Pouch containing cross-linked alginate

Abstract

An oral nicotine pouch composition is disclosed, comprising nicotine, water in an amount of at least 5% by weight of the pouch composition, an alginate, an inorganic divalent cation, and at least one pH adjusting agent comprising an inorganic phosphate. An oral nicotine pouch composition comprising an inorganic polyvalent cation and a pouch product is also disclosed.

Description

Technical Field

[0001] The present invention relates to an oral nicotine pouch composition as described in the claims and a nicotine pouch product as described in the claims.

Background Art

[0002] In recent years, various nicotine products with reduced tobacco content or without tobacco have also become available in the field of pouch products or pouches.

[0003] However, for pouch products, it is still desired to provide an improved experience to users by releasing nicotine faster and alleviating cravings faster, while at the same time providing a desirable user experience.

Summary of the Invention

[0004] The present invention relates to an oral nicotine pouch composition comprising nicotine, water in an amount of at least 5% by weight of the pouch composition, alginate, an inorganic divalent cation, and at least one pH regulator comprising an inorganic phosphate.

[0005] An advantage of the present invention may be to increase the user's pH value and promote effective nicotine uptake by using a pH regulator containing an inorganic phosphate. At the same time, off-notes associated with other pH regulators can be reduced, so there is a possibility of improving the taste. In combination with the use of alginate, which facilitates maintaining a moisture content above a certain level to provide a desirable mouthfeel, the pouch composition can be desirable for users for an improved mouthfeel and also provide effective craving relief.

[0006] Surprisingly, the inventors have found that a considerable improvement in processability can be obtained while retaining the above advantages. Typically, the use of water in a pouch composition can lead to clumping and deterioration of flow properties, potentially resulting in undesirable properties in terms of processability. Surprisingly, the present invention provides improved processability while retaining the advantages associated with the use of water and alginate in the pouch composition.

[0007] In this context, it should be noted that the term "inorganic divalent cation" refers to a single type of divalent cation or a mixture of two or more types of divalent cations. For example, two different types of divalent cations may be provided as salts with the same or different counterions, for example, as a combination of calcium chloride and magnesium chloride, or as a combination of calcium chloride and magnesium bromide. Alternatively, the same type of inorganic divalent cation may be provided as two or more different salts, i.e., salts having two or more different counterions, for example, as calcium chloride and calcium bromide.

[0008] In this context, the term "phosphate" refers to monophosphates, polyphosphates, such as pyrophosphates (also known as diphosphates), triphosphates, tetraphosphates, and any combination thereof. For example, when referring to a specific salt such as a sodium salt, such a reference refers to any sodium salt of that particular phosphate; for example, sodium pyrophosphate also refers to tetrasodium pyrophosphate.

[0009] In this context, the term "alginate" refers to the ionic form of alginate, such as the salt form, as well as alginic acid.

[0010] According to an advantageous embodiment of the present invention, the phosphate comprises at least two different phosphates.

[0011] According to embodiments of the present invention, the phosphate consists of a single phosphate.

[0012] According to an advantageous embodiment of the present invention, the phosphate comprises a monophosphate.

[0013] According to an advantageous embodiment of the present invention, the phosphate includes polyphosphates such as pyrophosphates.

[0014] According to an advantageous embodiment of the present invention, the phosphate includes a combination of a monophosphate and a polyphosphate such as a pyrophosphate.

[0015] In embodiments of the present invention, the phosphate is a combination of a monophosphate and a polyphosphate such as a pyrophosphate.

[0016] According to an advantageous embodiment of the present invention, the phosphate includes phosphates provided as salts with alkali metals such as sodium or potassium.

[0017] In embodiments of the present invention, the phosphate is provided as a salt with an alkali metal.

[0018] According to embodiments of the present invention, the phosphate includes phosphates provided as salts with sodium.

[0019] According to an advantageous embodiment of the present invention, the phosphate is provided as a salt with sodium.

[0020] According to an advantageous embodiment of the present invention, the phosphate comprises monosodium phosphate.

[0021] According to an advantageous embodiment of the present invention, the phosphate comprises disodium phosphate.

[0022] According to an advantageous embodiment of the present invention, the phosphate includes trisodium phosphate.

[0023] According to an advantageous embodiment of the present invention, the phosphate comprises monosodium diphosphate.

[0024] According to an advantageous embodiment of the present invention, the phosphate contains disodium diphosphate.

[0025] According to an advantageous embodiment of the present invention, the phosphate contains trisodium diphosphate.

[0026] According to an advantageous embodiment of the present invention, the phosphate contains tetrasodium diphosphate.

[0027] In a preferred embodiment of the present invention, the phosphate is anhydrous.

[0028] In an embodiment of the present invention, the phosphate contains a hydrated phosphate, that is, the phosphate contains crystal water of hydration.

[0029] According to an embodiment of the present invention, the phosphate contains a phosphate provided as a salt with potassium.

[0030] According to an advantageous embodiment of the present invention, the phosphate is provided as a salt with potassium.

[0031] In an embodiment of the present invention, the phosphate is provided as a water-soluble salt having a water solubility of at least 5 grams per 100 mL of water, for example, 5 to 500 grams per 100 mL of water, measured at 25 °C, atmospheric pressure, and pH 7.0.

[0032] According to an advantageous embodiment of the present invention, the phosphate is provided as a salt in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.2% by weight of the pouch composition, for example, at least 0.5% by weight of the pouch composition, for example, at least 1.0% by weight of the pouch composition.

[0033] In an embodiment of the present invention, the phosphate is provided as a salt in an amount of 7.0% by weight or less of the pouch composition, for example, 5.0% by weight or less of the pouch composition, for example, 4.5% by weight or less of the pouch composition, for example, 3.0% by weight or less of the pouch composition, for example, 2.0% by weight or less of the pouch composition.

[0034] In embodiments of the present invention, the phosphate is provided as a salt in an amount of 0.1 to 7.0% by weight of the pouch composition, for example, 0.1 to 5.0% by weight of the pouch composition, for example, 0.2 to 4.5% by weight of the pouch composition, for example, 0.5 to 3.0% by weight of the pouch composition, for example, 1.0 to 2.0% by weight of the pouch composition.

[0035] According to an advantageous embodiment of the present invention, the pouch composition contains alginate in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.2% by weight of the pouch composition, for example, at least 0.3% by weight of the pouch composition, for example, at least 0.4% by weight of the pouch composition.

[0036] In this context, please understand that the amount of alginate refers to the amount (weight) of alginate compounds, i.e., the alginate ions that have their counterions.

[0037] In embodiments of the present invention, the pouch composition contains alginate in an amount of 5.0% by weight or less of the pouch composition, for example, 3.0% by weight or less of the pouch composition, for example, 2.0% by weight or less of the pouch composition, for example, 1.5% by weight or less of the pouch composition, for example, 1.0% by weight or less of the pouch composition.

[0038] In embodiments of the present invention, the pouch composition contains alginate in an amount of 0.1 to 5.0% by weight of the pouch composition, for example, 0.1 to 3.0% by weight of the pouch composition, for example, 0.2 to 2.0% by weight of the pouch composition, for example, 0.3 to 1.5% by weight of the pouch composition, for example, 0.4 to 1.0% by weight of the pouch composition.

[0039] According to an advantageous embodiment of the present invention, the alginate is provided as a salt of an ion selected from the group consisting of alkali metal alginates, such as sodium alginate, potassium alginate, or any combination thereof.

[0040] In embodiments of the present invention, the alginate includes alginates selected from the group consisting of sodium alginate, potassium alginate, and any combination thereof.

[0041] In embodiments of the present invention, the alginate is selected from the group consisting of sodium alginate, potassium alginate, and any combination thereof.

[0042] In embodiments of the present invention, the alginate includes sodium alginate.

[0043] In embodiments of the present invention, the alginate is sodium alginate.

[0044] In embodiments of the present invention, the alginate includes potassium alginate.

[0045] In embodiments of the present invention, the alginate is potassium alginate.

[0046] According to an advantageous embodiment of the present invention, the inorganic divalent cation is selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.

[0047] According to an advantageous embodiment of the present invention, the inorganic divalent cation is selected from the group consisting of divalent cations of calcium, magnesium, and any combination thereof.

[0048] According to an advantageous embodiment of the present invention, the inorganic divalent cation includes a calcium ion.

[0049] In embodiments of the present invention, the inorganic divalent cation consists of a calcium ion.

[0050] According to an advantageous embodiment of the present invention, the inorganic divalent cation includes a magnesium ion.

[0051] In embodiments of the present invention, the inorganic divalent cation consists of a magnesium ion.

[0052] According to embodiments of the present invention, the divalent cation is provided as a salt.

[0053] According to an advantageous embodiment of the present invention, the divalent cation is provided as a water-soluble salt having a water solubility of at least 5 grams per 100 mL of water, as measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0054] Therefore, in this context, the term "water-soluble salt" refers to a salt that is water-soluble at a concentration of at least 5 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0055] In embodiments of the present invention, the divalent cation is provided as a water-soluble salt having a water solubility of 5 to 500 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0, for example, 5 to 350 grams per 100 mL of water.

[0056] According to an advantageous embodiment of the present invention, the inorganic divalent cation is provided as a salt comprising an anion selected from the group consisting of carboxylate salts, e.g., acetate, lactate, oxalate, propionate, or levulinate; organic sulfonate; organic sulfate; organic phosphate; chloride, bromide, nitrate, sulfate, hydrogen phosphate, oxide, and any combination thereof.

[0057] According to an advantageous embodiment of the present invention, the inorganic divalent cation is provided as an inorganic salt.

[0058] According to an advantageous embodiment of the present invention, the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chlorides, bromides, nitrates, sulfates, bicarbonates, hydrogen phosphates, oxides, hydroxides, and any combination thereof.

