and ion exchange resin in an amount of 10-95% by weight.

[0090] In one embodiment of the present invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of 5-50% by weight, and ion exchange resin in an amount of 10-95% by weight.

[0091] In one embodiment of the present invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of 10-30% by weight and ion exchange resin in an amount of 20-90% by weight.

[0092] In one embodiment of the present invention, the nicotine-ion exchange resin combination consists of nicotine in an amount of 10-30% by weight and ion exchange resin in an amount of 70-90% by weight.

[0093] In one embodiment of the present invention, the nicotine-ion exchange resin combination is substantially free of water.

[0094] In one embodiment of the present invention, the nicotine-ion exchange resin combination further comprises glycerol complexed to the ion exchange resin.

[0095] Glycerol may be added to reduce the dustiness of the nicotine-ion exchange resin combination.

[0096] In one embodiment of the invention, the nicotine-ion exchange resin combination further comprises glycerol in an amount of 0.1 to 50% by weight, such as 5 to 40% by weight, for example 5 to 30% by weight.

[0097] In one embodiment of the present invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of 5-50% by weight, and ion exchange resin in an amount of 20-75% by weight.

[0098] In one embodiment of the invention, the nicotine-ion exchange resin combination comprises water in an amount of 75% by weight or less, such as 50% by weight or less, for example 40% by weight or less, such as 30% by weight or less, for example 20% by weight or less, such as 10% by weight or less, for example 5% by weight or less.

[0099] In an advantageous embodiment of the invention, the ion exchange resin is (i) a methacrylic acid-based weakly acidic resin containing a carboxylic acid functional group; (ii) a copolymer of methacrylic acid and divinylbenzene, the copolymer containing carboxylic acid functionality; (iii) a polystyrene-based strongly acidic resin containing sulfonic acid functional groups; (iv) polystyrene-based intermediate acid type resins containing phosphonic acid functional groups, and (v) combinations thereof.

[0100] In an advantageous embodiment of the present invention, the ion exchange resin comprises a polacrilex resin.

[0101] In an advantageous embodiment of the invention, the ion exchange resin is a polacrilex resin.

[0102] In one embodiment of the present invention, the polacrilex resin includes or is Amberlite® IRP64.

[0103] In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of 15 to 65% by weight of the composition, such as 15 to 60% by weight of the composition, for example 15 to 50% by weight of the composition, such as 20 to 50% by weight of the composition, for example 20 to 40% by weight of the composition.

[0104] In one embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 20-65% by weight of the composition, for example 25-65% by weight of the composition.

[0105] In one embodiment of the invention, the pouch composition comprises water in an amount of 15 to 65% by weight of the composition, such as 15 to 60% by weight of the composition, for example 15 to 50% by weight of the composition, for example 15 to 40% by weight of the composition.

[0106] In one embodiment of the invention, the pouch composition comprises water in an amount of 15-60% by weight of the composition, such as 15-50% by weight of the composition, for example 15-40% by weight of the composition, such as 15-30% by weight of the composition.

[0107] In one embodiment of the present invention, the pouch composition comprises water in an amount of 15-40% by weight of the composition.

[0108] Water can be added as a separate component and mixed completely or partially with other components, such as fiber.For example, when adding a combination of nicotine ion exchange resin, which is composed of free base nicotine and a mixture of ion exchange resin and water, a significant amount of water in the final pouch composition may come from this mixture.For example, if the final amount of pouch composition contains 5% water from the nicotine-ion exchange resin combination, up to one-third of the water in the pouch composition comes from the nicotine-ion exchange resin combination.

[0109] In an advantageous embodiment of the invention, the pouch composition comprises at least one water-insoluble fiber.

[0110] In an advantageous embodiment of the invention, the pouch composition comprises at least one water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 45% by weight of the pouch composition, for example 15 to 40% by weight of the pouch composition.

[0111] In one embodiment of the present invention, the pouch composition comprises at least one water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 5 to 45% by weight of the pouch composition, for example 5 to 40% by weight of the pouch composition.

[0112] In one embodiment of the present invention, the pouch composition comprises at least one water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 50% by weight of the pouch composition, for example 15 to 50% by weight of the pouch composition.

[0113] An advantage of the above embodiment may be that a residue remains even after use of the nicotine pouch containing the pouch composition, which may provide a pleasant perception to the user of the nicotine pouch due to, for example, its similarity to tobacco-containing products.

[0114] Water-insoluble fiber can advantageously provide a desirable mouthfeel throughout the use of the pouch.

[0115] Another advantage of the present invention is that the combination of sugar alcohol, water-insoluble fiber, and water provides a very appealing soft, moist, moldable texture and mouthfeel. The desired texture and mouthfeel can be achieved, and the pouches produced can even be stored next to each other, for example, in a can, without sticking together too much and causing the pouches to burst upon removal.

[0116] In an advantageous embodiment of the invention, the water-insoluble fiber is a non-tobacco fiber.

[0117] In an advantageous embodiment of the invention, the water-insoluble fiber is a vegetable fiber.

[0118] In an advantageous embodiment of the invention, the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof.

[0119] Powdered cellulose within the scope of the present invention is understood to be cellulose prepared by treating α-cellulose obtained as pulp from several types of fibrous plant material, for example wood pulp.

[0120] In one embodiment of the present invention, the water-insoluble fiber comprises or consists of cereal fiber.

[0121] In one embodiment of the present invention, the water-insoluble fiber comprises or consists of fruit fiber and / or vegetable fiber.

[0122] In one embodiment of the present invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

[0123] In one embodiment of the present invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, pea fiber, or combinations thereof.

[0124] In one embodiment of the present invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, or a combination thereof.

