Pouch comprising particulate inorganic mineral filler

Abstract

A nicotine pouch composition is disclosed, the pouch composition comprising nicotine, water-insoluble fiber, water in an amount of at least 5% by weight of the pouch composition, and at least 1 % by weight of a particulate inorganic mineral filler comprising calcium carbonate, the inorganic mineral filler having a BET specific surface area of at least 15 m2 / g. Also, a nicotine pouch product comprising the pouch composition is disclosed.

Description

[0001] POUCH COMPRISING PARTICULATE INORGANIC MINERAL FILLER

[0002] FIELD OF INVENTION

[0003] The invention relates to an oral nicotine pouch composition according to the claims and a nicotine pouched product according to the claims.

[0004] BACKGROUND

[0005] In the latest years a wide range of nicotine products having a reduced tobacco content or without tobacco has been seen, also within the field of pouched products or pouches.

[0006] Yet for pouched products, it remains a desire to provide a faster nicotine release in order to give the user an improved experience by means of faster craving relief, while at the same time providing a desirable user experience.

[0007] At the same time, producing pouched products in a cost-efficient manner is desirable.

[0008] SUMMARY

[0009] The invention relates to a nicotine pouch composition, the pouch composition comprising nicotine, water-insoluble fiber, water in an amount of at least 5% by weight of the pouch composition, and at least 1 % by weight of a particulate inorganic mineral filler comprising calcium carbonate, the inorganic mineral filler having a BET specific surface area of at least 15 m2 / g.

[0010] An advantage of the invention may be that improved process characteristics, such as improved flowability, of the pouch composition may be obtained. In particular, the provided improved processability may be obtained without relying on e.g. silicon dioxide, which may be considered undesirable. Thus, even if omitting silicon dioxide, which may otherwise be added as a glidant and provide improved flowability, the pouch composition may have attained desirable characteristics with respect to flowability and processability. That is, the inventive inorganic mineral filler comprising calcium carbonate may act as a glidant in the pouch composition.

[0011] A further advantage of the invention may be that an improved release may be obtained, e.g. with respect to nicotine or flavor.

[0012] Particularly, an advantage of the invention may be a combination of good processability and good release characteristics. Typically, flowability improvement agents such as silicon dioxide may be added for better processability, yet this leads to less effective release of nicotine and flavor. Thus, the present inventors unexpectedly found that by using the claimed inorganic mineral filler having high specific surface area, desirable flowability and effective release of nicotine and flavor could be obtained at the same time.

[0013] According to an advantageous embodiment of the invention, the pouch composition comprises at least 2% by weight of the inorganic mineral filler, such as at least 4% by weight of the inorganic mineral filler, such as at least 6% by weight of the inorganic mineral filler.

[0014] In an embodiment of the invention, the pouch composition comprises the inorganic mineral filler in an amount of 1 to 10% by weight of the pouch composition, such as 2 to 10% by weight of the pouch composition, such as 4 to 9% by weight of the pouch composition, such as 6 to 8% by weight of the pouch composition.

[0015] In the present context the term “particulate inorganic mineral filler” refers to an inorganic mineral filler provided in particulate form. According to an embodiment, the BET specific surface area is measured in accordance with ISO 9277. According to an advantageous embodiment of the invention, the inorganic mineral filler comprises a natural calcium carbonate and / or a precipitated calcium carbonate.

[0016] According to an advantageous embodiment of the invention, the inorganic mineral filler has a BET specific surface area of at least 20 m2 / g, such as at least 25 m2 / g, such as at least 30 m2 / g, such as at least 40 m2 / g, such as at least 50 m2 / g.

[0017] According to an advantageous embodiment of the invention, the inorganic mineral filler has a BET specific surface area of no more than 300 m2 / g, such as no more than 250 m2 / g, such as no more than 200 m2 / g, such as no more than 150 m2 / g, such as no more than 100 m2 / g, such as no more than 75 m2 / g.

[0018] An advantage of the above embodiment may be that desirable release properties may be obtained.

[0019] In an embodiment of the invention, the inorganic mineral filler inorganic mineral has a BET specific surface area of 15 to 300 m2 / g, such as 20 to 250 m2 / g, such as 25 to 200 m2 / g, such as 30 to 150 m2 / g, such as 40 to 100 m2 / g, such as 40 to 80 m2 / g.

[0020] According to an advantageous embodiment of the invention, the inorganic mineral filler comprises calcium carbonate in an amount of at least 30% by weight of the inorganic mineral filler, such as at least 40% by weight of the inorganic mineral filler, such as at least 50% by weight of the inorganic mineral filler.

[0021] In an embodiment of the invention, the inorganic mineral filler comprises calcium carbonate in an amount of 30 to 90% by weight of the inorganic mineral filler, such as 40 to 80% by weight of the inorganic mineral filler, such as 40 to 60% by weight of the inorganic mineral filler.