[0059] According to an advantageous embodiment of the present invention, the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chlorides, bromides, bicarbonates, sulfates, and any combination thereof.

[0060] According to an advantageous embodiment of the present invention, the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chlorides, bromides, sulfates, and any combination thereof.

[0061] According to an advantageous embodiment of the present invention, the divalent cation is provided as an inorganic salt having a chloride.

[0062] According to an advantageous embodiment of the present invention, the divalent cation is provided as an inorganic salt having a bromide.

[0063] According to an advantageous embodiment of the present invention, the divalent cation is provided as an inorganic salt with a sulfate.

[0064] According to an advantageous embodiment of the present invention, the divalent cation is selected from the group consisting of calcium chloride, calcium bromide, calcium sulfate, magnesium chloride, magnesium bromide, magnesium sulfate, and any combination thereof.

[0065] According to embodiments of the present invention, the divalent cation includes a divalent cation provided as calcium chloride.

[0066] According to embodiments of the present invention, the divalent cation is provided as calcium chloride.

[0067] According to embodiments of the present invention, the divalent cation includes a divalent cation provided as calcium bromide.

[0068] According to embodiments of the present invention, the divalent cation is provided as calcium bromide.

[0069] According to embodiments of the present invention, the divalent cation includes a divalent cation provided as calcium sulfate.

[0070] According to embodiments of the present invention, the divalent cation is provided as calcium sulfate.

[0071] According to an advantageous embodiment of the present invention, the inorganic divalent cation is provided as a salt in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.2% by weight of the pouch composition, for example, at least 0.3% by weight of the pouch composition, for example, at least 0.4% by weight of the pouch composition.

[0072] In embodiments of the present invention, the inorganic divalent cation is provided as a salt in an amount of 5.0% by weight or less of the pouch composition, for example, 3.0% by weight or less of the pouch composition, for example, 2.0% by weight or less of the pouch composition, for example, 1.5% by weight or less of the pouch composition, for example, 1.0% by weight or less of the pouch composition.

[0073] In embodiments of the present invention, the inorganic divalent cation is provided as a salt in an amount of 0.1 to 5.0% by weight of the pouch composition, for example, 0.1 to 3.0% by weight of the pouch composition, for example, 0.2 to 2.0% by weight of the pouch composition, for example, 0.3 to 1.5% by weight of the pouch composition, for example, 0.4 to 1.0% by weight of the pouch composition.

[0074] According to an advantageous embodiment of the present invention, the pouch composition contains the alginate in a weight ratio of 1:2 to 3:1 relative to the amount of divalent cations, for example, 1:1 to 2:1 relative to the amount of divalent cations.

[0075] In the embodiments described above, the amount of alginate refers to alginate, where applicable, and the amount of divalent cation refers to a compound containing a divalent cation.

[0076] According to an advantageous embodiment of the present invention, the pouch composition contains the alginate in a weight ratio of 1:5 to 3:1 relative to the amount of phosphate, for example, 1:3 to 1:1 relative to the amount of phosphate, for example, 1:2 to 2:3 relative to the amount of phosphate.

[0077] According to embodiments of the present invention, the pouch composition contains the alginate in a weight ratio of 1:2 to 3:1 relative to the amount of phosphate, for example, 1:5 to 1:1 relative to the amount of phosphate, for example, 1:3 to 2:3 relative to the amount of phosphate.

[0078] According to embodiments of the present invention, the pouch composition contains the alginate in a weight ratio of 1:5 to 1:1 relative to the amount of phosphate, for example, 1:3 to 2:3 relative to the amount of phosphate.

[0079] In the embodiments described above, the amount of alginate refers to alginate, where applicable, and the amount of phosphate refers to a compound containing phosphate.

[0080] According to an advantageous embodiment of the present invention, the pouch composition contains the divalent cation in a weight ratio of 1:8 to 1:1 relative to the amount of phosphate, for example, 1:4 to 1:2 relative to the amount of phosphate.

[0081] In the above embodiment, the amount of divalent cation refers to the compound containing the divalent cation, and the amount of phosphate refers to the compound containing the phosphate.

[0082] According to an advantageous embodiment of the present invention, at least one pH adjusting agent comprises at least one further pH adjusting agent.

[0083] Therefore, in the above embodiment, the pouch composition comprises a phosphate and at least one further pH adjusting agent.

[0084] According to an advantageous embodiment of the present invention, at least one further pH adjustment includes a buffer, for example, an alkaline buffer.

[0085] In embodiments of the present invention, at least one further pH adjustment comprises a buffer.

[0086] According to an advantageous embodiment of the present invention, at least one further pH adjusting agent is an alkaline pH adjusting agent, such as an alkaline buffer.

[0087] An advantage of the above embodiment may be that it can promote more efficient absorption of nicotine through the oral mucosa.

[0088] According to an advantageous embodiment of the present invention, at least one further pH adjusting agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, magnesium carbonate, potassium bicarbonate, trometamol, or any combination thereof.

[0089] In the context of this invention, the term trometamol refers to (tris(hydroxymethyl)aminomethane), and is sometimes also called Tris buffer.

[0090] According to embodiments of the present invention, the pouch composition contains the further pH adjusting agent in an amount of at least 0.01% by weight of the pouch composition, for example, at least 0.5% by weight of the pouch composition, for example, at least 1% by weight of the pouch composition, for example, at least 2% by weight of the pouch composition, for example, at least 3% by weight of the pouch composition.

[0091] According to embodiments of the present invention, the pouch composition contains the further pH adjusting agent in an amount of 15% by weight or less of the pouch composition, for example, 10% by weight or less of the pouch composition, for example, 8% by weight or less of the pouch composition.

[0092] According to an advantageous embodiment of the present invention, the pouch composition contains the further pH adjusting agent in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.5 to 10% by weight of the pouch composition, for example, 1 to 10% by weight of the pouch composition, for example, 2 to 10% by weight of the pouch composition, for example, 3 to 8% by weight of the pouch composition.

[0093] In embodiments of the present invention, the further pH adjusting agent is water-soluble.

[0094] In embodiments of the present invention, the further pH adjusting agent has a water solubility of at least 5 grams per 100 mL of water, as measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0095] In embodiments of the present invention, the further pH adjusting agent has a water solubility of at least 5 to 500 grams per 100 mL of water, as measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0096] An advantage of the above embodiment may be that the high pH value obtained promotes relatively effective nicotine uptake.

[0097] According to an advantageous embodiment of the present invention, nicotine is selected from the group consisting of nicotine salts, free nicotine bases, nicotine-ion exchange resin combinations, nicotine inclusion complexes, or any non-covalent nicotine; nicotine bound to zeolite, nicotine bound to cellulose such as microcrystalline cellulose, starch microspheres, and mixtures thereof.

[0098] According to an advantageous embodiment of the present invention, the nicotine includes unsalted nicotine.

[0099] In embodiments of the present invention, the nicotine is composed of unsalted nicotine.

[0100] According to an advantageous embodiment of the present invention, nicotine includes nicotine free base.

[0101] In embodiments of the present invention, nicotine includes nicotine free base.

[0102] According to an advantageous embodiment of the present invention, the nicotine comprises nicotine mixed with an ion exchange resin.

[0103] In embodiments of the present invention, the nicotine comprises nicotine mixed with an ion exchange resin.

[0104] According to an advantageous embodiment of the present invention, the nicotine comprises free base nicotine mixed with an ion exchange resin, with a weight ratio of 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.0 between the free base nicotine and the ion exchange resin.

[0105] Therefore, in the embodiments of the present invention, the nicotine comprises free base nicotine mixed with an ion exchange resin, with a weight ratio of 1:10 to 2:1, preferably 1:2 to 2:1, and most preferably about 2:3 to 1:1 between the free base nicotine and the ion exchange resin.

[0106] According to an advantageous embodiment of the present invention, the nicotine comprises nicotine bound to an ion exchange resin.

[0107] In embodiments of the present invention, the nicotine includes nicotine bound to an ion exchange resin. In embodiments of the present invention, the ion exchange resin is (i) Methacrylic weakly acidic resin containing a carboxylic acid functional group, (ii) A copolymer of methacrylic acid and divinylbenzene, wherein the copolymer contains a carboxylic acid functional group, (iii) Polystyrene strongly acidic resin containing sulfonic acid functional groups, (iv) Polystyrene acidic resin containing a phosphonic acid functional group, and (v) comprising one or more resins selected from the group consisting of combinations thereof.

[0108] In embodiments of the present invention, the ion exchange resin includes polarilex resin.

[0109] In embodiments of the present invention, the ion exchange resin is polarilex resin.

[0110] The term NPR can be used as an abbreviation to refer to nicotine complexed with an ion exchange resin, specifically known as Polarcrilex resin.

[0111] According to an advantageous embodiment of the present invention, nicotine includes a nicotine salt.

[0112] In embodiments of the present invention, nicotine includes nicotine salts.

[0113] In embodiments of the present invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, nicotine chloride (e.g., nicotine hydrochloride and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine gensitate, nicotine lactate, nicotine mucoate, nicotine laurate, nicotine levulinate, nicotine malate, nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine zinc chloride, nicotine sulfate, nicotine tosylate, and their hydrates (e.g., nicotine zinc chloride monohydrate).

[0114] According to an advantageous embodiment of the present invention, nicotine comprises nicotine bitartrate.

[0115] The term NBT can be used as an abbreviation for nicotine beetartrate.

[0116] According to embodiments of the present invention, the nicotine salt is composed of nicotine bitartrate.

[0117] According to an advantageous embodiment of the present invention, nicotine includes synthetic nicotine.