[0125] Non-limiting examples of water-insoluble fibers that can be used include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel L00, Vitacel Erbsenfaser EF 150, Vitacel bamboo fiberbaf 90, Vitacel HF 600, Vitacel Cellulose L700G, Vitacel PF200, Vitacel potato fiber KF200, Vitacel bamboo fiberhaf BAF40, Vitacel Haferfaser / oat fiber HF-401-30 US.

[0126] Non-limiting examples of powdered cellulose that can be used include Vitacel L 00, Vitacel Cellulose L700G, Vitacel LC1000, Vitacel L600-20, Vitacel L600, and the like.

[0127] In one embodiment, the powdered cellulose is not chemically modified. Thus, the powdered cellulose may be, for example, a chemically unmodified cellulose fiber that does not contain microcrystalline cellulose (MCC).

[0128] In an advantageous embodiment of the invention, the water-insoluble fibres have a water-holding capacity of at least 200%, such as at least 300%, for example at least 400%.

[0129] An advantage of the above embodiment is that the pouch composition can have a high moisture content due to the high water holding capacity.

[0130] Furthermore, pouches with high moisture content have been found to have a desirable texture and mouthfeel, while the produced pouches can even be stored next to each other, for example in a can, without sticking together so much that the pouches burst when removed.

[0131] Also, water-insoluble fibers with high water-holding capacity may reduce the nicotine exchange caused by divalent cations that occurs before the pouch is used.

[0132] Therefore, pouches containing water-insoluble fibers with high water-holding capacity can advantageously reduce the relative standard deviation (RSD) of nicotine content.

[0133] In an advantageous embodiment of the present invention, the nicotine content among a series of at least 10 oral pouches comprising the aforementioned pouch composition maintains a relative standard deviation (RSD) of less than 10%, preferably less than 8%, more preferably at most 6%, even more preferably at most 4%, and most preferably at most 2%.

[0134] In one embodiment of the present invention, the nicotine content among a series of at least 10 oral pouches comprising the aforementioned pouch composition maintains a relative standard deviation (RSD) of 0.1-10%, preferably 0.1-8%, more preferably 0.1-6%, even more preferably 0.1-4%, and most preferably 0.1-2%.

[0135] In one embodiment of the present invention, the water-insoluble fiber has a water retention capacity of 300 to 1500%, for example 400 to 1300%.

[0136] In one embodiment of the present invention, the water-insoluble fiber has a water retention capacity of 200% to 1500%, such as 300 to 1300%, for example 200 to 800%, for example 300 to 800%, for example 400 to 600%.

[0137] In one embodiment of the present invention, the water-insoluble fiber has a water retention capacity of 200-1500%, such as 300-1300%, for example 300-900%, such as 300-700%, for example 400-700%.

[0138] In one embodiment of the present invention, the water-insoluble fiber has a water retention capacity of 200-1500%, such as 400-1500%, for example 500-1500%, for example 500-1200%, for example 500-1000%.

[0139] In one embodiment of the present invention, the water-insoluble fiber has a swelling power of at least 5.0 mL / g, for example, 5.0 to 20 mL / g.

[0140] The advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without compromising the mouthfeel during use. When a certain amount of water-insoluble fiber is used in place of the water-soluble ingredient, the swelling of the water-insoluble fiber during use prevents the dissolution of the water-soluble ingredient, so that the user does not feel any reduction in the pouch content during use.

[0141] In one embodiment of the present invention, the water-insoluble fiber is selected from pea fiber, powdered cellulose, and combinations thereof, and the pouch composition comprises a flavoring agent in an amount of 10% or less by weight of the pouch composition.

[0142] In one embodiment of the present invention, the pouch composition comprises a water-insoluble fiber selected from pea fiber and powdered cellulose, or a combination thereof, and a flavoring agent in an amount of 0.01 to 10% by weight of the pouch composition.

[0143] In an advantageous embodiment of the invention, the water-insoluble fibre has a density of from 50 to 500 grams per litre, such as from 100 to 400 grams per litre, for example from 200 to 300 grams per litre.

[0144] The use of water-insoluble fibers having a relatively low bulk density provides not only good mouthfeel but also effective release from the pouch due to the fact that the relatively low bulk density promotes effective salivation, thereby promoting dissolution and release of the water-soluble components of the composition.

[0145] In an advantageous embodiment of the invention, the pouch composition comprises a pH adjusting agent.

[0146] In an advantageous embodiment of the invention, the pouch composition comprises a pH adjuster in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.5 to 10% by weight of the pouch composition, for example 1 to 10% by weight of the pouch composition, for example 5 to 10% by weight of the pouch composition.

[0147] A relatively fast release rate and efficient uptake / absorption of nicotine can be desirable as it ensures a quick effect for the user, ie, relief from cravings.

[0148] Furthermore, the combination of efficient release and efficient absorption advantageously allows for a relatively high utilization of the nicotine dose within the pouch. By utilizing a relatively high nicotine dose within the pouch, the required nicotine dose of the pouch can be further reduced without compromising the effect obtained. Because nicotine can be relatively expensive, a lower nicotine dose can lead to reduced production costs, but can also be useful for users who wish to reduce their nicotine intake.

[0149] In an advantageous embodiment of the invention, the pH adjusting agent is a basic pH adjusting agent, such as a basic buffer.

[0150] In an advantageous embodiment of the invention, the pH adjusting agent is a buffer, such as a basic buffer.

[0151] In one embodiment of the present invention, the pouch composition is configured to provide a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (adjusted to a pH of 7.4).

[0152] An advantage of the above embodiment may be that the resulting high pH value promotes a more efficient uptake of nicotine.

[0153] Another advantage of the above embodiments is that the need for preservatives may be reduced or even eliminated, and that such preservatives, if present, may be used in small amounts.

[0154] The resulting high pH value can also advantageously provide a tingling sensation in the mouth that can be perceived as a desirable mouthfeel, similar to, for example, tobacco-based pouch products.