[0022] In an embodiment of the invention, the inorganic mineral filler comprises calcium carbonate in an amount of 50 to 85% by weight of the inorganic mineral filler, such as 60 to 80% by weight of the inorganic mineral filler, such as 70 to 80% by weight of the inorganic mineral filler.

[0023] In an embodiment of the invention, the inorganic mineral filler has an average grain diameter of 0.1 to 50 microns.

[0024] According to an advantageous embodiment of the invention, at least 50% by weight of the inorganic mineral filler has a particle size below 10 microns, such as below 8 microns.

[0025] In an embodiment of the invention, at least 50% by weight of the inorganic mineral filler has a particle size of 3 to 10 microns, such as 4 to 10 microns, such as 4 to 8 microns.

[0026] According to an advantageous embodiment of the invention, the pouch composition comprises less than 0.1% by weight of silicon dioxide, such as being substantially free of silicon dioxide, such as free of silicon dioxide.

[0027] According to an advantageous embodiment of the invention, the inorganic mineral filler comprises phosphate.

[0028] Thus, in an embodiment of the invention, the inorganic mineral filler comprises calcium carbonate and a phosphate salt.

[0029] According to an advantageous embodiment of the invention, the phosphate is provided as a calcium salt.

[0030] According to an advantageous embodiment of the invention, the inorganic mineral filler comprises tricalcium phosphate. According to an advantageous embodiment of the invention, the inorganic mineral filler is substantially composed of a combination of calcium carbonate and tricalcium phosphate.

[0031] In an embodiment of the invention, the inorganic mineral filler consists of a combination of calcium carbonate and tricalcium phosphate.

[0032] In an embodiment of the invention, the inorganic mineral filler comprises a hydroxyapatite.

[0033] According to an advantageous embodiment of the invention, the inorganic mineral filler comprises the phosphate containing calcium salt in an amount of at least 10% by weight of the inorganic mineral filler, such as at least 15% by weight of the inorganic mineral filler, such as at least 20% by weight of the inorganic mineral filler, such as at least 30% by weight of the inorganic mineral filler, such as at least 40% by weight of the inorganic mineral filler.

[0034] In an embodiment of the invention, the inorganic mineral filler comprises the phosphate containing calcium salt in an amount of 10 to 70% by weight of the inorganic mineral filler, such as in an amount of 15 to 60% by weight of the inorganic mineral filler, such as in an amount of 20 to 50% by weight of the inorganic mineral filler, such as in an amount of 20 to 40% by weight of the inorganic mineral filler, such as in an amount of 20 to 30% by weight of the inorganic mineral filler.

[0035] In an embodiment of the invention, the inorganic mineral filler comprises the phosphate containing calcium salt in an amount of 10 to 70% by weight of the inorganic mineral filler, such as in an amount of 15 to 70% by weight of the inorganic mineral filler, such as in an amount of 20 to 70% by weight of the inorganic mineral filler, such as in an amount of 30 to 60% by weight of the inorganic mineral filler, such as in an amount of 40 to 60% by weight of the inorganic mineral filler.

[0036] In an embodiment of the invention, the inorganic mineral filler comprises tricalcium phosphate in an amount of 10 to 70% by weight of the inorganic mineral filler, such as in an amount of 15 to 60% by weight of the inorganic mineral filler, such as in an amount of 20 to 50% by weight of the inorganic mineral filler, such as in an amount of 20 to 40% by weight of the inorganic mineral filler, such as in an amount of 20 to 30% by weight of the inorganic mineral filler.

[0037] In an embodiment of the invention, the inorganic mineral filler comprises tricalcium phosphate in an amount of 10 to 70% by weight of the inorganic mineral filler, such as in an amount of 15 to 70% by weight of the inorganic mineral filler, such as in an amount of 20 to 70% by weight of the inorganic mineral filler, such as in an amount of 30 to 60% by weight of the inorganic mineral filler, such as in an amount of 40 to 60% by weight of the inorganic mineral filler.

[0038] Manufacturing of inorganic mineral fillers comprising calcium carbonate, in particular inorganic mineral fillers comprising calcium carbonate and having a BET specific surface area of at least 15 m2 / g is described in detail in International patent application WO 2010 / 121620 Al, which is hereby incorporated by reference.

[0039] According to an advantageous embodiment of the invention, the pouch composition comprises at least one sugar alcohol.

[0040] An advantage of the above embodiment may be that a desirable sweetness is provided, e.g. for support of the flavor profile, and while retaining an attractive texture.

[0041] 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.

[0042] An advantage of the above embodiment may be that a desirable sweetness is provided, e.g. for support of the flavor profile, and while retaining an attractive texture.

