Non-tobacco oral nicotine pouch composition

Abstract

A non-tobacco oral nicotine pouch composition is disclosed, the pouch composition comprising water in an amount of at least 15% by weight of the pouch composition, nicotine, and at least one sugar alcohol, wherein the pouch composition does not contain a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. In addition, an oral pouch nicotine product is disclosed.

Description

TECHNICAL FIELD

[0001] The present invention relates to a non-tobacco oral nicotine pouch composition and an oral nicotine pouch product according to the claims. BACKGROUND

[0002] There are many well-known disadvantages of delivering nicotine by smoking, in particular health-related issues such as introduction of carcinogens.

[0003] However, tobacco substitutes also have disadvantages, such as insufficient relief of the user's craving.

[0004] Another challenge in the prior art is that the desired release of nicotine should be attractive to the user of the pouch from the user's perspective.

[0005] However, a further challenge related to the prior art can be that the pouch as a delivery vehicle for nicotine can be somewhat expensive and therefore puts restrictions on how the pouch is designed in order to control the manufacturing costs.

[0006] It is an object of one embodiment of the present invention to provide a nicotine containing pouch, such as a tobacco substitute, which can solve the above-mentioned problems. SUMMARY

[0007] The present invention relates to a non-tobacco oral nicotine pouch composition comprising

[0008] water in an amount of at least 15 wt% of the pouch composition,

[0009] nicotine, and

[0010] at least one sugar alcohol,

[0011] wherein the pouch composition does not contain a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose and glycerol.

[0012] One advantage of the present invention can be that a high nicotine release rate can be obtained in combination with a desired mouth feel (hereinafter referred to as soft and moist feel).

[0013] Another advantage of the present invention can be that a desired flavor perception can be obtained by an improved flavor release and a promotion of a combination of a desired mouth feel (hereinafter referred to as soft and moist feel).

[0014] An advantage of the present invention can be an improved nicotine release, an improved flavor release and an improved flavor sensation without compromising the moist mouth feel.

[0015] A still further advantage of the present invention is that the combination of sugar alcohol and water not only provides an attractive mouth feel but also a very attractive taste profile.

[0016] Traditionally, humectants can be added to protect the product from drying out and can also have a preservative effect.

[0017] A high water content can make the product susceptible to microbial growth, such as growth of yeast, mould and bacteria. This can not only compromise the health safety, but also lead to a significant deterioration of the user experience through visual changes, taste changes and deterioration of the product. Surprisingly, the inventors found that the pouch composition according to the invention has a desirable taste and mouthfeel, such as soft and moist, even after long storage.

[0018] Another advantage of the present invention can be that water is surprisingly effectively retained. Typically, water retention is provided by the introduction of humectants such as alginate, propylene glycol, hydroxypropyl cellulose or glycerol. However, even though the pouch composition of the present invention does not contain these substances as humectants, a beneficially effective water retention can be obtained.

[0019] In one embodiment of the present invention, the pouch composition does not contain a humectant in the form of a sugar alcohol comprising not more than three carbons. Examples of sugar alcohols comprising not more than three carbons include glycerol, propylene glycol and ethylene glycol.

[0020] In one advantageous embodiment of the present invention, the pouch composition does not contain a humectant consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin and xanthan gum.

[0021] Thus, in the above-mentioned embodiments, the pouch composition does not contain a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose, glycerol, modified starch, triacetin, polyethylene glycol (PEG), pectin and xanthan gum.

[0022] In one advantageous embodiment of the present invention, the pouch composition comprises 0 - 0.4 wt.% of a humectant.

[0023] Thus, in the above-mentioned embodiments, the pouch composition does not contain a humectant or contains a humectant in an amount of at most 0.4 wt.% of the pouch composition.

[0024] In one advantageous embodiment of the present invention, the pouch composition does not contain a humectant.

[0025] Thus, in the above-mentioned embodiments, the pouch composition does not contain any humectant, whether it is alginate, a sugar alcohol comprising not more than three carbons, hydroxypropyl cellulose, modified starch, triacetin, polyethylene glycol (PEG), pectin, xanthan gum, or other humectants.

[0026] In an embodiment of the application, the pouch composition comprises a sugar alcohol in an amount of at least 1 wt% of the composition, such as at least 2 wt% of the composition, such as at least 5 wt% of the composition, such as at least 10 wt% of the composition, such as at least 15 wt% of the composition.

[0027] In an embodiment of the application, the pouch composition comprises a sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition.

[0028] In an advantageous embodiment of the application, the pouch composition comprises at least one sugar alcohol in an amount of at least 1 wt% of the composition, such as at least 2 wt% of the composition, such as at least 5 wt% of the composition, such as at least 10 wt% of the composition, such as at least 15 wt% of the composition.

[0029] In an advantageous embodiment of the application, the pouch composition comprises at least one sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition.

[0030] In an embodiment of the application, 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 hydrolysate and any mixture thereof.

[0031] As an example embodiment, a hydrogenated starch hydrolysate comprising a mixture of mainly maltitol, sorbitol and other sugar alcohols can be used.

[0032] In an advantageous embodiment of the application, the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol.

[0033] Traditionally, directly compressible ingredients are used to increase the flowability of a powdered composition. Generally, flowability is used as a measure of processability when handling powdered compositions. However, when a large amount of water is added to a sugar alcohol containing composition, the composition tends to agglomerate and the flowability decreases dramatically, possibly even to a degree that it cannot be measured by conventional methods. Surprisingly, the inventors have found that the pouch composition of the present application comprising a non-DC sugar alcohol can still be processed into individual pouches in a filling machine. Thus, the present application facilitates efficient processing and thereby cost effective set-up by enabling the use of non-DC sugar alcohols and by, for example, avoiding filling of pouches by hand or very complex specially designed filling machines.

[0034] It should be noted that different sugar alcohols can be applied for taste and salivation purposes, wherein the sugar alcohol composition is made of different sugar alcohols having different properties in terms of storage, processability and / or taste.

[0035] In an advantageous embodiment of the present application, the at least one non-directly compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol and any combination thereof.

[0036] In an advantageous embodiment of the present application, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of at least 1 wt.% of the composition, such as at least 2 wt.% of the composition, such as at least 5 wt.% of the composition, such as at least 10 wt.% of the composition, such as at least 15 wt.% of the composition.

[0037] In an advantageous embodiment of the present application, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80 wt.% of the composition, such as 2 to 70 wt.% of the composition, such as 5 to 60 wt.% of the composition, such as 10 to 50 wt.% of the composition, such as 15 to 50 wt.% of the composition.

[0038] In an embodiment, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80 wt.% of the composition, such as 2 to 70 wt.% of the composition, such as 5 to 60 wt.% of the composition, such as 10 to 50 wt.% of the composition, such as 15 to 50 wt.% of the composition.

[0039] In an embodiment, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80 wt.% of the composition, such as 10 to 70 wt.% of the composition, such as 10 to 60 wt.% of the composition, such as 15 to 60 wt.% of the composition, such as 20 to 60 wt.% of the composition, such as 20 to 50 wt.% of the composition.

[0040] In an embodiment of the present application, xylitol, maltitol, mannitol, erythritol, isomalt, lactitol and mixtures thereof are used as the at least one non-directly compressible (non-DC) grade sugar alcohol.

[0041] In an embodiment of the present application, the at least one non-directly compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol and mixtures thereof.

[0042] In an embodiment of the present application, the pouch composition comprises at least one non-directly compressible (non-DC) grade sugar alcohol, such as at least two non-directly compressible (non-DC) grade sugar alcohols, such as at least three non-directly compressible (non-DC) grade sugar alcohols.

[0043] In an embodiment of the application, the at least two non-directly compressible (non-DC) grade sugar alcohols are selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

[0044] In an embodiment of the application, the at least three non-directly compressible (non-DC) grade sugar alcohols are selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

[0045] In an embodiment of the application, the at least one sugar alcohol comprises a directly compressible (DC) grade sugar alcohol.

[0046] In an embodiment of the application, the directly compressible (DC) grade sugar alcohol comprises a sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any mixture thereof.

[0047] Sorbitol is a directly compressible (DC) grade from nature.

[0048] In an advantageous embodiment of the application, the pouch composition comprises at least one further sugar alcohol.