[0155] In one embodiment of the present invention, the pH adjuster 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, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0156] In an advantageous embodiment of the present invention, the pH adjuster is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate, potassium bicarbonate, trometamol, phosphate buffer, or any combination thereof.

[0157] In the present context, the term trometamol refers to (tris(hydroxymethyl)aminomethane), also sometimes called Tris buffer.

[0158] In one embodiment of the present invention, the pouch composition further comprises an inorganic multivalent cation, for example an inorganic divalent cation.

[0159] In one embodiment of the present invention, the pouch composition further comprises an inorganic polyvalent cation selected from the group consisting of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, nickel polyvalent ions, such as Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+, or any combination thereof, or from the group consisting of Ca2+, Mg2+, and any combination thereof.

[0160] In an advantageous embodiment of the present invention, the pouch composition is configured to release at least 30% of the nicotine within 10 minutes when exposed to the in vitro conditions described in Example 6A.

[0161] In an advantageous embodiment of the invention, the pouch composition comprises sodium chloride in an amount of 0.0 to 3.0% by weight of the pouch composition, such as 0.05 to 1.0% by weight of the pouch composition, for example 0.1 to 1.0% by weight of the pouch composition.

[0162] NaCl may be advantageously added as a flavor enhancer in small amounts, i.e., 0.0 to 3.0% by weight. Addition of higher amounts of NaCl may induce an undesirable taste or mouthfeel.

[0163] In an advantageous embodiment of the invention, the pouch composition further comprises a preservative.

[0164] Preservatives can help protect the pouch composition from unwanted microbial growth.

[0165] In an advantageous embodiment of the invention, the pouch composition further comprises a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition, such as 0.1 to 0.2% by weight of the pouch composition.

[0166] Non-limiting examples of preservatives that can be used within the scope of the present invention include sorbic acid (E200) and its salts (e.g., sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and its salts (e.g., sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213)).

[0167] In an advantageous embodiment of the invention, the pouch composition comprises less than 0.1% by weight of preservatives, such as less than 0.05% by weight of preservatives.

[0168] Thus, the pouch composition can include a preservative in an amount of 0-0.1% by weight, for example, 0-0.05% by weight. This includes a zero preservative content, i.e., the pouch composition is preservative-free. A low amount of preservative, or even the absence of preservative, can be achieved by obtaining a relatively alkaline environment, for example, by using free base nicotine or by using an alkaline buffer.

[0169] In an advantageous embodiment of the present invention, the pouch composition is preservative-free.

[0170] In an advantageous embodiment of the present invention, the pouch composition is a non-tobacco pouch composition.

[0171] In an advantageous embodiment of the invention, the pouch composition comprises less than 2.0% by weight tobacco, such as less than 1.0% by weight tobacco, such as less than 0.5% by weight tobacco, such as 0.0% by weight tobacco.

[0172] In one embodiment of the present invention, the pouch composition does not comprise a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose, glycerol, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum, and the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, for example 15-50% by weight of the composition, for example 20-50% by weight of the composition, for example 20-40% by weight of the composition.

[0173] In an embodiment of the invention, the pouch composition does not include a water retention agent, and the pouch composition comprises water in an amount of 15 to 65% by weight of the composition, such as 15 to 60% by weight of the composition, for example 15 to 50% by weight of the composition, for example 20 to 50% by weight of the composition, for example 20 to 40% by weight of the composition.

[0174] In one embodiment of the invention, the pouch composition comprises at least one sugar alcohol in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, for example 5-60% by weight of the composition, such as 10-50% by weight of the composition, for example 15-50% by weight of the composition, wherein the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol.

[0175] In one embodiment of the invention, the pouch composition comprises at least one sugar alcohol in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, for example 5-60% by weight of the composition, such as 10-50% by weight of the composition, for example 15-50% by weight of the composition, wherein the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

[0176] In one embodiment of the invention, the pouch composition comprises at least one sugar alcohol in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, for example 5-60% by weight of the composition, such as 10-50% by weight of the composition, for example 15-50% by weight of the composition, and the at least one sugar alcohol comprises a non-direct compressible (non-DC) grade sugar alcohol in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, for example 5-60% by weight of the composition, such as 10-50% by weight of the composition, for example 15-50% by weight of the composition.

[0177] In one embodiment of the invention, the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof, in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, for example 5-60% by weight of the composition, such as 10-50% by weight of the composition, for example 15-50% by weight of the composition.

[0178] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, the nicotine-ion exchange resin combination comprising nicotine complexed with an ion exchange resin.

[0179] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, the nicotine-ion exchange resin combination being nicotine complexed with an ion exchange resin.

[0180] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, the nicotine-ion exchange resin combination comprising free base nicotine mixed with an ion exchange resin.

[0181] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, wherein the nicotine-ion exchange resin combination is free base nicotine mixed with an ion exchange resin.

[0182] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1-20% by weight of the pouch composition, and the nicotine-ion exchange resin combination comprises nicotine in an amount of 5-50% by weight.

[0183] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1-20% by weight of the pouch composition, the nicotine-ion exchange resin combination comprising nicotine in an amount of 5-50% by weight and ion exchange resin in an amount of 10-95% by weight.

[0184] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1-20% by weight of the pouch composition, the nicotine-ion exchange resin combination comprising nicotine in an amount of 5-50% by weight, and the ion exchange resin (i) a methacrylic acid-based weakly acidic resin containing a carboxylic acid functional group; (ii) a copolymer of methacrylic acid and divinylbenzene, the copolymer containing carboxylic acid functionality; (iii) a polystyrene-based strongly acidic resin containing sulfonic acid functional groups; (iv) polystyrene-based intermediate acid type resins containing phosphonic acid functional groups, and (v) combinations thereof.

