Bag with cross-linked alginate

Abstract

Oral nicotine pouch compositions 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 are disclosed. Oral nicotine pouch compositions and pouch products comprising inorganic multivalent cations are also disclosed.

Description

Technical Field

[0001] This invention relates to the oral nicotine pouch composition according to the claims and the nicotine pouch product according to the claims. Background Technology

[0002] In the past few years, a wide variety of nicotine products with reduced or no tobacco content have emerged, including in the bagged product or bag sector.

[0003] However, for bagged products, there is still a desire to provide a faster nicotine release to give users an improved experience through faster craving relief, while also providing the desired user experience. Summary of the Invention

[0004] This invention relates to oral nicotine pouch compositions comprising...

[0005] Nicotine,

[0006] The amount is at least 5% by weight of water in the bag composition.

[0007] Alginate,

[0008] Inorganic divalent cations, and

[0009] At least one pH adjuster containing inorganic phosphate.

[0010] One advantage of this invention is that the use of a pH adjuster containing inorganic phosphates can provide an improved pH level for the user, which is beneficial for effective nicotine intake. Simultaneously, an improved flavor is achieved because off-notes associated with other pH adjusters are reduced. The combined use of alginate, which helps maintain a moisture content above a predetermined level to provide the desired taste, results in a pouch composition that is desirable for the user due to the improved taste and effective craving relief.

[0011] Surprisingly, the inventors have discovered that, while obtaining the above advantages, a considerable improvement in processability can be achieved. Generally, the use of water in bag compositions can lead to undesirable characteristics regarding processability, as lumping can occur and flow characteristics can become poor. The present invention unexpectedly provides improved processability while retaining the advantages associated with including water in the bag composition and using alginate.

[0012] In the context of this invention, 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 having the same or different counter-charges, such as a combination of calcium chloride and magnesium chloride, or a combination of calcium chloride and magnesium bromide. Furthermore, the same type of inorganic divalent cation may be provided as two or more different salts, i.e., having two or more different counter-charges, such as calcium chloride and calcium bromide.

[0013] In the context of this invention, it should be noted that the term "phosphate" refers to monophosphate, polyphosphate such as pyrophosphate (also known as diphosphate), triphosphate, tetraphosphate, etc., and any combination thereof. It should be noted that when referring to certain salts, such as sodium salts, such a reference refers to any sodium salt of a particular phosphate; therefore, for example, sodium pyrophosphate can also refer to tetrasodium pyrophosphate.

[0014] In the context of this invention, the term "alginate" refers to the ionic form of alginate, such as the salt form, and alginic acid.

[0015] According to an advantageous embodiment of the invention, the phosphate comprises at least two different phosphates.

[0016] According to one embodiment of the present invention, the phosphate is composed of a single phosphate.

[0017] According to an advantageous embodiment of the invention, the phosphate comprises a monophosphate.

[0018] According to an advantageous embodiment of the invention, the phosphate comprises a polyphosphate, such as a pyrophosphate.

[0019] According to an advantageous embodiment of the invention, the phosphate comprises a combination of monophosphate and polyphosphate, such as pyrophosphate.

[0020] In one embodiment of the invention, the phosphate is a combination of monophosphate and polyphosphate, such as pyrophosphate.

[0021] According to an advantageous embodiment of the invention, the phosphate comprises a phosphate provided as a salt formed with an alkali metal such as sodium or potassium.

[0022] In one embodiment of the invention, the phosphate is provided as a salt formed with an alkali metal.

[0023] According to one embodiment of the invention, the phosphate comprises a phosphate provided as a salt formed with sodium.

[0024] According to an advantageous embodiment of the invention, the phosphate is provided as a salt formed with sodium.

[0025] According to an advantageous embodiment of the invention, the phosphate comprises monosodium phosphate.

[0026] According to an advantageous embodiment of the invention, the phosphate comprises disodium phosphate.

[0027] According to an advantageous embodiment of the invention, the phosphate comprises trisodium phosphate.

[0028] According to an advantageous embodiment of the invention, the phosphate comprises monosodium diphosphate.

[0029] According to an advantageous embodiment of the invention, the phosphate comprises disodium diphosphate.

[0030] According to an advantageous embodiment of the invention, the phosphate comprises trisodium diphosphate.

[0031] According to an advantageous embodiment of the invention, the phosphate comprises tetrasodium diphosphate.

[0032] In some preferred embodiments of the invention, the phosphate is anhydrous.

[0033] In some embodiments of the invention, the phosphate comprises hydrated phosphate, that is, the phosphate contains crystal-bound water.

[0034] According to one embodiment of the invention, the phosphate comprises a phosphate provided as a salt formed with potassium.

[0035] According to an advantageous embodiment of the invention, the phosphate is provided as a salt formed with potassium.

[0036] In one embodiment of the invention, the phosphate is provided as a water-soluble salt, wherein the water solubility of the water-soluble salt, measured at 25 degrees Celsius, atmospheric pressure and pH 7.0, is at least 5 grams per 100 mL of water, for example, 5 to 500 grams per 100 mL of water.

[0037] According to an advantageous embodiment of the invention, the phosphate is provided as a salt in an amount of at least 0.1% by weight of the bag composition, for example at least 0.2% by weight of the bag composition, for example at least 0.5% by weight of the bag composition, for example at least 1.0% by weight of the bag composition.

[0038] In one embodiment of the invention, the phosphate is provided as a salt in amounts of: no more than 7.0% by weight of the bag composition, for example, no more than 5.0% by weight of the bag composition, for example, no more than 4.5% by weight of the bag composition, for example, no more than 3.0% by weight of the bag composition, for example, no more than 2.0% by weight of the bag composition.

[0039] In one embodiment of the invention, the phosphate is provided as a salt in the following amounts: 0.1% to 7.0% by weight of the bag composition, for example 0.1% to 5.0% by weight of the bag composition, for example 0.2% to 4.5% by weight of the bag composition, for example 0.5% to 3.0% by weight of the bag composition, for example 1.0% to 2.0% by weight of the bag composition.

[0040] According to an advantageous embodiment of the invention, the bag composition contains alginate in the following amounts: at least 0.1% by weight of the bag composition, for example, at least 0.2% by weight of the bag composition, for example, at least 0.3% by weight of the bag composition, for example, at least 0.4% by weight of the bag composition.

[0041] In the context of this invention, it should be understood that the amount of alginate refers to the amount (by weight) of the alginate compound, namely the alginate ion and its counter-charge ion.

[0042] In one embodiment of the invention, the bag composition contains alginate in the following amounts: no more than 5.0% by weight of the bag composition, for example, no more than 3.0% by weight of the bag composition, for example, no more than 2.0% by weight of the bag composition, for example, no more than 1.5% by weight of the bag composition, for example, no more than 1.0% by weight of the bag composition.

[0043] In one embodiment of the invention, the bag composition contains alginate in the following amounts: 0.1% to 5.0% by weight of the bag composition, for example, 0.1% to 3.0% by weight of the bag composition, for example, 0.2% to 2.0% by weight of the bag composition, for example, 0.3% to 1.5% by weight of the bag composition, for example, 0.4% to 1.0% by weight of the bag composition.

[0044] According to an advantageous embodiment of the invention, the alginate is provided as a salt having an ion selected from alkali metal alginate, such as sodium alginate or potassium alginate, or any combination thereof.

[0045] In one embodiment of the invention, the alginate comprises alginate selected from sodium alginate, potassium alginate, and any combination thereof.

[0046] In one embodiment of the present invention, the alginate is selected from sodium alginate, potassium alginate, and any combination thereof.

[0047] In one embodiment of the invention, the alginate comprises sodium alginate.

[0048] In one embodiment of the invention, the alginate is sodium alginate.

[0049] In one embodiment of the invention, the alginate comprises potassium alginate.

[0050] In one embodiment of the invention, the alginate is potassium alginate.

[0051] According to an advantageous embodiment of the invention, the inorganic divalent cation is selected from divalent cations of calcium, magnesium, iron, and zinc, and any combination thereof.

[0052] According to an advantageous embodiment of the invention, the inorganic divalent cation is selected from divalent cations of calcium and magnesium, and any combination thereof.

[0053] According to an advantageous embodiment of the invention, the inorganic divalent cation comprises calcium ions.

[0054] In one embodiment of the present invention, the inorganic divalent cation is composed of calcium ions.

[0055] According to an advantageous embodiment of the invention, the inorganic divalent cation comprises magnesium ions.

[0056] In one embodiment of the present invention, the inorganic divalent cation is composed of magnesium ions.

[0057] According to one embodiment of the invention, the divalent cation is provided as a salt.

[0058] According to an advantageous embodiment of the invention, the divalent cation is provided as a water-soluble salt, wherein the water solubility of the water-soluble salt, measured at 25 degrees Celsius, atmospheric pressure and pH 7.0, is at least 5 grams per 100 mL of water.

