Composition and Product of Nicotine in Sachets

Description

56 Composition and Product of Nicotine in Sachets FIELD OF THE INVENTION

[001] The invention relates to an oral nicotine sachet composition according to the claims and to a nicotine sachet product according to the claims. BACKGROUND

[002] In recent years, a wide range of nicotine products with reduced or no tobacco content has been observed, also present in the field of sachet or bag products.

[003] However, for sachet products, there is still a desire to provide a faster release of nicotine to give the user an improved experience through faster craving relief, while at the same time providing a desirable user experience. SUMMARY

[004] The invention relates to an oral nicotine sachet composition comprising nicotine, water in an amount of at least 5% by weight of the sachet composition, alginate inorganic divalent cations, and at least one pH regulating agent comprising inorganic phosphate.

[005] One advantage of the invention may be that the use of a pH regulating agent comprising inorganic phosphate may provide an increase in the user's pH value, which facilitates the effective absorption of nicotine. At the same time, an improvement in taste may be obtained, since the residual notes associated with other pH regulating agents may be reduced. Combined with the use of alginate which facilitates the preservation of Petition 870250108592, dated 11 / 27 / 2025, page 6 / 76 / 56 water content above a predetermined level, in order to provide a desirable sensory impression in the mouth, the sachet composition may be desirable for the user due to an improved sensory impression in the mouth and also for providing effective relief of craving.

[006] Surprisingly, the present inventor has found that, while the above advantages are obtained, a considerable improvement in processability can be achieved. Typically, the use of water in the sachet composition can result in undesirable properties regarding processability, as clumping can occur and flow properties can worsen. The present invention surprisingly provides improved processability while maintaining the advantages associated with the inclusion of water in the sachet composition and the use of alginate.

[007] In the present context, it is noted that the term “inorganic divalent cations” refers to a single type of divalent cation or to a mixture of two or more types of divalent cations. For example, two different types of divalent cations may be provided as salts with the same counterion or a different counterion, for example, as a combination of calcium chloride and magnesium chloride, or as a combination of calcium chloride and magnesium bromide. Furthermore, the same type of inorganic divalent cations may be provided as two or more different salts, i.e., with two or more different counterions, for example, calcium chloride and calcium bromide.

[008] In the present context, it is noted that the term “phosphate” refers to monophosphate, polyphosphate, such as pyrophosphate (also known as diphosphate), triphosphate, tetraphosphate, etc., and any combinations thereof. It is noted that when referring to certain salts, such as sodium salts, such reference refers to any sodium salt of the specific phosphate, so that, for example, sodium pyrophosphate also refers to tetrasodium pyrophosphate. Petition 870250108592, dated 11 / 27 / 2025, page 7 / 76 / 56

[009] In the present context, the term “alginate” refers to the ionic form of alginate, for example, in the form of a salt, as well as alginic acid.

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

[0011] According to one embodiment of the invention, the phosphate consists of a single phosphate.

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

[0013] According to an advantageous embodiment of the invention, the phosphate comprises polyphosphate, such as pyrophosphate.

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

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

[0016] According to an advantageous embodiment of the invention, the phosphate comprises phosphate supplied as a salt with an alkali metal, such as sodium or potassium.

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

[0018] According to one embodiment of the invention, the phosphate comprises phosphate supplied as a salt with sodium.

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

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

[0021] According to an advantageous embodiment of the invention, the phosphate comprises disodium phosphate. Petition 870250108592, dated 11 / 27 / 2025, page 8 / 76 / 56

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

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

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

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

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

[0027] In preferred embodiments of the invention, the phosphate is anhydrous.

[0028] In embodiments of the invention, the phosphate comprises hydrated phosphate, that is, the phosphate comprises water bound to a crystal.

[0029] According to one embodiment of the invention, the phosphate comprises phosphate supplied as a salt with potassium.

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

[0031] In one embodiment of the invention, the phosphate is provided as a water-soluble 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, as in 5 to 500 grams per 100 ml of water.

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

[0033] In an advantageous embodiment of the invention, the phosphate is supplied as a salt in an amount of not more than 7.0% by weight of the composition in the sachet, as well as not more than 5.0% by weight of the composition Petition 870250108592, dated 11 / 27 / 2025, page 9 / 76 / 56 in sachet, with no more than 4.5%, by weight, of the composition in sachet, with no more than 3.0%, by weight, of the composition in sachet, with no more than 2.0%, by weight, of the composition in sachet.

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

[0035] According to an advantageous embodiment of the invention, the sachet composition comprises alginate in an amount of at least 0.1% by weight of the sachet composition, as at least 0.2% by weight of the sachet composition, as at least 0.3% by weight of the sachet composition, as at least 0.4% by weight of the sachet composition.

[0036] In the present context, it should be understood that the amount of alginate refers to the amounts (weights) of alginate compounds, that is, the alginate ion with its counterion.

[0037] In one embodiment of the invention, the sachet composition comprises alginate in an amount of not more than 5.0% by weight of the sachet composition, not more than 3.0% by weight of the sachet composition, not more than 2.0% by weight of the sachet composition, not more than 1.5% by weight of the sachet composition, not more than 1.0% by weight of the sachet composition.

[0038] In one embodiment of the invention, the sachet composition comprises alginate in an amount of 0.1 to 5.0% by weight of the sachet composition, such as 0.1 to 3.0% by weight of the sachet composition, such as 0.2 to 2.0% by weight of the sachet composition, such as 0.3 to 1.5% by weight of the sachet composition, such as 0.4 to 1.0% by weight of the sachet composition. Petition 870250108592, dated 11 / 27 / 2025, page 10 / 76 / 56

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

[0040] In one embodiment of the invention, the alginate comprises alginate selected from the group consisting of sodium alginate, potassium alginate and any combination thereof.

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

[0042] In one embodiment of the invention, the alginate comprises sodium alginate.

[0043] In one embodiment of the invention, the alginate is sodium alginate.

[0044] In one embodiment of the invention, the alginate comprises potassium alginate.

[0045] In one embodiment of the invention, the alginate is potassium alginate.

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

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

[0048] According to an advantageous embodiment of the invention, the inorganic divalent cations comprise calcium ions.

[0049] In one embodiment of the invention, inorganic divalent cations consist of calcium ions. Petition 870250108592, dated 11 / 27 / 2025, p. 11 / 76 / 56

[0050] According to an advantageous embodiment of the invention, the inorganic divalent cations comprise magnesium ions.

[0051] In one embodiment of the invention, the inorganic divalent cations consist of magnesium ions.

[0052] According to one embodiment of the invention, the divalent cations are provided as a salt.

[0053] According to an advantageous embodiment of the invention, the divalent cations are provided as a water-soluble 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.

[0054] Thus, in the present context, the term water-soluble salt refers to a salt with a solubility in water of at least 5 grams per 100 ml of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0055] In one embodiment of the invention, the divalent cations are provided as a water-soluble salt with a water solubility of 5 to 500 grams per 100 ml of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0, as well as 5 to 350 grams per 100 ml of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0056] According to an advantageous embodiment of the invention, the inorganic divalent cations are provided as a salt comprising anions selected from the group consisting of carboxylates, such as acetate, lactate, oxalate, propionate or levulinate; organic sulfonate; organic sulfate; organic phosphate; chloride, bromide, nitrate, sulfate, hydrogen phosphate, oxide and any combination thereof.

[0057] According to an advantageous embodiment of the invention, the inorganic divalent cations are provided as an inorganic salt.

[0058] According to an advantageous embodiment of the invention, the inorganic divalent cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of Petition 870250108592, dated 11 / 27 / 2025, page 12 / 76 / 56 chloride, bromide, nitrate, sulfate, hydrogen carbonate, hydrogen phosphate, oxide, hydroxide and any combination thereof.

[0059] According to an advantageous embodiment of the invention, the inorganic divalent cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of chloride, bromide, bicarbonate, sulfate and any combination thereof.

[0060] According to an advantageous embodiment of the invention, the inorganic divalent cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of chloride, bromide, sulfate and any combination thereof.

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

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

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

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

[0065] According to one embodiment of the invention, the divalent cations comprise divalent cations supplied as calcium chloride.

[0066] According to one embodiment of the invention, the divalent cations are provided as calcium chloride.

[0067] According to one embodiment of the invention, the divalent cations comprise divalent cations supplied as calcium bromide. Petition 870250108592, dated 11 / 27 / 2025, page 13 / 76 / 56

[0068] According to one embodiment of the invention, the divalent cations are provided as calcium bromide.

[0069] According to one embodiment of the invention, the divalent cations comprise divalent cations supplied as calcium sulfate.

[0070] According to one embodiment of the invention, the divalent cations are supplied as calcium sulfate.

[0071] According to an advantageous embodiment of the invention, the inorganic divalent cations are provided as a salt in an amount of at least 0.1% by weight of the composition in the sachet, as at least 0.2% by weight of the composition in the sachet, as at least 0.3% by weight of the composition in the sachet, as at least 0.4% by weight of the composition in the sachet.

[0072] In an advantageous embodiment of the invention, the inorganic divalent cations are provided as a salt in an amount of not more than 5.0% by weight of the composition in the sachet, not more than 3.0% by weight of the composition in the sachet, not more than 2.0% by weight of the composition in the sachet, not more than 1.5% by weight of the composition in the sachet, not more than 1.0% by weight of the composition in the sachet.

[0073] In one embodiment of the invention, the inorganic divalent cations are provided as a salt in an amount of 0.1 to 5.0% by weight of the composition in the sachet, as 0.1 to 3.0% by weight of the composition in the sachet, as 0.2 to 2.0% by weight of the composition in the sachet, as 0.3 to 1.5% by weight of the composition in the sachet, as 0.4 to 1.0% by weight of the composition in the sachet.

[0074] According to an advantageous embodiment of the invention, the sachet composition comprises said alginate in a weight ratio of 1:2 to 3:1 with respect to the amount of divalent cation, as well as 1:1 to 2:1 with respect to the amount of divalent cation.

[0075] In the above configuration, the amount of alginate refers to the salt. Petition 870250108592, dated 11 / 27 / 2025, page 14 / 76 / 56 of alginate where applicable and the amount of divalent cation refers to the compound comprising divalent cation.

[0076] According to an advantageous embodiment of the invention, the sachet composition comprises said alginate in a weight ratio of 1:5 to 3:1 relative to the amount of phosphate, such as 1:3 to 1:1 relative to the amount of phosphate, or 1:2 to 2:3 relative to the amount of phosphate.

[0077] According to an advantageous embodiment of the invention, the sachet composition comprises said alginate in a weight ratio of 1:2 to 3:1 relative to the amount of phosphate, such as 1:5 to 1:1 relative to the amount of phosphate, or 1:3 to 2:3 relative to the amount of phosphate.

[0078] According to one embodiment of the invention, the sachet composition comprises said alginate in a weight ratio of 1:5 to 1:1 relative to the amount of phosphate, as well as 1:3 to 2:3 relative to the amount of phosphate.

[0079] In the embodiment above, the amount of alginate refers to the alginate salt where applicable and the amount of phosphate refers to the compound comprising phosphate.

[0080] According to an advantageous embodiment of the invention, the sachet composition comprises said divalent cations in a weight ratio of 1:8 to 1:1 relative to the amount of phosphate, as well as 1:4 to 1:2 relative to the amount of phosphate.

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

[0082] According to an advantageous embodiment of the invention, at least one pH regulating agent comprises at least one additional pH regulating agent.

[0083] Thus, in the embodiment above, the composition in the sachet comprises phosphate and at least one additional pH regulator. Petition 870250108592, dated 11 / 27 / 2025, page 15 / 76 / 56

[0084] According to an advantageous embodiment of the invention, at least one additional pH regulating agent comprises a buffering agent, such as an alkaline buffering agent.

[0085] In one embodiment of the invention, at least one additional pH regulating agent consists of a buffering agent.