[0049] In an embodiment of the application, the pouch composition comprises at least one further sugar alcohol in an amount of at least 1 wt.-% of the composition, such as at least 2 wt.-% of the composition, such as at least 5 wt.-% of the composition, such as at least 10 wt.-% of the composition, such as at least 15 wt.-% of the composition.

[0050] In an embodiment of the application, the pouch composition comprises at least one further sugar alcohol in an amount of 1 to 50 wt.-% of the composition, such as 2 to 70 wt.-% of the composition, such as 5 to 40 wt.-% of the composition, such as 10 to 50 wt.-% of the composition, such as 15 to 30 wt.-% of the composition.

[0051] In an advantageous embodiment of the application, the at least one further sugar alcohol comprises a directly compressible (DC) grade sugar alcohol.

[0052] In an embodiment of the application, the at least one further sugar alcohol is a directly compressible (DC) grade sugar alcohol.

[0053] In an embodiment of the application, the at least one sugar alcohol comprises one or more non-directly compressible (non-DC) grade sugar alcohols and the at least one further sugar alcohol comprises a directly compressible (DC) grade sugar alcohol.

[0054] In an embodiment of the present application, the non-directly compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

[0055] The sugar alcohol can advantageously facilitate and induce saliva secretion from the pouch composition, thereby obtaining release of nicotine, e.g. from the pouch.

[0056] The sugar alcohol can advantageously be used to further increase the release of nicotine from the pouch.

[0057] Additionally, the sugar alcohol can advantageously be used to obtain a desired mouth feel by increasing saliva secretion and thereby counteract any local dehydration or mouth dryness feeling experienced by the pouch user.

[0058] In an embodiment, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition.

[0059] In an embodiment, the pouch composition comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 10 to 70 wt% of the composition, such as 10 to 60 wt% of the composition, such as 15 to 60 wt% of the composition, such as 20 to 60 wt% of the composition, such as 20 to 50 wt% of the composition.

[0060] In an embodiment of the present application, 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.

[0061] In an embodiment of the present application, 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.

[0062] In an embodiment of the present application, the at least one sugar alcohol comprises a sugar alcohol selected from the list consisting of maltitol, mannitol, sorbitol, lactitol, and any combination thereof.

[0063] In an embodiment of the present application, the pouch composition is free of DC grade xylitol.

[0064] In an embodiment of the present application, the pouch composition is free of xylitol.

[0065] In an embodiment of the present application, the pouch composition is free of DC grade sugar alcohol.

[0066] In one embodiment of the present application, the pouch composition comprises a sugar alcohol in an amount of at least 14.0 wt% of the pouch composition.

[0067] In one embodiment of the present application, the pouch composition comprises at least one non-wheat fiber.

[0068] In one embodiment of the present application, the pouch composition comprises at least one non-sodium carbonate pH adjuster.

[0069] In one embodiment of the present application, the pouch composition comprises a pH adjuster in an amount of more than 5.5 wt% of the pouch composition.

[0070] In one embodiment of the present application, the pouch composition comprises sodium chloride.

[0071] In one embodiment, the pouch composition comprises at least two non-directly compressible (non-DC) grade sugar alcohols selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

[0072] In one advantageous embodiment of the present application, the non-directly compressible (non-DC) grade sugar alcohol is provided in a granulate which has not been subjected to a granulation or agglomeration step.

[0073] The term directly compressible is well known in the field of tableting, i.e. in the technical field of compressing granulates into agglomerated compressed tablets. Many manufacturers of such granulates commonly refer to directly compressible as DC.

[0074] In one embodiment of the present application, the at least one non-directly compressible (non-DC) grade sugar alcohol is defined as non-DC grade according to compressibility index in European Pharmacopoeia 6.0 and wherein the granulate consisting of the non-DC grade sugar alcohol has a compressibility index of more than 21%.

[0075] In one embodiment of the present application, the at least one non-directly compressible (non-DC) grade sugar alcohol is defined as non-DC according to compressibility index in European Pharmacopoeia 6.0 and wherein the granulate consisting of the non-DC grade sugar alcohol has a compressibility index of more than 21% and less than 37%.

[0076] In one embodiment of the present application, the pouch composition comprises a further sugar alcohol, wherein the further sugar alcohol is directly compressible (DC).

[0077] In one embodiment of the present application, the further sugar alcohol is defined as DC according to compressibility index in European Pharmacopoeia 6.0 and wherein the granulate consisting of the further sugar alcohol has a compressibility index of less than 21%, such as less than 15%, such as less than 10%.

[0078] In an advantageous embodiment of the application, the pouch composition comprises nicotine in an amount of at least 0.1 wt.%, such as at least 0.2 wt.% of the pouch composition.

[0079] In an embodiment of the application, the pouch composition comprises nicotine in an amount of 0.1 to 5.0 wt.% of the pouch composition, such as 0.2 to 4.0 wt.% of the pouch composition, such as 1.0 to 2.0 wt.% of the pouch composition.

[0080] In an advantageous embodiment of the application, the pouch composition comprises nicotine selected from the group consisting of nicotine salts, nicotine free base, nicotine-ion exchange resin combinations, nicotine inclusion complexes or any non-covalently bound nicotine; nicotine bound to zeolites; nicotine bound to cellulose such as microcrystalline cellulose or starch microspheres, and mixtures thereof.

[0081] In an advantageous embodiment of the application, the pouch composition comprises nicotine-ion exchange resin combinations in an amount corresponding to 0.1 to 20 wt.% of the pouch composition.

[0082] In an advantageous embodiment of the application, the nicotine-ion exchange resin combinations comprise nicotine complexed with ion exchange resins.

[0083] In an advantageous embodiment of the application, the nicotine-ion exchange resin combinations are nicotine complexed with ion exchange resins.

[0084] Thus, in the above embodiments, the nicotine-ion exchange resin combinations consist of nicotine complexed with ion exchange resins.

[0085] In an advantageous embodiment of the application, the nicotine-ion exchange resin combinations comprise free base nicotine mixed with ion exchange resins.

[0086] An advantage of the above embodiments can be to provide a sustained release of nicotine. At the same time, the release rate of nicotine is not too slow to fail to give the user the desired relief from cravings.

[0087] In an advantageous embodiment of the application, the nicotine-ion exchange resin combinations comprise nicotine in an amount between 5 to 50 wt.%.

[0088] In an embodiment of the application, the nicotine-ion exchange resin combinations comprise nicotine complexed with ion exchange resins, wherein the nicotine constitutes an amount between 5 to 50 wt.% of the nicotine-ion exchange resin combinations.

[0089] In one embodiment of the present application, the nicotine-ion exchange resin combination consists of nicotine complexed with an ion exchange resin, wherein the nicotine constitutes an amount between 10 and 50 wt% of the nicotine-ion exchange resin combination, such as between 10 and 40 wt% of the nicotine-ion exchange resin combination, such as between 10 and 30 wt% of the nicotine-ion exchange resin combination, such as between 10 and 25 wt% of the nicotine-ion exchange resin combination.

[0090] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, wherein the nicotine constitutes an amount between 5 and 50 wt% of the nicotine-ion exchange resin combination.

[0091] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, wherein the nicotine constitutes an amount between 5 and 50 wt% of the nicotine-ion exchange resin combination, such as between 10 and 50 wt% of the nicotine-ion exchange resin combination, such as between 20 and 50 wt% of the nicotine-ion exchange resin combination, such as between 25 and 50 wt% of the nicotine-ion exchange resin combination, such as between 25 and 45 wt% of the nicotine-ion exchange resin combination.

[0092] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, wherein the nicotine constitutes an amount between 5 and 40 wt% of the nicotine-ion exchange resin combination, such as between 10 and 40 wt% of the nicotine-ion exchange resin combination, such as between 10 and 35 wt% of the nicotine-ion exchange resin combination, such as between 10 and 25 wt% of the nicotine-ion exchange resin combination, such as between 10 and 15 wt% of the nicotine-ion exchange resin combination.

[0093] In one advantageous embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 and 50 wt% and ion exchange resin in an amount between 10 and 95 wt%.

[0094] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 and 50 wt% and ion exchange resin in an amount between 10 and 95 wt%.

[0095] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount between 10 and 30 wt% and ion exchange resin in an amount between 20 and 90 wt%.

[0096] In one embodiment of the present application, the nicotine-ion exchange resin combination consists of nicotine in an amount of between 10 and 30 weight-% and ion exchange resin in an amount of between 70 and 90 weight-%.