[0185] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1-20% by weight of the pouch composition, the nicotine-ion exchange resin combination comprising nicotine in an amount of 5-50% by weight and ion exchange resin in an amount of 10-95% by weight, the ion exchange resin being (i) a methacrylic acid-based weakly acidic resin containing a carboxylic acid functional group; (ii) a copolymer of methacrylic acid and divinylbenzene, the copolymer containing carboxylic acid functionality; (iii) a polystyrene-based strongly acidic resin containing sulfonic acid functional groups; (iv) polystyrene-based intermediate acid type resins containing phosphonic acid functional groups, and (v) combinations thereof.

[0186] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1-20% by weight of the pouch composition, the nicotine-ion exchange resin combination comprising nicotine in an amount of 5-50% by weight, and the ion exchange resin is a polacrilex resin.

[0187] In one embodiment of the present invention, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1-20% by weight of the pouch composition, the nicotine-ion exchange resin combination comprising nicotine in an amount of 5-50% by weight and ion exchange resin in an amount of 10-95% by weight, and the ion exchange resin is a polacrilex resin.

[0188] In one embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, for example 15-50% by weight of the composition, such as 20-50% by weight of the composition, for example 20-40% by weight of the composition, and nicotine in an amount of 0.1-5.0% by weight of the pouch composition, such as 0.2-4.0% by weight of the pouch composition, for example 1.0-2.0% by weight of the pouch composition.

[0189] In one embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, for example 15-50% by weight of the composition, such as 20-50% by weight of the composition, for example 20-40% by weight of the composition, nicotine in an amount of 0.1-5.0% by weight of the pouch composition, such as 0.2-4.0% by weight of the pouch composition, for example 1.0-2.0% by weight of the pouch composition, and at least one water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-45% by weight of the pouch composition, for example 15-40% by weight of the pouch composition.

[0190] In one embodiment of the present invention, the pouch composition comprises at least one water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 45% by weight of the pouch composition, for example 15 to 40% by weight of the pouch composition, wherein the water insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof.

[0191] In one embodiment of the present invention, the pouch composition comprises a pH adjuster in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.5 to 10% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, for example 5 to 10% by weight of the pouch composition, wherein the pH adjuster is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate, potassium bicarbonate, trometamol, phosphate buffer, or any combination thereof.

[0192] In one embodiment of the present invention, the at least one sugar alcohol comprises a non-direct compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

[0193] In one embodiment of the invention, the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof, wherein the non-directly compressible (non-DC) grade sugar alcohol is provided as particles and has not been subjected to a granulation or agglomeration process.

[0194] The present invention further relates to an oral pouch nicotine product comprising a saliva-permeable pouch and a pouch composition of the present invention or any of its embodiments enclosed in said pouch.

[0195] In an advantageous embodiment of the invention, the pouch nicotine product comprises nicotine in an amount of 0.5 to 20 mg, such as 1.0 to 20 mg, for example 5.0 to 15 mg.

[0196] In an advantageous embodiment of the invention, the pouch nicotine product comprises a nicotine-ion exchange resin combination in an amount of 1 to 100 mg.

[0197] In one embodiment of the invention, the pouch nicotine product comprises the nicotine-ion exchange resin combination in an amount of 1-100 mg, such as 20-100 mg, for example 40-100 mg, such as 60-100 mg, for example 60-85 mg.

[0198] In one embodiment of the invention, the pouch nicotine product comprises the nicotine-ion exchange resin combination in an amount of 1-100 mg, such as 5-60 mg, for example 10-50 mg, for example 10-40 mg, for example 25-40 mg.

[0199] In one embodiment of the present invention, the pouch nicotine product is tobacco-free. DETAILED DESCRIPTION OF THE INVENTION

[0200] As used herein, the term "pouch composition" refers to a composition for use in an oral pouch, i.e., a pouch for oral use. Also, the terms "pouch composition" and "nicotine pouch composition" are used interchangeably.

[0201] As used herein, the term "pouch" is intended to mean a container typically formed by a web of fibrous material surrounding a cavity. The pouch is a pouch designed to administer an active ingredient into the oral cavity, and is therefore suitable for oral use and is non-toxic and water-insoluble. The fibrous material can form, for example, a woven or non-woven web or fabric. The pouch can be sealed, for example, by joining two corresponding sections of the web or fabric together along their edges to form a cavity for the nicotine and water-insoluble composition. To release nicotine, the pouch is made water-permeable to allow saliva from the oral cavity to penetrate the pouch and enter the cavity, where it can come into contact with the nicotine, thereby releasing it from the oral pouch.

[0202] As used herein, the term "humectant" refers to a humectant used to keep the pouch moist; that is, the humectant is added to the pouch composition for the purpose of keeping the pouch moist. Thus, the term humectant does not refer to a substance added for other purposes, but rather to a hygroscopic substance added for other purposes based on this specification, such as sugar alcohols, water-insoluble fibers, and glycerol bound to the ion exchange resin in a nicotine-ion exchange resin combination, such as nicotine-polacrilex. Examples of humectants include alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. Note that when glycerol is included as a humectant, it is added as free glycerol and is therefore liquid at room temperature. Other examples of humectants include triacetin, modified starch, pectin, xanthan gum, etc. The term humectant does not refer to a sugar alcohol containing four or more carbon atoms. The term humectant also does not refer to fiber, such as water-insoluble fiber, for example, wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof. The term humectant also does not include, for example, NaCl.

[0203] As used herein, a non-tobacco pouch composition refers to a non-tobacco-based composition. In one embodiment of the present invention, the non-tobacco pouch composition contains up to 2% tobacco fiber or no tobacco fiber.

[0204] As used herein, the term "nicotine" refers to nicotine used as a purified / isolated substance. Nicotine may be isolated from tobacco and added to the pouch composition. In particular, nicotine does not refer to tobacco material having nicotine content. Therefore, when referring to the amount of nicotine, also known as nicotine dose, the amount refers to the amount of pure nicotine. Nicotine also includes nicotine that is not obtained from tobacco, and is often referred to as synthetic nicotine.