[0086] According to an advantageous embodiment of the invention, at least one additional pH regulating agent is an alkaline pH regulating agent, such as an alkaline buffering agent.

[0087] One advantage of the above method may be that more efficient absorption of nicotine by the oral mucosa may be facilitated.

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

[0089] In the present context, the term trometamol refers to (tris(hydroxymethyl)aminomethane), also sometimes called tris buffer.

[0090] According to an advantageous embodiment of the invention, the sachet composition comprises said additional pH regulating agent in an amount of at least 0.01% by weight of the sachet composition, as in an amount of at least 0.5% by weight of the sachet composition, as in an amount of at least 1% by weight of the sachet composition, as in an amount of at least 2% by weight of the sachet composition, as in an amount of at least 3% by weight of the sachet composition.

[0091] According to one embodiment of the invention, the sachet composition comprises said additional pH regulating agent in an amount of not more than 15% by weight of the sachet composition, as well as in an amount of not more than 10% by weight of the sachet composition, Petition 870250108592, dated 11 / 27 / 2025, page 16 / 76 / 56 as in an amount of no more than 8%, by weight, of the composition in the sachet.

[0092] According to an advantageous embodiment of the invention, the sachet composition comprises said additional pH regulating agent in an amount of 0.01 to 15% by weight of the sachet composition, as in an amount of 0.5 to 10% by weight of the sachet composition, as in an amount of 1 to 10% by weight of the sachet composition, as in an amount of 2 to 10% by weight of the sachet composition, as in an amount of 3 to 8% by weight of the sachet composition.

[0093] In one embodiment of the invention, said additional pH regulating agent is water-soluble.

[0094] In one embodiment of the invention, said additional pH regulating agent 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.

[0095] In one embodiment of the invention, said additional pH regulating agent 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.

[0096] One advantage of the above method may be that relatively effective nicotine absorption is facilitated due to the high pH value obtained.

[0097] According to an advantageous embodiment of the invention, the nicotine is selected from the group consisting of a nicotine salt, nicotine-free base, a combination of nicotine ion-exchange resin, a nicotine inclusion complex or nicotine in any non-covalent bond; nicotine bound to zeolites, nicotine bound to cellulose, such as microcrystalline cellulose, starch microspheres and mixtures thereof.

[0098] According to an advantageous embodiment of the invention, the nicotine comprises non-saline nicotine.

[0099] In one embodiment of the invention, nicotine consists of Petition 870250108592, dated 11 / 27 / 2025, page 17 / 76 / 56 non-saline nicotine.

[00100] According to an advantageous embodiment of the invention, the nicotine comprises a freebase nicotine.

[00101] In one embodiment of the invention, the nicotine comprises a freebase nicotine.

[00102] According to an advantageous embodiment of the invention, the nicotine comprises nicotine mixed with ion exchange resin.

[00103] In one embodiment of the invention, nicotine comprises nicotine mixed with ion exchange resin.

[00104] According to an advantageous embodiment of the invention, the nicotine comprises freebase nicotine mixed with ion exchange resin in a ratio between the weight of freebase nicotine and the weight of ion exchange resin of 0.1 to 2.0, preferably 0.5 to 2.0 and, most preferably, about 0.67 to 1.0.

[00105] Thus, in one embodiment of the invention, the nicotine comprises freebase nicotine mixed with ion exchange resin in a ratio between the weight of freebase nicotine and the weight of ion exchange resin of 1:10 to 2:1, preferably 1:2 to 2:1 and, most preferably, about 2:3 to 1:1.

[00106] According to an advantageous embodiment of the invention, the nicotine comprises nicotine bound to an ion-exchange resin.

[00107] In one embodiment of the invention, nicotine comprises nicotine bound to an ion-exchange resin.

[00108] In one embodiment of the invention, the ion exchange resin comprises one or more resins selected from the group consisting of: (i) a type of weakly acidic methacrylic resin containing carboxylic functional groups, (ii) a copolymer of methacrylic acid and divinylbenzene, wherein said copolymer contains carboxylic functional groups, Petition 870250108592, dated 11 / 27 / 2025, page 18 / 76 / 56 (iii) a type of strongly acidic polystyrene resin containing sulfonic functional groups, (iv) a type of moderately acidic polystyrene resin containing phosphonic functional groups, and (v) a combination thereof.

[00109] In one embodiment of the invention, the ion exchange resin comprises polacrilex resin.

[00110] In one embodiment of the invention, the ion exchange resin is polacrilex resin.

[00111] The term NPR can be used as an abbreviation to denote nicotine complexed with the ion exchange resin specifically known as polacrilex resin.

[00112] According to an advantageous embodiment of the invention, the nicotine comprises a nicotine salt.

[00113] In one embodiment of the invention, the nicotine comprises a nicotine salt.

[00114] In one embodiment of the invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, nicotine chloride (for example, nicotine hydrochloride and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine genitate, 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 tosylate and hydrates thereof (for example, nicotine-zinc chloride monohydrate).

[00115] According to an advantageous embodiment of the invention, the nicotine salt comprises nicotine bitartrate.

[00116] The term “NBT” can be used as an abbreviation for Petition 870250108592, dated 11 / 27 / 2025, page 19 / 76 / 56, denote nicotine bitartrate.

[00117] According to one embodiment of the invention, the nicotine salt consists of nicotine bitartrate.

[00118] According to an advantageous embodiment of the invention, the nicotine comprises synthetic nicotine.

[00119] In one embodiment of the invention, the nicotine comprises synthetic nicotine.

[00120] According to an advantageous embodiment of the invention, the sachet composition comprises nicotine in an amount of at least 0.1% by weight of the sachet composition, as at least 0.25% by weight of the sachet composition, as at least 0.5% by weight of the sachet composition, as at least 1.0% by weight of the sachet composition, as at least 2.0% by weight of the sachet compositions, as at least 4.0% by weight of the sachet compositions.

[00121] In one embodiment of the invention, the sachet composition comprises nicotine in an amount of not more than 15.0% by weight of the sachet composition, as well as not more than 10.0% by weight of the sachet composition, as well as not more than 8.0% by weight of the sachet composition, as well as not more than 5.0% by weight of the sachet compositions.

[00122] In one embodiment of the invention, the sachet composition comprises nicotine in an amount of 0.1% to 15.0% by weight of the sachet composition, as well as 0.25% to 10.0% by weight of the sachet composition, as well as 1.0% to 8.0% by weight of the sachet composition, as well as 2.0% to 5.0% by weight of the sachet compositions.

[00123] According to an advantageous embodiment of the invention, the sachet composition comprises a nicotine ion exchange combination in an amount of 0.1 to 20% by weight of the sachet composition, as well as 1 to 18% by weight of the sachet composition, as well as 5 to 16% by weight of the sachet composition. Petition 870250108592, dated 11 / 27 / 2025, page 20 / 76 / 56

[00124] According to an advantageous embodiment of the invention, the nicotine ion exchange resin combination comprises nicotine complexed with ion exchange resin, wherein the nicotine constitutes an amount between 5 and 50%, by weight, of the nicotine ion exchange resin combination.

[00125] According to an advantageous embodiment of the invention, the nicotine ion exchange resin combination comprises nicotine in an amount between 5 and 50% by weight of the nicotine ion exchange resin combination and ion exchange resin in an amount between 10 and 95% by weight of the nicotine ion exchange resin combination.

[00126] According to an advantageous embodiment of the invention, the sachet composition comprises water in an amount of at least 10% by weight of the sachet composition, as well as at least 15% by weight of the sachet composition, as well as at least 20% by weight of the sachet composition.

[00127] One advantage of the above embodiment may be that a desirable, soft texture of the product in the sachet is facilitated. In addition, by including substantial amounts of water, nicotine release may be facilitated. If the water content of the sachet composition is low, the sachet composition may absorb saliva for an undesirably long period, whereas a sufficiently moist sachet composition may facilitate rapid nicotine release.

[00128] One advantage of the above method may be a relatively rapid release of nicotine.

[00129] One advantage of the above method may be a more effective release of nicotine.

[00130] In one embodiment of the invention, the sachet composition comprises water in an amount of not more than 20% by weight of the sachet composition, as well as not more than 15% by weight of the composition in Petition 870250108592, dated 11 / 27 / 2025, page 21 / 76 / 56 sachet, as no more than 10%, by weight, of the composition in the sachet.

[00131] According to an advantageous embodiment of the invention, the composition in sachets comprises water in an amount of not more than 65% by weight of the composition, as well as not more than 60% by weight of the composition, as well as not more than 50% by weight of the composition, as well as not more than 40% by weight of the composition.

[00132] According to an advantageous embodiment of the invention, the sachet composition comprises water in an amount of 5 to 65% by weight of the sachet composition, such as 10 to 65% by weight of the sachet composition, such as 15 to 60% by weight of the sachet composition, such as 15 to 50% by weight of the sachet composition, such as 20 to 50% by weight of the sachet composition, such as 20 to 40% by weight of the sachet composition.

[00133] In one embodiment of the invention, the sachet composition comprises water in an amount of 15 to 65% by weight of the sachet composition, as well as 20 to 65% by weight of the sachet composition, as well as 25 to 65% by weight of the sachet composition.

[00134] In one embodiment of the invention, the sachet composition comprises water in an amount of 15 to 65% by weight of the sachet composition, such as 15 to 60% by weight of the sachet composition, such as 15 to 50% by weight of the sachet composition, such as 15 to 40% by weight of the sachet composition.

[00135] In one embodiment of the invention, the sachet composition comprises water in an amount of 15 to 60% by weight of the sachet composition, as well as 15 to 50% by weight of the sachet composition, as well as 15 to 40% by weight of the sachet composition, as well as 15 to 30% by weight of the sachet composition.

[00136] In one embodiment of the invention, the sachet composition comprises water in an amount of 15 to 40%, by weight, of the sachet composition. Petition 870250108592, dated 11 / 27 / 2025, page 22 / 76 / 56

[00137] According to an advantageous embodiment of the invention, the sachet composition comprises at least one sugar alcohol.

[00138] One advantage of the above embodiment may be that a desirable sweetness is provided, for example, to support the flavor and aroma profile, while maintaining an appealing texture.

[00139] According to an advantageous embodiment of the invention, said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol and any combinations thereof.

[00140] One advantage of the above embodiment may be that a desirable sweetness is provided, for example, to support the flavor and aroma profile, while maintaining an appealing texture.

[00141] Thus, in the above embodiment, at least one sugar alcohol may include mixtures of different types of sugar alcohols, such as, for example, hydrogenated starch hydrolysates, which comprise a mixture mainly composed of maltitol, sorbitol and other sugar alcohols.

[00142] In one embodiment of the invention, said at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol and any combinations thereof.

[00143] According to an advantageous embodiment of the invention, said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and any combinations thereof.

[00144] In one embodiment of the invention, said at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and any combinations thereof.

[00145] In particular, with the use of sugar alcohols with Petition 870250108592, dated 11 / 27 / 2025, page 23 / 76 / 56 desirable characteristics in relation to, for example, the melting point - for example, that they are solid at room temperature of 25 degrees Celsius - a desirable texture is facilitated.

[00146] In one embodiment of the invention, the sachet composition comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol and any combinations thereof in an amount of at least 1% by weight of the sachet composition, as at least 2% by weight of the sachet composition, as at least 5% by weight of the sachet composition, as at least 10% by weight of the sachet composition, as at least 15% by weight of the sachet composition.

[00147] In one embodiment of the invention, the sachet composition comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol and any combinations thereof in an amount of 1 to 80% by weight of the sachet composition, such as 2 to 70% by weight of the sachet composition, such as 5 to 60% by weight of the sachet composition, such as 10 to 50% by weight of the sachet composition, such as 15 to 40% by weight of the sachet composition, such as 15 to 30% by weight of the sachet composition.