[0059] Therefore, in the context of this invention, the term water-soluble salt refers to a salt with a water solubility of at least 5 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0060] In one embodiment of the invention, the divalent cation is provided as a water-soluble salt, the 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, a water solubility of 5 to 350 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0061] According to an advantageous embodiment of the invention, the inorganic divalent cation is provided as a salt containing an anion selected from carboxylate groups, such as acetate, lactate, oxalate, propionate, or levulinate; organic sulfonate groups; organic sulfate groups; organic phosphate groups; chloride ions; bromide ions; nitrate ions; sulfate ions; hydrogen phosphate ions; oxygen ions; and any combination thereof.

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

[0063] According to an advantageous embodiment of the invention, the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from chloride ions, bromide ions, nitrate ions, sulfate ions, bicarbonate ions, hydrogen phosphate ions, oxygen ions, hydroxide ions, and any combination thereof.

[0064] According to an advantageous embodiment of the invention, the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from chloride ions, bromide ions, bicarbonate ions, sulfate ions, and any combination thereof.

[0065] According to an advantageous embodiment of the invention, the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from chloride ions, bromide ions, sulfate ions, and any combination thereof.

[0066] According to an advantageous embodiment of the invention, the divalent cation is provided as an inorganic salt having chloride ions.

[0067] According to an advantageous embodiment of the invention, the divalent cation is provided as an inorganic salt having bromide ions.

[0068] According to an advantageous embodiment of the invention, the divalent cation is provided as an inorganic salt having a sulfate group.

[0069] According to an advantageous embodiment of the invention, the divalent cation is selected from calcium chloride, calcium bromide, calcium sulfate, magnesium chloride, magnesium bromide, magnesium sulfate, and any combination thereof.

[0070] According to one embodiment of the invention, the divalent cation comprises a divalent cation provided as calcium chloride.

[0071] According to one embodiment of the invention, the divalent cation is provided as calcium chloride.

[0072] According to one embodiment of the invention, the divalent cation comprises a divalent cation provided as calcium bromide.

[0073] According to one embodiment of the invention, the divalent cation is provided as calcium bromide.

[0074] According to one embodiment of the invention, the divalent cation comprises a divalent cation provided as calcium sulfate.

[0075] According to one embodiment of the invention, the divalent cation is provided as calcium sulfate.

[0076] According to an advantageous embodiment of the invention, the inorganic divalent cation is provided as a salt in an amount of at least 0.1% of the bag composition, for example at least 0.2% by weight of the bag composition, for example at least 0.3% by weight of the bag composition, for example at least 0.4% by weight of the bag composition.

[0077] In one embodiment of the invention, the inorganic divalent cation is provided as a salt in the following amounts: not more than 5.0% by weight of the bag composition, for example, not more than 3.0% by weight of the bag composition, for example, not more than 2.0% by weight of the bag composition, for example, not more than 1.5% by weight of the bag composition, for example, not more than 1.0% by weight of the bag composition.

[0078] In one embodiment of the invention, the inorganic divalent cation is provided as a salt in the following amounts: 0.1 wt% to 5.0 wt% of the bag composition, for example 0.1 wt% to 3.0 wt% of the bag composition, for example 0.2 wt% to 2.0 wt% of the bag composition, for example 0.3 wt% to 1.5 wt% of the bag composition, for example 0.4 wt% to 1.0 wt% of the bag composition.

[0079] According to an advantageous embodiment of the invention, the bag composition comprises the alginate in a weight ratio of 1:2 to 3:1 relative to the amount of divalent cations, for example, a weight ratio of 1:1 to 2:1 relative to the amount of divalent cations.

[0080] In the above embodiments, the amount of alginate refers to alginate where applicable, and the amount of divalent cation refers to a compound containing a divalent cation.

[0081] According to an advantageous embodiment of the invention, the bag composition comprises the alginate in a weight ratio of 1:5 to 3:1 relative to the amount of phosphate, for example, a weight ratio of 1:3 to 1:1 relative to the amount of phosphate, for example, a weight ratio of 1:2 to 2:3 relative to the amount of phosphate.

[0082] According to one embodiment of the invention, the bag composition comprises the alginate in a weight ratio of 1:2 to 3:1 relative to the amount of phosphate, for example, a weight ratio of 1:5 to 1:1 relative to the amount of phosphate, for example, a weight ratio of 1:3 to 2:3 relative to the amount of phosphate.

[0083] According to one embodiment of the invention, the bag composition comprises the alginate in a weight ratio of 1:5 to 1:1 relative to the amount of phosphate, for example, in a weight ratio of 1:3 to 2:3 relative to the amount of phosphate.

[0084] In the above embodiments, the amount of alginate refers to alginate where applicable, and the amount of phosphate refers to compounds containing phosphate.

[0085] According to an advantageous embodiment of the invention, the bag composition comprises the divalent cation in a weight ratio of 1:8 to 1:1 relative to the amount of phosphate, for example, in a weight ratio of 1:4 to 1:2 relative to the amount of phosphate.

[0086] In the above embodiments, the amount of divalent cation refers to the compound containing divalent cation, and the amount of phosphate refers to the compound containing phosphate.

[0087] According to an advantageous embodiment of the invention, at least one pH adjuster comprises at least one additional pH adjuster.

[0088] Therefore, in the above embodiments, the bag composition comprises phosphate and at least one additional pH adjuster.

[0089] According to an advantageous embodiment of the invention, at least one additional pH adjuster comprises a buffer, such as an alkaline buffer.

[0090] In one embodiment of the invention, at least one additional pH adjuster consists of a buffer.

[0091] According to an advantageous embodiment of the invention, at least one additional pH adjuster is an alkaline pH adjuster, such as an alkaline buffer.

[0092] One advantage of the above implementation scheme is that it can promote more effective absorption of nicotine through the oral mucosa.

[0093] According to an advantageous embodiment of the invention, at least one additional pH adjuster is selected from sodium carbonate, sodium bicarbonate, potassium carbonate and magnesium carbonate, potassium bicarbonate, tromethamine, or any combination thereof.

[0094] In the context of this invention, the term tromethamine refers to (tris(hydroxymethyl)aminomethane), sometimes also called tris buffer.

[0095] According to one embodiment of the invention, the bag composition contains the additional pH adjuster in an amount of at least 0.01% by weight of the bag composition, for example, at least 0.5% by weight of the bag composition, for example, at least 1% by weight of the bag composition, for example, at least 2% by weight of the bag composition, for example, at least 3% by weight of the bag composition.

[0096] According to one embodiment of the invention, the bag composition contains the additional pH adjuster in an amount not exceeding 15% by weight of the bag composition, for example, not exceeding 10% by weight of the bag composition, for example, not exceeding 8% by weight of the bag composition.

[0097] According to an advantageous embodiment of the invention, the bag composition contains the additional pH adjuster in an amount of 0.01% to 15% by weight of the bag composition, for example, 0.5% to 10% by weight of the bag composition, for example, 1% to 10% by weight of the bag composition, for example, 2% to 10% by weight of the bag composition, for example, 3% to 8% by weight of the bag composition.

[0098] In one embodiment of the invention, the additional pH adjuster is water-soluble.

[0099] In one embodiment of the invention, the additional pH adjuster has a water solubility of at least 5 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0100] In one embodiment of the invention, the additional pH adjuster has a water solubility of at least 5 to 500 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0101] One advantage of the above implementation scheme is that the high pH value obtained promotes relatively effective nicotine uptake.

[0102] According to an advantageous embodiment of the invention, the nicotine is selected from nicotine salts, free nicotine bases, nicotine-ion exchange resin combinations, nicotine inclusion complexes, or nicotine in any non-covalently bonded form; nicotine bonded to zeolites, nicotine bonded to cellulose such as microcrystalline cellulose, nicotine bonded to starch microspheres, and mixtures thereof.

[0103] According to an advantageous embodiment of the invention, the nicotine comprises non-salt nicotine.

[0104] In one embodiment of the invention, the nicotine is composed of non-salt nicotine.

[0105] According to an advantageous embodiment of the invention, nicotine comprises free nicotine base.

[0106] In one embodiment of the invention, nicotine comprises free nicotine base.

[0107] According to an advantageous embodiment of the invention, the nicotine comprises nicotine mixed with an ion exchange resin.

[0108] In one embodiment of the invention, the nicotine comprises nicotine mixed with an ion exchange resin.

[0109] According to an advantageous embodiment of the invention, the nicotine comprises free nicotine mixed with an ion exchange resin, wherein the weight ratio of the free nicotine to the ion exchange resin is 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.0.