[0205] As used herein, the term "nicotine-ion exchange resin combination" refers to a combination that includes nicotine complexed with and / or mixed with an ion exchange resin.

[0206] As used herein, the term "nicotine complexed with an ion exchange resin" refers to nicotine that is bound to an ion exchange resin.

[0207] In this context, the term "free-base nicotine mixed with an ion exchange resin" refers to a mixture comprising free-base nicotine and an ion exchange resin. Even though some embodiments include a combination of nicotine complexed with an ion exchange resin and nicotine in free-base form mixed with an ion exchange resin, the term "free-base nicotine mixed with an ion exchange resin" requires the presence of nicotine in free-base form. In some embodiments, the mixture is an aqueous mixture. Free-base nicotine and water are mixed with the ion exchange resin, thereby obtaining a mixture comprising both free-base nicotine and the ion exchange resin. The free-base nicotine mixed with the ion exchange resin is referred to in the examples as a "premix."

[0208] As used herein, the term "powder composition" refers to a composition in the form of a powder, i.e., a particulate material having a relatively small particle size, for example, of 1 to 1200 micrometers. In particular, powder composition does not refer to powdered tobacco.

[0209] As used herein, the term "free base nicotine" refers to nicotine in a non-protonated form, and therefore does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin.Nevertheless, free base nicotine can be mixed with a certain amount of ion exchange resin or a water-soluble composition, such as sugar alcohol or water-soluble fiber.Free base nicotine includes both free base nicotine extracted from tobacco and synthetically produced free base nicotine, but free base nicotine is not provided in the form of tobacco or powdered tobacco.Typically, free base nicotine is provided as a liquid.

[0210] As used herein, the term "water-insoluble" refers to a water-soluble composition or substance with a relatively low water solubility, e.g., a water solubility of less than 0.1 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0. When referring to "insoluble," unless otherwise specified, it means water-insoluble.

[0211] As used herein, the term "effective release" refers to the total release of nicotine over the experimental release period or over the period of use.

[0212] As used herein, the term "dissolution" is the process by which a solid substance enters a solvent (e.g., oral saliva or water in a pouch) to produce a solution.

[0213] The pouches of the present invention release nicotine into the oral cavity and can provide a nicotine release profile that includes both rapid and sustained release periods.

[0214] As used herein, the term "rapid release" or "rapid release period" refers to the first 2 minutes of the nicotine release profile, and the term "sustained release period" refers to the period of the release profile thereafter until the end of the experiment or use.

[0215] As used herein, the term "rapid release rate" refers to nicotine per minute released within the first two minutes.

[0216] In one embodiment of the present invention, the pouch composition comprises a high-intensity sweetener.

[0217] 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.

[0218] In one embodiment of the present invention, the pouch composition comprises a bulk sweetener comprising sugar and / or sugar-free components.

[0219] In one embodiment of the present invention, the pouch composition comprises bulk sweetener in an amount of 1.0 to about 80% by weight of the pouch composition, more typically 5 to about 70% by weight of the pouch composition, more typically 10 to 60% by weight of the pouch composition, or 10 to 50% by weight of the pouch composition. In some embodiments, the inclusion of certain ingredients may further limit the approximate amount of bulk sweetener.

[0220] The sweetener is often capable of maintaining the flavor profile of the pouch composition.

[0221] Sugar sweeteners generally include, but are not limited to, sugar-containing ingredients commonly known in the pouch art, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dry invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.

[0222] Sugar sweeteners can be used in combination with sugarless sweeteners. Generally, sugarless sweeteners include ingredients that have sweetening properties but lack commonly known sugars, including, but not limited to, sugar alcohols containing four or more carbon atoms, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt, erythritol, lactitol, and the like, alone or in combination.

[0223] As used herein, the term "flavoring agent" is understood to have its ordinary meaning in the art. Flavoring agents include liquid and powdered flavoring agents. Thus, flavoring agents, by definition, do not include sweeteners (e.g., sugars, sugar alcohols, and high-intensity sweeteners), acids that impart pure sourness / tartness, or compounds that impart pure saltiness (e.g., NaCl) or pure bitterness. Flavor enhancers include substances that impart only saltiness, bitterness, or sourness. Thus, flavor enhancers include, for example, sodium chloride, citric acid, ammonium chloride, etc.

[0224] The flavoring agent may be a natural or synthetic flavoring agent.

[0225] In one embodiment of the invention, the pouch composition comprises a flavoring agent, which may typically be present in an amount of 0.01 to 15% by weight of the total composition of the pouch, for example 0.01 to 5% by weight of the total composition.

[0226] Non-exhaustive examples of flavoring agents suitable for embodiments of the present invention include coconut, coffee, chocolate, vanilla, grapefruit, orange, lime, menthol, licorice, caramel aroma, honey aroma, peanut, walnut, cashew nut, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essence, and essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the above fruits.

[0227] As used herein, the term "pH adjuster" refers to an agent that actively adjusts and regulates the pH value of a solution to which it is added or to which it is added. Thus, pH adjusters may be acids and bases, including acidic and alkaline buffers. On the other hand, pH adjusters do not include substances and compositions that can affect pH only through dilution. Furthermore, pH adjusters do not include, for example, flavoring agents, bulking agents, etc.

[0228] According to an embodiment of the present invention, the enhancing agent comprises one or more pH adjusting agents, such as buffering agents.

[0229] In one embodiment of the present invention, the pH adjuster 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, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0230] Typically, the pouch comprises an opening whose characteristic opening dimensions match the characteristic dimensions of the matrix composition so as to retain the matrix composition within the pouch prior to use and / or retain a portion of the matrix composition, e.g., a water-insoluble composition, within the pouch during use.