[00148] In one embodiment of the invention, the sachet composition comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and any combinations thereof in an amount of at least 1% by weight of the sachet composition, as at least 2% by weight of the sachet composition, as at least 5% by weight of the sachet composition, as at least 10% by weight of the sachet composition, as at least 15% by weight of the sachet composition.

[00149] In one embodiment of the invention, the sachet composition comprises sugar alcohol selected from the group consisting of xylitol, Petition 870250108592, dated 11 / 27 / 2025, page 24 / 76 / 56 maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and any combinations thereof in an amount of 1 to 80%, by weight, of the composition in sachets, as 2 to 70%, by weight, of the composition in sachets, as 5 to 60%, by weight, of the composition in sachets, as 10 to 50%, by weight, of the composition in sachets, as 15 to 40%, by weight, of the composition in sachets, as 15 to 30%, by weight, of the composition in sachets.

[00150] According to an advantageous embodiment of the invention, said at least one sugar alcohol comprises at least one sugar alcohol of a non-directly compressible (DC directly compressible) grade.

[00151] According to an advantageous embodiment of the invention, the sachet composition comprises said at least one sugar alcohol in an amount of at least 1% by weight of the sachet composition, as at least 2% by weight of the sachet composition, as at least 5% by weight of the sachet composition, as at least 10% by weight of the sachet composition, as at least 15% by weight of the sachet composition.

[00152] According to an advantageous embodiment of the invention, the sachet composition comprises said at least one sugar alcohol in an amount of 1 to 80% by weight of the sachet composition, such as 2 to 70% by weight of the sachet composition, such as 5 to 60% by weight of the sachet composition, such as 10 to 50% by weight of the sachet composition, such as 15 to 50% by weight of the sachet composition, such as 15 to 40% by weight of the sachet composition, such as 15 to 30% by weight of the sachet composition.

[00153] In one embodiment of the invention, the sachet composition comprises said composition at least one sugar alcohol in an amount of 5 to 70% by weight of the sachet composition, such as 10 to 70% by weight of the sachet composition, such as 15 to 70% by weight of the sachet composition, Petition 870250108592, dated 11 / 27 / 2025, page 25 / 76 / 56 as 20 to 70%, by weight, of the composition in sachets, as 20 to 60%, by weight, of the composition in sachets, as 20 to 50%, by weight, of the composition in sachets, as 20 to 40%, by weight, of the composition in sachets.

[00154] According to an advantageous embodiment of the invention, the sachet composition comprises water-insoluble fiber.

[00155] In one embodiment of the invention, the water-insoluble fiber comprises a tobacco-free fiber.

[00156] According to an advantageous embodiment of the invention, the water-insoluble fiber is a vegetable fiber.

[00157] According to an advantageous embodiment of the invention, the water-insoluble fiber is a tobacco-free fiber.

[00158] According to an advantageous embodiment of the invention, the sachet composition comprises tobacco-free water-insoluble fiber in an amount of at least 5% by weight of the sachet composition, as at least 10% by weight of the sachet composition, as at least 15% by weight of the sachet composition, as at least 20% by weight of the sachet composition.

[00159] Thus, the sachet composition of the above embodiment may comprise substantial amounts of water-insoluble fiber without tobacco and, in such cases, may be a tobacco-free sachet composition or a low-tobacco sachet composition.

[00160] In one embodiment of the invention, the sachet composition comprises tobacco-free water-insoluble fiber in an amount of not more than 60% by weight of the sachet composition, as well as not more than 50% by weight of the sachet composition, as well as not more than 40% by weight of the sachet composition, as well as not more than 40% by weight of the sachet composition.

[00161] In one embodiment of the invention, the sachet composition comprises tobacco-free water-insoluble fiber in an amount of 5 to 60 Petition 870250108592, dated 11 / 27 / 2025, page 26 / 76 / 56%, by weight, of the composition in sachets, such as 10 to 50%, by weight, of the composition in sachets, such as 15 to 40%, by weight, of the composition in sachets, such as at least 20 to 40%, by weight, of the composition in sachets.

[00162] According to an advantageous embodiment of the invention, the water-insoluble fibers are free of tobacco fibers.

[00163] Thus, in the embodiment above, water-insoluble fibers do not comprise any tobacco fibers or any fibers derived from tobacco, that is, water-insoluble fiber is a non-tobacco fiber. Considering that nicotine can be derived from tobacco or other sources, water-insoluble fibers do not comprise any tobacco fibers in the embodiment above.

[00164] According to an advantageous embodiment of the invention, the sachet composition is free of tobacco fibers.

[00165] Thus, in the above embodiment, the composition in the sachet does not comprise any tobacco fibers or any fibers derived from tobacco. In fact, considering that nicotine can be derived from tobacco or other sources, the composition in the sachet does not comprise any tobacco fibers in the above embodiment.

[00166] According to an advantageous embodiment of the invention, the sachet composition comprises said water-insoluble fiber in an amount of at least 5% by weight of the sachet composition, as at least 10% by weight of the sachet composition, as at least 15% by weight of the sachet composition, as at least 20% by weight of the sachet composition.

[00167] One advantage of the above method may be that a desirable texture is facilitated, for example, by the ability of the water-insoluble fiber to retain substantial amounts of water.

[00168] According to one embodiment of the invention, the sachet composition comprises said water-insoluble fiber in an amount of Petition 870250108592, dated 11 / 27 / 2025, page 27 / 76 / 56 no more than 70%, by weight, of the composition in sachets, as no more than 60%, by weight, of the composition in sachets, as no more than 45%, by weight, of the composition in sachets, as no more than 40%, by weight, of the composition in sachets.

[00169] According to one embodiment of the invention, the sachet composition comprises said water-insoluble fiber in an amount of 5 to 70% by weight of the sachet composition, such as 5 to 60% by weight of the sachet composition, such as 10 to 45% by weight of the sachet composition, such as 15 to 40% by weight of the sachet composition, such as 20 to 40% by weight of the sachet composition.

[00170] In one embodiment of the invention, the sachet composition comprises said water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition, as well as 5 to 45% by weight of the sachet composition, as well as 5 to 40% by weight of the sachet composition.

[00171] In one embodiment of the invention, the sachet composition comprises said water-insoluble fiber in an amount of 10 to 70% by weight of the sachet composition, as well as 10 to 60% by weight of the sachet composition, as well as 10 to 50% by weight of the sachet composition, as well as 15 to 50% by weight of the sachet composition.

[00172] According to an advantageous embodiment of the invention, the water-insoluble fiber comprises one or more selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose and any combination thereof.

[00173] In one embodiment of the invention, the water-insoluble fiber is selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, Petition 870250108592, dated 11 / 27 / 2025, page 28 / 76 / 56 rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose and any combination thereof.

[00174] According to an advantageous embodiment of the invention, the water-insoluble fiber comprises microcrystalline cellulose.

[00175] According to an advantageous embodiment of the invention, the water-insoluble fiber is free of microcrystalline cellulose.

[00176] In one embodiment of the invention, the water-insoluble fiber has a water-binding capacity of at least 200%, as well as at least 300%, or at least 400%.

[00177] In one embodiment of the invention, the water-insoluble fiber has a water-binding capacity of 200% to 1500%, as well as 300% to 1300%, as well as 200% to 800%, as well as 300% to 800%, as well as 400% to 600%.

[00178] In one embodiment of the invention, the water-insoluble fiber has a density of 50 to 500 grams per liter, such as 100 to 400 grams per liter, or 200 to 300 grams per liter.

[00179] In one embodiment of the invention, the sachet composition comprises water-insoluble fiber selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose and any combination thereof in an amount of at least 5% by weight of the sachet composition, as well as at least 10% by weight of the sachet composition, as well as at least 15% by weight of the sachet composition.

[00180] According to an advantageous embodiment of the invention, the sachet composition comprises tobacco in an amount of no more than 5% by weight of the sachet composition, or no more than 2% by weight of the sachet composition, or no more than 1% by weight of the composition. Petition 870250108592, dated 11 / 27 / 2025, page 29 / 76 / 56 sachet, with a maximum of 0.5%, by weight, of the composition in sachet, with a maximum of 0.1%, by weight, of the composition in sachet.

[00181] In one embodiment of the invention, the sachet composition comprises tobacco in an amount of 0.001 to 5% by weight of the sachet composition, such as 0.01 to 5% by weight of the sachet composition, such as 0.05 to 2% by weight of the sachet composition, such as 0.1 to 1% by weight of the sachet composition, such as 0.2 to 0.5% by weight of the sachet composition.

[00182] According to an advantageous embodiment of the invention, the sachet composition comprises a humectant.

[00183] To the extent that the alginate included in the sachet composition is considered a humectant, the above embodiment refers to an additional humectant.

[00184] In one embodiment, the humectant is selected from the group consisting of glycerol, propylene glycol, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.

[00185] In one embodiment of the invention, the humectant is selected from the group consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin and xanthan gum or any combination thereof.

[00186] In one embodiment of the invention, the humectant is selected from the group consisting of propylene glycol, hydroxypropyl cellulose and glycerol or any combination thereof.

[00187] One advantage of the above modality may be that a combination of a high nicotine release rate can be obtained together with a desirable sensory impression in the mouth, in this document a sensation of smoothness and moisture.

[00188] An additional advantage of the above embodiment may be that a desirable perception of taste and aroma can be obtained, facilitated by a Petition 870250108592, dated 11 / 27 / 2025, page 30 / 76 / 56 combination of an improved flavor and aroma release and a desirable sensory impression in the mouth, in the present sensation of smoothness and moisture.

[00189] The advantages of the above modality may be improved nicotine release, improved flavor and aroma release, and improved taste and aroma sensation without compromising the sensory impression of moisture in the mouth.

[00190] In one embodiment, the sachet composition comprises a humectant in an amount of 0.1 to 5, as 0.2 to 5%, by weight, of the sachet composition, as 0.5 to 2%, by weight, of the sachet composition.

[00191] According to an advantageous embodiment of the invention, the sachet composition comprises flavor and aroma.

[00192] In one embodiment of the invention, the sachet composition comprises flavor and aroma in an amount of at least 0.01%, by weight, of the sachet composition.

[00193] In one embodiment of the invention, the sachet composition comprises flavor and aroma in an amount of at least 15%, by weight, of the sachet composition.

[00194] In one embodiment of the invention, the sachet composition comprises flavor and aroma in an amount of 0.01 to 15%, by weight, of the sachet composition.

[00195] In one embodiment of the invention, the flavor and aroma comprise liquid flavor and aroma.

[00196] In one embodiment of the invention, the flavor and aroma comprise powdered flavor and aroma.

[00197] In one embodiment of the invention, the flavor and aroma comprise liquid flavor and aroma and powdered flavor and aroma.

[00198] According to an advantageous embodiment of the invention, the composition in the sachet is a powder composition.

[00199] As used herein, the term “powder composition” refers to Petition 870250108592, dated 11 / 27 / 2025, page 31 / 76 / 56 composition in powder form, that is, as a particulate material that has a relatively small particle size, for example, between 1 and 1200 micrometers. In particular, "powder composition" does not mean powdered tobacco.

[00200] The invention further relates to an oral nicotine sachet composition comprising nicotine, water in an amount of at least 5% by weight of the sachet composition, alginate inorganic multivalent cations, and at least one pH regulating agent comprising inorganic phosphate.

[00201] The above-mentioned aspect of the invention can be combined with any embodiment of the invention without necessarily including inorganic divalent cations.

[00202] According to an advantageous embodiment of the invention, said multivalent cations are selected from the group consisting of multivalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, nickel, such as Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+ and any combination thereof.

[00203] According to an advantageous embodiment of the invention, the multivalent cations are trivalent.

[00204] According to an advantageous embodiment of the invention, the multivalent cations are selected from the group consisting of trivalent aluminum cations, divalent calcium, magnesium, iron, zinc cations and any combination thereof.

[00205] According to an advantageous embodiment of the invention, multivalent cations are selected from the group consisting of cations Petition 870250108592, dated 11 / 27 / 2025, page 32 / 76 / 56 divalents of calcium, magnesium, iron, zinc and any combination thereof.