[0043] Thus, in the above embodiment, the at least one sugar alcohol may include mixtures of different types of sugar alcohols, such as e.g. hydrogenated starch hydrolysates, which comprises a mixture of primarily maltitol, sorbitol and further sugar alcohols.

[0044] In an 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.

[0045] 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.

[0046] In an 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.

[0047] In particular, by utilizing sugar alcohols with desirable characteristics with respect to e.g. melting point - e.g. being solid at ambient temperature of 25 degrees Celsius - a desirable texture is facilitated.

[0048] In an embodiment of the invention, said at least one sugar alcohol comprises at least one non directly compressible (non-DC) grade sugar alcohol. In an embodiment of the invention, the pouch 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 pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.

[0049] In an embodiment of the invention, the pouch 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 pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.

[0050] According to an advantageous embodiment of the invention, the pouch composition comprises said at least one sugar alcohol in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.

[0051] In an embodiment of the invention, the pouch composition comprises said at least one sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 2 to 70% by weight of the pouch composition, such as 5 to 60% by weight of the pouch composition, such as 10 to 50% by weight of the pouch composition, such as 15 to 50% by weight of the pouch composition, such as 15 to 40% by weight of the pouch composition, such as 15 to 30% by weight of the pouch composition.

[0052] In an embodiment of the invention, the pouch composition comprises said at least one sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 1 to 70% by weight of the pouch composition, such as 1 to 60% by weight of the pouch composition, such as 1 to 50% by weight of the pouch composition, such as 2 to 50% by weight of the pouch composition, such as 2 to 40% by weight of the pouch composition, such as 2 to 30% by weight of the pouch composition, such as 5 to 20% by weight of the pouch composition.

[0053] In an embodiment of the invention, the pouch composition comprises said at least one sugar alcohol in an amount of 5 to 70% by weight of the pouch composition, such as 10 to 70% by weight of the pouch composition, such as 15 to 70% by weight of the pouch composition, such as 20 to 70% by weight of the pouch composition, such as 20 to 60% by weight of the pouch composition, such as 20 to 50% by weight of the pouch composition, such as 20 to 40% by weight of the pouch composition.

[0054] An advantage of the above embodiment may be that a desirable sweetness is provided, e.g. for support of the flavor profile, and while retaining an attractive texture.

[0055] According to an advantageous embodiment of the invention, the pouch composition comprises water in an amount of at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition, such as at least 30% by weight of the pouch composition.

[0056] An advantage of the above embodiment may be that a desirable and soft texture of the pouched product is facilitated. Also, by including substantial amounts of water, release of nicotine may be facilitated. If the water content of the pouch composition is low, the pouch composition may absorb saliva for an undesirably long period, whereas a sufficiently wet pouch composition may facilitate fast release of nicotine.

[0057] An advantage of the above embodiment may be a relatively fast nicotine release. An advantage of the above embodiment may be a more effective release of nicotine.

[0058] In an embodiment of the invention, the pouch composition comprises water in an amount of no more than 65% by weight of the pouch composition, such as no more than 60% by weight of the pouch composition, such as no more than 50% by weight of the pouch composition, such as no more than 40% by weight of the pouch composition.

[0059] In an embodiment of the invention, the pouch composition comprises water in an amount of 5-65% by weight of the pouch composition, such as 10-65% by weight of the pouch composition, such as 15-60% by weight of the pouch composition, such as 15-50% by weight of the pouch composition, such as 20-50% by weight of the pouch composition, such as 20-40% by weight of the pouch composition.

[0060] In an embodiment of the invention, the pouch composition comprises water in an amount of 5-65% by weight of the pouch composition, such as 10-65% by weight of the pouch composition, such as 15-60% by weight of the pouch composition, such as 20-60% by weight of the pouch composition, such as 30-60% by weight of the pouch composition, such as 30-50% by weight of the pouch composition.

[0061] According to an advantageous embodiment of the invention, the pouch composition comprises water-insoluble fiber.

[0062] In an embodiment of the invention, the water-insoluble fiber comprises a nontobacco fiber.

[0063] According to an advantageous embodiment of the invention, the water-insoluble fiber is a plant fiber.

[0064] According to an advantageous embodiment of the invention, the pouch composition comprises said water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition.

[0065] In an embodiment of the invention, the pouch composition comprises said waterinsoluble fiber in an amount of 5 to 70 % by weight of the pouch composition, such as 5 to 60% by weight of the pouch composition, such as 10 to 45% by weight of the pouch composition, such as 15 to 40% by weight of the pouch composition, such as 20 to 40% by weight of the pouch composition.

[0066] An advantage of the above embodiment may be that a desirable texture is facilitated e.g. by the ability of the water-insoluble fiber to hold substantial amounts of water.

[0067] According to an advantageous embodiment of the invention, the water-insoluble fiber comprises one or more selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, microcrystalline cellulose, and any combination thereof.