[0110] Therefore, in one embodiment of the present invention, the nicotine comprises free nicotine mixed with an ion exchange resin, wherein the weight ratio of the free nicotine to the ion exchange resin is 1:10 to 2:1, preferably 1:2 to 2:1, and most preferably about 2:3 to 1:1.

[0111] According to an advantageous embodiment of the invention, the nicotine comprises nicotine bound to an ion exchange resin.

[0112] In one embodiment of the invention, the nicotine comprises nicotine bound to an ion exchange resin.

[0113] In one embodiment of the invention, the ion exchange resin comprises one or more resins selected from the following:

[0114] (i) A weakly acidic resin of methacrylic acid containing a carboxyl functional group.

[0115] (ii) A copolymer of methacrylic acid and divinylbenzene, said copolymer containing a carboxyl functional group,

[0116] (iii) Polystyrene resins containing sulfonic acid functional groups that are strongly acidic.

[0117] (iv) Polystyrene containing phosphonic acid functional groups, moderately acidic resins, and

[0118] (v) Its combination.

[0119] In one embodiment of the invention, the ion exchange resin comprises polyacrilexresin.

[0120] In one embodiment of the present invention, the ion exchange resin is a polykryl resin.

[0121] The term NPR can be used as an abbreviation to refer to nicotine compounded with ion exchange resins (specifically polycrystal resins).

[0122] According to an advantageous embodiment of the invention, nicotine comprises nicotine salt.

[0123] In one embodiment of the invention, nicotine comprises nicotine salt.

[0124] In one embodiment of the invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine hydrogen tartrate, nicotine chloride (e.g., nicotine hydrochloride and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine gensitate, nicotine lactate, nicotine mucate, nicotine laurate, nicotine levulinate, nicotine malate, nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine zinc chloride, nicotine sulfate, nicotine toluenesulfonate, and their hydrates (e.g., nicotine zinc chloride monohydrate).

[0125] According to an advantageous embodiment of the invention, the nicotine salt comprises nicotine tartrate.

[0126] The term NBT can be used as an abbreviation for nicotine tartrate.

[0127] According to one embodiment of the present invention, the nicotine salt is composed of nicotine tartrate bichloride.

[0128] According to an advantageous embodiment of the invention, the nicotine comprises synthetic nicotine.

[0129] In one embodiment of the invention, the nicotine comprises synthetic nicotine.

[0130] According to an advantageous embodiment of the 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.

[0131] In one embodiment of the invention, the pouch composition contains nicotine in an amount not exceeding 15.0% by weight of the pouch composition, for example, not exceeding 10.0% by weight of the pouch composition, for example, not exceeding 8.0% by weight of the pouch composition, for example, not exceeding 5.0% by weight of the pouch composition.

[0132] In one embodiment of the 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, 1.0% to 8.0% by weight of the pouch composition, for example, 2.0% to 5.0% by weight of the pouch composition.

[0133] According to an advantageous embodiment of the invention, the bag composition comprises a nicotine-ion exchange combination in an amount of 0.1% to 20% by weight of the bag composition, for example, 1% to 18% by weight of the bag composition, for example, 5% to 16% by weight of the bag composition.

[0134] According to an advantageous embodiment of the invention, the nicotine-ion exchange resin assembly comprises nicotine compounded with the ion exchange resin, wherein the nicotine accounts for 5% to 50% by weight of the nicotine-ion exchange resin assembly.

[0135] According to an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises 5% to 50% by weight of nicotine and 10% to 95% by weight of ion exchange resin.

[0136] According to an advantageous embodiment of the invention, the bag composition contains water in an amount of at least 10% by weight of the bag composition, for example, at least 15% by weight of the bag composition, for example, at least 20% by weight of the bag composition.

[0137] One advantage of the above implementation scheme is that it promotes the desired and soft texture of the pouch product. Furthermore, by including a large amount of water, nicotine release can be promoted. If the pouch composition has a low water content, it may absorb saliva for an undesirable extended period, while a sufficiently moist pouch composition promotes rapid nicotine release.

[0138] One advantage of the above implementation scheme is the relatively rapid release of nicotine.

[0139] One advantage of the above implementation scheme is that it can release nicotine more effectively.

[0140] In one embodiment of the invention, the bag composition contains water in an amount not exceeding 20% ​​by weight of the bag composition, for example, not exceeding 15% by weight of the bag composition, for example, not exceeding 10% by weight of the bag composition.

[0141] According to an advantageous embodiment of the invention, the bag composition contains water in an amount not exceeding 65% by weight of the bag composition, for example, not exceeding 60% by weight of the bag composition, for example, not exceeding 50% by weight of the bag composition, for example, not exceeding 40% by weight of the bag composition.

[0142] According to an advantageous embodiment of the invention, the bag composition contains water in an amount of 5% to 65% by weight of the bag composition, for example 10% to 65% by weight of the bag composition, for example 15% to 60% by weight of the bag composition, for example 15% to 50% by weight of the bag composition, for example 20% to 50% by weight of the bag composition, for example 20% to 40% by weight of the bag composition.

[0143] In one embodiment of the invention, the bag composition contains water in an amount of 15% to 65% by weight of the bag composition, for example, 20% to 65% by weight of the bag composition, for example, 25% to 65% by weight of the bag composition.

[0144] In one embodiment of the invention, the bag composition contains water in an amount of 15% to 65% by weight of the bag composition, for example, 15% to 60% by weight of the bag composition, for example, 15% to 50% by weight of the bag composition, for example, 15% to 40% by weight of the bag composition.

[0145] In one embodiment of the invention, the bag composition contains water in an amount of 15% to 60% by weight of the bag composition, for example, 15% to 50% by weight of the bag composition, for example, 15% to 40% by weight of the bag composition, for example, 15% to 30% by weight of the bag composition.

[0146] In one embodiment of the invention, the bag composition contains water in an amount of 15% to 40% by weight of the bag composition.

[0147] According to an advantageous embodiment of the invention, the bag composition comprises at least one sugar alcohol.

[0148] One advantage of the above implementation scheme is that it provides the desired sweetness, for example, to support flavor characteristics, while retaining an appealing texture.

[0149] According to an advantageous embodiment of the invention, the at least one sugar alcohol comprises one or more of the following: xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, glycerol, and any combination thereof.

[0150] One advantage of the above implementation scheme is that it provides the desired sweetness, for example, to support flavor characteristics, while retaining an appealing texture.

[0151] Therefore, in the above embodiments, at least one sugar alcohol may comprise a mixture of different types of sugar alcohols, such as hydrogenated starch hydrolysate, which comprises mainly a mixture of maltitol, sorbitol and other sugar alcohols.

[0152] In one embodiment of the present invention, the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, glycerol, and any combination thereof.

[0153] According to an advantageous embodiment of the invention, the at least one sugar alcohol comprises one or more of the following: xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, and any combination thereof.

[0154] In one embodiment of the present invention, the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, and any combination thereof.

[0155] In particular, the desired texture is facilitated by utilizing sugar alcohols with desired characteristics (the desired characteristics being, for example, melting point – for example, solid at an ambient temperature of 25 degrees Celsius).

[0156] In one embodiment of the invention, the bag composition comprises a sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, glycerol, and any combination thereof, wherein the amount of the sugar alcohol is at least 1% by weight of the bag composition, for example, at least 2% by weight of the bag composition, for example, at least 5% by weight of the bag composition, for example, at least 10% by weight of the bag composition, for example, at least 15% by weight of the bag composition.

[0157] In one embodiment of the invention, the bag composition comprises a sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, glycerol, and any combination thereof, wherein the amount of the sugar alcohol is from 1% to 80% by weight of the bag composition, for example, from 2% to 70% by weight of the bag composition, for example, from 5% to 60% by weight of the bag composition, for example, from 10% to 50% by weight of the bag composition, for example, from 15% to 40% by weight of the bag composition, for example, from 15% to 30% by weight of the bag composition.

[0158] In one embodiment of the invention, the bag composition comprises a sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, and any combination thereof, wherein the amount of the sugar alcohol is at least 1% by weight of the bag composition, for example, at least 2% by weight of the bag composition, for example, at least 5% by weight of the bag composition, for example, at least 10% by weight of the bag composition, for example, at least 15% by weight of the bag composition.

[0159] In one embodiment of the invention, the bag composition comprises a sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, and any combination thereof, wherein the amount of the sugar alcohol is from 1% to 80% by weight of the bag composition, for example, from 2% to 70% by weight of the bag composition, for example, from 5% to 60% by weight of the bag composition, for example, from 10% to 50% by weight of the bag composition, for example, from 15% to 40% by weight of the bag composition, for example, from 15% to 30% by weight of the bag composition.

[0160] According to an advantageous embodiment of the invention, the at least one sugar alcohol comprises at least one non-directly compressible (non-DC) grade sugar alcohol.