[00206] The invention further relates to a nicotine product in sachets comprising a sachet composition according to the invention and any of its embodiments and a saliva-permeable sachet enclosing said sachet composition.

[00207] According to an advantageous embodiment of the invention, the product in sachets comprises said composition in sachets in an amount of at least 50 mg, as well as at least 100 mg, as well as at least 150 mg, as well as at least 200 mg, as well as at least 300 mg.

[00208] In one embodiment of the invention, the product in sachets comprises said composition in sachets in an amount of not more than 700 mg, not more than 600 mg, not more than 500 mg, not more than 400 mg, not more than 350 mg, not more than 300 mg, not more than 250 mg, not more than 200 mg.

[00209] In one embodiment of the invention, the product in sachets comprises said composition in sachets in quantities of 50 to 700 mg, such as 60 to 600 mg, such as 75 to 500 mg, such as 75 to 400 mg, such as 75 to 350 mg, such as 100 to 300 mg, such as 125 to 250 mg, such as 150 to 200 mg.

[00210] In one embodiment of the invention, the product in sachets comprises said composition in sachets in quantities of 100 to 700 mg, 150 to 600 mg, 200 to 500 mg, or 300 to 400 mg.

[00211] According to an advantageous embodiment of the invention, the product in sachets comprises nicotine in an amount of at least 1 mg, as well as at least 2 mg, as well as at least 4 mg, as well as at least 6 mg.

[00212] In one embodiment of the invention, the product in sachets comprises nicotine in an amount of not more than 25 mg, not more than 20 mg, not more than 15 mg, not more than 10 mg.

[00213] In one embodiment of the invention, the product in sachets Petition 870250108592, dated 11 / 27 / 2025, page 33 / 76 / 56 includes nicotine in quantities of 1 mg to 25 mg, as well as 2 mg to 20 mg, 4 mg to 15 mg, and 6 mg to 10 mg. DETAILED DESCRIPTION

[00214] As used herein, the term “sachet composition” refers to the composition for use in an oral sachet, i.e., in sachets for oral use. Thus, the sachet composition refers to the composition enclosed in the sachet. Furthermore, the terms “sachet composition”, “nicotine composition in sachet” and “solid oral nicotine formulation” are used interchangeably when referring to the composition enclosed in the sachet.

[00215] As used herein, the term “nicotine” refers to nicotine used as a refined / isolated substance. Specifically, nicotine does not refer to tobacco materials that have a nicotine content. Thus, when reference is made to quantities of nicotine, which should also be understood as the dose of nicotine, the quantities will refer to the amount of pure nicotine.

[00216] Nicotine also includes nicotine not obtained from tobacco, often called synthetic nicotine.

[00217] As used herein, unless specifically indicated otherwise, a “ratio” refers to the ratio by weight, that is, the weight of a first component divided by the weight of a second component.

[00218] As used herein, the term “freebase nicotine” refers to the non-protonated form of nicotine and therefore does not include nicotine salts or nicotine supplied as a complex between nicotine and an ion-exchange resin. However, freebase nicotine may be mixed with an amount of ion-exchange resin or water-soluble compositions such as sugar alcohols or water-soluble fibers. While freebase nicotine includes both freebase nicotine extracted from tobacco and synthetically manufactured freebase nicotine, freebase nicotine is not supplied in the form of tobacco or powdered tobacco. Typically, freebase nicotine Petition 870250108592, dated 11 / 27 / 2025, page 34 / 76 / 56 free is provided as a liquid.

[00219] As used herein, the term “sachet” is intended to mean a container typically formed from a mat of a fibrous material enclosing a cavity. The sachet is a sachet designed for administration of an active ingredient into the oral cavity and is therefore adapted for oral use; it is non-toxic and insoluble in water. The fibrous material may, for example, form a woven or non-woven fabric or mat. The sachet may, for example, be sealed by joining two corresponding parts of mat or fabric together along their edges to form a cavity for the nicotine and the insoluble water composition. To release the nicotine, the sachet is made permeable to water so as to allow saliva from the oral cavity to penetrate the sachet and enter the cavity, where the saliva can come into contact with the nicotine, thus releasing the nicotine from the oral sachet.

[00220] As used herein, the term “nicotine ion exchange resin combination” refers to a combination comprising nicotine complexed with ion exchange resin and / or freebase nicotine mixed with ion exchange resin.

[00221] As used herein, the term “nicotine complexed with ion-exchange resin” refers to nicotine bound to an ion-exchange resin.

[00222] In the present context, the term “freebase nicotine mixed with ion exchange resin” refers to a mixture comprising freebase nicotine and ion exchange resin. It should be mentioned that, even though some embodiments comprise a combination of nicotine complexed with ion exchange resin and nicotine in its freebase form mixed with ion exchange resin, the term “freebase nicotine mixed with ion exchange resin” requires the presence of nicotine in its freebase form. In some embodiments, the mixture is an aqueous mixture. Freebase nicotine and water are mixed with ion exchange resin, thus obtaining a mixture comprising both Petition 870250108592, dated 11 / 27 / 2025, page 35 / 76 / 56 freebase nicotine as well as ion exchange resin. Freebase nicotine mixed with ion exchange resin is called a "premix" in the examples.

[00223] As used herein, the term “powder composition” refers to the composition in powder form, i.e., as a particulate material having a relatively small particle size, for example, between 1 and 1200 micrometers. Specifically, “powder composition” does not mean powdered tobacco.

[00224] As used herein, the term “humectant” is understood to be a wetting agent used to keep the sachets moist, i.e., a humectant is added to the sachet composition for the purpose of keeping the sachet moist. Consequently, the term “humectant” does not refer to substances added for other purposes, as well as hygroscopic substances added for other purposes, such as sugar alcohols, water-insoluble fibers, and glycerol associated with ion-exchange resin in nicotine ion-exchange resin combinations, such as polacrilex-nicotine. Examples of humectants include propylene glycol, hydroxypropyl cellulose, and glycerol. Note that when glycerol is included as a humectant, the glycerol is added as free glycerol and is therefore liquid at room temperature. Additional examples of humectants include triacetin, modified starch, pectin, xanthan gum, etc. The term humectant does not refer to sugar alcohols comprising 4 or more carbons.Furthermore, the term humectant does not refer to fibers, such as water-insoluble fibers like wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof. Additionally, the term humectant does not include, for example, NaCl. Petition 870250108592, dated 11 / 27 / 2025, page 36 / 76 / 56

[00225] As used herein, the term “water-soluble” refers to a relatively high solubility in water, for example, a water solubility greater than 5 grams of a water-soluble composition or substance per 100 ml of water measured at 25 degrees Celsius, atmospheric pressure and a pH of 7.0. A reference to a “soluble” composition or substance is understood to mean water-soluble unless otherwise indicated.

[00226] As used herein, the term “insoluble in water” refers to relatively low solubility in water, for example, a water solubility of less than 0.1 grams of composition or substance per 100 ml of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0. The reference to “insoluble” is understood to mean insoluble in water, unless otherwise indicated. Therefore, compositions or substances with a water solubility between 0.1 and 5 grams per 100 ml of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0 are considered neither water-soluble nor water-insoluble, but to have an intermediate water solubility.

[00227] The sachets of the invention provide a release of nicotine in the oral cavity. A nicotine release profile can be obtained that comprises both a rapid release period and a sustained release period.

[00228] As used herein, the term “rapid release” or “rapid-release period” may refer to the initial 2 minutes of the nicotine release profile, while the term “sustained-release period” refers to the subsequent period of the release profile until the end of the experiment or the end of use.

[00229] As used herein, the term “rapid release rate” refers to the nicotine released per minute within the first 2 minutes.

[00230] As used herein, the term “effective release” refers to the total release of nicotine during the experimental release period or the period of use. Petition 870250108592, dated 11 / 27 / 2025, page 37 / 76 / 56

[00231] As used herein, the term “dissolve” is the process where a solid substance enters a solvent (such as oral saliva or water within the sachet) to produce a solution.

[00232] Typically, sachets comprise openings, where the characteristic opening dimension is adapted to a characteristic dimension of the matrix composition so as to retain the matrix composition within the sachet before use and / or to retain a portion of the matrix composition, such as a water-insoluble composition, within the sachet during use.

[00233] To obtain a sachet that has suitable opening dimensions in view of the matrix composition to be used, the material for the sachet may be selected accordingly, for example, comprising woven and / or non-woven fabric.

[00234] In other words, according to the various embodiments, the sachet forms a membrane that allows the passage of saliva and prevents or inhibits the passage of said matrix composition. The sachet membrane can be of any suitable material, for example, woven or non-woven fabric (e.g., cotton, wool, etc.), heat-sealable non-woven cellulose, or other polymeric materials, such as a synthetic, semi-synthetic, or natural polymeric material. An example of a suitable sachet material is paper made from pulp and a small amount of wet-resistance agent. A suitable material for use must provide a semi-permeable membrane layer to prevent the powder or composition from escaping from the bag or sachet during use. Suitable materials are also those that do not have a significant impact on the release of nicotine from the sachet.

[00235] The composition in sachets is placed in sachets and held in place by a seal. An ideal sachet is chemically and physically stable, pharmaceutically acceptable, insoluble in water, easy to fill with powder and seal, and provides a semi-permeable membrane layer that prevents Petition 870250108592, dated 11 / 27 / 2025, page 38 / 76 / 56 that the powder comes out of the sachet, but allows saliva and the suspended components dissolved in the same or sufficiently small amounts of the composition in the sachet, such as nicotine, to pass through said sachet.

[00236] The sachet can be placed in the oral cavity by the user. Saliva then enters the sachet, and the nicotine and other components, which are soluble in saliva, begin to dissolve and are transported with the saliva out of the sachet into the oral cavity, where the nicotine can be absorbed.

[00237] According to one embodiment of the invention, the sachet composition may additionally comprise one or more additives.

[00238] In one embodiment of the invention, said additives are selected from the group consisting of bile salts, citrates, cyclodextrins, detergents, fatty acids, labrasol, lecithins, phospholipids, synthetic and natural surfactants, nonionic surfactants, solvents, steroidal detergents, solubilizing agents, pH regulators, mucolytic or mucus-clearing agents, membrane penetration enhancers, or any combination thereof. pH regulators include buffers.

[00239] As used herein, the term “pH regulating agent” refers to agents whose active ingredient adjusts and regulates the pH value of the solution to which they have been added or are to be added. Thus, pH regulating agents can be acids and bases, including acidic buffering agents and alkaline buffering agents. On the other hand, pH regulating agents do not include substances and compositions that can only affect pH by dilution. Furthermore, pH regulating agents do not include, for example, flavors, fillers, etc.

[00240] In one embodiment of the invention, said additional pH regulating agents are selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, acid Petition 870250108592, dated 11 / 27 / 2025, page 39 / 76 / 56 succinic acid, propionic acid, ascorbic acid, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, trometamol, amino acids or any combination thereof.

[00241] According to various embodiments of the invention, one or more sugar alcohols may be included in the sachet as part of the sachet composition, for example, as a carrier or part thereof, or as a sweetener. Suitable sugar alcohols include sugar alcohols selected from the sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt groups, or any combination thereof.

[00242] In one embodiment of the invention, the sachet composition comprises a high-intensity sweetener.

[00243] Preferred high-intensity sweeteners include, but are not limited to, sucralose, aspartame, acesulfame salts such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination.

[00244] In one embodiment of the invention, the sachet composition comprises bulk sweeteners, including components with and / or without sugar.

[00245] In one embodiment of the invention, the sachet composition comprises bulk sweetener in an amount of 1.0 to about 80% by weight of the sachet composition, more typically constituting 5 to about 70% by weight of the sachet composition and, most commonly, 10 to 60% by weight of the sachet composition or 10 to 50% by weight of the sachet composition. The bulk sweeteners may function as both a sweetener and a humectant. In some embodiments, the inclusion of certain ingredients may further limit the approximate amounts of bulk sweetener.