[0231] To obtain a pouch with a suitable opening size considering the matrix composition used, the material of the pouch can be selected accordingly, for example, including woven and / or nonwoven fabrics.

[0232] In other words, according to various embodiments, the pouch forms a membrane that allows saliva to pass through and prevents or blocks the passage of the matrix composition. The membrane of the pouch can be any suitable material, such as woven or nonwoven fabric (e.g., cotton, fleece, etc.), heat-sealable nonwoven cellulose, or other polymeric materials, such as synthetic, semi-synthetic, or natural polymeric materials. An example of a suitable pouch material is paper made from pulp and a small amount of wet strength agent. A suitable material for use must provide a semi-permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. A suitable material also does not significantly affect the release of nicotine from the pouch.

[0233] The pouch composition is filled into the pouch and maintained therein by sealing. An ideal pouch is chemically and physically stable, pharmaceutically acceptable, insoluble in water, easy to fill and seal with powder, and provides a semi-permeable membrane layer that prevents the powder from leaving the bag but allows saliva and components of the pouch composition in the pouch that are dissolved in saliva or small enough to be suspended in saliva, such as nicotine, to pass through the pouch.

[0234] The pouch may be placed in the oral cavity by a user, and as saliva enters the pouch, the nicotine and other saliva-soluble components begin to dissolve and are carried with the saliva out of the pouch into the oral cavity where the nicotine can be absorbed. [Example]

[0235] Example 1A - Preparation of a pouch designed for administration of nicotine The pouch material is a heat-sealable nonwoven cellulose, such as a long fiber paper. Pouches not in the form of a nonwoven cellulose fabric can also be used in accordance with the present invention.

[0236] The powder is filled into the pouch and is retained within the pouch by a seal.

[0237] Example 1B - Preparation of a pouch designed for administration of nicotine The pouch material is manufactured using rayon fibers, such as viscose rayon staple fibers, and the pouch membrane is heat sealed along its edges except for an opening at one end to the interior cavity formed by the pouch membrane.

[0238] The powder is filled into the pouch and is retained within the pouch by a seal.

[0239] Example 2: Preparation of Nicotine Premix Water was placed in a 60-liter planetary Bear Varimixer mixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was stirred at high speed for an additional 5 minutes. The total process time was 20 minutes.

[0240] Thus, a mixture of nicotine and cation exchange resin was prepared from the ingredients listed in the table below. Premix I: [Table 1] Table 1. Ingredients used in the preparation of Nicotine Premix I (5.7% nicotine). % Water in the resulting nicotine-resin composition: 71.4 Premix II: [Table 2] Table 2. Ingredients used in the manufacture of Nicotine Premix II (13.2% nicotine). % water in the resulting nicotine-resin composition: 34.1. Premix III: [Table 3] Table 3. Ingredients used in the preparation of Nicotine Premix III (18.5% nicotine). % water in the resulting nicotine-resin composition: 7.5. Premix IV: [Table 4] Table 4. Ingredients used in the preparation of Nicotine Premix IV (10% nicotine). % Water in the resulting nicotine-resin composition: 50.0. Premix V: [Table 5] Table 5. Ingredients used in the preparation of Nicotine Premix V (20% nicotine). % water in the resulting nicotine-resin composition: 31.5. Premix VI: [Table 6] Table 6. Ingredients used in the preparation of Nicotine Premix VI (30% nicotine). % water in the resulting nicotine-resin composition: 27.5. Premix VII [Table 7] Table 7. Ingredients used in the preparation of Nicotine Premix VII (35% nicotine). % water in the resulting nicotine-resin composition: 25.6. Premix VIII: [Table 8] Table 8. Ingredients used in the preparation of Nicotine Premix VIII (42% nicotine). % water in the resulting nicotine-resin composition: 22.8.

[0241] Example 3: Preparation of pouch composition Pouches are prepared containing the powder compositions outlined in Tables 9-21. The pouches are made as follows.

[0242] The fiber and water were mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients were then added successively with continuous mixing: first nicotine (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant, if present (mixed for 2 minutes), then liquid flavor, if present (mixed for 1 minute), and glidant, if present (mixed for 1 minute). Total mixing time was 9-11 minutes.

[0243] Example 4: Preparation of filled pouches The final pouch composition is filled into pouches (target fill weight of 500 mg powder per pouch). The pouch material from Example 1A or 1B can be used. The powder is filled into the pouch and retained in the pouch by a seal.

[0244] Example 5A: Pouch A pouch composition is prepared with the ingredients in Table 9 using the preparation method described in Example 3.

[0245] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 9] Table 9: Pouch composition.

[0246] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0247] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0248] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0249] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0250] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0251] Potassium sorbate is used as a preservative. Other preservatives described herein can also be used in combination with or in place of potassium sorbate.

[0252] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0253] Example 5B: Pouch A pouch composition is prepared with the ingredients in Table 10 using the preparation method described in Example 3.

[0254] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 10] Table 10:

[0255] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0256] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0257] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0258] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0259] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

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

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

[0262] Example 5C: Pouch A pouch composition is prepared with the ingredients in Table 11 using the preparation method described in Example 3.

[0263] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 11] Table 11: Pouch composition.

[0264] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0265] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0266] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0267] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0268] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

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

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

[0271] Example 5D: Pouch A pouch composition is prepared with the ingredients in Table 12 using the preparation method described in Example 3.

[0272] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 12] Table 12: Pouch composition.

[0273] Pouch contents: 500mg total.

[0274] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0275] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0276] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0277] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0278] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0279] Example 5E: Pouch A pouch composition is prepared with the ingredients in Table 13 using the preparation method described in Example 3.

[0280] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 13] Table 13: Pouch composition.

[0281] Pouch contents: 500mg total.