[0097] In one embodiment of the present application, the nicotine-ion exchange resin combination is essentially free of water.

[0098] In one embodiment of the present application, the nicotine-ion exchange resin combination further comprises glycerol complexed with the ion exchange resin.

[0099] Glycerol can be added for the purpose of reducing the dustiness of the nicotine-ion exchange resin combination.

[0100] In one embodiment of the present application, the nicotine-ion exchange resin combination further comprises glycerol in an amount of 0.1 to 50 weight-%, such as 5 to 40 weight-%, such as 5 to 30 weight-%.

[0101] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50 weight-% and ion exchange resin in an amount of between 20 and 75 weight-%.

[0102] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises water in an amount of not more than 75 weight-%, such as not more than 50 weight-%, such as not more than 40 weight-%, such as not more than 30 weight-%, such as not more than 20 weight-%, such as not more than 10 weight-%, such as not more than 5 weight-%.

[0103] In one advantageous embodiment of the present application, the ion exchange resin comprises one or more resins selected from the group consisting of:

[0104] (i) a resin of the methacrylic weakly acidic type containing carboxylic functional groups,

[0105] (ii) a copolymer of methacrylic acid and divinylbenzene containing carboxylic functional groups,

[0106] (iii) a resin of the polystyrene strongly acidic type containing sulfonic functional groups,

[0107] (iv) a resin of the polystyrene medium acidic type containing phosphoric functional groups, and

[0108] (v) combinations thereof.

[0109] In one advantageous embodiment of the present application, the ion exchange resin comprises a polacrilex resin.

[0110] In one advantageous embodiment of the present application, the ion exchange resin is a polacrilex resin.

[0111] In one embodiment of the application, the polacrilex resin comprises or is IRP64.

[0112] In an advantageous embodiment of the application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition.

[0113] In one embodiment of the application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 20-65 wt% of the composition, such as 25-65 wt% of the composition.

[0114] In one embodiment of the application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 15-40 wt% of the composition.

[0115] In one embodiment of the application, the pouch composition comprises water in an amount of 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 15-40 wt% of the composition, such as 15-30 wt% of the composition.

[0116] In one embodiment of the application, the pouch composition comprises water in an amount of 15-40 wt% of the composition.

[0117] The water can be added as a separate component to be mixed completely or partially into other components, such as the fibres. For example, when a nicotine-ion exchange resin combination consisting of freebase nicotine mixed with an ion exchange resin and water is added, a significant amount of water in the final pouch composition can come from this mixture. For example, if the final amount of the pouch composition comprises 5% water from the nicotine-ion exchange resin combination, then up to one third of the water in the pouch composition originates from the nicotine-ion exchange resin combination.

[0118] In an advantageous embodiment of the application, the pouch composition comprises at least one water insoluble fibre.

[0119] In an advantageous embodiment of the application, the pouch composition comprises at least one water insoluble fibre in an amount between 5 and 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition.

[0120] In one embodiment of the application, the pouch composition comprises at least one water insoluble fibre in an amount between 5 and 50 wt% of the pouch composition, such as 5-45 wt% of the pouch composition, such as 5-40 wt% of the pouch composition.

[0121] In one embodiment of the present application, the pouch composition comprises at least one water insoluble fiber in an amount between 5 to 50 weight-% of the pouch composition, such as 10-50 weight-% of the pouch composition, such as 15-50 weight-% of the pouch composition.

[0122] One advantage of the above embodiments can be that a residue is left even after use of the nicotine pouch comprising the pouch composition. This can give a pleasant perception to the user of the nicotine pouch, for example due to similarity with tobacco containing products.

[0123] The water insoluble fiber can advantageously provide a desired mouthfeel throughout the use of the pouch.

[0124] Another advantage of the present application is that a very attractive soft, moist and moldable texture and mouthfeel is obtained due to the combination of sugar alcohol, water insoluble fiber and water. A desired texture and mouthfeel can be obtained while still being able to store the manufactured pouches together abutting in for example a can without sticking together too much resulting in breakage of the pouches when taken out.

[0125] In one advantageous embodiment of the present application, the water insoluble fiber is a non-tobacco fiber.

[0126] In one advantageous embodiment of the present application, the water insoluble fiber is a plant fiber.

[0127] In one advantageous embodiment of the present application, the water insoluble fiber is selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn 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.

[0128] Powdered cellulose within the scope of the present application is to be understood as cellulose made by processing a-cellulose obtained from pulp such as wood pulp from a line of fiber plant material.

[0129] In one embodiment of the present application, the water insoluble fiber comprises or consists of cereal plant fiber.

[0130] In one embodiment of the present application, the water insoluble fiber comprises or consists of fruit and / or vegetable fiber.

[0131] In one embodiment of the present application, the water insoluble composition comprises or consists of water insoluble fiber selected from the group consisting of wheat fiber, oat fiber, pea fiber, powdered cellulose or combinations thereof.

[0132] In one embodiment of the present application, the water insoluble composition comprises or consists of water insoluble fibers selected from the group consisting of wheat fibers, oat fibers, pea fibers, or combinations thereof.

[0133] In one embodiment of the present application, the water insoluble composition comprises or consists of water insoluble fibers selected from the group consisting of wheat fibers, oat fibers, or combinations thereof.

[0134] Non-limiting examples of useful water insoluble fibers include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel L00, Vitacel Erbsenfaser EF 150, Vitacel bamboo fiber baf 90, Vitacel HF 600, Vitacel Cellulose L700G, Vitacel PF200, Vitacel potato fiber KF200, Vitacel bamboo fiber haf BAF40, Vitacel Haferfaser / oat fiber HF-401-30US.

[0135] Non-limiting examples of useful powdered cellulose include Vitacel L 00, Vitacel Cellulose L700G, Vitacel LC1000, Vitacel L600-20, Vitacel L600, and the like.

[0136] In one embodiment, the powdered cellulose is not chemically modified. Thus, the powdered cellulose can be a non-chemically modified cellulose fiber which does not include, for example, microcrystalline cellulose (MCC).

[0137] In one advantageous embodiment of the present application, the water insoluble fibers have a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

[0138] One advantage of the above embodiments can be that the high water binding capacity enables the pouch composition to have a high water content.

[0139] Furthermore, it was found that pouches having a high water content have a desirable texture and mouthfeel, while still being possible to store the manufactured pouches together abutting in, for example, a can, without sticking together too much resulting in breakage of the pouches when taken out.

[0140] In addition, the water insoluble fibre having a high water binding capacity can reduce any nicotine exchange caused by divalent cations that occurs before the pouch is used.

[0141] Thus, the pouch comprising the water insoluble fibre having a high water binding capacity can advantageously reduce the relative standard deviation (RSD) of the nicotine content.

[0142] In an advantageous embodiment of the present application, the nicotine content between a series of at least 10 oral pouches comprising the pouch composition remains below a relative standard deviation (RSD) of 10%, preferably below 8%, more preferably at most 6%, even more preferably at most 4%, most preferably at most 2%.

[0143] In an embodiment of the present application, the nicotine content between a series of at least 10 oral pouches comprising the pouch composition remains a relative standard deviation (RSD) of 0.1-10%, preferably 0.1-8%, more preferably 0.1-6%, even more preferably 0.1-4%, most preferably 0.1-2%.

[0144] In an embodiment of the present application, the water insoluble fibre has a water binding capacity of 300 to 1500%, such as 400 to 1300%.

[0145] In an embodiment of the present application, the water insoluble fibre has a water binding capacity of 200% to 1500%, such as 300 to 1300%, such as 200 to 800%, such as 300 to 800%, such as 400 to 600%.

[0146] In an embodiment of the present application, the water insoluble fibre has a water binding capacity of 200 to 1500%, such as 300 to 1300%, such as 300 to 900%, such as 300 to 700%, such as 400 to 700%.

[0147] In an embodiment of the present application, the water insoluble fibre has a water binding capacity of 200 to 1500%, such as 400 to 1500%, such as 500 to 1500%, such as 500 to 1200%, such as 500 to 1000%.

[0148] In an embodiment of the present application, the water insoluble fibre has a swelling capacity of at least 5.0 mL / g, such as 5.0-20 mL / g.