[00246] Sweeteners can often contribute to the profile of Petition 870250108592, dated 11 / 27 / 2025, page 40 / 76 / 56 flavor and aroma of the composition in sachet.

[00247] Sugar-based sweeteners generally include, but are not limited to, saccharide-containing components, commonly known in the sachet art, such as sucrose, dextrose, maltose, sucrose, lactose, sorbose, dextrin, trehalose, D-tagatose, dry invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup and the like, alone or in combination.

[00248] The sweetener can be used in combination with sugar-free sweeteners. In general, sugar-free sweeteners include components with sweetening characteristics, but which are devoid of commonly known sugars and include, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.

[00249] As used herein, the term “flavor and aroma” is understood by its common meaning in the art. Flavor and aroma include liquid and powdered flavors. Thus, flavors do not actually include sweeteners (such as sugar, sugar alcohols, and high-intensity sweeteners) or acids that provide pure acidity / pure sourness, nor compounds that provide pure salinity (e.g., NaCl) or pure bitterness. Flavor and aroma enhancers include substances that provide only salinity, bitterness, or acidity. Flavor and aroma enhancers include, for example, NaCl, citric acid, ammonium chloride, etc. Flavors and aromas can be natural or synthetic.

[00250] In one embodiment of the invention, the sachet composition comprises flavor and aroma. The flavor and aroma may typically be present in amounts between 0.01 and 15%, by weight, of the total composition of the sachet, as well as between 0.01 and 5%, by weight, of the total composition.

[00251] Non-exhaustive examples of suitable flavors in embodiments of the present invention are coconut, coffee, chocolate, vanilla, grape, Petition 870250108592, dated 11 / 27 / 2025, page 41 / 76 / 56 orange, lemon, menthol, licorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus and mint, fruit essence, such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple and plum essence. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay leaf oil, anise, thyme, cedar leaf oil, nutmeg and the oils of the aforementioned fruits.

[00252] In several embodiments of the invention, the sachet composition comprises a composition modifier. The composition modifier can be added to manipulate the properties of the sachet composition and / or parts thereof, such as flowability, texture, homogeneity, etc.

[00253] Composition modifiers may, according to various embodiments, be selected from the group consisting of metallic stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, silicate dioxide, talc, magnesium stearates, calcium stearates, fumed silica, hydrogenated cottonseed oil powder, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides and mixtures thereof. In particular, metallic stearates, such as magnesium stearate, may be advantageous.

[00254] Composition modifiers can be added to the sachet composition in several ways.

[00255] For example, composition modifiers can be added by thoroughly mixing the powder during the last few minutes of the final mixing.

[00256] Alternatively, composition modifiers can be added after the granulation steps in a granulation premix. Petition 870250108592, dated 11 / 27 / 2025, page 42 / 76 / 56

[00257] The composition modifier, such as magnesium stearate, may have a sealing effect and may be used to control nicotine release and sachet solubility.

[00258] According to one embodiment of the invention, the sachet composition comprises polyvinylpyrrolidone (PVP). The sachet composition may also be PVP-free.

[00259] One advantage of the above method may be that a more uniform composition can be obtained. Examples Example 1A - Preparation of sachets designed for nicotine administration

[00260] The material of the sachets is heat-sealable nonwoven cellulose, such as long-fiber paper. Sachets that are not in the form of nonwoven cellulose fabric can also be used according to the invention.

[00261] The powder is placed in sachets and is kept in the sachet by a seal. Example 1B - Preparation of sachets designed for nicotine administration

[00262] The material of the sachets is manufactured using rayon fibers, such as viscose rayon textile fibers. The sachet membrane is heat-sealed along its edges, except for an opening at one end into an internal cavity formed by the sachet membrane.

[00263] The powder is placed in sachets and is kept in the sachet by a seal. Example 2: Preparation of nicotine premixes

[00264] A 60-liter Bear Varimixer planetary mixer was loaded with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at room temperature. Then, the Petition 870250108592, dated 11 / 27 / 2025, page 43 / 76 / 56. Amberlite® IRP64 ion exchange resin was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped if necessary. Finally, the mixer was stirred for another 5 minutes at high speed. The total processing time was 20 minutes.

[00265] Thus, mixtures of nicotine and cation exchange resin were produced from the constituents shown in the tables below. Premix I: Constituent Quantity (kg) Quantity (%) Nicotine 1.0 5.7 Water 12.5 71.4 Resin 4.0 22.9 Total 17.5 100.0 Table 1. Ingredients used to manufacture nicotine premix I (5.7% nicotine). % of water in the resulting nicotine resin composition: 71.4 Premix II:________________________________________________________________ Constituent Quantity (kg) Quantity (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100.0 Table 2. Ingredients used to manufacture Nicotine II premix (13.2% nicotine).

[00266] % of water in the composition of nicotine resin obtained: 34.1. Premix III:__________________________________________________________________ Constituent Quantity (kg) Quantity (%) Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100.0 Petition 870250108592, dated 11 / 27 / 2025, pp. 44 / 76 / 56 Table 3. Ingredients used to manufacture nicotine premix III (18.5% nicotine). % of water in the resulting nicotine resin composition: 7.5. Premix IV:____________________________________________________________ Constituent Quantity (kg) Quantity (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100.0 Table 4. Ingredients used to manufacture the IV nicotine premix (10% nicotine). % of water in the resulting nicotine resin composition: 50.0. Premix V:___________________________________________________________ Constituent Quantity (kg) Quantity (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100.0 Table 5. Ingredients used to manufacture nicotine premix V (20% nicotine). % of water in the resulting nicotine resin composition: 31.5. Premix VI:____________________________________________________________ Constituent Quantity (kg) Quantity (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100.0 Table 6. Ingredients used to manufacture the nicotine VI premix (30% nicotine). % of water in the resulting nicotine resin composition: 27.5. Premix VII__________________________________________________________ Constituent Quantity (kg) Quantity (%) Nicotine 3.83 35.0 Water 2.80 25.6 Resin 4.32 39.4 Petition 870250108592, dated 11 / 27 / 2025, pages 45 / 76 / 56 Total 10.95 100.0 Table 7. Ingredients used to manufacture nicotine premix VII (35% nicotine). % of water in the resulting nicotine resin composition: 25.6. Premix VIII:___________________________________________________________ Constituent Quantity (kg) Quantity (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100.0 Table 8. Ingredients used to manufacture Nicotine Premix VIII (42% nicotine). % of water in the resulting nicotine resin composition: 22.8. Example 3: Preparation of compositions in sachets

[00267] Sachets are prepared comprising powder compositions as described in Tables 9 to 21. The sachets are made as follows.

[00268] Fiber and water are mixed using a Bear Varimixer planetary mixer for 5 minutes. Then, the following ingredients were subsequently added under continuous mixing: first, the nicotine (mixed for 2 minutes), then the remaining ingredients, except flavor and aroma liquids and sliders, if any (mixed for 2 minutes), then flavor and aroma liquids, if any (mixed for 1 minute), then sliders, if any (mixed for 1 minute). The total mixing time is 9 to 11 minutes.

[00269] For sachet compositions comprising no or low amounts of water, the sachet compositions may alternatively be made as follows:

[00270] Fibers and other dry ingredients are mixed using a Bear Varimixer planetary mixer for 5 minutes. Then, the following ingredients were subsequently added under continuous mixing: first, the nicotine (mixed for 2 minutes), then the remaining liquid ingredients, if any, except for liquid flavor and aroma and sliders, if any. Petition 870250108592, dated 11 / 27 / 2025, page 46 / 76 / 56 (mixed for 2 minutes), then liquid flavor and aroma, if any (mixed for 1 minute), then slider, if any (mixed for 1 minute). Total mixing time is 9 to 11 minutes. Example 4: Preparing pre-filled sachets

[00271] The sachets are filled with the final sachet composition (target fill weight of 500 mg of powder per sachet). The sachet material from Example 1A or 1B may be used. The powder is placed in sachets and held in place by a seal. Example 5A: Sachets

[00272] The sachet compositions are prepared from the ingredients in Table 9 using the preparation method described in Example 3.

[00273] The sachets are filled with sachet compositions, as described in example 4 (the sachet material from example 1A was used, but 1B could also have been applied). Sachets PAM01 PAM02 PAM03 PAM04 PAM05 PAM06 C1 Nicotine quantity 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Raw material Percentage by weight Premix II 14.6 14.6 14.6 14.6 14.6 14.6 14.6 CaSO4 0.1 0.5 2.5 0.2 1.0 2.5 Xylitol 16.8 14.9 13.4 16.6 13.4 7.4 13.4 Purified water 25 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 30 Sodium alginate 0.5 0.5 0.5 0.2 1.0 2.5 2.0 Phosphate buffer 1.0 1.0 1.0 0.4 2.0 5.0 - Sodium carbonate 3.0 3.0 3.0 3.0 3.0 3.0 5.0 Flavor and aroma 6.9 6.9 6.9 6.9 6.9 6.9 6.9 High-intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 Table 9: Compositions in sachets.

[00274] Sachet contents: total of 500 mg. Petition 870250108592, dated 11 / 27 / 2025, pages 47 / 76 / 56

[00275] Wheat fiber, trade name: “Vitacel 600 WF plus”. Other fibers may also be used, such as water-insoluble vegetable fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber and bamboo fiber.

[00276] Sodium carbonate is used as an alkaline buffering agent along with phosphate buffer. As described herein, other buffering agents may also be used in combination with sodium carbonate or as an alternative.

[00277] The phosphate buffer may be composed of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[00278] Example of flavor and aroma, a mixture of, for example, menthol and peppermint may be used. In fact, as described herein, other flavors may also be used, in combination with menthol and / or peppermint, or replacing them. The flavor and aroma may be liquid or flavored, or a combination, i.e., a liquid flavor and aroma and a powdered flavor and aroma are added.

[00279] Acesulfame potassium and / or sucralose can, for example, be used as high-intensity sweeteners. Other high-intensity sweeteners described herein may be used in combination with, or instead of, acesulfame potassium and / or sucralose.

[00280] Potassium sorbate is used as a preservative. As described herein, other preservatives may also be used in combination with, or instead of, potassium sorbate.

[00281] Silicon dioxide is used as a glide agent. Other possible glide agents include, for example, magnesium stearate, starch and Petition 870250108592, dated 11 / 27 / 2025, page 48 / 76 / 56 talc. Example 5B: Sachets Sachets PAM10 PAM11 PAM12 PAM13 PAM14 PAM15 Nicotine content 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Raw material Percentage by weight Premix II 14.6 14.6 14.6 14.6 14.6 14.6 CaSO4 0.5 0.5 0.5 0.5 0.5 0.5 Xylitol 15.8 14.9 13.4 16.3 14.4 11.4 Purified water 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 Sodium alginate 0.1 1.0 2.5 0.5 0.5 0.5 Phosphate buffer 1.0 1.0 1.0 0.1 2.0 5.0 Sodium carbonate 3.0 3.0 3.0 3.0 3.0 3.0 Flavor and aroma 6.9 6.9 6.9 6.9 6.9 6.9 High-intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 Table 10: Compositions in sachets.

[00282] Sachet contents: total of 500 mg.

[00283] Wheat fiber, trade name: “Vitacel 600 WF plus”. Other fibers may also be used, such as water-insoluble vegetable fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber and bamboo fiber.

[00284] Sodium carbonate is used as an alkaline buffering agent along with phosphate buffer. As described herein, other buffering agents may also be used in combination with sodium carbonate or as an alternative.

[00285] The phosphate buffer may be composed of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate. Petition 870250108592, dated 11 / 27 / 2025, pp. 49 / 76 / 56

[00286] Example of flavor and aroma, a mixture of, for example, menthol and peppermint may be used. In fact, as described herein, other flavors may also be used, in combination with menthol and / or peppermint, or replacing them. The flavor and aroma may be liquid or flavored, or a combination, i.e., a liquid flavor and aroma and a powdered flavor and aroma are added.