[0118] In embodiments of the present invention, nicotine includes synthetic nicotine.

[0119] According to an advantageous embodiment of the present invention, the pouch composition contains nicotine in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.25% by weight of the pouch composition, for example, at least 0.5% by weight of the pouch composition, for example, at least 1.0% by weight of the pouch composition, for example, at least 2.0% by weight of the pouch composition, for example, at least 4.0% by weight of the pouch composition.

[0120] In embodiments of the present invention, the pouch composition contains nicotine in an amount of 15.0% by weight or less of the pouch composition, for example, 10.0% by weight or less of the pouch composition, for example, 8.0% by weight or less of the pouch composition, for example, 5.0% by weight or less of the pouch composition.

[0121] In embodiments of the present invention, the pouch composition contains nicotine in an amount of 0.1 to 15.0% by weight of the pouch composition, for example, 0.25 to 10.0% by weight of the pouch composition, for example, 0.1 to 8.0% by weight of the pouch composition, for example, 2.0 to 5.0% by weight of the pouch composition.

[0122] According to an advantageous embodiment of the present invention, the pouch composition contains a nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition, for example, 1 to 18% by weight of the pouch composition, for example, 5 to 16% by weight of the pouch composition.

[0123] According to an advantageous embodiment of the present invention, the nicotine-ion exchange resin combination comprises nicotine complexed with the ion exchange resin, wherein the nicotine constitutes 5 to 50% by weight of the nicotine-ion exchange resin combination.

[0124] According to an advantageous embodiment of the present invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of 5 to 50% by weight of the nicotine-ion exchange resin combination and ion exchange resin in an amount of 10 to 95% by weight of the nicotine-ion exchange resin combination.

[0125] According to an advantageous embodiment of the present invention, the pouch composition contains water in an amount of at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, for example, at least 20% by weight of the pouch composition.

[0126] An advantage of the above embodiments is that a desirable soft texture for the pouch product may be promoted. Furthermore, the inclusion of a large amount of water may facilitate nicotine release. If the moisture content of the pouch composition is low, the pouch composition may absorb saliva for an undesirably long period, but a sufficiently moistened pouch composition may promote rapid nicotine release.

[0127] An advantage of the above embodiment may be the relatively rapid release of nicotine.

[0128] The advantage of the above embodiment may be a more effective release of nicotine.

[0129] In one embodiment of the present invention, the pouch composition contains water in an amount of 20% by weight or less of the pouch composition, for example, 15% by weight or less of the pouch composition, for example, 10% by weight or less of the pouch composition.

[0130] According to an advantageous embodiment of the present invention, the pouch composition contains water in an amount of 65% by weight or less of the pouch composition, for example, 60% by weight or less of the pouch composition, for example, 50% by weight or less of the pouch composition, for example, 40% by weight or less of the pouch composition.

[0131] According to an advantageous embodiment of the present invention, the pouch composition contains water in an amount of 5 to 65% by weight of the pouch composition, for example, 10 to 65% by weight of the pouch composition, for example, 15 to 60% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition, for example, 20 to 50% by weight of the pouch composition, for example, 20 to 40% by weight of the pouch composition.

[0132] In embodiments of the present invention, the pouch composition contains water in an amount of 15 to 65% by weight of the pouch composition, for example, 20 to 65% by weight of the pouch composition, for example, 25 to 65% by weight of the pouch composition.

[0133] In embodiments of the present invention, the pouch composition contains water in an amount of 15 to 65% by weight of the pouch composition, for example, 15 to 60% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition.

[0134] In embodiments of the present invention, the pouch composition contains water in an amount of 15 to 60% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 15 to 30% by weight of the pouch composition.

[0135] In embodiments of the present invention, the pouch composition contains water in an amount of 15 to 40% by weight of the pouch composition.

[0136] According to an advantageous embodiment of the present invention, the pouch composition comprises at least one sugar alcohol.

[0137] The advantages of the above embodiment may be, for example, that a desirable sweetness is provided while maintaining an appealing texture in order to support the flavor profile.

[0138] According to an advantageous embodiment of the present invention, the at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combination thereof.

[0139] The advantages of the above embodiment may be, for example, that a desirable sweetness is provided while maintaining an appealing texture in order to support the flavor profile.

[0140] Therefore, in the above embodiments, at least one sugar alcohol may include a mixture of different types of sugar alcohols, such as a hydrolyzed starch product mainly comprising maltitol, sorbitol, and a mixture of further sugar alcohols.

[0141] In embodiments of the present invention, the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combination thereof.

[0142] According to an advantageous embodiment of the present invention, the at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combination thereof.

[0143] In embodiments of the present invention, the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combination thereof.

[0144] In particular, the desired texture can be enhanced by using sugar alcohols that have desirable properties with respect to their melting point (for example, solid at an ambient temperature of 25 degrees Celsius).

[0145] In embodiments of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combination thereof, in an amount of at least 1% by weight of the pouch composition, for example, at least 2% by weight of the pouch composition, for example, at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition.

[0146] In embodiments of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combination thereof, in an amount of 1 to 80% by weight of the pouch composition, for example, 2 to 70% by weight of the pouch composition, for example, 5 to 60% by weight of the pouch composition, for example, 10 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 15 to 30% by weight of the pouch composition.

[0147] In embodiments of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combination thereof, in an amount of at least 1% by weight of the pouch composition, for example, at least 2% by weight of the pouch composition, for example, at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition.

[0148] In embodiments of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combination thereof, in an amount of 1 to 80% by weight of the pouch composition, for example, 2 to 70% by weight of the pouch composition, for example, 5 to 60% by weight of the pouch composition, for example, 10 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 15 to 30% by weight of the pouch composition.

[0149] According to an advantageous embodiment of the present invention, the at least one sugar alcohol comprises at least one indirectly compressible (non-DC) grade sugar alcohol.

[0150] According to an advantageous embodiment of the present invention, the pouch composition contains at least one sugar alcohol in an amount of at least 1% by weight of the pouch composition, for example, at least 2% by weight of the pouch composition, for example, at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition.

[0151] According to an advantageous embodiment of the present invention, the pouch composition contains at least one sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 2 to 70% by weight of the pouch composition, for example, 5 to 60% by weight of the pouch composition, for example, 10 to 50% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 15 to 30% by weight of the pouch composition.

[0152] In embodiments of the present invention, the pouch composition contains at least one sugar alcohol in an amount of 5 to 70% by weight of the pouch composition, for example, 10 to 70% by weight of the pouch composition, for example, 15 to 70% by weight of the pouch composition, for example, 20 to 70% by weight of the pouch composition, for example, 20 to 60% by weight of the pouch composition, for example, 20 to 50% by weight of the pouch composition, for example, 20 to 40% by weight of the pouch composition.

[0153] According to an advantageous embodiment of the present invention, the pouch composition comprises water-insoluble fibers.

[0154] In embodiments of the present invention, the water-insoluble fibers include non-tobacco fibers.

[0155] According to an advantageous embodiment of the present invention, the water-insoluble fiber is a plant fiber.

[0156] According to an advantageous embodiment of the present invention, the water-insoluble fiber is a non-tobacco fiber.

[0157] According to an advantageous embodiment of the present invention, the pouch composition contains non-tobacco water-insoluble fibers in an amount of at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, for example, at least 20% by weight of the pouch composition.

[0158] Therefore, the pouch composition of the above embodiment may contain a large amount of non-tobacco water-insoluble fiber, and in such cases, it may be a non-tobacco pouch composition or a low-tobacco pouch composition.

[0159] In embodiments of the present invention, the pouch composition contains non-tobacco water-insoluble fibers in an amount of 60% by weight or less of the pouch composition, for example, 50% by weight or less of the pouch composition, for example, 40% by weight or less of the pouch composition, for example, 40% by weight or less of the pouch composition.

[0160] In embodiments of the present invention, the pouch composition contains non-tobacco water-insoluble fibers in an amount of 5 to 60% by weight of the pouch composition, for example, 10 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 20 to 40% by weight of the pouch composition.

[0161] According to an advantageous embodiment of the present invention, the water-insoluble fibers do not contain tobacco fibers.

[0162] Therefore, in the above embodiments, the water-insoluble fibers do not contain tobacco fibers or tobacco-derived fibers; that is, the water-insoluble fibers are non-tobacco fibers. Nicotine may be derived from tobacco or other sources, but the water-insoluble fibers in the above embodiments do not contain any tobacco fibers.

[0163] According to an advantageous embodiment of the present invention, the pouch composition does not contain tobacco fibers.

[0164] Therefore, in the above embodiments, the pouch composition does not contain tobacco fibers or tobacco-derived fibers. Naturally, nicotine may be derived from tobacco or other sources, but in the above embodiments, the pouch composition does not contain any tobacco fibers.

[0165] According to an advantageous embodiment of the present invention, the pouch composition contains the water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, for example, at least 20% by weight of the pouch composition.

[0166] An advantage of the above embodiment may be that, for example, the water-insoluble fibers have the ability to retain a large amount of water, thereby promoting a desirable texture.

[0167] According to an advantageous embodiment of the present invention, the pouch composition contains the water-insoluble fiber in an amount of 70% by weight or less of the pouch composition, for example, 60% by weight or less of the pouch composition, for example, 45% by weight or less of the pouch composition, for example, 40% by weight or less of the pouch composition.

[0168] According to an advantageous embodiment of the present invention, the pouch composition contains the water-insoluble fiber in an amount of 5 to 70% by weight of the pouch composition, for example, 5 to 60% by weight of the pouch composition, for example, 10 to 45% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 20 to 40% by weight of the pouch composition.

[0169] In embodiments of the present invention, the pouch composition contains the water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 5 to 45% by weight of the pouch composition, for example, 5 to 40% by weight of the pouch composition.