[0149] One advantage of the above embodiments is that the amount of water insoluble fibre can be reduced without compromising the mouthfeel during use. If an amount of water insoluble fibre is substituted for the water soluble component, the swelling of the water insoluble fibre during use will counteract the dissolution of the water soluble component, and thus the user will not experience any reduction in the contents of the pouch during use.

[0150] In an embodiment of the application, the water insoluble fibre is selected from the group consisting of pea fibre, powdered cellulose and combinations thereof, and wherein the pouch composition comprises flavouring in an amount of not more than 10 wt.% of the pouch composition.

[0151] In an embodiment of the application, the pouch composition comprises water insoluble fibre selected from the group consisting of pea fibre and powdered cellulose or combinations thereof and flavouring in an amount of between 0.01 and 10 wt.% of the pouch composition.

[0152] In an advantageous embodiment of the application, the water insoluble fibre has a density of between 50 and 500 g / l, such as between 100 and 400 g / l, such as between 200 and 300 g / l.

[0153] The use of water insoluble fibre having a relatively low bulk density will not only provide a good mouth feel, but also the fact that the relatively low bulk density facilitates effective saliva secretion dissolving and releasing the water soluble ingredients of the composition will provide an effective release from the pouch.

[0154] In an advantageous embodiment of the application, the pouch composition comprises a pH adjusting agent.

[0155] In an advantageous embodiment of the application, the pouch composition comprises a pH adjusting agent in an amount of between 0.01 and 15 wt.% of the pouch composition, such as between 0.5 and 10 wt.% of the pouch composition, such as between 1 and 10 wt.% of the pouch composition, such as between 5 and 10 wt.% of the pouch composition.

[0156] Obtaining a relatively fast nicotine release rate and effective uptake / absorption can be desirable as this will ensure a fast effect on the user, i.e. craving relief.

[0157] Furthermore, the combination of effective release and effective absorption advantageously enables a relatively high utilisation of the nicotine dose within the pouch. A relatively high utilisation of the nicotine dose within the pouch can further provide a reduction of the necessary nicotine dose of the pouch without compromising the effect produced. A lower nicotine dose can in turn lead to a reduction in production costs as nicotine can be relatively expensive, but can also help users who want to reduce their nicotine intake.

[0158] In an advantageous embodiment of the application, the pH adjusting agent is a basic pH adjusting agent, such as a basic buffer.

[0159] In an advantageous embodiment of the application, the pH adjusting agent is a buffer, such as a basic buffer.

[0160] In one embodiment of the present application, the pouch composition is suitable to give a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 gram of the pouch composition is added to 20 mL of a 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4).

[0161] One advantage of the above embodiments can be that a relatively effective nicotine uptake is facilitated due to the obtained high pH value.

[0162] Another advantage of the above embodiments can be that the need for preservatives can be reduced or even eliminated and, if not absent, low amounts of such preservatives can be used.

[0163] In addition, the obtained high pH value can advantageously provide a tingling sensation in the mouth that can be perceived as a desirable mouth feel, e.g. due to similarity with tobacco based pouch products.

[0164] In one embodiment of the present application, the pH adjusting agent is selected from acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-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, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide or any combination thereof.

[0165] In one advantageous embodiment of the present application, the pH adjusting agent is selected from sodium carbonate, sodium bicarbonate, potassium carbonate and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffer, or any combination thereof.

[0166] In the present context, the term tromethamine refers to (tris(hydroxymethyl)aminomethane), also sometimes referred to as tris buffer.

[0167] In one embodiment of the present application, the pouch composition further comprises an inorganic polyvalent cation, such as an inorganic divalent cation.

[0168] In one embodiment of the present application, the pouch composition further comprises an inorganic polyvalent cation selected from calcium, magnesium, zinc, aluminium, barium, iron, manganese, copper, lead, cobalt, nickel, such as Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+or any combination thereof, or selected from Ca2+, Mg2+and any combination thereof.

[0169] In one advantageous embodiment of the present application, the pouch composition is suitable to release at least 30% of the nicotine within 10 minutes when exposed to the in vitro conditions described in Example 6A.

[0170] In an advantageous embodiment of the application, the pouch composition comprises sodium chloride in an amount of 0.0-3.0 wt% of the pouch composition, such as 0.05-1.0 wt% of the pouch composition, such as 0.1-1.0 wt% of the pouch composition.

[0171] NaCI can advantageously be added in small amounts, i.e. 0.0-3.0 wt%, as a flavour enhancer. Adding higher amounts of NaCI can cause an undesired taste or mouthfeel.

[0172] In an advantageous embodiment of the application, the pouch composition further comprises a preservative.

[0173] The preservative can help to keep the pouch composition free from undesired microbial growth.

[0174] In an advantageous embodiment of the application, the pouch composition further comprises a preservative in an amount of 0.05 to 0.5 wt% of the pouch composition, such as 0.1 to 0.2 wt% of the pouch composition.

[0175] Non-limiting examples of preservatives that can be used within the scope of the present application 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)).

[0176] In an advantageous embodiment of the application, the pouch composition comprises less than 0.1 wt% of a preservative, such as less than 0.05 wt% of a preservative.

[0177] Thus, the pouch composition can comprise a preservative in an amount of 0 to 0.1 wt%, such as in an amount of 0 to 0.05 wt%. This includes zero content of preservative, i.e. the pouch composition is free of preservative. A low amount of preservative or even no preservative can be achieved by obtaining a relatively alkaline environment, such as by using freebase nicotine or by using an alkaline buffer.

[0178] In an advantageous embodiment of the application, the pouch composition is free of preservative.

[0179] In an advantageous embodiment of the application, the pouch composition is a non-tobacco pouch composition.

[0180] In an advantageous embodiment of the application, the pouch composition comprises less than 2.0 wt% of tobacco, such as less than 1.0 wt% of tobacco, such as less than 0.5 wt% of tobacco, such as 0.0 wt% of tobacco.

[0181] In an embodiment of the application, the pouch composition does not contain a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose, glycerin, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum and the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition.

[0182] In an embodiment of the application, the pouch composition does not contain a humectant and the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition.

[0183] In an embodiment of the application, the pouch composition comprises at least one sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition and the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol.

[0184] In an embodiment of the application, the pouch composition comprises at least one sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition and 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.

[0185] In an embodiment of the application, the pouch composition comprises at least one sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition and the at least one sugar alcohol comprises a non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition.

[0186] In an embodiment of the application, 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 and in an amount of 1 to 80 weight percent of the composition, such as 2 to 70 weight percent of the composition, such as 5 to 60 weight percent of the composition, such as 10 to 50 weight percent of the composition, such as 15 to 50 weight percent of the composition.

[0187] In an embodiment of the application, the pouch composition comprises a nicotine- ion exchange resin combination in an amount corresponding to 0.1 to 20 weight percent of the pouch composition and the nicotine-ion exchange resin combination comprises nicotine complexed with an ion exchange resin.

[0188] In an embodiment of the application, the pouch composition comprises a nicotine- ion exchange resin combination in an amount corresponding to 0.1 to 20 weight percent of the pouch composition and the nicotine-ion exchange resin combination is nicotine mixed with an ion exchange resin.

[0189] In an embodiment of the application, the pouch composition comprises a nicotine- ion exchange resin combination in an amount corresponding to 0.1 to 20 weight percent of the pouch composition and the nicotine-ion exchange resin combination comprises freebase nicotine mixed with an ion exchange resin.

[0190] In an embodiment of the application, the pouch composition comprises a nicotine- ion exchange resin combination in an amount corresponding to 0.1 to 20 weight percent of the pouch composition and the nicotine-ion exchange resin combination is freebase nicotine mixed with an ion exchange resin.

[0191] In an embodiment of the application, the pouch composition comprises a nicotine- ion exchange resin combination in an amount corresponding to 0.1 to 20 weight percent of the pouch composition and wherein the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 to 50 weight percent.

[0192] In an embodiment of the application, the pouch composition comprises a nicotine- ion exchange resin combination in an amount corresponding to 0.1 to 20 weight percent of the pouch composition and wherein the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 to 50 weight percent and ion exchange resin in an amount between 10 to 95 weight percent.

[0193] In an embodiment of the application, the pouch composition comprises a nicotine- ion exchange resin combination in an amount corresponding to 0.1 to 20 weight percent of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 to 50 weight percent and wherein the ion exchange resin comprises one or more resins selected from the group consisting of:

[0194] (i) a methacrylic weakly acidic type resin containing carboxylic functional groups,

[0195] (ii) a copolymer of methacrylic acid and divinylbenzene containing carboxylic functional groups,

[0196] (iii) a polystyrene strongly acidic type resin containing sulfonic functional groups,

[0197] (iv) a polystyrene moderately acidic type resin containing phosphoric functional groups, and

[0198] (v) combinations thereof.