[0068] In an embodiment of the invention, the water-insoluble fiber comprises one or more selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof.

[0069] According to an advantageous embodiment of the invention, the water-insoluble fiber comprises microcrystalline cellulose.

[0070] According to an advantageous embodiment of the invention, the water-insoluble fiber is free of microcrystalline cellulose. According to an advantageous embodiment of the invention, the pouch composition comprises flavor.

[0071] In an embodiment of the invention, the flavor comprises liquid flavor.

[0072] In an embodiment of the invention, the flavor comprises powdered flavor.

[0073] In an embodiment of the invention, the flavor comprises liquid flavor and powdered flavor.

[0074] According to an advantageous embodiment of the invention, the pouch composition comprises flavor in an amount of at least 0.1% by weight of the pouch composition.

[0075] In an embodiment of the invention, the tablet comprises flavor in an amount of 0.1 to 15.0% by weight of the tablet, such as 0.1 to 10.0% by weight of the tablet, such as 0.1 to 5.0% by weight of the tablet, such as 0.2 to 3.0% by weight of the tablet.

[0076] In an embodiment of the invention, the pouch composition is free of flavor.

[0077] According to an advantageous embodiment of the invention, the water-insoluble fiber is a non-tobacco fiber.

[0078] In an embodiment of the invention, the pouch composition comprises non-tobacco water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition. Thus, the pouch composition of the above embodiment may comprise substantial amounts of non-tobacco water-insoluble fiber and in such cases may be a nontobacco pouch composition or a low tobacco pouch composition.

[0079] In an embodiment of the invention, the pouch composition comprises non-tobacco water-insoluble fiber in an amount of 5-60% by weight of the pouch composition, such as 10-50% by weight of the pouch composition, such as 15-40% by weight of the pouch composition, such as 20-40% by weight of the pouch composition.

[0080] According to an advantageous embodiment of the invention, the pouch composition comprises tobacco in an amount of no more than 5% by weight of the pouch composition, such as no more than 2% by weight of the pouch composition, such as no more than 1% by weight of the pouch composition, such as no more than 0.5% by weight of the pouch composition, such as no more than 0.1% by weight of the pouch composition.

[0081] In an embodiment of the invention, the water-insoluble fibers are free of tobacco fibers.

[0082] According to an advantageous embodiment of the invention, the pouch composition is free of tobacco fibers.

[0083] Thus, in the above embodiment the pouch composition does not comprise any tobacco fibers or any fibers derived from tobacco. Of course, whereas the nicotine may be derived from tobacco or from other sources, the pouch composition does not comprise any tobacco fibers in the above embodiment.

[0084] According to an advantageous embodiment of the invention, the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, a nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non- covalent binding; nicotine bound to zeolites, nicotine bound to cellulose, such as microcrystalline cellulose, starch microspheres, and mixtures thereof.

[0085] In an embodiment of the invention, the nicotine comprises non-salt nicotine.

[0086] According to an advantageous embodiment of the invention, the nicotine comprises nicotine free base.

[0087] According to an advantageous embodiment of the invention, the nicotine comprises nicotine mixed with ion exchange resin.

[0088] In the present context, it should be understood that nicotine mixed with ion exchange resin refers to nicotine in the form of free base nicotine and provided as mixed with ion exchange resin. Thus, nicotine mixed with ion exchange resin refers to free base nicotine mixed with ion exchange resin.

[0089] According to an advantageous embodiment of the invention, the nicotine comprises free-base nicotine mixed with ion exchange resin in a weight ratio between the free- base nicotine and the ion exchange resin of 0.1 to 2.0, preferably from 0.5 to 2.0, and most preferred about 0.67 to 1.0.

[0090] In an embodiment of the invention, the nicotine consists of free base nicotine mixed with ion exchange resin.

[0091] According to an advantageous embodiment of the invention, the nicotine comprises nicotine bound to an ion exchange resin.

[0092] In an embodiment of the invention, the nicotine comprises nicotine bound to an ion exchange resin. In an embodiment of the invention, the nicotine consists of nicotine bound to an ion exchange resin.

[0093] In an embodiment of the invention, the ion exchange resin comprises one or more resin(s) selected from the group consisting of:

[0094] (i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups,

[0095] (ii) a copolymer of methacrylic acid and divinylbenzene, said copolymer containing carboxylic functional groups,

[0096] (iii) a polystyrene, strongly acidic type of resin containing sulphonic functional groups,

[0097] (iv) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups, and

[0098] (v) a combination thereof.

[0099] According to an advantageous embodiment of the invention, the ion exchange resin comprises polacrilex resin.

[0100] According to an advantageous embodiment of the invention, the ion exchange resin is polacrilex resin.

[0101] The term NPR may be used as an abbreviation to denote nicotine complexed with the ion-exchange resin specifically known as polacrilex resin.