[0282] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0283] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0284] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0285] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0286] Potassium sorbate is used as a preservative. Other preservatives described herein can also be used in combination with or in place of potassium sorbate.

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

[0288] Example 5F: Pouch A pouch composition is prepared with the ingredients in Table 14 using the preparation method described in Example 3.

[0289] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 14] Table 14: Pouch composition.

[0290] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0291] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0292] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0293] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0294] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

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

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

[0297] Example 5G: Pouch A pouch composition is prepared with the ingredients in Table 15 using the preparation method described in Example 3.

[0298] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 15] Table 15: Pouch composition.

[0299] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0300] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0301] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0302] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0303] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

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

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

[0306] Example 5H: Pouch A pouch composition is prepared with the ingredients in Table 16 using the preparation method described in Example 3.

[0307] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 16] Table 16: Pouch composition.

[0308] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0309] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0310] Sodium carbonate and optionally sodium bicarbonate are used as alkaline buffers. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0311] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0312] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

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

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

[0315] Example 5I: Pouch A pouch composition is prepared with the ingredients in Table 17 using the preparation method described in Example 3.

[0316] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 17] Table 17: Pouch composition.

[0317] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0318] Wheat fiber, trade name "Vitacel 600 WF plus" or "Vitacel 200WF".

[0319] Oat fiber, trade name "Vitacel HF 600".

[0320] Pea fiber, product name "Vitacel EF150".

[0321] Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, powdered cellulose, cellulose fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber, cellulose fiber can be used as well.

[0322] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0323] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0324] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0325] Potassium sorbate is used as a preservative. Other preservatives described herein can also be used in combination with or in place of potassium sorbate.

[0326] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0327] Example 5J: Pouch A pouch composition is prepared with the ingredients in Table 18 using the preparation method described in Example 3.

[0328] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 18] Table 18: Pouch composition.

[0329] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0330] Wheat fiber, trade name "Vitacel 600 WF plus" or "Vitacel 200WF".

[0331] Oat fiber, trade name "Vitacel HF 600".

[0332] Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

[0333] Pea fiber, product name "Vitacel EF150".

[0334] Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, powdered cellulose, cellulose fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber, cellulose fiber can be used as well.

[0335] Sodium carbonate, sodium bicarbonate, and / or trometamol are used as alkaline buffers. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0336] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0337] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0338] Potassium sorbate is used as a preservative. Other preservatives described herein can also be used in combination with or in place of potassium sorbate.

[0339] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0340] Example 5K: Pouch A pouch composition is prepared with the ingredients in Table 19 using the preparation method described in Example 3.

[0341] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 19] Table 19: Pouch composition.

[0342] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g. Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0343] Sodium carbonate, sodium bicarbonate, and / or trometamol are used as alkaline buffers. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0344] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0345] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0346] Potassium sorbate is used as a preservative. Other preservatives described herein can also be used in combination with or in place of potassium sorbate.

[0347] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0348] Example 5L: Pouch A pouch composition is prepared with the ingredients in Table 20 using the preparation method described in Example 3.

[0349] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 20] Table 20: Pouch composition. Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0350] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0351] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0352] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0353] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0354] Potassium sorbate is used as a preservative. Other preservatives described herein can also be used in combination with or in place of potassium sorbate.

[0355] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0356] Example 5M: Pouch A pouch composition is prepared with the ingredients in Table 21 using the preparation method described in Example 3.

[0357] The pouch composition is filled into pouches as described in Example 4 (pouch material from Example 1A was used, but 1B can also be applied). [Table 21] Table 21: Pouch composition.

[0358] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g.

[0359] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-soluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, cellulose fiber can be used as well.

[0360] Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants described herein can also be used in combination with or as a substitute for sodium alginate, glycerol, or HPC.

[0361] Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with sodium carbonate or alternatives.

[0362] An example of a flavoring agent may be a mixture of menthol and peppermint.Of course, other flavoring agents described herein may be used in combination with or instead of menthol and / or peppermint.The flavoring agent may be liquid or flavored, or a combination, i.e., a liquid flavoring agent, and a powdered flavoring agent may be added.

[0363] As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0364] Potassium sorbate is used as a preservative. Other preservatives described herein can also be used in combination with or in place of potassium sorbate.

[0365] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0366] Example 6A: Pouch release experiments (in vitro) The release properties of the pouches were tested in an in vitro experiment.

[0367] Reaction tubes with a diameter of approximately 2 cm and containing 10 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4) were warmed to 37° C. One reaction tube was used per time point.

[0368] Using tweezers, the pouch was submerged in the buffer solution of the first reaction tube. After the designated time, the pouch was grasped with the tweezers, gently rotated in the buffer solution, then 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.

[0369] The entire release experiment was carried out at 37 degrees Celsius. No stirring or shaking was performed during the release experiment.

[0370] The amount of nicotine released was determined by analyzing buffer samples at various time points using standard HPLC.

[0371] Example 6B: Release Test for Pouches P 120-123 Release experiments were performed as described in Example 6A. [Table 22] Table 22: Percent nicotine released from nicotine pouches at various time points, with and without CaCl2, and with and without alginate.

[0372] Evaluation: The results show an increased nicotine release from pouches without sodium alginate.

[0373] The results also show that the presence of CaCl2 increases the release of nicotine from the pouches. The presence of CaCl2 increases the initial release rate and also appears to increase the effective release of nicotine.

[0374] Furthermore, the results show that increasing the nicotine content of the premix also increases the nicotine release from the pouch.

[0375] Example 7A: Weight Loss Over Time Pouch compositions containing different moisture retention agents (comparative formulations) and no moisture retention agent were prepared and placed directly into an open container at 25 degrees Celsius and 60% RH (relative humidity). [Table 23] Table 23: Relative weight loss in % for comparative pouch compositions containing various moisture retention agents and a pouch composition without moisture retention agent.