[00287] Acesulfame potassium and / or sucralose can, for example, be used as high-intensity sweeteners. Other high-intensity sweeteners described herein may be used in combination with, or instead of, acesulfame potassium and / or sucralose.

[00288] Potassium sorbate is used as a preservative. As described herein, other preservatives may also be used in combination with, or instead of, potassium sorbate.

[00289] Silicon dioxide is used as a glide agent. Other possible glide agents include, for example, magnesium stearate, starch, and talc. Example 5C: Sachets

[00290] The sachet compositions are prepared from the ingredients in Table 11 using the preparation method described in Example 3.

[00291] The sachets are filled with sachet compositions, as described in example 4 (the sachet material from example 1A was used, but 1B could also have been applied). PAM 20 PAM 21 PAM 22 PAM 23 PAM 24 PAM 25 Sachets Nicotine content 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Raw material Percentage by weight Premix II 14.6 14.6 14.6 14.6 14.6 14.6 CaSO4 0.5 0.5 0.5 0.5 0.5 0.5 Erythritol 15.4 - - - 5.4 - Maltitol - 15.4 - - - - Sorbitol - - 15.4 - - - Xylitol - - - 5.2 11 32 Petition 870250108592, dated 11 / 27 / 2025, page 50 / 76 / 56 Purified water 25 25 25 29.8 24.5 17.5 Wheat fiber 30 30 30 35.4 29.5 20.9 Sodium alginate 0.5 0.5 0.5 0.5 0.5 0.5 Phosphate buffer 1.0 1.0 1.0 1.0 1.0 1.0 Sodium carbonate 3.0 3.0 3.0 3.0 3.0 3.0 Flavor and aroma 6.9 6.9 6.9 6.9 6.9 6.9 High-intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 Table 11: Compositions in sachets.

[00292] Sachet contents: total of 500 mg.

[00293] Wheat fiber, trade name: “Vitacel 600 WF plus”. Other fibers may also be used, such as water-insoluble vegetable fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber and bamboo fiber.

[00294] Sodium carbonate is used as an alkaline buffering agent along with phosphate buffer. As described herein, other buffering agents may also be used in combination with sodium carbonate or as an alternative.

[00295] The phosphate buffer may be composed of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[00296] Example of flavor and aroma, a mixture of, for example, menthol and peppermint may be used. In fact, as described herein, other flavors may also be used, in combination with menthol and / or peppermint, or replacing them. The flavor and aroma may be liquid or flavored, or a combination, i.e., a liquid flavor and aroma and a powdered flavor and aroma are added. Petition 870250108592, dated 11 / 27 / 2025, page 51 / 76 / 56

[00297] Acesulfame potassium and / or sucralose can, for example, be used as high-intensity sweeteners. Other high-intensity sweeteners described herein may be used in combination with, or instead of, acesulfame potassium and / or sucralose.

[00298] Potassium sorbate is used as a preservative. As described herein, other preservatives may also be used in combination with, or instead of, potassium sorbate.

[00299] Silicon dioxide is used as a glide agent. Other possible glide agents include, for example, magnesium stearate, starch, and talc. Example 5D: Sachets

[00300] The sachet compositions are prepared from the ingredients in Table 12 using the preparation method described in Example 3.

[00301] The sachets are filled with sachet compositions, as described in example 4 (the sachet material from example 1A was used, but 1B could also have been applied). Sachets PAM30 PAM31 PAM32 PAM33 PAM34 PAM35 PAM36 Nicotine content 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Raw material Percentage by weight Premix II 14.6 14.6 14.6 14.6 14.6 14.6 14.6 MgSO4 - - - 0.5 - - - CaCl2 - - - - 0.5 - 0.5 MgBr2 - - - - - 0.5 - CaSO4 0.5 0.5 0.5 - - - 0.5 Xylitol 18.4 16.9 14.4 15.4 15.4 15.4 14.9 Purified water 25 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 30 Sodium alginate 0.5 0.5 0.5 0.5 0.5 0.5 0.5 Phosphate buffer 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Tris - - 4.0 - - - - Sodium carbonate - 1.5 - 3.0 3.0 3.0 3.0 Flavor and aroma 6.9 6.9 6.9 6.9 6.9 6.9 6.9 High-intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Petition 870250108592, dated 11 / 27 / 2025, page 52 / 76 / 56 Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 Table 12: Compositions in sachets.

[00302] Sachet contents: total of 500 mg.

[00303] Wheat fiber, trade name: “Vitacel 600 WF plus”. Other fibers may also be used, such as water-insoluble vegetable fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber and bamboo fiber.

[00304] Sodium carbonate is used as an alkaline buffering agent along with phosphate buffer. As described herein, other buffering agents may also be used in combination with sodium carbonate or as an alternative.

[00305] The phosphate buffer may be composed of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[00306] Example of flavor and aroma, a mixture of, for example, menthol and peppermint may be used. In fact, as described herein, other flavors may also be used, in combination with menthol and / or peppermint, or replacing them. The flavor and aroma may be liquid or flavored, or a combination, i.e., a liquid flavor and aroma and a powdered flavor and aroma are added.

[00307] Acesulfame potassium and / or sucralose can, for example, be used as high-intensity sweeteners. Other high-intensity sweeteners described herein may be used in combination with, or instead of, acesulfame potassium and / or sucralose.

[00308] Potassium sorbate is used as a preservative. Petition 870250108592, dated 11 / 27 / 2025, page 53 / 76 / 56 As described here, other preservatives may also be used in combination with, or instead of, potassium sorbate.

[00309] Silicon dioxide is used as a glide agent. Other possible glide agents include, for example, magnesium stearate, starch, and talc. Example 5E: Sachets

[00310] The sachet compositions are prepared from the ingredients in Table 13 using the preparation method described in Example 3.

[00311] The sachets are filled with sachet compositions, as described in example 4 (the sachet material from example 1A was used, but 1B could also have been applied). PAM 41 PAM 42 PAM 43 PAM 44 PAM 45 PAM 46 Sachets Nicotine content 9.6 mg 9.6 mg 9.6 mg 9.6 mg 4.8 14.7 Raw material Percentage by weight NPR (16%) 12 - - - - - NBT - 5.5 1.8 - - - Premix VI - - - 4.0 3.2 5.8 Premix II - - 10 5.5 9.1 CaSO4 0.5 0.5 0.5 0.5 0.5 0.5 Xylitol 18 24.5 18.2 20.5 26.8 15.1 Purified water 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 Sodium alginate 0.5 0.5 0.5 0.5 0.5 0.5 Phosphate buffer 1.0 1.0 1.0 1.0 1.0 1.0 Sodium carbonate 3.0 3.0 3.0 3.0 3.0 3.0 Flavor and aroma 6.9 6.9 6.9 6.9 6.9 6.9 High-intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 Table 13: Compositions in sachets.

[00312] Sachet contents: total of 500 mg.

[00313] Wheat fiber, trade name: “Vitacel 600 WF plus”. Other Petition 870250108592, dated 11 / 27 / 2025, page 54 / 76 / 56 fibers can also be used, such as water-insoluble vegetable fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber and bamboo fiber.

[00314] Sodium carbonate is used as an alkaline buffering agent along with phosphate buffer. As described herein, other buffering agents may also be used in combination with sodium carbonate or as an alternative.

[00315] The phosphate buffer may be composed of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[00316] Example of flavor and aroma, a mixture of, for example, menthol and peppermint may be used. In fact, as described herein, other flavors may also be used, in combination with menthol and / or peppermint, or replacing them. The flavor and aroma may be liquid or flavored, or a combination, i.e., a liquid flavor and aroma and a powdered flavor and aroma are added.

[00317] Acesulfame potassium and / or sucralose can, for example, be used as high-intensity sweeteners. Other high-intensity sweeteners described herein may be used in combination with, or instead of, acesulfame potassium and / or sucralose.

[00318] Potassium sorbate is used as a preservative. As described herein, other preservatives may also be used in combination with, or instead of, potassium sorbate.

[00319] Silicon dioxide is used as a glide agent. Other possible glide agents include, for example, magnesium stearate, starch, and talc. Petition 870250108592, dated 11 / 27 / 2025, page 55 / 76 / 56 Example 5F: Sachets

[00320] The sachet compositions are prepared from the ingredients in Table 14A using the preparation method described in Example 3.

[00321] The sachets are filled with sachet compositions, as described in example 4 (the sachet material from example 1A was used, but 1B could also have been applied). PAM51 PAM52 PAM53 PAM54 Sachets. Nicotine content: 9.6 mg, 9.6 mg, 9.6 mg, 9.6 mg. Raw material. Content in: Percentage by weight Premix II 14.6 14.6 14.6 14.6 CaSO4 0.5 0.5 0.5 0.5 Xylitol 43.4 5.4 15.4 15.4 Purified water 12 29 25 25 Oat fiber 15 36 - - Powdered cellulose - - 30 - MCC - - - 30 Sodium alginate 0.5 0.5 0.5 0.5 Phosphate buffer 1.0 1.0 1.0 1.0 Sodium carbonate 3.0 3.0 3.0 3.0 Flavor and aroma 6.9 6.9 6.9 6.9 High-intensity sweetener 1.0 1.0 1.0 1.0 Potassium sorbate 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 Total 100 100 100 100 Table 14A: Compositions in sachets.

[00322] Sachet contents: total of 500 mg.

[00323] Powdered cellulose, trade name “Vitacel L700G”.

[00324] Oat fiber, trade name: “Vitacel HF 600”.

[00325] Microcrystalline cellulose (MCC), trade name: “Vivapur 102”.

[00326] Other fibers can also be used, such as water-insoluble vegetable fibers, such as wheat fiber, oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, fiber Petition 870250108592, dated 11 / 27 / 2025, page 56 / 76 / 56 barley, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber and bamboo fiber.

[00327] Sodium carbonate is used as an alkaline buffering agent along with phosphate buffer. As described herein, other buffering agents may also be used in combination with sodium carbonate or as an alternative.

[00328] The phosphate buffer may be composed of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[00329] Example of flavor and aroma, a mixture of, for example, menthol and peppermint may be used. In fact, as described herein, other flavors may also be used, in combination with menthol and / or peppermint, or replacing them. The flavor and aroma may be liquid or flavored, or a combination, i.e., a liquid flavor and aroma and a powdered flavor and aroma are added.

[00330] Acesulfame potassium and / or sucralose can, for example, be used as high-intensity sweeteners. Other high-intensity sweeteners described herein may be used in combination with, or instead of, acesulfame potassium and / or sucralose.

[00331] Potassium sorbate is used as a preservative. As described herein, other preservatives may also be used in combination with, or instead of, potassium sorbate.

[00332] Silicon dioxide is used as a glide agent. Other possible glide agents include, for example, magnesium stearate, starch, and talc. Example 5G: Sachets

[00333] The sachet compositions are prepared from Petition 870250108592, dated 11 / 27 / 2025, page 57 / 76 / 56 ingredients in table 14B using the preparation method described in example 3.

[00334] The sachets are filled with sachet compositions, as described in example 4 (the sachet material from example 1A was used, but 1B could also have been applied). Sachets C2 PAM61 C3 PAM62 C4 PAM63 Nicotine content 7.5 mg 7.5 mg 7.5 mg 7.5 mg 10.0 mg 10.0 mg Raw material Content in. Percentage by weight Premix II 11.4 11.4 11.4 11.4 15.2 15.2 CaSO4 - 0.2 - 0.2 - 0.3 Erythritol 16.0 16.0 17.0 17.0 13.6 13.6 Purified water 25 25 26 26 25 25 Wheat fiber 30 30 30 30 30 30 Sodium alginate 1.0 0.3 1.0 0.3 1.5 0.5 Disodium phosphate (phosphate buffer) - 0.2 - 0.2 - 0.3 Tetrasodium diphosphate (phosphate buffer) - 0.3 - 0.3 - 0.4 Sodium carbonate 3.0 3.0 3.0 3.0 3.0 3.0 Flavor and aroma 10.7 10.7 8.7 8.7 8.8 8.8 High-intensity sweetener 0.8 0.8 0.8 0.8 0.8 0.8 Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 Table 14B: Compositions in sachets.