[0102] According to an advantageous embodiment of the invention, the nicotine comprises a nicotine salt, such as nicotine bitartrate.

[0103] In an embodiment of the invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, nicotine chloride (e.g., nicotine hydrochloride and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine lactate, nicotine mucate, nicotine laurate, nicotine levulinate, nicotine malate nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine sulfate, hydrates thereof, or any combination thereof.

[0104] The term NBT may be used as an abbreviation to denote nicotine bitartrate.

[0105] According to an embodiment of the invention, the nicotine salt consists of nicotine bitartrate.

[0106] In an embodiment of the invention, the nicotine comprises synthetic nicotine.

[0107] In an embodiment of the invention, the nicotine consists of synthetic nicotine.

[0108] In an embodiment of the invention, the nicotine is not bound to a matrix.

[0109] In an embodiment of the invention, the nicotine is not bound to calcium carbonate.

[0110] According to an advantageous embodiment of the invention, the nicotine does not comprise a premix of nicotine free base mixed with calcium carbonate.

[0111] Thus, according to the above embodiment, the nicotine does not comprise nicotine mixed with calcium carbonate as a carrier.

[0112] According to an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.25% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1.0% by weight of the pouch composition, such as at least 2.0% by weight of the pouch compositions, such as at least 4.0% by weight of the pouch compositions. In an embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 50% by weight of nicotine-ion exchange resin combination.

[0113] In an embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of 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.

[0114] According to an advantageous embodiment of the invention, the pouch composition comprises a pH regulating agent, such as an alkaline pH regulating agent, such as an alkaline buffering agent.

[0115] In an embodiment of the invention, the pouch composition comprises a buffering agent, such as an alkaline buffering agent.

[0116] According to an advantageous embodiment of the invention, the pH regulating agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, amino acids, trometamol, or any combination thereof.

[0117] According to an advantageous embodiment of the invention, the pouch composition comprises pH regulating agent in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 3% by weight of the pouch composition.

[0118] In an embodiment of the invention, the pouch composition comprises said further pH regulating agent in an amount of 0.1 to 15% by weight of the pouch composition, such as in an amount of 0.5 to 10% by weight of the pouch composition, such as in an amount of 1 to 10% by weight of the pouch composition, such as in an amount of 2 to 10% by weight of the pouch composition, such as in an amount of 3 to 8% by weight of the pouch composition.

[0119] An advantage of the above embodiment may be that a more efficient absorption of nicotine through the oral mucosa may be facilitated.

[0120] An advantage of the above embodiment may be that a relatively effective uptake of nicotine is facilitated due to the high pH value obtained.

[0121] According to an advantageous embodiment of the invention, the pouch composition comprises humectant.

[0122] In an embodiment of the invention, the pouch composition comprises humectant in an amount of 0.5 to 10% by weight of the pouch composition, such as 0.5 to 5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition.

[0123] In an embodiment of the invention, the humectant(s) are selected from the group consisting of alginate, propylene glycol, hydroxypropyl cellulose, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

[0124] In an embodiment of the invention, the humectant(s) are selected from the group consisting of alginate, propylene glycol, and hydroxypropyl cellulose.

[0125] In an embodiment of the invention, the pouch composition is free of humectants selected from the group consisting of alginate, propylene glycol, and hydroxypropyl cellulose.

[0126] An advantage of the above embodiment may be that a combination of a high nicotine release rate may be obtained together with a desirable mouthfeel, hereunder softness and moisture feeling. A further advantage of the above embodiment may be that a desirable flavor perception may be obtained, facilitated by a combination of an improved flavor release and a desirable mouthfeel, hereunder softness and moisture feeling.

[0127] Advantages of the above embodiment may be improved release of nicotine, improved release of flavor, and improved flavor sensation without compromising the moisture mouth feel.

[0128] In an embodiment of the invention, the pouch composition is free of humectants selected from the group consisting of alginate, propylene glycol, hydroxypropyl cellulose, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

[0129] In an embodiment of the invention, the pouch composition is free of humectants.

[0130] According to an advantageous embodiment of the invention, the pouch composition comprises alginate.

[0131] In an embodiment of the invention, the pouch composition comprises alginate in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.2% by weight of the pouch composition, such as at least 0.3% by weight of the pouch composition, such as at least 0.4% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition.

[0132] In an embodiment of the invention, the pouch composition comprises alginate in an amount of 0.1 to 3% by weight of the pouch composition, such as 0.2 to 2.5% by weight of the pouch composition, such as 0.3 to 2% by weight of the pouch composition, such as 0.4 to 2% by weight of the pouch composition, such as 0.5 to 1.5% by weight of the pouch composition, such as about 1.0% by weight of the pouch composition. According to an advantageous embodiment of the invention, the pouch composition is free of alginate.