[0199] In one embodiment of the application, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20 wt% of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 to 50 wt% and ion exchange resin in an amount of between 10 to 95 wt% and wherein the ion exchange resin comprises one or more resins selected from the group consisting of:

[0200] (i) a methacrylic weakly acidic type resin containing carboxylic functional groups,

[0201] (ii) a copolymer of methacrylic acid and divinylbenzene containing carboxylic functional groups,

[0202] (iii) a polystyrene strongly acidic type resin containing sulfonic functional groups,

[0203] (iv) a polystyrene moderately acidic type resin containing phosphoric functional groups, and

[0204] (v) combinations thereof.

[0205] In one embodiment of the application, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20 wt% of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 to 50 wt% and wherein the ion exchange resin is a polacrilex resin.

[0206] In one embodiment of the application, the pouch composition comprises a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20 wt% of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 to 50 wt% and ion exchange resin in an amount of between 10 to 95 wt% and wherein the ion exchange resin is a polacrilex resin.

[0207] In an embodiment of the present application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition, nicotine in an amount of 0.1 to 5.0 wt% of the pouch composition, such as 0.2 to 4.0 wt% of the pouch composition, such as 1.0 to 2.0 wt% of the pouch composition.

[0208] In an embodiment of the present application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition, nicotine in an amount of 0.1 to 5.0 wt% of the pouch composition, such as 0.2 to 4.0 wt% of the pouch composition, such as 1.0 to 2.0 wt% of the pouch composition, and at least one water insoluble fiber in an amount of between 5 to 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition.

[0209] In an embodiment of the present application, the pouch composition comprises at least one water insoluble fiber in an amount of between 5 to 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition, wherein the water insoluble fiber is selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn 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.

[0210] In an embodiment of the present application, the pouch composition comprises a pH adjusting agent in an amount of between 0.01 to 15 wt% of the pouch composition, such as between 0.5 to 10 wt% of the pouch composition, such as between 1 to 10 wt% of the pouch composition, such as between 5 to 10 wt% of the pouch composition, and the pH adjusting agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffer, or any combination thereof.

[0211] In an embodiment of the present application, 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.

[0212] In one embodiment of the present application, 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, which is provided in a granulate, which has not been subjected to a granulation or an agglomeration step.

[0213] The present application also relates to an oral pouch nicotine product comprising a saliva permeable pouch and a pouch composition of the present application or any embodiment thereof enclosed in the pouch.

[0214] In an advantageous embodiment of the present application, the pouch nicotine product comprises nicotine in an amount of 0.5 to 20 mg, such as 1.0 to 20 mg, such as 5.0 to 15 mg.

[0215] In an advantageous embodiment of the present application, the pouch nicotine product comprises a nicotine-ion exchange resin combination in an amount of 1 to 100 mg.

[0216] In one embodiment of the present application, the pouch nicotine product comprises a nicotine-ion exchange resin combination in an amount of 1 to 100 mg, such as 20 to 100 mg, such as 40 to 100 mg, such as 60 to 100 mg, such as 60 to 85 mg.

[0217] In one embodiment of the present application, the pouch nicotine product comprises a nicotine-ion exchange resin combination in an amount of 1 to 100 mg, such as 5 to 60 mg, such as 10 to 50 mg, such as 10 to 40 mg, such as 25 to 40 mg.

[0218] In one embodiment of the present application, the pouch nicotine product does not contain tobacco. DETAILED DESCRIPTION

[0219] As used herein, the term "pouch composition" refers to a composition for use in an oral pouch, i.e. a pouch for oral use. Further, the terms "pouch composition" and "nicotine pouch composition" are used interchangeably.

[0220] As used herein, the term "pouch" is intended to mean a container formed typically from a web of fibrous material enclosing a cavity. The pouch is a pouch designed for administration of an active ingredient in the oral cavity and is thus suitable for oral use, it is non-toxic and is water-insoluble. The fibrous material can for example form a woven or non-woven web or fabric. For example, the pouch can be sealed by bonding two respective webs or fabrics to each other along their edges to form a cavity for the nicotine and the water-insoluble composition. In order to release the nicotine, the pouch is made water-permeable so as to allow saliva from the oral cavity to penetrate the pouch and enter the cavity, where the saliva can come into contact with the nicotine, whereby the nicotine is released from the oral pouch.

[0221] As used herein, the term "humectant" is understood to mean a wetting agent for keeping the pouch moist, i.e. a humectant is added to the pouch composition for the purpose of keeping the pouch moist. Thus, the term humectant does not refer to substances added for other purposes, also below hygroscopic substances added for other purposes, such as sugar alcohols, water insoluble fibers and glycerol associated with nicotine-ion exchange resin combinations such as the ion exchange resin in nicotine polacrilex. Examples of humectants include alginate, propylene glycol, hydroxypropyl cellulose and glycerol. It is noted that when glycerol is introduced as a humectant, the glycerol is added as free glycerol and thus is a liquid at room temperature. Further examples of humectants include triacetin, modified starch, pectin, xanthan gum, etc. The term humectant does not refer to sugar alcohols comprising 4 or more carbons. In addition, the term humectant does not refer to fibers, such as water insoluble fibers, such as wheat fiber, pea fiber, rice fiber, corn 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. In addition, the term humectant does not include e.g. NaCI.

[0222] As used herein, a non-tobacco pouch composition refers to a composition based on non-tobacco. In one embodiment of the application, the non-tobacco pouch composition comprises at most 2% tobacco fibers, or is free of tobacco fibers.

[0223] As used herein, the term "nicotine" refers to nicotine used as a refined / isolated substance. Nicotine can be isolated from tobacco and added to the pouch composition. In particular, nicotine does not refer to tobacco material having a nicotine content. Thus, when referring to a nicotine amount (also understood as a nicotine dose), the amount refers to the amount of pure nicotine. Nicotine also encompasses nicotine not obtained from tobacco, often referred to as synthetic nicotine.

[0224] As used herein, the term "nicotine-ion exchange resin combination" refers to a combination comprising nicotine complexed with an ion exchange resin and / or nicotine mixed with an ion exchange resin.

[0225] As used herein, the term "nicotine complexed with an ion exchange resin" refers to nicotine bound to an ion exchange resin.

[0226] In the present context, the term "free base nicotine mixed with ion exchange resin" refers to a mixture comprising free base nicotine and ion exchange resin. It is noted that even if some embodiments comprise a combination of nicotine complexed with ion exchange resin and nicotine in its free base form mixed with ion exchange resin, the term "free base nicotine mixed with ion exchange resin" requires the presence of nicotine in its free base form. In some embodiments, the mixture is an aqueous mixture. The free base nicotine and water are mixed with the ion exchange resin, whereby a mixture comprising both free base nicotine and ion exchange resin is obtained. The free base nicotine mixed with ion exchange resin is referred to as "premix" in the examples.

[0227] As used herein, the term "powder composition" refers to a composition in the form of a powder, i.e. as a particulate material having a relatively small particle size, e.g. between 1 and 1200 micrometers. In particular, the powder composition does not mean a powdered tobacco.

[0228] As used herein, the term "free base nicotine" refers to the non- protonated form of nicotine and thus does not include nicotine salts or nicotine provided as a complex between nicotine and ion exchange resin. However, the free base nicotine can be mixed with an amount of ion exchange resin or a water-soluble composition such as a sugar alcohol or a water-soluble fibre. While the free base nicotine includes both free base nicotine extracted from tobacco as well as synthetically manufactured free base nicotine, the free base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, the free base nicotine is provided in a liquid.

[0229] As used herein, the term "water-insoluble" refers to a relatively low water-solubility, e.g. a water-solubility of less than 0.1 gram of the water-soluble composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0. When referring to "insoluble", it is meant water-insoluble unless otherwise specified.

[0230] As used herein, the term "effective release" refers to the total release of nicotine during the experimental release period or use period.

[0231] As used herein, the term "dissolution" is the process in which a solid substance enters a solvent, such as oral saliva or water in the pouch, to create a solution.