[00335] Sachet contents: total of 500 mg.

[00336] Wheat fiber, trade name: “Vitacel 600 WF plus”. Other fibers may also be used, such as water-insoluble vegetable fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber and bamboo fiber.

[00337] Sodium carbonate is used as an alkaline buffering agent along with phosphate buffer. As described herein, other buffering agents may also be used in combination with sodium carbonate or as an alternative. Petition 870250108592, dated 11 / 27 / 2025, page 58 / 76 / 56

[00338] The phosphate buffer (if present) may consist of a single phosphate, such as sodium phosphate, potassium phosphate, sodium pyrophosphate, sodium polyphosphate, or a combination of two or more phosphates, such as sodium phosphate and sodium pyrophosphate.

[00339] Example of flavor and aroma, a mixture of, for example, menthol and peppermint may be used. In fact, as described herein, other flavors may also be used, in combination with menthol and / or peppermint, or replacing them. The flavor and aroma may be liquid or flavored, or a combination, i.e., a liquid flavor and aroma and a powdered flavor and aroma are added.

[00340] Acesulfame potassium and / or sucralose can, for example, be used as high-intensity sweeteners. Other high-intensity sweeteners described herein may be used in combination with, or instead of, acesulfame potassium and / or sucralose.

[00341] Potassium sorbate is used as a preservative. As described herein, other preservatives may also be used in combination with, or instead of, potassium sorbate.

[00342] Silicon dioxide is used as a glide agent. Other possible glide agents include, for example, magnesium stearate, starch, and talc. Example 6A: User evaluation.

[00343] The sachets produced from the invention have been evaluated and found to be highly suitable as vehicles for nicotine delivery, insofar as they provide a favorable release of nicotine and, at the same time, are pleasant for the user, for example, with regard to a desirable sensory impression in the mouth, such as a moist and moldable texture and a desirable flavor. Example 6B: Processability

[00344] The sachet products were evaluated in relation to Petition 870250108592, dated 11 / 27 / 2025, page 59 / 76 / 56 processability by assessment of clump formation during processing.

[00345] Processability was further evaluated by means of a sieve analysis using a sieve tower. In this document, the fractions of product powder passing through certain sieve sizes during a fixed sieving time were measured. A higher powder fraction passing through the sieve during the specified and fixed sieving time indicates improved processability of the product powder. Example 7: Processability Evaluation

[00346] The sachet products PAM02 and C1 were evaluated for processability by means of a sieve analysis using a sieve tower.

[00347] The analyses were performed on a Retsch AS 200 control sieve shaker with a sieve with a mesh size of 1.7 mm. The sieving procedure was as follows: A 100 g sample of product powder was placed on top of the sieve, the lid was secured, and the shaker was started. The sample was shaken for 1 min with an amplitude of 0.6 mm.

[00348] The fractions of product powder (%, by weight) that pass through the sieve after 1 min of sieving time were measured, producing the results as seen in Table 15. Sample ID Fraction of powder passing through the sieve, %, by weight C1 (comparative) 38.4 PAM02 69.4 Table 15. Screening tower analysis.

[00349] PAM02 was found to have excellent processability compared to the comparison sample, as evidenced by the sieving test results. Example 8: Processability assessment Petition 870250108592, dated 11 / 27 / 2025, pages 60 / 76 / 56

[00350] Products in sachets C2, PAM61, C3, PAM62, C4 and PAM63 were evaluated for processability by means of a sieve analysis using a sieve tower.

[00351] The analyses were performed on a Retsch AS 200 control sieve shaker with a sieve with a mesh size of 1.7 mm. The sieving procedure was as follows: A 100 g sample of product powder was placed on top of the sieve, the lid was secured, and the shaker was started. The sample was shaken for 1 min with an amplitude of 0.6 mm.

[00352] The fractions of product powder (%, by weight) that pass through the sieve after 1 min of sieving time were measured, producing the results as seen in Table 16. Sample ID | Fraction of powder passing through the sieve, %, by weight | C2 (comparative) | 89.2 | PAM61 | 94.5 | C3 (comparative) | 83.4 | PAM62 | 94.4 | C4 (comparative) | 89.9 | PAM63 | 95.3 Table 16. Screening tower analysis.

[00353] Compared to the corresponding comparative sample C2 without divalent cations and without inorganic phosphate, the PAM61 sachet product of the invention was found to have significantly improved processability, as evidenced by the sieving test results.

[00354] Similarly, the PAM62 sachet product of the invention was found to have significantly improved processability compared to the corresponding comparative sample C3, and the PAM63 sachet product of the invention was found to have significantly improved processability compared to the corresponding comparative sample C4. Petition 870250108592, dated 11 / 27 / 2025, pp. 61 / 76

Claims

1 / 14 CLAIMS 1. Oral nicotine composition in sachet form, characterized in that it comprises: nicotine, water in an amount of at least 5% by weight of the composition in the sachet, alginate inorganic divalent cations, and at least one pH regulating agent comprising inorganic phosphate.

2. Nicotine composition in oral sachet according to claim 1, characterized in that the phosphate comprises at least two different phosphates.

3. Nicotine composition in oral sachet according to claim 1 or 2, characterized in that the phosphate comprises monophosphate.

4. Nicotine composition in oral sachet according to any of claims 1 to 3, characterized in that the phosphate comprises polyphosphate, such as pyrophosphate.

5. Nicotine composition in oral sachet according to any of claims 1 to 4, characterized in that the phosphate comprises a combination of monophosphate and polyphosphate, such as pyrophosphate.

6. Nicotine composition in oral sachet according to any one of claims 1 to 5, characterized in that the phosphate comprises phosphate supplied as a salt with an alkali metal, such as sodium or potassium.

7. Nicotine composition in oral sachet according to any of claims 1 to 6, characterized in that the phosphate is provided as a salt with sodium. Petition 870250108592, dated 11 / 27 / 2025, p. 62 / 76 2 / 14 8. Nicotine composition in oral sachet according to any one of claims 1 to 7, characterized in that the phosphate comprises monosodium phosphate.

9. Nicotine composition in oral sachet according to any one of claims 1 to 8, characterized in that the phosphate comprises disodium phosphate.

10. Nicotine composition in oral sachet according to any one of claims 1 to 9, characterized in that the phosphate comprises trisodium phosphate.

11. Nicotine composition in oral sachet according to any one of claims 1 to 10, characterized in that the phosphate comprises monosodium diphosphate.

12. Nicotine composition in oral sachet according to any one of claims 1 to 11, characterized in that the phosphate comprises disodium diphosphate.

13. Nicotine composition in oral sachet according to any of claims 1 to 12, characterized in that the phosphate comprises trisodium diphosphate.

14. Nicotine composition in oral sachet according to any of claims 1 to 13, characterized in that the phosphate comprises tetrasodium diphosphate.

15. Oral nicotine composition in sachets according to any one of claims 1 to 14, characterized in that the phosphate is provided as a salt with potassium.

16. Oral nicotine composition in sachet according to any of claims 1 to 15, characterized in that the composition in sachet is provided as a salt in an amount of at least 0.1% by weight of the composition in sachet, as at least 0.2% by weight of the composition in sachet, as at least 0.5% by weight of the composition in sachet, as at least 1.0% by weight of the composition in sachet.

17. Oral nicotine composition in sachet according to any of claims 1 to 16, characterized in that the composition in the sachet comprises alginate in an amount of at least 0.1% by weight of the composition in the sachet, as at least 0.2% by weight of the composition in the sachet, as at least 0.3% by weight of the composition in the sachet, as at least 0.4% by weight of the composition in the sachet.

18. Oral nicotine composition in sachet according to any of claims 1 to 17, characterized in that the alginate is provided as a salt with an ion selected from the group consisting of alkali metal alginate, such as sodium alginate or potassium alginate or any combination thereof.

19. Nicotine composition in oral sachet according to any of claims 1 to 18, characterized in that the inorganic divalent cations are selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc and any combination thereof.

20. Nicotine composition in oral sachet according to any of claims 1 to 19, characterized in that the inorganic divalent cations are selected from the group consisting of divalent cations of calcium, magnesium and any combination thereof.

21. Nicotine composition in oral sachet according to any one of claims 1 to 20, characterized in that the inorganic divalent cations comprise calcium ions.

22. Nicotine composition in oral sachet according to any of claims 1 to 21, characterized in that the inorganic divalent cations comprise magnesium ions. Petition 870250108592, dated 11 / 27 / 2025, pp. 64 / 76 4 / 14 23. Nicotine composition in oral sachet according to any of claims 1 to 22, characterized in that the divalent cations are provided as a water-soluble 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.

24. Oral nicotine composition in sachets according to any of claims 1 to 23, characterized in that the inorganic divalent cations are provided as a salt comprising anions selected from the group consisting of carboxylates, such as acetate, lactate, oxalate, propionate or levulinate; organic sulfonate; organic sulfate; organic phosphate; chloride, bromide, nitrate, sulfate, hydrogen phosphate, oxide and any combination thereof.

25. Nicotine composition in oral sachet according to any one of claims 1 to 24, characterized in that the inorganic divalent cations are provided as an inorganic salt.

26. Oral nicotine sachet composition according to any of claims 1 to 25, characterized in that the inorganic divalent cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of chloride, bromide, nitrate, sulfate, hydrogen carbonate, hydrogen phosphate, oxide, hydroxide and any combination thereof.

27. Oral nicotine composition in sachet according to any of claims 1 to 26, characterized in that the inorganic divalent cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of chloride, bromide, bicarbonate, sulfate and any combination thereof.

28. Oral nicotine composition in sachet according to any of claims 1 to 27, characterized in that the divalent inorganic cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of chloride, bromide, sulfate and any combination thereof.

29. Nicotine composition in oral sachet according to any one of claims 1 to 28, characterized in that the divalent cation is provided as an inorganic chloride salt.

30. Nicotine composition in oral sachet according to any one of claims 1 to 28, characterized in that the divalent cation is provided as an inorganic salt with bromide.

31. Nicotine composition in oral sachet according to any one of claims 1 to 28, characterized in that the divalent cation is provided as an inorganic salt with sulfate.

32. Nicotine composition in oral sachet according to any of claims 1 to 31, characterized in that the divalent cations are selected from the group consisting of calcium chloride, calcium bromide, calcium sulfate, magnesium chloride, magnesium bromide, magnesium sulfate and any combination thereof.

33. Oral nicotine composition in sachet according to any of claims 1 to 32, characterized in that the sachet composition comprises tobacco-free water-insoluble fiber in an amount of at least 0.1% by weight of the sachet composition, as at least 0.2% by weight of the sachet composition, as at least 0.3% by weight of the sachet composition, as at least 0.4% by weight of the sachet composition.

34. Oral nicotine composition in sachet according to any of claims 1 to 33, characterized in that the sachet composition comprises said alginate in a weight ratio of 1:2 to 3:1 with respect to the amount of divalent cation, as well as 1:1 to 2:1 with respect to the amount of divalent cation. Petition 870250108592, dated 11 / 27 / 2025, pp. 66 / 76 6 / 14 35. Oral nicotine composition in sachet according to any of claims 1 to 34, characterized in that the sachet composition comprises said alginate in a weight ratio of 1:5 to 3:1 relative to the amount of phosphate, such as 1:3 to 1:1 relative to the amount of phosphate, or 1:2 to 2:3 relative to the amount of phosphate.