[0170] In embodiments of the present invention, the pouch composition contains the water-insoluble fiber in an amount of 10 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, for example, 10 to 50% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition.

[0171] According to an advantageous embodiment of the present invention, the water-insoluble fiber comprises one or more 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, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and any combination thereof.

[0172] In embodiments of the present invention, 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, apple fiber, cocoa fiber, wheat bran fiber, bamboo fiber, powdered cellulose, and any combination thereof.

[0173] According to an advantageous embodiment of the present invention, the water-insoluble fiber comprises microcrystalline cellulose.

[0174] According to an advantageous embodiment of the present invention, the water-insoluble fiber does not contain microcrystalline cellulose.

[0175] In embodiments of the present invention, the water-insoluble fiber has a water-binding capacity of at least 200%, for example, at least 300%, for example, at least 400%.

[0176] In embodiments of the present invention, the water-insoluble fiber has a water-binding capacity of 200% to 1500%, for example, 300% to 1300%, for example, 200% to 800%, for example, 300% to 800%, for example, 400% to 600%.

[0177] In embodiments of the present invention, the water-insoluble fibers have a density of 50 to 500 grams per liter, for example, 100 to 400 grams per liter, for example, 200 to 300 grams per liter.

[0178] In embodiments of the present invention, the pouch composition contains at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, a water-insoluble fiber 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, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and any combination thereof.

[0179] According to an advantageous embodiment of the present invention, the pouch composition contains tobacco in an amount of 5% by weight or less of the pouch composition, for example, 2% by weight or less of the pouch composition, for example, 1% by weight or less of the pouch composition, for example, 0.5% by weight or less of the pouch composition, for example, 0.1% by weight or less of the pouch composition.

[0180] In embodiments of the present invention, the pouch composition contains tobacco in an amount of 0.001 to 5% by weight of the pouch composition, for example, 0.01 to 5% by weight of the pouch composition, for example, 0.05 to 2% by weight of the pouch composition, for example, 0.1 to 1% by weight of the pouch composition, for example, 0.2 to 0.5% by weight of the pouch composition.

[0181] According to an advantageous embodiment of the present invention, the pouch composition includes a humectant.

[0182] To the extent that the alginate contained in the pouch composition is considered a humectant, the above embodiments refer to further humectants.

[0183] In the embodiment, the humectant is selected from the group consisting of glycerol, propylene glycol, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.

[0184] In embodiments of the present invention, the humectant is selected from the group consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum, or any combination thereof.

[0185] In embodiments of the present invention, the humectant is selected from the group consisting of propylene glycol, hydroxypropyl cellulose, and glycerol, or any combination thereof.

[0186] The advantages of the above embodiment may be that a high nicotine release rate and a desirable mouthfeel, specifically a combination of softness and moistness, can be obtained.

[0187] A further advantage of the above embodiment may be that a desirable flavor perception can be obtained, which is facilitated by an improved flavor release and a combination of desirable mouthfeel, hereafter referred to as softness and moistness.

[0188] The advantages of the above embodiment may include improved nicotine release, improved flavor release, and improved flavor sensation without compromising a smooth mouthfeel.

[0189] In the embodiment, the pouch composition contains a humectant in an amount of 0.1 to 5% by weight of the pouch composition, for example, 0.2 to 5% by weight, or for example, 0.5 to 2% by weight of the pouch composition.

[0190] According to an advantageous embodiment of the present invention, the pouch composition contains a flavoring agent.

[0191] In embodiments of the present invention, the pouch composition contains a flavoring in an amount of at least 0.01% by weight of the pouch composition.

[0192] In embodiments of the present invention, the pouch composition contains a flavoring in an amount of at least 15% by weight of the pouch composition.

[0193] In embodiments of the present invention, the pouch composition contains a flavoring in an amount of at least 0.01 to 15% by weight of the pouch composition.

[0194] In embodiments of the present invention, the flavoring includes a liquid flavoring.

[0195] In embodiments of the present invention, the flavoring agent includes powdered flavoring agents.

[0196] In embodiments of the present invention, the flavorings include liquid flavorings and powdered flavorings.

[0197] According to an advantageous embodiment of the present invention, the pouch composition is a powder composition.

[0198] As used herein, the term "powdered composition" refers to a composition in powder form, i.e., a composition as a particulate material having a relatively small particle size of, for example, 1 to 1200 micrometers. In particular, "powdered composition" does not mean powdered tobacco.

[0199] The present invention further relates to an oral nicotine pouch composition, Nicotine and, At least 5% by weight of water in the pouch composition, Alginate and Inorganic polyvalent cations, The present invention relates to an oral nicotine pouch composition comprising at least one pH adjusting agent containing an inorganic phosphate.

[0200] The above embodiments of the present invention can be combined with any embodiment of the present invention without necessarily including an inorganic divalent cation.

[0201] According to an advantageous embodiment of the present invention, the polyvalent cation is selected from the group consisting of polyvalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, and nickel, for example, Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+, and any combination thereof.

[0202] According to an advantageous embodiment of the present invention, the polyvalent cation is trivalent.

[0203] According to an advantageous embodiment of the present invention, the polyvalent cation is selected from the group consisting of the trivalent cation of aluminum, the divalent cations of calcium, magnesium, iron, and zinc, and any combination thereof.

[0204] According to an advantageous embodiment of the present invention, the polyvalent cation is selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.

[0205] The present invention further relates to a nicotine pouch product comprising a pouch composition according to the present invention or any embodiment thereof, and a saliva-permeable pouch for enclosing the pouch composition.

[0206] According to an advantageous embodiment of the present invention, the pouch product contains an amount of the pouch composition of at least 50 mg, for example, at least 100 mg, for example, at least 150 mg, for example, at least 200 mg, for example, at least 300 mg.

[0207] In embodiments of the present invention, the pouch product contains the pouch composition in an amount of 700 mg or less, for example, 600 mg or less, for example, 500 mg or less, for example, 400 mg or less, for example, 350 mg or less, for example, 300 mg or less, for example, 250 mg or less, for example, 200 mg or less.

[0208] In embodiments of the present invention, the pouch product contains the pouch composition in an amount of 50 to 700 mg, for example, 60 to 600 mg, for example, 75 to 500 mg, for example, 75 to 400 mg, for example, 75 to 350 mg, for example, 100 to 300 mg, for example, 125 to 250 mg, for example, 150 to 200 mg.

[0209] In embodiments of the present invention, the pouch product contains the pouch composition in an amount of 100 to 700 mg, for example, 150 to 600 mg, for example, 200 to 500 mg, for example, 300 to 400 mg.

[0210] According to an advantageous embodiment of the present invention, the pouch product contains at least 1 mg, for example, at least 2 mg, for example, at least 4 mg, for example, at least 6 mg of nicotine.

[0211] In embodiments of the present invention, the pouch product contains nicotine in an amount of 25 mg or less, for example, 20 mg or less, for example, 15 mg or less, for example, 10 mg or less.

[0212] In embodiments of the present invention, the pouch product contains an amount of nicotine ranging from 1 mg to 25 mg, for example, 2 mg to 20 mg, for example, 4 mg to 15 mg, for example, 6 mg to 10 mg. [Modes for carrying out the invention]

[0213] As used herein, the term “pouch composition” refers to a composition for use in an oral pouch, i.e., a pouch for oral use. Therefore, “pouch composition” refers to a composition enclosed within a pouch. Furthermore, the terms “pouch composition,” “nicotine pouch composition,” and “solid oral nicotine formulation” are used interchangeably when referring to a composition enclosed within a pouch.

[0214] As used herein, the term “nicotine” refers to nicotine used as a purified / isolated substance. In particular, nicotine does not refer to tobacco material containing nicotine. Therefore, when referring to the amount of nicotine (also understood as nicotine dose), this amount refers to the amount of pure nicotine.

[0215] Nicotine also includes nicotine that cannot be obtained from tobacco, often called synthetic nicotine.

[0216] As used herein, unless otherwise specified, “ratio” refers to a weight ratio, i.e., the weight of the first component divided by the weight of the second component.

[0217] As used herein, the term “free base nicotine” refers to the unprotonated form of nicotine and therefore does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin. Nevertheless, free base nicotine may be mixed with a certain amount of ion exchange resin or a water-soluble composition such as a sugar alcohol or water-soluble fiber. Free base nicotine includes both free base nicotine extracted from tobacco and free base nicotine produced synthetically, but free base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free base nicotine is provided as a liquid.

[0218] As used herein, the term “pouch” is intended to mean a container typically formed by a web of fibrous material enclosing a cavity. This pouch is designed for the administration of an active ingredient in the oral cavity and is therefore suitable for oral use, non-toxic, and non-water-soluble. The fibrous material may, for example, form a woven or non-woven web or fabric. The pouch may be sealed, for example, by joining two corresponding parts of the web or fabric together along their edges to form a cavity for nicotine and a non-water-soluble composition. To release nicotine, the pouch is made water-permeable so as to allow saliva from the oral cavity to permeate the pouch and enter the oral cavity, and the saliva can come into contact with the nicotine in the oral cavity, thereby releasing the nicotine from the oral pouch.

[0219] As used herein, the term “nicotine-ion exchange resin combination” refers to a combination comprising nicotine complexed with an ion exchange resin and / or free base nicotine mixed with an ion exchange resin.

[0220] As used herein, the term "nicotine complexed with ion exchange resin" refers to nicotine bound to an ion exchange resin.