[0161] According to an advantageous embodiment of the invention, the bag composition comprises the at least one sugar alcohol in an amount of at least 1% by weight of the bag composition, for example, at least 2% by weight of the bag composition, for example, at least 5% by weight of the bag composition, for example, at least 10% by weight of the bag composition, for example, at least 15% by weight of the bag composition.

[0162] According to an advantageous embodiment of the invention, the bag composition comprises the at least one sugar alcohol in an amount of 1% to 80% by weight of the bag composition, for example, 2% to 70% by weight of the bag composition, for example, 5% to 60% by weight of the bag composition, for example, 10% to 50% by weight of the bag composition, for example, 15% to 50% by weight of the bag composition, for example, 15% to 40% by weight of the bag composition, for example, 15% to 30% by weight of the bag composition.

[0163] In one embodiment of the invention, the bag composition comprises the at least one sugar alcohol in an amount of 5% to 70% by weight of the bag composition, for example, 10% to 70% by weight of the bag composition, for example, 15% to 70% by weight of the bag composition, for example, 20% to 70% by weight of the bag composition, for example, 20% to 60% by weight of the bag composition, for example, 20% to 50% by weight of the bag composition, for example, 20% to 40% by weight of the bag composition.

[0164] According to an advantageous embodiment of the invention, the bag composition comprises water-insoluble fibers.

[0165] In one embodiment of the invention, the water-insoluble fiber comprises non-tobacco fiber.

[0166] According to an advantageous embodiment of the invention, the water-insoluble fiber is a plant fiber.

[0167] According to an advantageous embodiment of the invention, the water-insoluble fiber is a non-tobacco fiber.

[0168] According to an advantageous embodiment of the invention, the bag composition comprises non-tobacco water-insoluble fibers in an amount of at least 5% by weight of the bag composition, for example, at least 10% by weight of the bag composition, for example, at least 15% by weight of the bag composition, for example, at least 20% by weight of the bag composition.

[0169] Therefore, the bag composition of the above embodiments may contain a large amount of non-tobacco water-insoluble fibers, and in such cases may be a non-tobacco bag composition or a low-tobacco bag composition.

[0170] In one embodiment of the invention, the bag composition comprises non-tobacco water-insoluble fibers in an amount not exceeding 60% by weight of the bag composition, for example, not exceeding 50% by weight of the bag composition, for example, not exceeding 40% by weight of the bag composition, for example, not exceeding 40% by weight of the bag composition.

[0171] In one embodiment of the invention, the bag composition comprises non-tobacco water-insoluble fibers in an amount of 5% to 60% by weight of the bag composition, for example 10% to 50% by weight of the bag composition, for example 15% to 40% by weight of the bag composition, for example 20% to 40% by weight of the bag composition.

[0172] According to an advantageous embodiment of the invention, the water-insoluble fiber does not contain tobacco fiber.

[0173] Therefore, in the above embodiments, the water-insoluble fiber does not contain any tobacco fiber or any fiber derived from tobacco; that is, the water-insoluble fiber is a non-tobacco fiber. Although nicotine may be derived from tobacco or from other sources, in the above embodiments, the water-insoluble fiber does not contain any tobacco fiber.

[0174] According to an advantageous embodiment of the invention, the bag composition is free of tobacco fibers.

[0175] Therefore, in the above embodiments, the bag composition does not contain any tobacco fiber or any fiber derived from tobacco. Of course, although nicotine may be derived from tobacco or other sources, in the above embodiments, the bag composition does not contain any tobacco fiber.

[0176] According to an advantageous embodiment of the invention, the bag composition comprises the water-insoluble fiber in an amount of at least 5% by weight of the bag composition, for example at least 10% by weight of the bag composition, for example at least 15% by weight of the bag composition, for example at least 20% by weight of the bag composition.

[0177] One advantage of the above implementation scheme is that, for example, the ability of water-insoluble fibers to retain a large amount of water promotes the desired texture.

[0178] According to an advantageous embodiment of the invention, the bag composition comprises the water-insoluble fiber in an amount not exceeding 70% by weight of the bag composition, for example, not exceeding 60% by weight of the bag composition, for example, not exceeding 45% by weight of the bag composition, for example, not exceeding 40% by weight of the bag composition.

[0179] According to an advantageous embodiment of the invention, the bag composition comprises the water-insoluble fiber in an amount of 5% to 70% by weight of the bag composition, for example, 5% to 60% by weight of the bag composition, for example, 10% to 45% by weight of the bag composition, for example, 15% to 40% by weight of the bag composition, for example, 20% to 40% by weight of the bag composition.

[0180] In one embodiment of the invention, the bag composition comprises the water-insoluble fiber in an amount of 5% to 50% by weight of the bag composition, for example, 5% to 45% by weight of the bag composition, for example, 5% to 40% by weight of the bag composition.

[0181] In one embodiment of the invention, the bag composition comprises the water-insoluble fiber in an amount of 10% to 70% by weight of the bag composition, for example, 10% to 60% by weight of the bag composition, for example, 10% to 50% by weight of the bag composition, for example, 15% to 50% by weight of the bag composition.

[0182] According to an advantageous embodiment of the invention, the water-insoluble fiber comprises one or more selected from: wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and any combination thereof.

[0183] In one embodiment of the present invention, the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and any combination thereof.

[0184] According to an advantageous embodiment of the invention, the water-insoluble fiber comprises microcrystalline cellulose.

[0185] According to an advantageous embodiment of the invention, the water-insoluble fiber does not contain microcrystalline cellulose.

[0186] In one embodiment of the invention, the water-insoluble fiber has a water-binding capacity of at least 200%, for example at least 300%, for example at least 400%.

[0187] In one embodiment of the 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%.

[0188] In one embodiment of the invention, the density of the water-insoluble fiber is 50 g / L to 500 g / L, for example 100 g / L to 400 g / L, for example 200 g / L to 300 g / L.

[0189] In one embodiment of the invention, the bag composition comprises a water-insoluble fiber selected from the following: wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and any combination thereof, wherein the amount of the water-insoluble fiber is at least 5% by weight of the bag composition, for example, at least 10% by weight of the bag composition, for example, at least 15% by weight of the bag composition.

[0190] According to an advantageous embodiment of the invention, the bag composition contains tobacco in an amount not exceeding 5% by weight of the bag composition, for example, not exceeding 2% by weight of the bag composition, for example, not exceeding 1% by weight of the bag composition, for example, not exceeding 0.5% by weight of the bag composition, for example, not exceeding 0.1% by weight of the bag composition.

[0191] In one embodiment of the invention, the bag composition comprises tobacco in an amount of 0.001% to 5% by weight of the bag composition, for example, 0.01% to 5% by weight of the bag composition, for example, 0.05% to 2% by weight of the bag composition, for example, 0.1% to 1% by weight of the bag composition, for example, 0.2% to 0.5% by weight of the bag composition.

[0192] According to an advantageous embodiment of the invention, the bag composition contains a humectant.

[0193] The above embodiments refer to additional humectants in terms of the extent to which the alginate contained in the bag composition is considered a humectant.

[0194] In one embodiment, the humectant is selected from glycerin, propylene glycol, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.

[0195] In one embodiment of the invention, the humectant is selected from modified starch, triacetin, polyethylene glycol (PEG), pectin and xanthan gum, or any combination thereof.

[0196] In one embodiment of the present invention, the humectant is selected from propylene glycol, hydroxypropyl cellulose and glycerin, or any combination thereof.

[0197] One advantage of the above implementation scheme is that it can achieve a combination of high nicotine release rate and desired taste (hereinafter referred to as softness and moistness).

[0198] Another advantage of the above implementation scheme is that it can promote the desired flavor perception through the combination of improved flavor release and desired mouthfeel (hereinafter referred to as softness and moisture).

[0199] The advantage of the above implementation scheme is that it can improve nicotine release, flavor release and flavor sensation without compromising the moist mouthfeel.

[0200] In one embodiment, the bag composition comprises a humectant in an amount of 0.1% to 5% by weight of the bag composition, for example, 0.2% to 5% by weight, for example, 0.5% to 2% by weight of the bag composition.

[0201] According to an advantageous embodiment of the invention, the bag composition contains a flavoring agent.

[0202] In one embodiment of the invention, the bag composition contains at least 0.01% by weight of a flavoring agent.

[0203] In one embodiment of the invention, the bag composition contains at least 15% by weight of a flavoring agent.

[0204] In one embodiment of the invention, the bag composition contains 0.01% to 15% by weight of a flavoring agent.

[0205] In one embodiment of the invention, the flavoring agent comprises a liquid flavoring agent.

[0206] In one embodiment of the invention, the flavoring agent comprises a powdered flavoring agent.

[0207] In one embodiment of the invention, the flavoring agent comprises a liquid flavoring agent and a powdered flavoring agent.