36. Oral nicotine composition in sachet according to any of claims 1 to 35, characterized in that the sachet composition comprises said alginate in a weight ratio of 1:2 to 3:1 with respect to the amount of phosphate, such as 1:5 to 1:1 with respect to the amount of phosphate, or 1:3 to 2:3 with respect to the amount of phosphate.

37. Oral nicotine composition in sachet according to any of claims 1 to 36, characterized in that the sachet composition comprises said divalent cations in a weight ratio of 1:8 to 1:1 relative to the amount of phosphate, as well as 1:4 to 1:2 relative to the amount of phosphate.

38. Nicotine composition in oral sachet according to any of claims 1 to 37, characterized in that at least one pH regulating agent comprises at least one additional pH regulating agent.

39. Nicotine composition in oral sachet according to any of claims 1 to 38, characterized in that at least one additional pH regulator comprises a buffering agent, such as an alkaline buffering agent.

40. Nicotine composition in oral sachet according to any one of claims 1 to 39, characterized in that at least one additional pH regulator is an alkaline pH regulator, such as an alkaline buffering agent.

41. Oral nicotine composition in sachet according to any of claims 1 to 40, characterized in that the pH regulator is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate and magnesium carbonate, potassium bicarbonate, trometamol or any combination thereof.

42. Oral nicotine composition in sachet according to any of claims 1 to 41, characterized in that the composition in the sachet comprises a pH regulating agent in an amount of 0.01 to 15% by weight of the composition in the sachet, as in an amount of 0.5 to 10% by weight of the composition in the sachet, as in an amount of 1 to 10% by weight of the composition in the sachet, as in an amount of 2 to 10% by weight of the composition in the sachet, as in an amount of 3 to 8% by weight of the composition in the sachet.

43. Oral nicotine pouch composition according to any of claims 1 to 42, characterized in that the nicotine is selected from the group consisting of a nicotine salt, a nicotine-free base, a nicotine ion-exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent bond; nicotine bound to zeolites, nicotine bound to cellulose, such as microcrystalline cellulose, starch microspheres and mixtures thereof.

44. Oral nicotine sachet composition according to any one of claims 1 to 43, characterized in that the nicotine comprises non-saline nicotine.

45. Nicotine composition in oral sachet according to any of claims 1 to 44, characterized in that the nicotine comprises nicotine free base.

46. ​​Nicotine composition in oral sachet according to any of claims 1 to 45, characterized in that the nicotine comprises nicotine mixed with ion exchange resin.

47. Oral nicotine composition according to any of claims 1 to 46, characterized in that the nicotine Petition 870250108592, dated 11 / 27 / 2025, page 68 / 76 8 / 14 comprises freebase nicotine mixed with ion exchange resin in a ratio between the weight of freebase nicotine and ion exchange resin of 0.1 to 2.0, preferably 0.5 to 2.0 and, most preferably, about 0.67 to 1.

0.

48. Nicotine composition in oral sachet according to any of claims 1 to 47, characterized in that the nicotine comprises nicotine bound to an ion-exchange resin.

49. Nicotine composition in oral sachet according to any of claims 1 to 48, characterized in that the nicotine comprises a nicotine salt.

50. Nicotine composition in oral sachet according to any of claims 1 to 49, characterized in that the nicotine salt comprises nicotine bitartrate.

51. Oral nicotine composition in sachet according to any of claims 1 to 50, characterized in that the nicotine comprises synthetic nicotine.

52. Oral nicotine composition in sachet according to any of claims 1 to 51, characterized in that the sachet composition comprises nicotine in an amount of at least 0.1% by weight of the sachet composition, as at least 0.25% by weight of the sachet composition, as at least 0.5% by weight of the sachet composition, as at least 1.0% by weight of the sachet composition, as at least 2.0% by weight of the sachet compositions, as at least 4.0% by weight of the sachet compositions.

53. Oral nicotine pouch composition according to any of claims 1 to 52, characterized in that the pouch composition comprises a nicotine ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition, as well as 1 to 18% by weight of the pouch composition, as well as 5 to 16% by weight of the Petition 870250108592, dated 11 / 27 / 2025, page 69 / 76 9 / 14 pouch composition.

54. Nicotine composition in oral sachet according to any of claims 1 to 53, characterized in that the nicotine ion exchange resin combination comprises nicotine complexed with ion exchange resin, wherein the nicotine constitutes an amount between 5 and 50% by weight of the nicotine ion exchange resin combination.

55. Nicotine composition in oral sachet according to any of claims 1 to 54, characterized in that the nicotine ion exchange resin combination comprises nicotine in an amount between 5 and 50% by weight of the nicotine ion exchange resin combination and ion exchange resin in an amount between 10 and 95% by weight of the nicotine ion exchange resin combination.

56. Oral nicotine composition in sachet according to any of claims 1 to 55, characterized in that the composition in the sachet comprises water in an amount of at least 10% by weight of the composition in the sachet, as well as at least 15% by weight of the composition in the sachet, as well as at least 20% by weight of the composition in the sachet.

57. Oral nicotine composition in sachet according to any of claims 1 to 56, characterized in that the composition in the sachet comprises water in an amount of not more than 65% by weight of the composition in the sachet, not more than 60% by weight of the composition in the sachet, not more than 50% by weight of the composition in the sachet, not more than 40% by weight of the composition in the sachet.

58. Oral nicotine composition in sachet according to any of claims 1 to 57, characterized in that the composition in the sachet comprises water in an amount of 5 to 65% by weight of the composition in the sachet, as 10 to 65% by weight of the composition in Petition 870250108592, dated 11 / 27 / 2025, page 70 / 76 10 / 14 sachet, as 15 to 60% by weight of the composition in the sachet, as 15 to 50% by weight of the composition, as 20 to 50% by weight of the composition in the sachet, as 20 to 40% by weight of the composition in the sachet.

59. Oral nicotine composition in sachet according to any of claims 1 to 58, characterized in that the sachet composition comprises at least one sugar alcohol.

60. Nicotine composition in oral sachet according to any of claims 1 to 59, characterized in that said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol and any combination thereof.

61. Oral nicotine composition in sachet according to any of claims 1 to 60, characterized in that said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and any combination thereof.

62. Oral nicotine pouch composition according to any of claims 1 to 61, characterized in that said at least one sugar alcohol comprises at least one sugar alcohol of a non-directly compressible (non-DC) grade.

63. Oral nicotine composition in sachet according to any of claims 1 to 62, characterized in that the composition in sachet comprises said at least one sugar alcohol in an amount of at least 1% by weight of the composition in sachet, as at least 2% by weight of the composition in sachet, as at least 5% by weight of the composition in sachet, as at least 10% by weight of the composition in sachet, as at least 15% by weight of the composition in sachet.

64. Oral nicotine composition in sachet according to Petition 870250108592, dated 11 / 27 / 2025, pp. 71 / 76 11 / 14 any of claims 1 to 63, characterized in that the composition in sachet comprises said at least one sugar alcohol in an amount of 1 to 80% by weight of the composition in sachet, as 2 to 70% by weight of the composition in sachet, as 5 to 60% by weight of the composition in sachet, as 10 to 50% by weight of the composition in sachet, as 15 to 50% by weight of the composition in sachet, as 15 to 40% by weight of the composition in sachet, as 15 to 30% by weight of the composition in sachet.

65. Nicotine composition in oral sachet according to any of claims 1 to 64, characterized in that the sachet composition comprises water-insoluble fiber.

66. Nicotine composition in oral sachet according to any of claims 1 to 65, characterized in that the water-insoluble fiber is a vegetable fiber.

67. Nicotine composition in oral sachet according to any of claims 1 to 66, characterized in that the water-insoluble fiber is a tobacco-free fiber.

68. Oral nicotine composition in sachet according to any of claims 1 to 67, characterized in that the sachet composition comprises tobacco-free water-insoluble fiber in an amount of at least 5% by weight of the sachet composition, as at least 10% by weight of the sachet composition, as at least 15% by weight of the sachet composition, as at least 20% by weight of the sachet composition.

69. Nicotine composition in oral sachet according to any of claims 1 to 68, characterized in that the water-insoluble fibers are free of tobacco fibers.

70. Oral nicotine composition in sachet according to any of claims 1 to 69, characterized in that the sachet composition is free of tobacco fibers. Petition 870250108592, dated 11 / 27 / 2025, pp. 72 / 76 12 / 14 71. Oral nicotine composition in sachet according to any of claims 1 to 70, characterized in that the sachet composition comprises tobacco-free water-insoluble fiber in an amount of at least 5% by weight of the sachet composition, as at least 10% by weight of the sachet composition, as at least 15% by weight of the sachet composition, as at least 20% by weight of the sachet composition.

72. Oral nicotine composition in sachet according to any of claims 1 to 71, characterized in that it comprises said water-insoluble fiber in an amount of 5 to 70% by weight of the composition in sachets, as well as 5 to 60% by weight of the composition in sachets, as well as 10 to 45% by weight of the composition in sachets, as well as 15 to 40% by weight of the composition in sachets, as well as 20 to 40% by weight of the composition in sachets.

73. Oral nicotine pouch composition according to any of claims 1 to 72, characterized in that the water-insoluble fiber comprises one or more selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose and any combination thereof.

74. Nicotine composition in oral sachet according to any of claims 1 to 73, characterized in that the water-insoluble fiber comprises microcrystalline cellulose.

75. Nicotine composition in oral sachet according to any of claims 1 to 74, characterized in that the water-insoluble fiber is free of microcrystalline cellulose.

76. Oral nicotine composition in sachet according to Petition 870250108592, dated 11 / 27 / 2025, pp. 73 / 76 13 / 14 any of claims 1 to 75, characterized in that the composition in sachet comprises tobacco in an amount of not more than 5% by weight of the composition in sachet, not more than 2% by weight of the composition in sachet, not more than 1% by weight of the composition in sachet, not more than 0.5% by weight of the composition in sachet, not more than 0.1% by weight of the composition in sachet.

77. Nicotine composition in oral sachet according to any of claims 1 to 76, characterized in that the sachet composition comprises a humectant.

78. Oral nicotine composition in sachet according to any of claims 1 to 77, characterized in that the sachet composition comprises flavoring.

79. Oral nicotine composition in sachet form according to any of claims 1 to 78, characterized in that the composition in the sachet is a powder composition.

80. Nicotine composition in oral sachet, characterized in that it comprises: nicotine, water in an amount of at least 5% by weight of the composition in the sachet, alginate inorganic multivalent cations, and at least one pH regulating agent comprising inorganic phosphate.

81. Oral nicotine composition in sachet according to claim 80, characterized in that said multivalent cations are selected from the group consisting of multivalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, nickel, such as Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Petition 870250108592, dated 11 / 27 / 2025, page 74 / 76 14 / 14 Mn4+, Cu4+ and any combination thereof.

82. Nicotine composition in oral sachet according to claim 80 or 81, characterized in that the multivalent cations are trivalent.

83. Nicotine composition in oral sachet according to any of claims 1 to 82, characterized in that the multivalent cations are selected from the group consisting of trivalent aluminum cations, divalent calcium, magnesium, iron, zinc cations and any combination thereof.

84. Nicotine composition in oral sachet according to any of claims 1 to 83, characterized in that the multivalent cations are selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc and any combination thereof.

85. Nicotine product in sachet form, characterized in that it comprises a sachet composition, as defined in any of claims 1 to 84, and a saliva-permeable sachet enclosing said sachet composition, 86. Nicotine product in sachets according to claim 85, the product in sachets being characterized in that it comprises said composition in sachets in an amount of at least 50 mg, as well as at least 100 mg, as well as at least 150 mg, as well as at least 200 mg, as well as at least 300 mg.

87. Nicotine product in sachet according to claim 85 or 86, characterized in that the composition in the sachet comprises nicotine in an amount of at least 1 mg, or at least 2 mg, or at least 4 mg, or at least 6 mg. Petition 870250108592, dated 11 / 27 / 2025, pp. 75 / 76