[0221] In this context, the term “free base nicotine mixed with ion exchange resin” refers to a mixture containing free base nicotine and ion exchange resin. Note that even if some embodiments include a combination of nicotine complexed with ion exchange resin and nicotine in free base form mixed with ion exchange resin, the term “free base nicotine mixed with ion exchange resin” requires the presence of nicotine in free base form. In some embodiments, the mixture is an aqueous mixture. By mixing free base nicotine and water with ion exchange resin, a mixture containing both free base nicotine and ion exchange resin is obtained. Free base nicotine mixed with ion exchange resin is referred to as “premix” in some embodiments.

[0222] As used herein, the term "powdered composition" refers to a composition in powder form, i.e., a composition as a particulate material having a relatively small particle size of, for example, 1 to 1200 micrometers. In particular, "powdered composition" does not mean powdered tobacco.

[0223] As used herein, the term “humectant” is understood to mean a humectant used to keep a pouch moist, i.e., a humectant is added to the pouch composition for the purpose of keeping the pouch moist. Therefore, the term humectant does not refer to substances added for other purposes, and hereafter also refers to hygroscopic substances added for other purposes, such as nicotine-ion exchange resin combinations, for example, sugar alcohols associated with ion exchange resins in nicotine polarilex, water-insoluble fibers, and glycerol. Examples of humectants include propylene glycol, hydroxypropyl cellulose, and glycerol. Note that when glycerol is included as a humectant, it is added as free glycerol and is therefore liquid at room temperature. Further examples of humectants include triacetin, modified starch, pectin, and xanthan gum. The term humectant does not refer to sugar alcohols containing four or more carbon atoms. Furthermore, the term "humectant" does not refer to 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. Also, the term "humectant" does not include, for example, NaCl.

[0224] As used herein, the term “water-soluble” refers to relatively high water solubility, for example, water solubility of more than 5 grams of a water-soluble composition or substance per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0. When referring to a “soluble” composition or substance, unless otherwise specified, it means water-soluble.

[0225] As used herein, the term “water-insoluble” refers to relatively low water solubility, for example, less than 0.1 grams of a composition or substance per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0. When “insoluble” is used, it means water-insoluble unless otherwise specified. Therefore, a composition or substance having water solubility of 0.1 to 5 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0, is considered to have intermediate water solubility, but is neither water-soluble nor water-insoluble.

[0226] The pouch of the present invention provides nicotine release into the oral cavity. A nicotine release profile can be obtained that includes both a rapid-release period and a sustained-release period.

[0227] As used herein, the terms “immediate release” or “immediate release period” may refer to the first two minutes of the nicotine release profile, while the term “sustained release period” refers to the period of the release profile thereafter, until the end of the experiment or end of use.

[0228] As used herein, the term “rapid release rate” refers to the amount of nicotine released per minute within the first two minutes.

[0229] As used herein, the term "effective release" refers to the total release of nicotine over the release or use period of an experiment.

[0230] As used herein, the term “dissolve” refers to the process by which a solid substance enters a solvent (such as saliva in the mouth or water in a pouch) to produce a solution.

[0231] Typically, the pouch includes an opening, and the characteristic dimensions of the opening are adapted to the characteristic dimensions of the matrix composition so as to hold the matrix composition inside the pouch before use and / or to hold a portion of the matrix composition (such as a water-insoluble composition) inside the pouch during use.

[0232] In order to obtain a pouch having suitable opening dimensions considering the matrix composition used, the material of the pouch may be selected accordingly, and may include, for example, woven fabrics and / or nonwoven fabrics.

[0233] In other words, according to various embodiments, the pouch forms a membrane that allows saliva to pass through and prevents or inhibits the passage of the matrix composition. The membrane of the pouch may be any suitable material, such as woven or nonwoven fabrics (e.g., cotton, fleece, etc.), heat-sealable nonwoven cellulose, or other polymer materials such as synthetic, semi-synthetic, or natural polymer materials. An example of a suitable pouch material is paper made from pulp and a small amount of wet-strengthening agent. A suitable material for use must provide a semipermeable membrane layer to prevent the powder or composition from leaking out of the bag or pouch during use. The suitable material also does not significantly affect the release of nicotine from the pouch.

[0234] The pouch composition is filled into a pouch and retained within the pouch by sealing. An ideal pouch is chemically and physically stable, pharmaceutically acceptable, water-insoluble, easy to fill and seal with powder, and provides a semipermeable membrane layer (which prevents the powder from leaking out of the bag but allows saliva and components dissolved in it or suspended in sufficiently small amounts (such as nicotine) to pass through the pouch from the pouch composition).

[0235] The pouch may be placed in the mouth by the user. Saliva then enters the pouch, and the nicotine and other components, which are soluble in saliva, begin to dissolve and are transported from the pouch to the mouth along with the saliva, where the nicotine can be absorbed.

[0236] According to embodiments of the present invention, the pouch composition may further comprise one or more additives.

[0237] In embodiments of the present invention, the additive is selected from the group consisting of bile salts, citrates, cyclodextrins, detergents, fatty acids, labrasols, lecithin, phospholipids, synthetic and natural surfactants, nonionic surfactants, solvents, steroid detergents, solubilizers, pH adjusters, mucolytic or mucolytic agents, membrane permeability enhancers, or any combination thereof. pH adjusters include buffer solutions.

[0238] As used herein, the term "pH adjuster" refers to an agent that actively adjusts and regulates the pH value of a solution to which the agent has been added or to which it is to be added. Therefore, pH adjusters may include acids and bases, including acidic and alkaline buffers. On the other hand, pH adjusters do not include substances and compositions that can only affect pH by dilution. Furthermore, pH adjusters do not include, for example, flavorings, fillers, etc.

[0239] In embodiments of the present invention, the further pH adjusting agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, trometamol, amino acids, or any combination thereof.

[0240] According to various embodiments of the present invention, one or more sugar alcohols may be included in the pouch as part of the pouch composition, for example, as a carrier or part thereof, or as a sweetener. Suitable sugar alcohols include sugar alcohols selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed starch, isomalt, or any combination thereof.

[0241] In embodiments of the present invention, the pouch composition contains a high-intensity sweetener.

[0242] Preferred high-intensity sweeteners include, but are not limited to, sucralose, aspartam, salts of acesulfame (such as acesulfame potassium), alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcone, thaumatin, monellin, and stevioside, either alone or in combination.

[0243] In embodiments of the present invention, the pouch composition contains a bulk sweetener containing sugar and / or a sugar-free component.

[0244] In embodiments of the present invention, the pouch composition comprises a bulk sweetener in an amount of 1.0 to about 80% by weight of the pouch composition, more typically comprising 5 to about 70% by weight of the pouch composition, and more generally comprising 10 to 60% by weight, or 10 to 50% by weight of the pouch composition. The bulk sweetener can function as both a sweetener and a humectant. In some embodiments, the approximate amount of the bulk sweetener can be further limited by including certain components.

[0245] Sweeteners can often support the flavor profile of the pouch composition.

[0246] Sugar sweeteners generally include, but are not limited to, sugar-containing components commonly known in the pouch technology field, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, and galactose, either alone or in combination.

[0247] Sweeteners can be used in combination with sugar-free sweeteners. Generally, sugar-free sweeteners contain components that have sweet properties but lack commonly known sugars, and include, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrolyzed starch, maltitol, isomalt, erythritol, and lactitol, either alone or in combination.

[0248] As used herein, the term “flavoring” is understood to have the ordinary meaning of the term in the art. Flavorings include liquid and powder flavorings. Therefore, flavorings do not include sweeteners (such as sugars, sugar alcohols, and high-intensity sweeteners), or acids that provide pure acidity / sourness, nor compounds that provide pure saltiness (e.g., NaCl) or pure bitterness. Flavor enhancers include substances that provide only saltiness, bitterness, or sourness. Therefore, flavor enhancers include, for example, NaCl, citric acid, and ammonium chloride. Flavorings may be natural or synthetic flavorings.

[0249] In embodiments of the present invention, the pouch composition contains a flavoring agent. The flavoring agent may typically be present in an amount of 0.01 to 15% by weight of the total composition of the pouch, for example, 0.01 to 5% by weight of the total composition.

[0250] Non-exclusive examples of flavorings suitable for embodiments of the present invention include 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 essences (from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essences). Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay leaf oil, anise, thyme, cedar leaf oil, nutmeg, and the oils of the aforementioned fruits.

[0251] In various embodiments of the present invention, the pouch composition includes a composition modifier. The composition modifier may be added to manipulate the properties of the pouch composition and / or some of its properties, such as fluidity, texture, and homogeneity.

[0252] The composition modifier can be selected from the group consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycol, polyoxyethylene monostearate, animal fats, silicates, silicon dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides, and mixtures thereof, according to various embodiments. In particular, metal stearates such as magnesium stearate may be advantageous.

[0253] Composition modifiers can be added to pouch compositions in various ways.

[0254] For example, a composition modifier may be added by mixing the entire powder during the last few minutes of the final mixing.

[0255] Alternatively, the composition modifier may be added to the granulation premix after the granulation process.

[0256] Composition modifiers such as magnesium stearate may have a sealing effect and can be used to control nicotine release and pouch solubility.

[0257] According to embodiments of the present invention, the pouch composition contains polyvinylpyrrolidone (PVP). The pouch composition may also not contain PVP.

[0258] One advantage of the above embodiment may be that a more uniform composition can be obtained. [Examples]

[0259] Example 1A - Preparation of a pouch designed for nicotine administration The pouch material is a heat-sealable nonwoven cellulose, such as long-fiber paper. Pouches other than those in the form of nonwoven cellulose cloth can also be used according to the present invention.

[0260] The powder is filled into a pouch and sealed to maintain its position within the pouch.

[0261] Example 1B - Preparation of a pouch designed for nicotine administration The pouch material is manufactured using rayon fibers, such as viscose rayon short fibers. The pouch membrane is heat-sealed along its edges, except for an opening at one end, and the pouch membrane forms an inner cavity.