[0208] According to an advantageous embodiment of the invention, the bag composition is a powder composition.

[0209] As used herein, the term "powder composition" refers to a composition in powder form, i.e., as particulate matter having a relatively small particle size, such as 1 micrometer to 1200 micrometers. In particular, powder composition does not mean powdered tobacco.

[0210] The present invention also relates to an oral nicotine bag composition comprising

[0211] Nicotine,

[0212] The amount is at least 5% by weight of water in the bag composition.

[0213] Alginate,

[0214] Inorganic multivalent cations, and

[0215] At least one pH adjuster containing inorganic phosphate.

[0216] The above aspects of the present invention can be combined with any embodiment of the present invention, and do not necessarily include inorganic divalent cations.

[0217] According to an advantageous embodiment of the invention, the polyvalent cation is selected from polyvalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, and nickel, such as Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+, and any combination thereof.

[0218] According to an advantageous embodiment of the invention, the polyvalent cation is trivalent.

[0219] According to an advantageous embodiment of the invention, the polyvalent cation is selected from trivalent aluminum cations, divalent calcium, magnesium, iron, zinc cations, and any combination thereof.

[0220] According to an advantageous embodiment of the invention, the polyvalent cation is selected from divalent cations of calcium, magnesium, iron, and zinc, and any combination thereof.

[0221] The present invention also relates to nicotine pouch products comprising a pouch composition according to the present invention or any embodiment thereof, and a saliva-permeable pouch encapsulating said pouch composition.

[0222] According to an advantageous embodiment of the invention, the bagged product comprises the bag 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.

[0223] In one embodiment of the invention, the bagged product comprises the bag composition in an amount not exceeding 700 mg, for example not exceeding 600 mg, for example not exceeding 500 mg, for example not exceeding 400 mg, for example not exceeding 350 mg, for example not exceeding 300 mg, for example not exceeding 250 mg, for example not exceeding 200 mg.

[0224] In one embodiment of the invention, the bagged product comprises the bag composition in an amount of 50 mg to 700 mg, such as 60 mg to 600 mg, such as 75 mg to 500 mg, such as 75 mg to 400 mg, such as 75 mg to 350 mg, such as 100 mg to 300 mg, such as 125 mg to 250 mg, such as 150 mg to 200 mg.

[0225] In one embodiment of the invention, the bagged product comprises the bag composition in an amount of 100 mg to 700 mg, such as 150 mg to 600 mg, such as 200 mg to 500 mg, such as 300 mg to 400 mg.

[0226] According to an advantageous embodiment of the invention, the bagged product contains nicotine in an amount of at least 1 mg, such as at least 2 mg, such as at least 4 mg, such as at least 6 mg.

[0227] In one embodiment of the invention, the bagged product contains nicotine in an amount not exceeding 25 mg, for example not exceeding 20 mg, for example not exceeding 15 mg, for example not exceeding 10 mg.

[0228] In one embodiment of the invention, the bagged product contains nicotine in an amount of 1 mg to 25 mg, such as 2 mg to 20 mg, such as 4 mg to 15 mg, such as 6 mg to 10 mg. Detailed Implementation

[0229] As used herein, the term "bag composition" refers to a composition contained in an oral pouch, i.e., a bag intended for oral use. Therefore, a bag composition refers to a composition encapsulated within a bag. Furthermore, the terms "bag composition," "nicotine pouch composition," and "solid oral nicotine formulation" are used interchangeably when referring to a composition encapsulated within a bag.

[0230] As used in this article, the term "nicotine" refers to nicotine used as a refined / separated substance. Specifically, nicotine does not refer to tobacco material containing nicotine contents. Therefore, when referring to nicotine quantity (also understood as nicotine dosage), the quantity refers to the amount of pure nicotine.

[0231] Nicotine also includes nicotine that is not obtained from tobacco, which is often referred to as synthetic nicotine.

[0232] Unless otherwise specified, “ratio” as used herein refers to a weight ratio, which is the weight of the first component divided by the weight of the second component.

[0233] As used herein, the term "free nicotine" refers to the non-protonated form of nicotine and therefore does not include nicotine salts or nicotine provided as a complex between nicotine and ion exchange resins. However, free nicotine may be mixed with a certain amount of ion exchange resin or water-soluble compositions such as sugar alcohols or water-soluble cellulose. While free nicotine includes both free nicotine extracted from tobacco and synthetically produced free nicotine, it is not provided in the form of tobacco or powdered tobacco. Generally, free nicotine is provided as a liquid.

[0234] As used herein, the term "bag" is intended to refer to a container typically formed of a mesh of fibrous material that encloses a cavity. A bag is designed for the application of an active ingredient to the oral cavity and is therefore suitable for oral use; it is non-toxic and not water-soluble. The fibrous material can be, for example, formed into a woven or non-woven mesh or fabric. A bag can be sealed, for example, by bonding two corresponding pieces of mesh or fabric together along their edges to form a cavity for nicotine and non-water-soluble compositions. For nicotine release, the bag is made water-permeable to allow saliva to permeate from the oral cavity and enter the cavity, where it can come into contact with the nicotine, thereby releasing it from the bag.

[0235] As used in this article, the term "nicotine-ion exchange resin combination" refers to a combination containing nicotine compounded with an ion exchange resin and / or free nicotine mixed with an ion exchange resin.

[0236] The term “nicotine combined with ion exchange resin” as used in this article refers to nicotine combined with ion exchange resin.

[0237] In the context of this invention, the term "free nicotine mixed with an ion exchange resin" refers to a mixture comprising free nicotine and an ion exchange resin. It should be noted that even though some embodiments include a combination of nicotine compounded with an ion exchange resin and nicotine mixed with the ion exchange resin in its free alkali form, the term "free nicotine mixed with an ion exchange resin" still requires the presence of nicotine in its free alkali form. In some embodiments, the mixture is an aqueous mixture. Free nicotine and water are mixed with an ion exchange resin, thereby obtaining a mixture comprising both free nicotine and the ion exchange resin. The free nicotine mixed with the ion exchange resin is referred to in the examples as a "premix".

[0238] As used herein, the term "powder composition" refers to a composition in powder form, i.e., as particulate matter having a relatively small particle size, such as 1 micrometer to 1200 micrometers. In particular, powder composition does not mean powdered tobacco.

[0239] As used herein, the term "humectant" is understood to mean a wetting agent used to keep the bag moist, i.e., an humectant added to the bag composition for the purpose of keeping the bag moist. Therefore, the term humectant does not refer to substances added for other purposes, nor to hygroscopic substances added below for other purposes, such as sugar alcohols, water-insoluble fibers, and glycerol associated with the ion exchange resin in a nicotine-ion exchange resin combination, such as nicotine polycrystal. Some examples of humectants include propylene glycol, hydroxypropyl cellulose, and glycerol. It should be noted that when glycerol is included as a humectant, glycerol is added as free glycerol and is therefore liquid at room temperature. Other examples of humectants include triacetin, modified starch, pectin, xanthan gum, etc. The term humectant does not refer to sugar alcohols containing four or more carbons. Furthermore, the term "humectant" does not refer to fibers, such as water-insoluble fibers, including wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof. Additionally, the term "humectant" does not include, for example, NaCl.

[0240] As used herein, the term "water-soluble" refers to a relatively high water solubility, such as a water solubility of more than 5 grams of a water-soluble composition or substance per 100 mL of water, measured at 25°C, atmospheric pressure, and pH 7.0. Unless otherwise stated, when referring to a "soluble" composition or substance, it means that it is water-soluble.

[0241] As used herein, the term "water-insoluble" refers to relatively low water solubility, such as less than 0.1 g of a composition or substance per 100 mL of water, measured at 25°C, atmospheric pressure, and pH 7.0. Unless otherwise stated, when referring to "insoluble," it means water-insoluble. Therefore, a composition or substance having a water solubility of 0.1 g to 5 g per 100 mL of water, measured at 25°C, atmospheric pressure, and pH 7.0, is considered neither water-soluble nor water-insoluble, but rather to have moderate water solubility.

[0242] The pouch of the present invention provides nicotine release into the oral cavity. A nicotine release profile including both a rapid release phase and a sustained release phase can be obtained.

[0243] The terms “rapid release” or “rapid release period” used in this article may refer to the first 2 minutes of the nicotine release curve, while the term “sustained release period” refers to the subsequent period of the release curve until the end of the experiment or use.

[0244] The term “rapid release rate” as used in this article refers to the amount of nicotine released per minute in the first 2 minutes.

[0245] The term “effective release” as used in this article refers to the total release of nicotine during the release period or use period of the experiment.

[0246] The term “dissolution” as used in this article refers to the process in which a solid substance enters a solvent (such as saliva in the mouth or water in a bag) to produce a solution.