[0133] In an 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 combinations thereof.

[0134] According to an advantageous embodiment of the invention, the pouch composition is a powdered composition.

[0135] The invention further relates to a nicotine pouched product comprising a pouch composition according to the invention or any of its embodiments and a saliva- permeable pouch enclosing said pouch composition.

[0136] The invention further relates to a nicotine pouched product comprising a pouch composition, the pouch composition comprising nicotine, water-insoluble fiber, water in an amount of at least 5% by weight of the pouch composition, and at least 1 % by weight of a particulate inorganic mineral filler comprising calcium carbonate, the inorganic mineral filler having a BET specific surface area of at least 15 m2 / g.

[0137] According to an advantageous embodiment of the invention, the pouched product comprises said pouch composition in an amount of at least 50 mg, such as at least 100 mg, such as at least 150 mg, such as at least 200 mg, such as at least 300 mg, such as at least 400 mg, such as at least 500 mg.

[0138] In an embodiment of the invention, the pouched product comprises said pouch composition in an amount of no more than 700 mg, such as no more than 600 mg, such as no more than 500 mg, such as no more than 400 mg, such as no more than 350 mg, such as no more than 300 mg, such as no more than 250 mg, such as no more than 200 mg. In an embodiment of the invention, the pouched product comprises said pouch composition in an amount of 50-700 mg, such as 100-700 mg, such as 150-600 mg, such as 200-500 mg, such as 300-400 mg.

[0139] According to an advantageous embodiment of the invention, the pouched product comprises nicotine in an amount of at least 1 mg, such as at least 2 mg, such as at least 4 mg, such as at least 6 mg.

[0140] In an embodiment of the invention, the pouched product comprises nicotine in an amount of at least 1 mg, such as at least 2 mg, such as at least 4 mg, such as at least 6 mg.

[0141] In an embodiment of the invention, the pouched product comprises nicotine in an amount of no more than 25 mg, such as no more than 20 mg, such as no more than 15 mg, such as no more than 10 mg.

[0142] In an embodiment of the invention, the pouched product comprises nicotine in an amount of 1 mg to 25 mg, such as 2 mg to 20 mg, such as 4 mg to 15 mg, such as 6 mg to 10 mg.

[0143] FIGURES

[0144] The invention will now be described with reference to the figures, where Figure 1 illustrates in vitro release of nicotine from example pouches according to embodiments of the invention, where the x-axis shows time in minutes and where the y-axis shows release of nicotine in percentage of the total nicotine content.

[0145] DETAILED DESCRIPTION

[0146] As used herein the term “pouch composition” refers to the composition for use in an oral pouch, i.e. in pouches for oral use. Thus, pouch composition refers to the composition enclosed within the pouch. Also, the terms “pouch composition”, “nicotine pouch composition” and “solid oral nicotine formulation” are used interchangeably, when referring to the composition being enclosed within the pouch.

[0147] As used herein the term “nicotine” refers to nicotine used as a refined / isolated substance. Particularly, nicotine does not refer to tobacco materials having a content of nicotine. Thus, when referring to nicotine amounts also to be understood as the nicotine dose, the amounts refer to the amount of pure nicotine.

[0148] Nicotine also covers nicotine not obtained from tobacco, often referred to as synthetic nicotine.

[0149] As used herein the term “high specific surface area filler” (also denoted “high SSA filler”) refers to a particulate inorganic mineral filler comprising calcium carbonate and having a BET specific surface area of at least 15 m2 / g. In embodiments of the invention, the high specific surface area filler comprises phosphate salt, such as tricalcium phosphate. In an embodiment, the high specific surface area filler does not comprise silicon dioxide.

[0150] As used herein, unless specifically noted otherwise, a “ratio” refers to the weight ratio, i.e. the weight of a first component divided by the weight of a second component.

[0151] As used herein the term “free-base nicotine” refers to non-protonated form of nicotine, and therefore does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin. Nevertheless, the free-base nicotine may be mixed with an amount of ion exchange resin or water-soluble compositions such as sugar alcohols or water-soluble fibers. While free-base nicotine includes both free-base nicotine extracted from tobacco as well as synthetically manufactured free-base nicotine, the free-base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free-base nicotine is provided as a liquid.

[0152] As used herein the term “pouch” is intended to mean a container typically formed by a web of a fibrous material enclosing a cavity. The pouch is pouch designed for administration of an active ingredient in the oral cavity, and thus it is adapted for oral use, it is non-toxic and not water-soluble. The fibrous material may e.g. form a woven or non-woven web or fabric. The pouch may for example be sealed by bonding two corresponding pieces of web or fabric to each other along their edges to form a cavity for the nicotine and the non-water-soluble composition. In order to release the nicotine, the pouch is made water-permeable so as to allow saliva from the oral cavity to penetrate the pouch and enter the cavity, where the saliva can come into contact with the nicotine, whereby the nicotine are released from the oral pouch.