[0262] The powder is filled into a pouch and sealed to maintain its position within the pouch.

[0263] Example 2: Preparation of Nicotine Premix Water was added to a 60-liter Planetary Bear Varimixer mixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, Amberlite® IRP64 ion exchange resin was weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, opening and scraping as needed. Finally, the mixer was stirred at high speed for another 5 minutes. The total process time was 20 minutes.

[0264] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in the table below.

[0265] [Table 1]

[0266] [Table 2] Water content (%) in the resulting nicotine-resin composition: 34.1%.

[0267] [Table 3]

[0268] [Table 4]

[0269] [Table 5]

[0270] [Table 6]

[0271] [Table 7]

[0272] [Table 8]

[0273] Example 3: Preparation of pouch composition Prepare pouches containing the powder compositions outlined in Tables 9-21. Prepare the pouches as follows:

[0274] The fiber and water were mixed for 5 minutes using a Planetary Bear Varimixer mixer. Then, under continuous mixing, the following ingredients were added sequentially: first, nicotine (mixed for 2 minutes), then the remaining ingredients except for (if present) liquid flavoring and flow accelerator (mixed for 2 minutes), then (if present) liquid flavoring (mixed for 1 minute), and then (if present) flow accelerator (mixed for 1 minute). The total mixing time was 9-11 minutes.

[0275] In the case of a pouch composition that contains no water or only a small amount of water, the pouch composition may be prepared as follows:

[0276] Mix the fibers and other dry ingredients using a planetary Bear Varimixer for 5 minutes. Then, under continuous mixing, the following ingredients are added sequentially: first, nicotine (mixed for 2 minutes), then the remaining liquid ingredients (excluding liquid flavoring and flow promoter if present) (mixed for 2 minutes), then the liquid flavoring (if present) (mixed for 1 minute), and then the flow promoter (if present) (mixed for 1 minute). The total mixing time is 9 - 11 minutes.

[0277] Example 4: Preparation of Filled Pouches Fill the final pouch composition into pouches (powder with a target filling weight of 500 mg per pouch). The pouch material of Example 1A or 1B may be used. The powder is filled into the pouches and maintained inside the pouches by sealing.

[0278] Example 5A: Pouches Prepare the pouch composition from the ingredients in Table 9 using the preparation method described in Example 3.

[0279] Fill the pouch composition into pouches as described in Example 4 (using the pouch material of Example 1A, although 1B could also be applied).

[0280] [Table 9]

[0281] Pouch content volume: 500 mg in total. Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-insoluble plant fibers, such as crow wheat fiber, pea fiber, rice fiber, corn fiber, crow wheat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber can also be used similarly.

[0282] Sodium carbonate is used as an alkaline buffer in combination with phosphate buffer. Other buffers described herein may also be used in combination with sodium carbonate or its substitutes.

[0283] A phosphate buffer may consist of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, or sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[0284] As an example of a flavoring, a mixture of menthol and peppermint may be used. Of course, other flavorings described herein may also be used in combination with or in place of menthol and / or peppermint. The flavorings may be liquid, flavored, or in combination (i.e., liquid and powdered flavorings may be added).

[0285] As an example, acesulfame potassium and / or sucralose may be used as a high-intensity sweetener. Other usable high-intensity sweeteners described herein may be used in combination with or as substitutes for acesulfame potassium and / or sucralose.

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

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

[0288] Example 5B: Pouch

[0289] [Table 10]

[0290] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber may also be used.

[0291] Sodium carbonate is used as an alkaline buffer in combination with phosphate buffer. Other buffers described herein may also be used in combination with sodium carbonate or its substitutes.

[0292] A phosphate buffer may consist of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, or sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[0293] As an example of a flavoring, a mixture of menthol and peppermint may be used. Of course, other flavorings described herein may also be used in combination with or in place of menthol and / or peppermint. The flavorings may be liquid, flavored, or in combination (i.e., liquid and powdered flavorings may be added).

[0294] As an example, acesulfame potassium and / or sucralose may be used as a high-intensity sweetener. Other usable high-intensity sweeteners described herein may be used in combination with or as substitutes for acesulfame potassium and / or sucralose.

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

[0296] Silicon dioxide is used as the flow promoter. Other possible flow promoters include, for example, magnesium stearate, starch, and talc.

[0297] Example 5C: Pouch The pouch composition is prepared from the components in Table 11 using the preparation method described in Example 3.

[0298] The pouch composition is filled into the pouch as described in Example 4 (the pouch material of Example 1A was used, but 1B could also have been applied).

[0299] [Table 11]

[0300] Pouch content: 500 mg in total. Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-insoluble plant fibers, such as rye fiber, pea fiber, rice fiber, corn fiber, rye fiber, tomato fiber, barley fiber, lime fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber, can also be used similarly.

[0301] Sodium carbonate is used as an alkaline buffer together with the phosphate buffer. Other buffers described herein can also be used in combination with sodium carbonate or substitutes.

[0302] The phosphate buffer can be composed of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[0303] As an example of a flavoring, a mixture of menthol and peppermint may be used. Of course, other flavorings described herein may also be used in combination with or in place of menthol and / or peppermint. The flavorings may be liquid, flavored, or in combination (i.e., liquid and powdered flavorings may be added).

[0304] As an example, acesulfame potassium and / or sucralose may be used as a high-intensity sweetener. Other usable high-intensity sweeteners described herein may be used in combination with or as substitutes for acesulfame potassium and / or sucralose.

[0305] Potassium sorbate is used as a preservative. Other preservatives described herein may also be used in combination with or in place of potassium sorbate.

[0306] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include, for example, magnesium stearate, starch, and talc.

[0307] Example 5D: Pouch The pouch composition is prepared from the components listed in Table 12 using the preparation method described in Example 3.

[0308] The pouch composition is filled into the pouch as described in Example 4 (the pouch material of Example 1A was used, but Example 1B could also be used).

[0309] [Table 12]

[0310] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber may also be used.

[0311] Sodium carbonate is used as an alkaline buffer in combination with phosphate buffer. Other buffers described herein may also be used in combination with sodium carbonate or its substitutes.

[0312] A phosphate buffer may consist of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, or sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[0313] As an example of a flavoring, a mixture of menthol and peppermint may be used. Of course, other flavorings described herein may also be used in combination with or in place of menthol and / or peppermint. The flavorings may be liquid, flavored, or in combination (i.e., liquid and powdered flavorings may be added).

[0314] As an example, acesulfame potassium and / or sucralose may be used as a high-intensity sweetener. Other usable high-intensity sweeteners described herein may be used in combination with or as substitutes for acesulfame potassium and / or sucralose.

[0315] Potassium sorbate is used as a preservative. Other preservatives described herein may also be used in combination with or in place of potassium sorbate.

[0316] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include, for example, magnesium stearate, starch, and talc.

[0317] Example 5E: Pouch The pouch composition is prepared from the components listed in Table 13 using the preparation method described in Example 3.

[0318] The pouch composition is filled into the pouch as described in Example 4 (the pouch material of Example 1A was used, but Example 1B could also be used).

[0319] [Table 13]

[0320] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber may also be used.

[0321] Sodium carbonate is used as an alkaline buffer in combination with phosphate buffer. Other buffers described herein may also be used in combination with sodium carbonate or its substitutes.

[0322] A phosphate buffer may consist of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, or sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[0323] As an example of a flavoring, a mixture of menthol and peppermint may be used. Of course, other flavorings described herein may also be used in combination with or in place of menthol and / or peppermint. The flavorings may be liquid, flavored, or in combination (i.e., liquid and powdered flavorings may be added).

[0324] As an example, acesulfame potassium and / or sucralose may be used as a high-intensity sweetener. Other usable high-intensity sweeteners described herein may be used in combination with or as substitutes for acesulfame potassium and / or sucralose.

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

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

[0327] Example 5F: Pouch The pouch composition is prepared from the components listed in Table 14A using the preparation method described in Example 3.

[0328] The pouch composition is filled into the pouch as described in Example 4 (the pouch material of Example 1A was used, but Example 1B could also be used).

[0329] [Table 14]

[0330] Pouch contents: 500mg total.

[0331] Powdered cellulose, product name "Vitacel L700G".

[0332] Oat fiber, product name "Vitacel HF 600".

[0333] Microcrystalline cellulose (MCC), trade name "Vivapur 102".

[0334] Other fibers, such as water-insoluble plant fibers, including wheat fiber, oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber, may also be used.

[0335] Sodium carbonate is used as an alkaline buffer in combination with phosphate buffer. Other buffers described herein may also be used in combination with sodium carbonate or its substitutes.

[0336] A phosphate buffer may consist of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, or sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[0337] As an example of a flavoring, a mixture of menthol and peppermint may be used. Of course, other flavorings described herein may also be used in combination with or in place of menthol and / or peppermint. The flavorings may be liquid, flavored, or in combination (i.e., liquid and powdered flavorings may be added).

[0338] As an example, acesulfame potassium and / or sucralose may be used as a high-intensity sweetener. Other usable high-intensity sweeteners described herein may be used in combination with or as substitutes for acesulfame potassium and / or sucralose.

[0339] Potassium sorbate is used as a preservative. Other preservatives described herein may also be used in combination with or in place of potassium sorbate.

[0340] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include, for example, magnesium stearate, starch, and talc.

[0341] Example 5G: Pouch The pouch composition is prepared from the components in Table 14B using the preparation method described in Example 3.

[0342] The pouch composition is filled into the pouch as described in Example 4 (the pouch material of Example 1A was used, but Example 1B could also be used).

[0343] [Table 15]

[0344] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber may also be used.