[0247] Typically, a bag includes an opening, wherein the characteristic opening size is adapted to the characteristic size of the base composition so as to retain the base composition inside the bag before use and / or to retain a portion of the base composition (e.g., a water-insoluble composition) inside the bag during use.

[0248] Considering the matrix composition to be used, in order to obtain a bag with a suitable opening size, the material for the bag can be selected accordingly, for example, containing woven and / or nonwoven fabrics.

[0249] In other words, according to various embodiments, the bag forms a membrane that allows saliva to pass through while blocking or inhibiting the passage of the matrix composition. The membrane of the bag can be any suitable material, such as woven or nonwoven fabrics (e.g., cotton, pile fabric, etc.); heat-sealable nonwoven cellulose; or other polymeric materials, such as synthetic, semi-synthetic, or natural polymeric materials. One example of a suitable bag material is paper made from pulp and a small amount of wet strength agent. Suitable materials must provide a semi-permeable membrane layer to prevent powder or composition from leaving the pack or bag during use. Suitable materials are also those that do not significantly affect the release of nicotine from the bag.

[0250] The bag composition is filled into a bag and held in the bag by a seal. Ideally, the bag is chemically and physically stable, pharmaceutically acceptable, insoluble in water, easily filled with powder and sealed, and provides a semi-permeable membrane layer that prevents the powder from leaving the bag but allows saliva and sufficiently small suspended components of the bag composition dissolved in saliva or from the bag (e.g., nicotine) to pass through the bag.

[0251] The user can place the pouch in their mouth. Saliva then enters the pouch, and the nicotine and other components soluble in the saliva begin to dissolve and are transported out of the pouch and into the mouth, where the nicotine can be absorbed.

[0252] According to one embodiment of the invention, the bag composition may also contain one or more additives.

[0253] In one embodiment of the invention, the additive is selected from bile salts, citrates, cyclodextrins, detergents, fatty acids, labrasol, lecithin, phospholipids, synthetic and natural surfactants, nonionic surfactants, solvents, steroidal detergents, solubilizers, pH adjusters, mucus dissolving and scavenging agents or mucus removers, membrane penetration enhancers, or any combination thereof. pH adjusters include buffers.

[0254] As used herein, the term "pH adjuster" refers to a reagent that actively adjusts and regulates the pH value of a solution to which it has been added or is to be added. Therefore, pH adjusters can be acids and bases, including acidic buffers and basic buffers. On the other hand, pH adjusters do not include substances and compositions that can only affect pH through dilution. Furthermore, pH adjusters do not include, for example, flavoring agents, fillers, etc.

[0255] In one embodiment of the present invention, the additional pH adjuster is selected from: acetic acid, adipic acid, citric acid, fumaric acid, gluconic acid-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, tromethamine, amino acids, or any combination thereof.

[0256] According to various embodiments of the invention, the bag may contain one or more sugar alcohols as part of the bag composition, for example, as a carrier or part thereof, or as a sweetener. Suitable sugar alcohols include those selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysate, isomaltitol, or any combination thereof.

[0257] In one embodiment of the invention, the bag composition comprises a high-intensity sweetener.

[0258] Preferred high-intensity sweeteners include, but are not limited to, sucralose alone or in combination, aspartame, salts of acesulfame potassium (e.g., acesulfame potassium), alitame, saccharin and its salts, cyclohexanesulfonic acid and its salts, glycyrrhizin, dihydrochalcone, kiwifruit protein, indigofera protein, steviol glycosides, etc.

[0259] In one embodiment of the invention, the bag composition comprises a bulk sweetener containing sugar components and / or sugar-free components.

[0260] In one embodiment of the invention, the bag composition comprises a filler sweetener in an amount of 1.0% to about 80% by weight of the bag composition, more typically 5% to about 70% by weight of the bag composition, and more generally 10% to 60% by weight or 10% to 50% by weight of the bag composition. The filler sweetener can be used not only as a sweetener but also as a humectant. In some embodiments, the inclusion of certain ingredients can further limit the approximate amount of the filler sweetener.

[0261] Sweeteners can often contribute to the flavor profile of bag compositions.

[0262] Sweeteners typically include, but are not limited to, sugar-containing components known in the industry, such as sucrose, dextrose, maltose, lactose, sorbitol, dextrin, trehalose, D-tagatose, dry invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, etc., either alone or in combination.

[0263] This sweetener can be used in combination with sugar-free sweeteners. Generally, sugar-free sweeteners include components that have sweetening properties but do not contain known sugars, and include, but are not limited to, sugar alcohols, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysate, maltitol, isomaltitol, erythritol, lactitol, etc., alone or in combination.

[0264] The term "flavoring agent" as used herein is understood to have its common meaning in the art. Flavoring agents include liquid flavoring agents and powdered flavoring agents. Therefore, flavoring agents certainly do not include sweeteners (e.g., sugars, sugar alcohols, and high-intensity sweeteners) or acids that provide pure acidity / sourness, nor do they include 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, ammonium chloride, etc. Flavoring agents can be natural or synthetic.

[0265] In one embodiment of the invention, the bag composition comprises a flavoring agent. The flavoring agent may typically be present in an amount from 0.01% to 15% by weight of the total composition of the bag, for example, from 0.01% to 5% by weight of the total composition.

[0266] Non-exhaustive examples of suitable flavoring agents in embodiments of the 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, deer antler, spearmint, eucalyptus, and mint, and fruit flavorings (e.g., flavorings from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum). Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, laurel oil, fennel, thyme, cedarwood oil, nutmeg, and oils from the aforementioned fruits.

[0267] In several embodiments of the invention, the bag composition includes a composition modifier. The composition modifier may be added to modify properties of the bag composition and / or a portion thereof, such as flowability, texture, uniformity, etc.

[0268] According to various embodiments, the composition modifier may be selected from metal stearates, modified calcium carbonate, hydrogenated vegetable oil, partially hydrogenated vegetable oil, polyethylene glycol, polyoxyethylene monostearate, animal fat, silicates, silicate dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, hydrogenated vegetable oil, hydrogenated soybean oil, emulsifiers, triglycerides, and mixtures thereof. In particular, metal stearates, such as magnesium stearate, may be advantageous.

[0269] Composition modifiers can be added to the bag composition in a variety of ways.

[0270] For example, composition modifiers can be added via the whole powder mixture during the last few minutes of final mixing.

[0271] Alternatively, the composition modifier can be added after the granulation step of the granulated premix.

[0272] Composition modifiers such as magnesium stearate can have a sealing effect and can be used to control nicotine release and bag solubility.

[0273] According to one embodiment of the invention, the bag composition comprises polyvinylpyrrolidone (PVP). The bag composition may also be PVP-free.

[0274] One advantage of the above embodiments is that a more uniform composition can be obtained.

[0275] Example

[0276] Example 1A – Preparation of a bag designed for nicotine administration

[0277] The bag is made of heat-sealable nonwoven cellulose, such as long-fiber paper. According to the invention, bags that are not in the form of nonwoven cellulose fabric can also be used.

[0278] The powder is filled into the bag and kept inside by sealing.

[0279] Example 1B – Preparation of a bag designed for nicotine administration

[0280] The bag is made from rayon fibers, such as viscose rayon staple fibers. The bag film is heat-sealed along its edges, except for an opening at one end that leads into the cavity formed by the bag film.

[0281] The powder is filled into the bag and kept inside by sealing.

[0282] Example 2: Preparation of Nicotine Premix

[0283] Fill a 60-liter planetary Bear Varimixer mixer with water and weigh and add nicotine. Stir the mixer at low speed for 1 minute at ambient temperature. Then weigh and add the Amberlite® IRP64 ion exchange resin to the mixer. Turn off the mixer and stir at high speed for 5 minutes, then open and scrape down (if necessary). Finally, stir the mixer at high speed for another 5 minutes. The total treatment time is 20 minutes.

[0284] Thus, a mixture of nicotine and cation exchange resin is produced from the components described in the table below.

[0285] Table 1. Components used to prepare nicotine premix I (5.7% nicotine). Water content in the obtained nicotine-resin composition: 71.4%.

[0286] Premix I:

[0287]

[0288] Table 2. Components used to prepare nicotine premix II (13.2% nicotine). Water content in the obtained nicotine-resin composition: 34.1%.

[0289] Premix II:

[0290]

[0291] Table 3. Components used to prepare nicotine premix III (18.5% nicotine). Water content in the obtained nicotine-resin composition: 7.5%.

[0292] Premix III:

[0293]

[0294] Table 4. Components used to prepare nicotine premix IV (10% nicotine). Water % in the obtained nicotine-resin composition: 50.0%.

[0295] Premix IV:

[0296]

[0297] Table 5. Components used to prepare nicotine premix V (20% nicotine). Water content in the obtained nicotine-resin composition: 31.5%.