[0153] As used herein, the term “nicotine-ion exchange resin combination” refer to a combination comprising nicotine complexed with ion exchange resin and / or free-base nicotine mixed with ion exchange resin.

[0154] As used herein, the term “nicotine complexed with ion-exchange resin” refers to nicotine bound to an ion exchange resin.

[0155] In the present context, the term “free-base nicotine mixed with ion exchange resin” refers to a mixture comprising free-base nicotine and ion exchange resin. It is noted that even if some embodiments comprise a combination of nicotine complexed with ion exchange resin and nicotine in its free-base form mixed with ion exchange resin, the term "free-base nicotine mixed with ion exchange resin" requires the presence of nicotine in its free-base form. In some embodiments, the mixture is an aqueous mixture. Free-base nicotine and water is mixed with ion-exchange resin, whereby a mixture comprising both free-base nicotine and ion exchange resin is obtained. Free- base nicotine mixed with ion exchange resin is referred to as “premix” in the examples. As used herein the term “powder composition” refers to composition in the form of powder, i.e. as a particulate material having a relatively small particle size, for example between 1 and 1200 micrometer. Particularly, by powder composition is not meant a powdered tobacco.

[0156] As used herein the term “humectant” is understood as a moistening agent used to keep pouches moist, i.e. a humectant is added to the pouch composition with the purpose of keeping the pouch moist. Hence, the term humectant does not refer to substances added for other purposes, hereunder also 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 nicotine polacrilex. Examples of humectants include propylene glycol, and hydroxypropyl cellulose. Further examples of humectants include triacetin, modified starch, pectin, xanthan gum, etc. The term humectant does not refer to sugar alcohols comprising 4 or more carbons. Also, the term humectant does not refer to fibers, such as water-insoluble fiber, such as wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, and combinations thereof. Also, the term humectant does not include e.g. NaCl.

[0157] As used herein the term “water-soluble” refers to a relatively high water-solubility, for example a water-solubility of more than 5 gram of water-soluble composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH of 7.0. When referring to a “soluble” composition or substance, water-soluble is meant, unless otherwise stated.

[0158] As used herein the term “water-insoluble” refers to relatively low water-solubility, for example a water-solubility of less than 0.1 gram of composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH of 7.0. When referring to “insoluble”, water-insoluble is meant unless otherwise stated. Therefore, compositions or substances having a water-solubility of between 0.1 and 5 gram per of composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH of 7.0 are considered neither water-soluble nor water-insoluble, but having an intermediate water-solubility.

[0159] The pouches of the invention provide a nicotine release into the oral cavity. A release profile of nicotine may be obtained which both comprises a fast release period and a sustained release period.

[0160] As used herein the term “effective release” refers to the total release of nicotine over the release period of the experiment or the use period.

[0161] As used herein, the term “dissolve” is the process where a solid substance enters a solvent (such as oral saliva or water within the pouch) to yield a solution.

[0162] Typically, the pouches comprise openings, where the characteristic opening dimension is adapted to a characteristic dimension of the matrix composition so as to retain the matrix composition inside the pouch before use and / or to retain a part of the matrix composition, such as a water-insoluble composition, inside the pouch during use.

[0163] In order to obtain a pouch having suitable opening dimensions in view of the matrix composition to be used, the material for the pouch may be selected accordingly, e.g. comprising e.g. woven and / or non-woven fabric.

[0164] In other words, according to the various embodiments, the pouch forms a membrane allowing passage of saliva and prevents or inhibits passage of said matrix composition. The membrane of the pouch may be of any suitable material e.g. woven or non-woven fabric (e.g. cotton, fleece etc.), heat sealable non-woven cellulose or other polymeric materials such as a synthetic, semi-synthetic or natural polymeric material. An example of suitable pouch material is paper made of pulp and a small amount of wet strength agent. A material suitable for use must provide a semi- permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. Suitable materials are also those that do not have a significant impact on the release of nicotine from the pouch.

[0165] The pouch composition is filled into pouches and is maintained in the pouch by a sealing. An ideal pouch is chemically and physically stable, it is pharmaceutically acceptable, it is insoluble in water, it is easy to fill with powder and seal, and it provides a semi-permeable membrane layer which prevent the powder from leaving the bag, but permit saliva and therein dissolved or sufficiently small suspended components from the pouch composition in the pouch, such as nicotine, to pass through said pouch.

[0166] The pouch may be placed in the oral cavity by the user. Saliva then enters into the pouch, and the nicotine and other components, which are soluble in saliva, start to dissolve and are transported with the saliva out of the pouch into the oral cavity, where the nicotine may be absorbed.