[0345] Sodium carbonate is used as an alkaline buffer in combination with phosphate buffer. Other buffers described herein may also be used in combination with sodium carbonate or its substitutes.

[0346] (If present) the phosphate buffer may consist of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[0347] As an example of a flavoring, a mixture of menthol and peppermint may be used. Of course, other flavorings described herein may also be used in combination with or in place of menthol and / or peppermint. The flavorings may be liquid, flavored, or in combination (i.e., liquid and powdered flavorings may be added).

[0348] As an example, acesulfame potassium and / or sucralose may be used as a high-intensity sweetener. Other usable high-intensity sweeteners described herein may be used in combination with or as substitutes for acesulfame potassium and / or sucralose.

[0349] Potassium sorbate is used as a preservative. Other preservatives described herein may also be used in combination with or in place of potassium sorbate.

[0350] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include, for example, magnesium stearate, starch, and talc.

[0351] Example 6A: User evaluation. The manufactured pouches of the present invention were evaluated and found to be highly suitable as nicotine delivery vehicles in that they provide a favorable release of nicotine and, at the same time, are pleasant to the user in terms of desirable mouthfeel and taste, such as a moist, moldable texture.

[0352] Example 6B: Processability The processability of the pouch product was evaluated by assessing the formation of lumps during processing.

[0353] Furthermore, processability was evaluated by sieving analysis using a sieving tower. Here, the percentage of product powder that passed through a specific sieve size during a given sieving time was measured. A higher percentage of powder passing through the sieve during a given sieving time indicates improved processability of the product powder.

[0354] Example 7: Processability Evaluation Pouch products PAM02 and C1 were evaluated for processability using sieving analysis with a sieving tower.

[0355] The analysis was performed using a Retsch AS 200 control sieve shaker equipped with a sieve with a mesh size of 1.7 mm. The sieving procedure was as follows: A 100 g sample of product powder was placed on the sieve, the lid was closed, and the shaker was started. The sample was shaken for 1 minute at an amplitude of 0.6 mm.

[0356] The percentage (by weight) of product powder that passed through the sieve after 1 minute of sieving was measured, and the results shown in Table 15 were obtained.

[0357] [Table 16]

[0358] As is evident from the sieving test results, PAM02 was found to have superior processability compared to the comparative sample.

[0359] Example 8: Processability Evaluation Pouch products C2, PAM61, C3, PAM62, C4, and PAM63 were evaluated for processability by sieving analysis using a sieving tower.

[0360] The analysis was performed using a Retsch AS 200 control sieve shaker equipped with a sieve with a mesh size of 1.7 mm. The sieving procedure was as follows: A 100 g sample of product powder was placed on the sieve, the lid was closed, and the shaker was started. The sample was shaken for 1 minute at an amplitude of 0.6 mm.

[0361] The percentage (by weight) of product powder that passed through the sieve after 1 minute of sieving was measured, and the results shown in Table 16 were obtained.

[0362] [Table 17]

[0363] Compared to the corresponding comparative sample C2, which does not contain divalent cations or inorganic phosphates, the pouch product PAM61 of the present invention was found to have significantly improved processability, as is evident from the results of the sieving test.

[0364] Similarly, it was found that the pouch product PAM62 of the present invention has significantly improved processability compared to the corresponding comparative sample C3, and that the pouch product PAM63 of the present invention has significantly improved processability compared to the corresponding comparative sample C4.

Claims

1. An oral nicotine pouch composition, Nicotine and, The pouch composition contains at least 5% by weight of water, Alginate and Inorganic divalent cations and An oral nicotine pouch composition comprising at least one pH adjusting agent containing an inorganic phosphate.

2. The oral nicotine pouch composition according to claim 1, wherein the phosphate comprises at least two different phosphates.

3. The oral nicotine pouch composition according to claim 1 or 2, wherein the phosphate comprises a monophosphate.

4. The oral nicotine pouch composition according to any one of claims 1 to 3, wherein the phosphate comprises a polyphosphate such as pyrophosphate.

5. The oral nicotine pouch composition according to any one of claims 1 to 4, wherein the phosphate includes a combination of a monophosphate and a polyphosphate such as a pyrophosphate.

6. The oral nicotine pouch composition according to any one of claims 1 to 5, wherein the phosphate comprises a phosphate provided as a salt with an alkali metal such as sodium or potassium.

7. The oral nicotine pouch composition according to any one of claims 1 to 6, wherein the phosphate is provided as a salt with sodium.

8. The oral nicotine pouch composition according to any one of claims 1 to 7, wherein the phosphate comprises monosodium phosphate.

9. The oral nicotine pouch composition according to any one of claims 1 to 8, wherein the phosphate comprises disodium phosphate.

10. The oral nicotine pouch composition according to any one of claims 1 to 9, wherein the phosphate comprises trisodium phosphate.

11. The oral nicotine pouch composition according to any one of claims 1 to 10, wherein the phosphate comprises monosodium diphosphate.

12. The oral nicotine pouch composition according to any one of claims 1 to 11, wherein the phosphate comprises disodium diphosphate.

13. The oral nicotine pouch composition according to any one of claims 1 to 12, wherein the phosphate comprises trisodium diphosphate.

14. The oral nicotine pouch composition according to any one of claims 1 to 13, wherein the phosphate comprises tetrasodium diphosphate.

15. The oral nicotine pouch composition according to any one of claims 1 to 14, wherein the phosphate is provided as a salt with potassium.

16. The oral nicotine pouch composition according to any one of claims 1 to 15, wherein the phosphate is provided as a salt in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.2% by weight of the pouch composition, for example, at least 0.5% by weight of the pouch composition, for example, at least 1.0% by weight of the pouch composition.

17. The oral nicotine pouch composition according to any one of claims 1 to 16, wherein the pouch composition contains alginate in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.2% by weight of the pouch composition, for example, at least 0.3% by weight of the pouch composition, for example, at least 0.4% by weight of the pouch composition.

18. The oral nicotine pouch composition according to any one of claims 1 to 17, wherein the alginate is provided as a salt with an ion selected from the group consisting of an alkali metal alginate such as sodium alginate or potassium alginate, or any combination thereof.

19. The oral nicotine pouch composition according to any one of claims 1 to 18, wherein the inorganic divalent cation is selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.

20. The oral nicotine pouch composition according to any one of claims 1 to 19, wherein the inorganic divalent cation is selected from the group consisting of calcium, magnesium, and any combination thereof.

21. The oral nicotine pouch composition according to any one of claims 1 to 20, wherein the inorganic divalent cation comprises a calcium ion.

22. The oral nicotine pouch composition according to any one of claims 1 to 21, wherein the inorganic divalent cation comprises a magnesium ion.

23. The oral nicotine pouch composition according to any one of claims 1 to 22, wherein the divalent cation is provided as a water-soluble salt having at least 5 grams of water solubility per 100 mL of water, as measured at 25 degrees Celsius, atmospheric pressure, and pH 7.

0.

24. The oral nicotine pouch composition according to any one of claims 1 to 23, wherein the inorganic divalent cation is provided as a salt comprising an anion selected from the group consisting of carboxylate salts such as acetate, lactate, oxalate, propionate, or levulinate; organic sulfonate; organic sulfate; organic phosphate; chloride, bromide, nitrate, sulfate, hydrogen phosphate, oxide, and any combination thereof.

25. The oral nicotine pouch composition according to any one of claims 1 to 24, wherein the inorganic divalent cation is provided as an inorganic salt.

26. The oral nicotine pouch composition according to any one of claims 1 to 25, wherein the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chlorides, bromides, nitrates, sulfates, bicarbonates, hydrogen phosphates, oxides, hydroxides, and any combination thereof.

27. The oral nicotine pouch composition according to any one of claims 1 to 26, wherein the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chlorides, bromides, bicarbonates, sulfates, and any combination thereof.

28. The oral nicotine pouch composition according to any one of claims 1 to 27, wherein the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chlorides, bromides, sulfates, and any combination thereof.

29. The oral nicotine pouch composition according to any one of claims 1 to 28, wherein the divalent cation is provided as an inorganic salt with a chloride.

30. The oral nicotine pouch composition according to any one of claims 1 to 28, wherein the divalent cation is provided as an inorganic salt with a bromide.

31. The oral nicotine pouch composition according to any one of claims 1 to 28, wherein the divalent cation is provided as an inorganic salt with a sulfate.

32. The oral nicotine pouch composition according to any one of claims 1 to 31, wherein the divalent cation is selected from the group consisting of calcium chloride, calcium bromide, calcium sulfate, magnesium chloride, magnesium bromide, magnesium sulfate, and any combination thereof.

33. The oral nicotine pouch composition according to any one of claims 1 to 32, wherein the inorganic divalent cation is provided as a salt in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.2% by weight of the pouch composition, for example, at least 0.3% by weight of the pouch composition, for example, at least 0.4% by weight of the pouch composition.

34. The oral nicotine pouch composition according to any one of claims 1 to 33, wherein the pouch composition contains the alginate in a weight ratio of 1:2 to 3:1 with respect to the amount of divalent cations, for example, 1:1 to 2:1 with respect to the amount of divalent cations.

35. The oral nicotine pouch composition according to any one of claims 1 to 34, wherein the pouch composition contains the alginate in a weight ratio of 1:5 to 3:1 relative to the amount of phosphate, for example, 1:3 to 1:1 relative to the amount of phosphate, for example, 1:2 to 2:3 relative to the amount of phosphate.

36. The oral nicotine pouch composition according to any one of claims 1 to 35, wherein the pouch composition contains the alginate in a weight ratio of 1:2 to 3:1 relative to the amount of phosphate, for example, 1:5 to 1:1 relative to the amount of phosphate, for example, 1:3 to 2:3 relative to the amount of phosphate.