[0232] The pouch of the present application provides nicotine release into the oral cavity. A nicotine release profile comprising both a fast release period and a sustained release period can be obtained.

[0233] As used herein, the term "fast release" or "fast release period" can refer to the initial 2 minutes of the nicotine release profile, while the term "sustained release period" refers to the subsequent period of the release profile up to the end of the experiment or use.

[0234] As used herein, the term "fast release rate" refers to the amount of nicotine released per minute in the first 2 minutes.

[0235] In one embodiment of the application, the pouch composition comprises a high intensity sweetener.

[0236] 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, rebaudioside A, and the like, alone or in combination.

[0237] In one embodiment of the application, the pouch composition comprises a bulk sweetener, which includes sugar and / or sugarless components.

[0238] In one embodiment of the application, the pouch composition comprises a bulk sweetener in an amount of from 1.0 to about 80% by weight of the pouch composition, more typically from 5 to about 70% by weight of the pouch composition, more usually from 10 to 60% by weight of the pouch composition or from 10-50% by weight of the pouch composition. In some embodiments, the introduction of certain ingredients can further limit the approximate amount of bulk sweetener.

[0239] Sweeteners generally can support the flavor profile of the pouch composition.

[0240] Sugar sweeteners generally include, but are not limited to, sugar containing components commonly known in the art of pouches, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.

[0241] Sugar sweeteners can be used in combination with sugarless sweeteners. Generally, sugarless sweeteners include components having sweetening properties but not containing commonly known sugars and include, but are not limited to, sugar alcohols containing 4 or more carbons, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzate, maltitol, isomalt, erythritol, lactitol, and the like, alone or in combination.

[0242] As used herein, the term "flavor" is to be understood as having its ordinary meaning within the art. Flavors include both liquid and powdered flavors. Thus, flavors do not include sweeteners (such as sugars, sugar alcohols, and high intensity sweeteners) or acids providing pure sourness / acid taste, nor do they include compounds providing pure saltiness (e.g., NaCl) or pure bitterness, of course. Flavor enhancers include substances that provide only saltiness, bitterness, or sourness. Flavor enhancers thus include, for example, sodium chloride, citric acid, ammonium chloride, and the like.

[0243] The flavoring agent can be a natural or synthetic flavoring agent.

[0244] In one embodiment of the present application, the pouch composition comprises a flavoring agent. The flavoring agent can generally be present in an amount between 0.01 and 15 wt.% of the total composition of the pouch, such as between 0.01 and 5 wt.% of the total composition.

[0245] Non-exhaustive examples of flavoring agents suitable for use in embodiments of the present application are coconut, coffee, chocolate, vanilla, grapefruit, orange, lime, menthol, licorice, caramel, honey, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint fruit essential oils, such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essential oils. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the aforementioned fruits.

[0246] As used herein, the term "pH adjusting agent" refers to agents that actively regulate and adjust the pH of a solution to which they have been or will be added. Thus, pH adjusting agents can be acids and bases, including acidic and basic buffers. On the other hand, pH adjusting agents do not include substances and compositions that affect pH only by dilution. Furthermore, pH adjusting agents do not include, for example, flavoring agents, fillers, and the like.

[0247] According to one embodiment of the present application, the enhancer comprises one or more pH adjusting agents, such as buffers.

[0248] In one embodiment of the present application, the pH adjusting agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-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, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0249] Generally, the pouch comprises an opening, wherein the characteristic opening size is adapted to the characteristic size of the substrate composition in order to retain the substrate composition within the pouch prior to use and / or to retain a portion of the substrate composition, such as a water-insoluble composition, within the pouch during use.

[0250] In order to obtain a pouch having a suitable opening size in view of the substrate composition to be used, the material of the pouch can be selected accordingly, for example including, for example, woven and / or non-woven fabrics.

[0251] In other words, according to various embodiments, the pouch forms a membrane that allows saliva to pass through and prevents or inhibits passage of the substrate composition. The membrane of the pouch can be any suitable material, such as a woven or nonwoven fabric (e.g., cotton, pile fabric, etc.), a heat-sealable nonwoven cellulosic or other polymeric material, such as a synthetic, semi-synthetic, or natural polymeric material. One example of a suitable pouch material is paper made from pulp and a small amount of wet strength agent. The material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from leaving the pouch or bag during use. Suitable materials are also those that do not have a significant effect on the release of nicotine from the pouch.

[0252] The pouch composition is filled into the pouch and held in the pouch by a seal. The ideal pouch is chemically and physically stable, it is pharmaceutically acceptable, it is insoluble in water, it is easy to fill with powder and seal, and it provides a semi-permeable membrane layer that prevents the powder from leaving the pouch but allows saliva and dissolved components from the pouch composition, such as nicotine, that are small enough to pass through the pouch.

[0253] The pouch can be placed in the oral cavity by the user. Saliva then enters the pouch, the nicotine and other components that are soluble in saliva begin to dissolve and pass out of the pouch with the saliva into the oral cavity where the nicotine can be absorbed.

[0254] Example

[0255] Example 1A - Preparation of a pouch designed for administration of nicotine

[0256] The material of the pouch is a heat-sealable nonwoven cellulosic, such as a long fiber paper. Pouches that are not in the form of a nonwoven cellulosic fabric can also be used according to the invention.

[0257] The powder is filled into the pouch and held in the pouch by a seal.

[0258] Example 1B - Preparation of a pouch designed for administration of nicotine

[0259] The material of the pouch is manufactured using rayon fibers, such as viscose rayon. The pouch film is heat sealed along its edges, except for an opening in one end into the interior cavity formed by the pouch film.

[0260] The powder is filled into the pouch and held in the pouch by a seal.

[0261] Example 2: Preparation of a nicotine premix

[0262] A 60 liter planetary Bear Varimixer mixer was charged with water and the nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. The ion exchange resin was then weighed and added IRP64 and added to the mixer. The mixer was turned off and stirred at high speed for 5 minutes, turned on and scraped down if necessary. The mixer was finally stirred at high speed for a further 5 minutes. The total processing time was 20 minutes.

[0263] Thus, a mixture of nicotine and cation exchange resin is produced from the constituent ingredients set out in the table below.

[0264] Premix I:

[0265] Ingredients Amount (kg) Amount (%) Nicotine Water Resin 1.0 5.7 Total 12.5 71.4 Ingredients Amount (kg) Amount (%) 4.0 22.9 Nicotine 17.5 100.0

[0266] Table 1. Ingredients used to make nicotine premix I (5.7% nicotine). % water in resulting nicotine-resin composition: 71.4

[0267] Premix II:

[0268]

[0269]

[0270] Table 2. Ingredients used to make nicotine premix II (13.2% nicotine).

[0271] % water in resulting nicotine-resin composition: 34.1.

[0272] Premix III:

[0273] Water Resin Total Ingredients Amount (kg) Amount (%) 1.08 18.5 Nicotine 0.44 7.5 Water 4.32 74.0 Resin 5.84 100.0

[0274] Table 3. Ingredients used to make nicotine premix III (18.5% nicotine). % water in resulting nicotine-resin composition: 7.5.

[0275] Premix IV:

[0276] Total Ingredients Amount (kg) Amount (%) Nicotine Water 1.08 10.0 Resin 5.40 50.0 Total 4.32 40.0 Ingredients Amount (kg) Amount (%) 10.8 100.0

[0277] Table 4. Ingredients used to make nicotine premix IV (10% nicotine). % water in resulting nicotine-resin composition: 50.0.

[0278] Premix V:

[0279] Nicotine Water Resin Total 1.78 20.0 Ingredients Amount (kg) Amount (%) 2.80 31.5 Nicotine 4.32 48.5 Water 8.90 100.0

[0280] Table 5. Ingredients used to make nicotine premix V (20% nicotine). % water in resulting nicotine-resin composition: 31.5.

[0281] Premix VI:

[0282]

[0283]

[0284] Table 6. Ingredients for making nicotine premix VI (30% nicotine). % water in resulting nicotine-resin composition: 27.5.

[0285] Premix VII

[0286] Resin Total Ingredients Amount (kg) Amount (%) Nicotine 3.83 35.0 Water 2.80 25.6 Resin 4.32 39.4 Total 10.95 100.0

[0287] Table 7. Ingredients for making nicotine premix VII (35% nicotine). % water in resulting nicotine-resin composition: 25.6.