[0376] Evaluation: The results show a higher weight loss for pouch compositions containing humectants selected from alginate, glycerol, and hydroxypropyl cellulose.

[0377] Example 8A: User Ratings The produced pouches of the present invention were evaluated and found to be highly suitable as a delivery vehicle for nicotine in that the pouches conveniently release nicotine while at the same time being pleasant to the user, e.g., with respect to a desirable mouthfeel, e.g., a moist, moldable texture and a desirable taste.

[0378] Example 8B: User Ratings The pouches were evaluated by a panel of four trained evaluators, each of whom evaluated every sample twice. The panel evaluated the pouches over a 15-minute period on two different parameters: overall taste and sweetness intensity.

[0379] Tests were conducted on pouches with two different flavors.

[0380] Pouch P117-1 corresponds to P117 with lemon and orange flavorings.

[0381] Comparative P117-C1 is based on P117 but contains 2.0% alginate, 10.0% flavors (lemon and orange), and the erythritol content has been adjusted to total 100%.

[0382] Pouch P117-2 corresponds to P117 with raspberry and licorice.

[0383] Comparative P117-C2 is based on P117 but contains 2.0% alginate, 10.0% flavors (raspberry and licorice), and the erythritol content has been adjusted to total 100%. [Table 24] Table 24.

[0384] Evaluation: The testing committee found that pouches P117-1 and P117-2, which contain no alginate and a small amount of flavor, received similar or higher scores in overall taste and sweetness intensity over the test period when compared to pouches P117-C1 and P117-C2, which contain alginate and a large amount of flavor.

[0385] Surprisingly, it was found that the pouches P117-1 and P117-2 of the present invention received higher scores for both overall taste and sweetness during the initial period of use, i.e., up to 5 minutes, and that the pouches P117-1 and P117-2 of the present invention showed similar or higher scores over the 5-15 minute use period, despite the lower amount of flavoring in the pouches P117-1 and P117-2 of the present invention that were tested.

Claims

1. 1. A non-tobacco pouch composition for an oral nicotine pouch, said pouch composition comprising: Water in an amount of 15 to 40% by weight of the pouch composition; nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition; at least one sugar alcohol in an amount of 10-50% by weight of the pouch composition; the at least one sugar alcohol comprises a non-direct compressible (non-DC) grade sugar alcohol; the pouch composition comprises a non-direct compressible (non-DC) grade sugar alcohol in an amount of at least 5% by weight of the pouch composition; the non-direct compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and combinations thereof; the pouch composition does not contain a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol; the pouch composition comprises at least one water-insoluble fiber in an amount of 10 to 45% by weight of the pouch composition; the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof; Non-tobacco pouch compositions.

2. 10. The non-tobacco pouch composition of claim 1, wherein the pouch composition is further free of moisture retention agents consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

3. 3. The non-tobacco pouch composition of claim 1, wherein the pouch composition comprises 0 to 0.4% by weight of a moisture retention agent.

4. The non-tobacco pouch composition according to any one of claims 1 to 3, wherein the pouch composition does not contain a moisture retention agent.

5. 5. The non-tobacco pouch composition of any one of claims 1 to 4, wherein said pouch composition comprises said at least one sugar alcohol in an amount of at least 15% by weight of said pouch composition.

6. 6. The non-tobacco pouch composition of any one of claims 1 to 5, wherein the non-direct compressible (non-DC) grade sugar alcohol is provided as particles that have not been subjected to a granulation or agglomeration process.

7. 7. The non-tobacco pouch composition of any of claims 1 to 6, wherein the pouch composition comprises nicotine in an amount of at least 0.2% by weight of the pouch composition.

8. 8. The non-tobacco pouch composition of any of claims 1 to 7, wherein the pouch composition comprises nicotine selected from the group consisting of nicotine salts, nicotine free base, nicotine-ion exchange resin combinations, nicotine-containing complexes or any non-covalently bound nicotine, nicotine bound to zeolites, nicotine bound to cellulose, microcrystalline cellulose or starch microspheres, and mixtures thereof.

9. 9. The non-tobacco pouch composition of any one of claims 1 to 8, wherein the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition.

10. 10. The non-tobacco pouch composition of claim 9, wherein the nicotine-ion exchange resin combination comprises nicotine complexed with an ion exchange resin.

11. 11. The non-tobacco pouch composition of claim 9 or 10, wherein the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin.

12. 12. The non-tobacco pouch composition of any one of claims 9 to 11, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of 5 to 50% by weight.

13. The ion exchange resin (i) a methacrylic acid-based weakly acidic resin containing a carboxylic acid functional group; (ii) a copolymer of methacrylic acid and divinylbenzene, the copolymer comprising a carboxylic acid functional group; (iii) a polystyrene-based strongly acidic resin containing a sulfonic acid functional group; (iv) polystyrene-based intermediate acid type resins containing phosphonic acid functional groups, and 13. The non-tobacco pouch composition of any of claims 9 to 12, comprising one or more resins selected from the group consisting of: (v) combinations thereof.

14. The non-tobacco pouch composition of any one of claims 9 to 13, wherein the ion exchange resin comprises a polacrilex resin.

15. 15. The non-tobacco pouch composition of any preceding claim, wherein the pouch composition comprises water in an amount of 20 to 40% by weight of the composition.

16. 16. The non-tobacco pouch composition of any one of claims 1 to 15, wherein the water-insoluble fiber is a non-tobacco fiber.

17. 17. The non-tobacco pouch composition according to any one of claims 1 to 16, wherein the water-insoluble fiber is a vegetable fiber.

18. The non-tobacco pouch composition of any one of claims 1 to 17, wherein the pouch composition comprises a pH adjuster.

19. An oral pouch nicotine product comprising a saliva-permeable pouch and the non-tobacco pouch composition of any one of claims 1 to 18 enclosed in the saliva-permeable pouch.

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