37. The oral nicotine pouch composition according to any one of claims 1 to 36, wherein the pouch composition contains the divalent cation in a weight ratio of 1:8 to 1:1 relative to the amount of phosphate, for example, 1:4 to 1:2 relative to the amount of phosphate.

38. The oral nicotine pouch composition according to any one of claims 1 to 37, wherein the at least one pH adjusting agent comprises at least one further pH adjusting agent.

39. The oral nicotine pouch composition according to any one of claims 1 to 38, wherein the at least one further pH adjustment comprises a buffer such as an alkaline buffer.

40. The oral nicotine pouch composition according to any one of claims 1 to 39, wherein the at least one further pH adjusting agent is an alkaline pH adjusting agent such as an alkaline buffer.

41. The oral nicotine pouch composition according to any one of claims 1 to 40, wherein the at least one further pH adjusting agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate, potassium bicarbonate, trometamol, or any combination thereof.

42. The oral nicotine pouch composition according to any one of claims 1 to 41, wherein the pouch composition contains the further pH adjusting agent in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.5 to 10% by weight of the pouch composition, for example, 1 to 10% by weight of the pouch composition, for example, 2 to 10% by weight of the pouch composition, for example, 3 to 8% by weight of the pouch composition.

43. The oral nicotine pouch composition according to any one of claims 1 to 42, wherein the nicotine is selected from the group consisting of nicotine salts, free nicotine bases, nicotine-ion exchange resin combinations, nicotine inclusion complexes, or any non-covalent nicotine; nicotine bound to zeolite, nicotine bound to cellulose such as microcrystalline cellulose, starch microspheres, and mixtures thereof.

44. The oral nicotine pouch composition according to any one of claims 1 to 43, wherein the nicotine comprises unsalted nicotine.

45. The oral nicotine pouch composition according to any one of claims 1 to 44, wherein the nicotine comprises a free nicotine base.

46. The oral nicotine pouch composition according to any one of claims 1 to 45, wherein the nicotine comprises nicotine mixed with an ion exchange resin.

47. The oral nicotine pouch composition according to any one of claims 1 to 46, wherein the nicotine comprises free base nicotine mixed with an ion exchange resin, with a weight ratio of 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.0 between the free base nicotine and the ion exchange resin.

48. The oral nicotine pouch composition according to any one of claims 1 to 47, wherein the nicotine comprises nicotine bound to an ion exchange resin.

49. The oral nicotine pouch composition according to any one of claims 1 to 48, wherein the nicotine comprises a nicotine salt.

50. The oral nicotine pouch composition according to any one of claims 1 to 49, wherein the nicotine salt comprises nicotine bitartrate.

51. The oral nicotine pouch composition according to any one of claims 1 to 50, wherein the nicotine comprises synthetic nicotine.

52. The oral nicotine pouch composition according to any one of claims 1 to 51, wherein the pouch composition contains nicotine in an amount of at least 0.1% by weight of the pouch composition, for example, at least 0.25% by weight of the pouch composition, for example, at least 0.5% by weight of the pouch composition, for example, at least 1.0% by weight of the pouch composition, for example, at least 2.0% by weight of the pouch composition, for example, at least 4.0% by weight of the pouch composition.

53. The oral nicotine pouch composition according to any one of claims 1 to 52, wherein the pouch composition contains a nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition, for example, 1 to 18% by weight of the pouch composition, for example, 5 to 16% by weight of the pouch composition.

54. The oral nicotine pouch composition according to any one of claims 1 to 53, wherein the nicotine-ion exchange resin combination includes nicotine complexed with the ion exchange resin, and the nicotine constitutes 5 to 50% by weight of the nicotine-ion exchange resin combination.

55. The oral nicotine pouch composition according to any one of claims 1 to 54, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of 5 to 50% by weight of the nicotine-ion exchange resin combination and ion exchange resin in an amount of 10 to 95% by weight of the nicotine-ion exchange resin combination.

56. The oral nicotine pouch composition according to any one of claims 1 to 55, wherein the pouch composition contains water in an amount of at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, for example, at least 20% by weight of the pouch composition.

57. The oral nicotine pouch composition according to any one of claims 1 to 56, wherein the pouch composition contains water in an amount of 65% by weight or less of the pouch composition, for example, 60% by weight or less of the pouch composition, for example, 50% by weight or less of the pouch composition, for example, 40% by weight or less of the pouch composition.

58. The oral nicotine pouch composition according to any one of claims 1 to 57, wherein the pouch composition contains water in an amount of 5 to 65% by weight of the pouch composition, for example, 10 to 65% by weight of the pouch composition, for example, 15 to 60% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition, for example, 20 to 50% by weight of the pouch composition, for example, 20 to 40% by weight of the pouch composition.

59. The oral nicotine pouch composition according to any one of claims 1 to 58, wherein the pouch composition comprises at least one sugar alcohol.

60. The oral nicotine pouch composition according to any one of claims 1 to 59, wherein the at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combination thereof.

61. The oral nicotine pouch composition according to any one of claims 1 to 60, wherein the at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combination thereof.

62. The oral nicotine pouch composition according to any one of claims 1 to 61, wherein the at least one sugar alcohol comprises at least one indirectly compressible (non-DC) grade sugar alcohol.

63. The oral nicotine pouch composition according to any one of claims 1 to 62, wherein the pouch composition contains at least 1% by weight of the pouch composition, for example, at least 2% by weight of the pouch composition, for example, at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, or the same amount of at least one sugar alcohol.

64. The oral nicotine pouch composition according to any one of claims 1 to 63, wherein the pouch composition contains at least one sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 2 to 70% by weight of the pouch composition, for example, 5 to 60% by weight of the pouch composition, for example, 10 to 50% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 15 to 30% by weight of the pouch composition.

65. The oral nicotine pouch composition according to any one of claims 1 to 64, wherein the pouch composition comprises water-insoluble fibers.

66. The oral nicotine pouch composition according to any one of claims 1 to 65, wherein the water-insoluble fiber is a plant fiber.

67. The oral nicotine pouch composition according to any one of claims 1 to 66, wherein the water-insoluble fiber is a non-tobacco fiber.

68. The oral nicotine pouch composition according to any one of claims 1 to 67, wherein the pouch composition contains non-tobacco water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, for example, at least 20% by weight of the pouch composition.

69. The oral nicotine pouch composition according to any one of claims 1 to 68, wherein the water-insoluble fibers do not contain tobacco fibers.

70. The oral nicotine pouch composition according to any one of claims 1 to 69, wherein the pouch composition does not contain tobacco fibers.

71. The oral nicotine pouch composition according to any one of claims 1 to 70, wherein the pouch composition contains the water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, for example, at least 10% by weight of the pouch composition, for example, at least 15% by weight of the pouch composition, for example, at least 20% by weight of the pouch composition.

72. The oral nicotine pouch composition according to any one of claims 1 to 71, wherein the pouch composition contains the water-insoluble fiber in an amount of 5 to 70% by weight of the pouch composition, for example, 5 to 60% by weight of the pouch composition, for example, 10 to 45% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 20 to 40% by weight of the pouch composition.

73. The oral nicotine pouch composition according to any one of claims 1 to 72, wherein the water-insoluble fiber comprises one or more 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, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and any combination thereof.

74. The oral nicotine pouch composition according to any one of claims 1 to 73, wherein the water-insoluble fiber comprises microcrystalline cellulose.

75. The oral nicotine pouch composition according to any one of claims 1 to 74, wherein the water-insoluble fiber does not contain microcrystalline cellulose.

76. The oral nicotine pouch composition according to any one of claims 1 to 75, wherein the pouch composition contains tobacco in an amount of 5% by weight or less of the pouch composition, for example, 2% by weight or less of the pouch composition, for example, 1% by weight or less of the pouch composition, for example, 0.5% by weight or less of the pouch composition, for example, 0.1% by weight or less of the pouch composition.

77. The oral nicotine pouch composition according to any one of claims 1 to 76, wherein the pouch composition comprises a humectant.

78. The oral nicotine pouch composition according to any one of claims 1 to 77, wherein the pouch composition comprises a flavoring agent.

79. The oral nicotine pouch composition according to any one of claims 1 to 78, wherein the pouch composition is a powder composition.

80. An oral nicotine pouch composition, Nicotine and, The pouch composition contains at least 5% by weight of water, Alginate and Inorganic polyvalent cations, An oral nicotine pouch composition comprising at least one pH adjusting agent containing an inorganic phosphate.

81. The oral nicotine pouch composition according to claim 80, wherein the polyvalent cation is selected from the group consisting of polyvalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, and nickel, for example, Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+, and any combination thereof.

82. The oral nicotine pouch composition according to claim 80 or 81, wherein the polyvalent cation is trivalent.

83. The oral nicotine pouch composition according to any one of claims 1 to 82, wherein the polyvalent cation is selected from the group consisting of a trivalent cation of aluminum, a divalent cation of calcium, magnesium, iron, and zinc, and any combination thereof.

84. The oral nicotine pouch composition according to any one of claims 1 to 83, wherein the polyvalent cation is selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.

85. A nicotine pouch product comprising a pouch composition according to any one of claims 1 to 84, and a saliva-permeable pouch for enclosing the pouch composition.

86. The nicotine pouch product according to claim 85, wherein the pouch product contains the pouch composition in an amount of at least 50 mg, for example, at least 100 mg, for example, at least 150 mg, for example, at least 200 mg, for example, at least 300 mg.

87. The nicotine pouch product according to claim 85 or 86, wherein the pouch product contains an amount of at least 1 mg, for example, at least 2 mg, for example, at least 4 mg, for example, at least 6 mg of nicotine.

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