[0288] Premix VIII:

[0289] Ingredients Amount (kg) Amount (%) Nicotine Water Resin 5.15 42.0 Total 2.80 22.8 ​ 4.32 35.2 ​ 12.27 100.0

[0290] Table 8. Ingredients for making nicotine premix VIII (42% nicotine). % water in resulting nicotine-resin composition: 22.8.

[0291] Example 3: Preparation of pouch compositions

[0292] Pouches containing the powdered compositions as listed in Tables 9-21 were prepared. Pouches were prepared as follows.

[0293] The fibers and water were mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were subsequently added under continuous mixing: first the nicotine (mixed for 2 minutes), then the remaining ingredients except for the liquid flavorant and the flow agent (if any) (mixed for 2 minutes), then the liquid flavorant (if any) (mixed for 1 minute), then the flow agent (if any) (mixed for 1 minute). The total mixing time was 9-11 minutes.

[0294] Example 4: Preparation of filled pouches

[0295] The final pouch compositions were filled into pouches (target fill weight was 500 mg of powder per pouch). The pouch material of Example 1A or 1B can be used. The powder was filled into the pouches and held in the pouches by sealing.

[0296] Example 5A: Pouches

[0297] The pouch compositions were prepared from the ingredients in Table 9 using the preparation method described in Example 3.

[0298] The pouch compositions were filled into pouches as described in Example 4 (using the pouch material of Example 1A, but 1B can also be applied).

[0299]

[0300] Table 9: Bag composition.

[0301] Bag content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0302] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0303] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0304] As an example, menthol and / or peppermint can be used as a flavouring agent. Other flavouring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavouring agent can be liquid or flavouring or a combination, i.e. both a liquid flavouring and a powdered flavouring is added.

[0305] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0306] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0307] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0308] Example 5B: Bag

[0309] The bag composition is prepared from the ingredients in Table 10 using the preparation method described in Example 3.

[0310] The bag composition is filled into a bag as described in Example 4 (using the bag material of Example 1A, but also applicable 1B).

[0311]

[0312] Table 10:

[0313] Bag content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0314] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0315] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0316] As an example, menthol and / or peppermint can be used as flavoring agents. Other flavoring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e. both a liquid flavoring agent and a powdered flavoring agent are added.

[0317] As an example, acesulfame potassium and / or sucralose can be used as high intensity sweeteners. Other useful high intensity sweeteners as described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0318] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0319] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0320] Example 5C: Pouch

[0321] The pouch composition is prepared from the ingredients in Table 11 using the preparation method described in Example 3.

[0322] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but also applicable 1B).

[0323]

[0324]

[0325] Table 11: Pouch composition.

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

[0327] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0328] Sodium carbonate is used as the alkaline buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0329] Flavoring agents, for example, a mixture of menthol and peppermint can be used. Of course, other flavoring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0330] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0331] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0332] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0333] Example 5D: Pouch

[0334] The pouch composition is prepared from the ingredients in Table 12 using the preparation method described in Example 3.

[0335] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but 1B can also apply).

[0336]

[0337]

[0338] Table 12: Pouch Composition.

[0339] Pouch contents: 500 mg total.

[0340] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0341] Sodium carbonate is used as the alkaline buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0342] Flavoring agents, for example, a mixture of menthol and peppermint can be used. Of course, other flavoring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0343] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0344] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0345] Example 5E: Pouch

[0346] The pouch composition is prepared from the ingredients in Table 13 using the preparation method described in Example 3.

[0347] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but 1B can also be applied).

[0348]

[0349] Table 13: Pouch Composition.

[0350] Pouch contents: 500 mg total.

[0351] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0352] Sodium carbonate is used as the alkaline buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0353] Flavorants, for example, a mixture of menthol and peppermint can be used. Of course, other flavorants as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavorant can be liquid or flavored or a combination, i.e., both a liquid flavorant and a powdered flavorant are added.

[0354] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0355] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0356] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0357] Example 5F: Pouch

[0358] The pouch composition is prepared from the ingredients in Table 14 using the preparation method described in Example 3.

[0359] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0360]

[0361]

[0362] Table 14: Pouch Composition.

[0363] Pouch contents: 500 mg total, i.e., nicotine concentration 19.2 mg / g.

[0364] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0365] Sodium carbonate is used as the alkaline buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0366] Flavorants, for example, a mixture of menthol and peppermint can be used. Of course, other flavorants as described herein can be used in combination with or instead of menthol and / or peppermint. The flavorant can be liquid or flavored or a combination, i.e. both a liquid flavorant and a powdered flavorant are added.

[0367] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can be used in combination with or instead of acesulfame potassium and / or sucralose.

[0368] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with or instead of potassium sorbate.

[0369] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0370] Example 5G: Pouch

[0371] The pouch composition is prepared from the ingredients in Table 15 using the preparation method described in Example 3.

[0372] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but also applicable 1B).

[0373]

[0374]

[0375] Table 15: Pouch composition.

[0376] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0377] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0378] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0379] Flavoring agents, for example, can be a mixture of menthol and peppermint. Of course, other flavoring agents as described herein can also be used in combination with or in place of menthol and / or peppermint. Flavoring agents can be liquid or flavored or a combination thereof; that is, liquid flavoring agents and powdered flavoring agents can be added.

[0380] As an example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other available high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0381] Potassium sorbate is used as a preservative. It can be used in combination with potassium sorbate or as a substitute for potassium sorbate with other preservatives as described herein.

[0382] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0383] Example 5H: Bag

[0384] The bag composition was prepared from the ingredients in Table 16 using the preparation method described in Example 3.

[0385] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but 1B can also be applied).

[0386]

[0387] Table 16: Bag Compositions.

[0388] Bag contents: 500mg total, which is 19.2mg / g nicotine concentration.

[0389] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber.

[0390] Sodium carbonate and optionally sodium bicarbonate are used as alkaline buffers. Other buffers as described herein may also be used in combination with or in place of sodium carbonate.

[0391] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners described herein can be used in combination with or instead of acesulfame potassium and / or sucralose.

[0392] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners described herein can be used in combination with or instead of acesulfame potassium and / or sucralose.

[0393] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with or instead of potassium sorbate.

[0394] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0395] Example 5I: Pouches

[0396] Pouch compositions are prepared from the ingredients in Table 17 using the preparation method described in Example 3.

[0397] Pouch compositions are filled into pouches as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0398]

[0399]

[0400] Table 17: Pouch compositions.

[0401] Pouch contents: 500 mg total, i.e. nicotine concentration 19.2 mg / g.

[0402] Wheat fibre, trade name "Vitacel 600WF plus" or "Vitacel 200WF".

[0403] Oat fibre, trade name "Vitacel HF 600".

[0404] Pea fibre, trade name "Vitacel EF150".

[0405] Other fibres can also be used, such as water insoluble plant fibres such as oat fibre, pea fibre, rice fibre, corn fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, powdered cellulose, cellulose fibre, apple fibre, cocoa fibre, bamboo fibre, bran fibre, and cellulose fibre.

[0406] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0407] As an example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e. both a liquid flavoring agent and a powdered flavoring agent are added.

[0408] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0409] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0410] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0411] Example 5J: Pouches

[0412] The pouch composition is prepared from the ingredients in Table 18 using the preparation method described in Example 3.

[0413] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but also applicable 1B).

[0414]

[0415]

[0416] Table 18: Pouch composition.

[0417] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0418] Wheat fibre, trade name "Vitacel 600WF plus" or "Vitacel 200WF".

[0419] Oat fibre, trade name "Vitacel HF 600".

[0420] Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

[0421] Pea fibre, trade name "Vitacel EF150".

[0422] Other fibers can also be used, such as water insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0423] Sodium carbonate, sodium bicarbonate, and / or tromethamine are used as the alkaline buffering agent. Other buffering agents as described herein can also be used in combination with or instead of sodium carbonate.

[0424] As an example, a mixture of menthol and peppermint can be used as the flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0425] As an example, acesulfame potassium and / or sucralose can be used as the high intensity sweetener. Other useful high intensity sweeteners described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0426] Potassium sorbate is used as the preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0427] Silicon dioxide is used as the glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0428] Example 5K: Pouch

[0429] The pouch composition is prepared from the ingredients in Table 19 using the preparation method described in Example 3.

[0430] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but 1B can also apply).

[0431]

[0432]

[0433] Table 19: Pouch Composition.