[0298] Premix V:

[0299]

[0300] Table 6. Components used to prepare nicotine premix VI (30% nicotine). Water content in the obtained nicotine-resin composition: 27.5%.

[0301] Premix VI:

[0302]

[0303] Table 7. Components used to prepare nicotine premix VII (35% nicotine). Water content in the obtained nicotine-resin composition: 25.6%.

[0304] Premix VII

[0305]

[0306] Table 8. Components used to prepare nicotine premix VIII (42% nicotine). Water content in the obtained nicotine-resin composition: 22.8%.

[0307] Premix VIII:

[0308]

[0309] Example 3: Preparation of the bag composition

[0310] Prepare bags comprising the powdered compositions listed in Tables 9 to 21. The bags are manufactured as follows.

[0311] Use a planetary Bear Varimixer mixer to mix the fiber and water for 5 minutes. Then, add the following ingredients in continuous mixing: first the nicotine (mix for 2 minutes), then the remaining ingredients except for the liquid flavoring and flow aid (if any) (mix for 2 minutes), then the liquid flavoring (if any) (mix for 1 minute), and then the flow aid (if any) (mix for 1 minute). The total mixing time is 9 to 11 minutes.

[0312] For bag compositions that do not contain water or contain a small amount of water, the bag composition may be manufactured as follows, as an alternative.

[0313] Use a planetary Bear Varimixer mixer to blend the fibers and other dry ingredients for 5 minutes. Then, add the following ingredients in continuous blending: first the nicotine (blend for 2 minutes), then the remaining liquid ingredients (if any), excluding liquid flavorings and flow aids (blend for 2 minutes), then the liquid flavorings (if any) (blend for 1 minute), and then the flow aids (if any) (blend for 1 minute). The total blending time is 9 to 11 minutes.

[0314] Example 4: Preparation of filling bags

[0315] Fill the bags with the final bag composition (target fill weight 500 mg powder / bag). The bag material of Example 1A or 1B can be used. Fill the bags with powder and retain them in the bags by sealing.

[0316] Example 5A: Bag

[0317] The bag composition was prepared using the preparation method described in Example 3 from the ingredients in Table 9.

[0318] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but the bag material of 1B can also be applied).

[0319] Table 9: Bag Compositions.

[0320]

[0321] Bag contents: 500 mg total.

[0322] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber.

[0323] Sodium carbonate is used together with phosphate buffer as an alkaline buffer. Other buffers as described herein may also be used in combination with sodium carbonate or alternatives.

[0324] Phosphate buffers can be composed 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.

[0325] For example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint, or can be substituted for them. Flavoring agents can be liquid or have a specific flavor, or a combination thereof, i.e., adding liquid flavoring agents and powdered flavoring agents.

[0326] For example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other high-intensity sweeteners available herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0327] Potassium sorbate is used as a preservative. Other preservatives, as described in this article, can also be used in combination with or in place of potassium sorbate.

[0328] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0329] Example 5B: Bag

[0330] Table 10: Bag Compositions.

[0331]

[0332] Bag contents: 500 mg total.

[0333] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber.

[0334] Sodium carbonate is used together with phosphate buffer as an alkaline buffer. Other buffers as described herein may also be used in combination with sodium carbonate or alternatives.

[0335] Phosphate buffers can be composed 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.

[0336] For example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint, or can be substituted for them. Flavoring agents can be liquid or have a specific flavor, or a combination thereof, i.e., adding liquid flavoring agents and powdered flavoring agents.

[0337] For example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other high-intensity sweeteners available herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

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

[0339] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0340] Example 5C: Bag

[0341] The bag composition was prepared using the preparation method described in Example 3 from the ingredients in Table 11.

[0342] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but the bag material of 1B can also be applied).

[0343] Table 11: Bag Compositions.

[0344]

[0345]

[0346] Bag contents: 500 mg total.

[0347] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber.

[0348] Sodium carbonate is used together with phosphate buffer as an alkaline buffer. Other buffers as described herein may also be used in combination with sodium carbonate or alternatives.

[0349] Phosphate buffers can be composed 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.

[0350] For example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint, or can be substituted for them. Flavoring agents can be liquid or have a specific flavor, or a combination thereof, i.e., adding liquid flavoring agents and powdered flavoring agents.

[0351] For example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other high-intensity sweeteners available herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0352] Potassium sorbate is used as a preservative. Other preservatives, as described in this article, can also be used in combination with or in place of potassium sorbate.

[0353] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0354] Example 5D: Bag

[0355] The bag composition was prepared using the preparation method described in Example 3 from the ingredients in Table 12.

[0356] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but the bag material of 1B can also be applied).

[0357] Table 12: Bag Compositions.

[0358]

[0359] Bag contents: 500 mg total.

[0360] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber.

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

[0362] Phosphate buffers can be composed 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.

[0363] For example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint, or can be substituted for them. Flavoring agents can be liquid or have a specific flavor, or a combination thereof, i.e., adding liquid flavoring agents and powdered flavoring agents.

[0364] For example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other available high-intensity sweeteners as described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0365] Potassium sorbate is used as a preservative. Other preservatives, as described in this article, can also be used in combination with or in place of potassium sorbate.

[0366] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0367] Example 5E: Bag

[0368] The bag composition was prepared using the preparation method described in Example 3 from the ingredients in Table 13.

[0369] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but the bag material of 1B can also be applied).

[0370] Table 13: Bag Compositions.

[0371]

[0372] Bag contents: 500 mg total.

[0373] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber.

[0374] Sodium carbonate is used together with phosphate buffer as an alkaline buffer. Other buffers as described herein may also be used in combination with sodium carbonate or alternatives.

[0375] Phosphate buffers can be composed 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.

[0376] For example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint, or can be substituted for them. Flavoring agents can be liquid or have a specific flavor, or a combination thereof, i.e., adding liquid flavoring agents and powdered flavoring agents.

[0377] For example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other high-intensity sweeteners available herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0378] Potassium sorbate is used as a preservative. Other preservatives, as described in this article, can also be used in combination with or in place of potassium sorbate.

[0379] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0380] Example 5F: Bag

[0381] The bag composition was prepared using the preparation method described in Example 3 from the ingredients in Table 14A.

[0382] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but the bag material of 1B can also be applied).

[0383] Table 14A: Bag Compositions.

[0384]

[0385] Bag contents: 500 mg total.

[0386] Powdered cellulose, trade name "Vitacel L700G".

[0387] Oat fiber, trade name "Vitacel HF 600".

[0388] Microcrystalline cellulose (MCC), trade name "Vivapur 102".

[0389] Other fibers can also be used, such as water-insoluble plant fibers, such as wheat fiber, oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber.

[0390] Sodium carbonate is used together with phosphate buffer as an alkaline buffer. Other buffers as described herein may also be used in combination with sodium carbonate or alternatives.

[0391] Phosphate buffers can be composed 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.

[0392] For example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint, or can be substituted for them. Flavoring agents can be liquid or have a specific flavor, or a combination thereof, i.e., adding liquid flavoring agents and powdered flavoring agents.

[0393] For example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other high-intensity sweeteners available herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0394] Potassium sorbate is used as a preservative. Other preservatives, as described in this article, can also be used in combination with or in place of potassium sorbate.

[0395] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0396] Example 5G: Bag

[0397] The bag composition was prepared using the preparation method described in Example 3 from the ingredients in Table 14B.

[0398] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but the bag material of 1B can also be applied).

[0399] Table 14B: Bag Compositions.

[0400]

[0401] Bag contents: 500 mg total.

[0402] Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, and bamboo fiber.

[0403] Sodium carbonate is used together with phosphate buffer as an alkaline buffer. Other buffers as described herein may also be used in combination with sodium carbonate or alternatives.

[0404] Phosphate buffer (if present) 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.

[0405] For example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can also be used in combination with menthol and / or peppermint, or can be substituted for them. Flavoring agents can be liquid or have a specific flavor, or a combination thereof, i.e., adding liquid flavoring agents and powdered flavoring agents.

[0406] For example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other high-intensity sweeteners available herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0407] Potassium sorbate is used as a preservative. Other preservatives, as described in this article, can also be used in combination with or in place of potassium sorbate.

[0408] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0409] Example 6A: User Evaluation.

[0410] The pouch produced by this invention was evaluated and found to be very suitable as a nicotine delivery carrier because it provides favorable nicotine release while simultaneously providing the user with pleasure, for example, regarding the desired mouthfeel (e.g., a moist and moldable texture) and desired flavor.

[0411] Example 6B: Processability

[0412] The processability of the bagged product was evaluated by assessing the formation of clumps during processing.

[0413] Processability was further evaluated using a sieving tower via sieving analysis. Here, the product powder fraction passing through a specific sieve size during a fixed sieving time was measured. Higher powder fractions passing through the sieve during the specified fixed sieving time indicate improved processability of the product powder.

[0414] Example 7: Manufacturability Assessment

[0415] The processability of bag products PAM02 and C1 was evaluated using a sieving tower via sieving analysis.

[0416] Analysis was performed on a Retsch AS 200 controlled sieve vibrator with a sieve size of 1.7 mm. The sieving process was as follows: 100 g of product powder sample was placed on top of the sieve, the lid was tightened, and the vibrator was started. The sample was vibrated at an amplitude of 0.6 mm for 1 minute.

[0417] The product powder fraction (wt%) was measured after a 1-minute sieving time, and the results are shown in Table 15.

[0418] Table 15. Analysis of sieve towers.

[0419]

[0420] As demonstrated by the sieving test results, PAM02 exhibits superior processability compared to the comparison sample.

[0421] Example 8: Manufacturability Assessment

[0422] The processability of bag products C2, PAM61, C3, PAM62, C4 and PAM63 was evaluated using a sieving tower via sieving analysis.

[0423] Analysis was performed on a Retsch AS 200 controlled sieve vibrator with a sieve size of 1.7 mm. The sieving process was as follows: 100 g of product powder sample was placed on top of the sieve, the lid was tightened, and the vibrator was started. The sample was vibrated at an amplitude of 0.6 mm for 1 minute.

[0424] The product powder fraction (wt%) after sieving time of 1 minute was measured, and the results are shown in Table 16.

[0425] Table 16. Analysis of sieve towers.

[0426]

[0427]

[0428] As demonstrated by the sieving test results, the bag product PAM61 of the present invention exhibits significantly improved processability compared to the corresponding comparative sample C2, which is free of divalent cations and inorganic phosphates.

[0429] Similarly, it was found that the bag product PAM62 of the present invention has significantly improved processability compared to the corresponding comparative sample C3, and it was found that the bag product PAM63 of the present invention has significantly improved processability compared to the corresponding comparative sample C4.

Claims

1. An oral nicotine pouch composition comprising Nicotine, The amount is at least 5% by weight of water in the bag composition. Alginate, Inorganic divalent cations, and At least one pH adjuster containing inorganic phosphate.

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

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

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

5. The oral nicotine bag composition according to any one of claims 1 to 4, wherein the phosphate comprises a combination of monophosphate and polyphosphate, the polyphosphate being, for example, pyrophosphate.

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

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

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

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

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

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

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

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

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

15. The oral nicotine bag composition according to any one of claims 1 to 14, wherein the phosphate is provided as a salt formed 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 comprises an 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 having an ion selected from alkali metal alginate, such as sodium alginate or potassium alginate, or any combination thereof.

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

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

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

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

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, the water-soluble salt having a water solubility of at least 5 grams per 100 mL of water as measured at 25°C, atmospheric pressure and pH 7.

0.

24. The oral nicotine bag 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 carboxylate groups, such as acetate, lactate, oxalate, propionate, or levulinate; organic sulfonate groups; organic sulfate groups; organic phosphate groups; chloride ions; bromide ions; nitrate ions; sulfate ions; hydrogen phosphate ions; oxygen ions; and any combination thereof.

25. The oral nicotine bag 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 bag 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 chloride ions, bromide ions, nitrate ions, sulfate ions, bicarbonate ions, hydrogen phosphate ions, oxygen ions, hydroxide ions, and any combination thereof.

27. The oral nicotine bag 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 chloride ions, bromide ions, bicarbonate ions, sulfate ions, and any combination thereof.

28. The oral nicotine bag 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 chloride ions, bromide ions, sulfate ions, and any combination thereof.

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

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

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

32. The oral nicotine bag composition according to any one of claims 1 to 31, wherein the divalent cation is selected from 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 comprises the alginate in a weight ratio of 1:2 to 3:1 relative to the amount of divalent cations, for example, a weight ratio of 1:1 to 2:1 relative 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 comprises the alginate in a weight ratio of 1:5 to 3:1 relative to the amount of phosphate, for example, a weight ratio of 1:3 to 1:1 relative to the amount of phosphate, for example, a weight ratio of 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 comprises the alginate in a weight ratio of 1:2 to 3:1 relative to the amount of phosphate, for example, a weight ratio of 1:5 to 1:1 relative to the amount of phosphate, for example, a weight ratio of 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 comprises the divalent cation in a weight ratio of 1:8 to 1:1 relative to the amount of phosphate, for example, in a weight ratio of 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 adjuster comprises at least one additional pH adjuster.

39. The oral nicotine pouch composition according to any one of claims 1 to 38, wherein the at least one additional pH adjuster 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 additional pH adjuster is an alkaline pH adjuster, 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 additional pH adjuster is selected from sodium carbonate, sodium bicarbonate, potassium carbonate and magnesium carbonate, potassium bicarbonate, tromethamine, or any combination thereof.

42. The oral nicotine pouch composition according to any one of claims 1 to 41, wherein the pouch composition comprises the additional pH adjuster in an amount of 0.01% to 15% by weight of the pouch composition, for example, in an amount of 0.5% to 10% by weight of the pouch composition, for example, in an amount of 1% to 10% by weight of the pouch composition, for example, in an amount of 2% to 10% by weight of the pouch composition, for example, in an amount of 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 nicotine salts, free nicotine bases, nicotine-ion exchange resin combinations, nicotine inclusion complexes, or nicotine in any non-covalently bonded form; nicotine bonded to zeolite; nicotine bonded to cellulose; nicotine bonded to starch microspheres; and mixtures thereof, wherein the cellulose is, for example, microcrystalline cellulose.

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

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

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 nicotine mixed with an ion exchange resin, the weight ratio of the free nicotine to the ion exchange resin being 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.

0.

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 bag composition according to any one of claims 1 to 49, wherein the nicotine salt comprises nicotine tartrate.

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, for example at least 0.25% by weight, for example at least 0.5% by weight, for example at least 1.0% by weight, for example at least 2.0% by weight, for example at least 4.0% by weight.

53. The oral nicotine pouch composition according to any one of claims 1 to 52, wherein the pouch composition comprises an amount of nicotine-ion exchange combination 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 composition comprises nicotine compounded with the ion exchange resin, wherein the nicotine accounts for 5% to 50% by weight of the nicotine-ion exchange resin composition.

55. The oral nicotine pouch composition according to any one of claims 1 to 54, wherein the nicotine-ion exchange resin combination comprises nicotine and an ion exchange resin, wherein the amount of nicotine is from 5% to 50% by weight of the nicotine-ion exchange resin combination, and the amount of the ion exchange resin is from 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: not more than 65% by weight of the pouch composition, for example, not more than 60% by weight of the pouch composition, for example, not more than 50% by weight of the pouch composition, for example, not more than 40% by weight 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 the following amounts: 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 of the following: xylitol, maltitol, mannitol, erythritol, isomaltitol, 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 of the following: xylitol, maltitol, mannitol, erythritol, isomaltitol, 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 non-directly 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 comprises 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.

64. The oral nicotine pouch composition according to any one of claims 1 to 63, wherein the pouch composition comprises at least one sugar alcohol in the following amounts: 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 bag 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 comprises 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 fiber is free of tobacco fiber.

70. The oral nicotine pouch composition according to any one of claims 1 to 69, wherein the pouch composition is free of tobacco fibers.

71. The oral nicotine pouch composition according to any one of claims 1 to 70, wherein the pouch composition comprises 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 comprises 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 bag composition according to any one of claims 1 to 72, wherein the water-insoluble fiber comprises one or more selected from: wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and any combination thereof.

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

75. The oral nicotine bag composition according to any one of claims 1 to 74, wherein the water-insoluble fiber is free of microcrystalline cellulose.

76. The oral nicotine pouch composition according to any one of claims 1 to 75, wherein the pouch composition comprises tobacco in an amount of: no more than 5% by weight of the pouch composition, for example, no more than 2% by weight of the pouch composition, for example, no more than 1% by weight of the pouch composition, for example, no more than 0.5% by weight of the pouch composition, for example, no more than 0.1% by weight 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 comprising Nicotine, The amount is at least 5% by weight of water in the bag composition. Alginate, Inorganic multivalent cations, and At least one pH adjuster containing inorganic phosphate.

81. The oral nicotine pouch composition according to claim 80, wherein the polyvalent cation is selected from polyvalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, and nickel, such as 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 bag composition according to any one of claims 1 to 82, wherein the polyvalent cation is selected from trivalent aluminum cations, divalent calcium, magnesium, iron, zinc, and any combination thereof.

84. The oral nicotine bag composition according to any one of claims 1 to 83, wherein the polyvalent cation is selected from divalent cations of calcium, magnesium, iron, and 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 encapsulating 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 nicotine in 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.

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