[0434] Pouch contents: 500 mg total, i.e., nicotine concentration 19.2 mg / g.

[0435] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0436] Sodium carbonate, sodium bicarbonate and / or tromethamine are used as basic buffering agents. Other buffering agents as described herein can also be used in combination with or instead of sodium carbonate.

[0437] Flavouring agents, for example, a mixture of menthol and peppermint can be used. Of course, other flavouring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavouring agent can be liquid or powdered or a combination, i.e. both a liquid flavouring agent and a powdered flavouring agent are added.

[0438] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0439] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0440] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0441] Example 5L: Pouches

[0442] Pouch compositions were prepared from the ingredients in Table 20 using the preparation method described in Example 3.

[0443] The pouch compositions were filled into pouches as described in Example 4 (using the pouch material of Example 1A, but 1B can also be applied).

[0444]

[0445]

[0446] Table 20: Pouch compositions.

[0447] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0448] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0449] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0450] Flavoring agents, for example, a mixture of menthol and peppermint can be used. Of course, other flavoring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0451] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0452] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0453] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0454] Example 5M: Pouch

[0455] The pouch composition is prepared from the ingredients in Table 21 using the preparation method described in Example 3.

[0456] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but 1B can also apply).

[0457]

[0458]

[0459] Table 21: Pouch Composition.

[0460] Pouch contents: 500 mg total, i.e., nicotine concentration 19.2 mg / g.

[0461] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn 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, and cellulose fiber.

[0462] Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerin, or HPC or as a replacement for sodium alginate, glycerin, or HPC.

[0463] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with sodium carbonate or as a replacement for sodium carbonate.

[0464] As an example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint or as a replacement for menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0465] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as a replacement for acesulfame potassium and / or sucralose.

[0466] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with potassium sorbate or as a replacement for potassium sorbate.

[0467] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0468] Example 6A: Bag Release Experiment (in vitro)

[0469] The release properties of the bag were tested in an in vitro experiment.

[0470] 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 degrees Celsius. One reaction tube was used for each time point.

[0471] The bag was submerged in the buffer of the first reaction tube using a pair of tweezers. After the specified time period, the bag was pinched with the tweezers and gently swirled in the buffer, then removed from the first reaction tube and added to the next reaction tube, which represented the next time point. This procedure was repeated until the desired number of time points were tested.

[0472] The entire release experiment was performed at 37 degrees Celsius. No agitation or shaking was applied during the release experiment.

[0473] The amount of nicotine released was determined by analyzing the buffer samples at different time points using standard HPLC.

[0474] Example 6B: Release experiment performed on pouches P 120-123

[0475] The release experiment was performed as described in Example 6A.

[0476]

[0477] Table 22: shows the percentage of nicotine released from the nicotine pouches at different time points with and without CaCI2 and with or without alginate.

[0478] Evaluation: The results show that the nicotine release from pouches not containing sodium alginate is increased.

[0479] In addition, the results show that the presence of CaCI2 increases the release of nicotine from the pouches. The presence of CaCI2 both increases the initial release rate and seems to increase the effective release of nicotine.

[0480] Furthermore, the results show that increasing the nicotine content of the premix also increases the release of nicotine from the pouches.

[0481] Example 7A: Weight loss over time

[0482] Pouch compositions with different humectants (comparative formulations) and without humectant were prepared and placed directly in open containers at 25 degrees Celsius and 60% RH (relative humidity).

[0483]

[0484] Table 23: shows the relative weight loss in % from the comparative pouch compositions with different humectants and from the pouch composition without humectant.

[0485] Evaluation: The results show that the weight loss from pouch compositions comprising a humectant selected from alginate, glycerol and hydroxypropyl cellulose is higher.

[0486] Example 8A: User evaluation.

[0487] The pouches of the invention produced were evaluated and found to be highly suitable as delivery vehicles for nicotine as they provide good nicotine release while being pleasant for the user, e.g. in terms of desired mouthfeel such as moistness and malleable structure and desired taste.

[0488] Example 8B: User evaluation.

[0489] The test panel consisting of 4 trained assessors evaluated the pouches. Each assessor evaluated all samples twice. The test panel evaluated the pouches for 2 different parameters: overall taste and sweetness intensity, in 15 minutes.

[0490] Pouches with two different flavorings were tested.

[0491] Pouch P117-1 corresponds to P117 with lemon and orange flavoring.

[0492] P117-C1 was used for comparison, which is based on P117, but has 2.0% alginate, 10.0% flavoring (lemon and orange) and wherein the content of erythritol is adjusted to 100% in total.

[0493] Pouch P117-2 corresponds to P117 with raspberry and liquorice flavoring.

[0494] P117-C2 was used for comparison, which is based on P117, but has 2.0% alginate, 10.0% flavoring (raspberry and liquorice) and wherein the content of erythritol is adjusted to 100% in total.

[0495]

[0496] Table 24.

[0497] Evaluation: The test panel found that pouches P117-1 and P117-2, which did not contain alginate and had a lower amount of flavoring, scored similar or even higher in overall taste and sweetness intensity during the test session, compared to pouches P117-C1 and P117-C2, which contained alginate and had a higher amount of flavoring.

[0498] Surprisingly, it was found that pouches P117-1 and P117-2 of the application scored higher in overall taste and sweetness during the initial time of use (i.e. within 5 minutes of use). In addition, it was found that pouches P117-1 and P117-2 of the application scored similar or higher during 5 to 15 minutes of use, despite the lower amount of flavoring in the pouches P117-1 and P117-2 of the application that were tested.

Claims

1. A non-tobacco oral nicotine pouch composition, the pouch composition comprising water in an amount of at least 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, and at least one sugar alcohol in an amount of 10% to 50% by weight of the pouch composition, wherein the at least one sugar alcohol comprises a non-directly compressible grade sugar alcohol, wherein the pouch composition is free of a humectant consisting of any one or more of alginate, propylene glycol, hydroxypropyl cellulose, or glycerol, and wherein the pouch composition comprises at least one water insoluble fiber in an amount of 10% to 45% by weight of the pouch composition, wherein the at least one water insoluble fiber is selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose that is not chemically modified, and combinations thereof.

2. The non-tobacco oral nicotine pouch composition of claim 1, wherein the pouch composition is further free of a humectant consisting of modified starch, triacetin, polyethylene glycol, pectin, and xanthan gum.

3. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition comprises 0-0.4% by weight of a humectant.

4. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition is free of a humectant.

5. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition comprises the at least one sugar alcohol in an amount of at least 15% by weight of the composition.

6. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the at least one sugar alcohol comprises a non-directly compressible grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

7. The non-tobacco oral nicotine pouch composition of claim 6, wherein the non-directly compressible grade sugar alcohol is provided in a granulate that has not been subjected to a granulation or an agglomeration step.

8. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition comprises nicotine in an amount of at least 0.2% by weight of the pouch composition.

9. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition comprises nicotine selected from the group consisting of nicotine salts, nicotine free base, nicotine-ion exchange resin combinations, nicotine-inclusion complexes, nicotine bound to zeolites, nicotine bound to cellulose, and mixtures thereof.

10. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition comprises nicotine-ion exchange resin combinations in an amount of 0.1 to 20% by weight of the pouch composition.

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

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

13. The non-tobacco oral nicotine pouch composition of claim 10, wherein the nicotine- ion exchange resin combination comprises nicotine in an amount between 5 and 50% by weight.

14. The non-tobacco oral nicotine pouch composition of claim 10, wherein the ion exchange resin comprises one or more resins selected from the group consisting of: (i) a methacrylic weakly acidic type resin containing carboxylic functional groups, (ii) a copolymer of methacrylic acid and divinylbenzene containing carboxylic functional groups, (iii) a polystyrene strongly acidic type resin containing sulfonic functional groups, (iv) a polystyrene moderately acidic type resin containing phosphoric functional groups, and (v) combinations thereof.

15. The non-tobacco oral nicotine pouch composition of claim 10, wherein the ion exchange resin comprises polacrilex resin.

16. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition comprises water in an amount of 20-40% by weight of the composition.

17. The non-tobacco oral nicotine pouch composition of claim 1 or 2, wherein the pouch composition comprises a pH adjusting agent.

18. An oral pouch nicotine product, the product comprising a saliva permeable pouch and the pouch composition of any one of claims 1 to 17 enclosed in the pouch.

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