[0167] According to an embodiment of the invention, the pouch composition may further comprise one or more additives.

[0168] In an 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, solubilization agents, pH regulating agents, mucolytic or mucus clearing agents, membrane penetration-enhancing agents, or any combination thereof. pH regulating agents include buffers.

[0169] As used herein, the term “pH regulating agent” refers to agents, which active adjust and regulates the pH value of the solution to which they have been added or are to be added. Thus, pH regulating agents may be acids and bases, including acidic buffering agents and alkaline buffering agents. On the other hand, pH regulating agents does not including substances and compositions that can only affect the pH by dilution. Furthermore, pH regulating agents does not include e.g. flavoring, fillers, etc.

[0170] According to various embodiments of the invention, one or more sugar alcohols may be included in the pouch as part of the pouch composition, e.g. as a carrier or part thereof, or as a sweetener. Suitable sugar alcohols include sugar alcohols selected from the group of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, or any combination thereof.

[0171] In an embodiment of the invention the pouch composition comprises high intensity sweetener.

[0172] Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination.

[0173] In an embodiment of the invention, the pouch composition comprises bulk sweeteners including sugar and / or sugarless components.

[0174] In an embodiment of the invention, the pouch composition comprises bulk sweetener in the amount of 1.0 to about 80% by weight of the pouch composition, more typically constitute 5 to about 70% by weight of the pouch composition, and more commonly 10 to 60% by weight of the pouch composition or 10-50% by weight of the pouch composition. Bulk sweeteners may function both as a sweetener and also as a humectant. In some embodiments, inclusion of certain ingredients may limit the about amounts of bulk sweetener further. The sweeteners may often support the flavor profile of the pouch composition.

[0175] Sugar sweeteners generally include, but are not limited to saccharide-containing components commonly known in the art of pouches, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, com syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.

[0176] The sweetener can be used in combination with sugarless sweeteners. Generally, sugarless sweeteners include components with sweetening characteristics but which are devoid of the commonly known sugars and comprise, but are not limited to, sugar alcohols, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.

[0177] As used herein the term “flavor” is understood as having its ordinary meaning within the art. Flavor includes liquid and powdered flavors. Thus, flavors do of course not include sweeteners (such as sugar, sugar alcohols and high intensity sweeteners), or acids providing pure acidity / sourness, nor compounds providing pure saltiness (e.g. NaCl) or pure bitterness. Flavor enhancers include substances that only provide saltiness, bitterness or sourness. Flavor enhancers thus include e.g. NaCl, Citric acid, ammonium chloride etc. The flavors can be natural or synthetic flavors.

[0178] In an embodiment of the invention the pouch composition comprises flavor. Flavor may typically be present in amounts between 0.01 and 15% by weight of the total composition of the pouch, such as between 0.01 and 5% by weight of the total composition.

[0179] Non-exhaustive examples of flavors suitable in embodiments of the present invention are coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essence. The essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.

[0180] In various embodiments of the invention, the pouch composition comprises composition modifier. The composition modifier may be added to engineer the properties of the pouch composition and / or parts thereof, such as flowability, texture, homogeneity etc.

[0181] The composition modifiers may, according to various embodiments, be selected group consisting of metallic stearates, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, talc, magnesium stearates, calcium stearates, fumed silica, powdered hydrogenated cottonseed oils, hydrogenated vegetable oils, hydrogenated soya oil, emulsifiers, triglycerides, and mixtures thereof. Particularly, metallic stearates, such as magnesium stearate, may be advantageous.

[0182] The composition modifiers may be added to the pouch composition in various ways.

[0183] For example, the composition modifiers may be added by full powder mixture during the last few minutes of the final mixing.

[0184] Alternatively, the composition modifiers may be added after granulation steps on a granulation premix.

[0185] The composition modifier, such as magnesium stearate, may have a sealing effect and can be used to control the release of the nicotine and the solubility of the pouch.

[0186] According to an embodiment of the invention, the pouch composition comprises polyvinylpyrrolidone (PVP). The pouch composition may also be free of PVP. One advantage of the above embodiment may be that a more uniform composition may be obtained.

[0187] EXAMPLES

[0188] Example 1A - Preparation of pouches designed for administration of nicotine

[0189] The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.

[0190] The powder is filled into pouches and is maintained in the pouch by a sealing.

[0191] Example IB - Preparation of pouches designed for administration of nicotine

[0192] The material of the pouches is manufactured using rayon fibers, such as viscose rayon staple fibers. The pouch membrane is heat sealed along its edges except for an opening in one end into an inner cavity formed by the pouch membrane.

[0193] The powder is filled into pouches and is maintained in the pouch by a sealing.

[0194] Example 2: Preparation of nicotine premixes

[0195] A 60 liter planetary Bear Varimixer mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite ® IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally the mixer was stirred for further 5 minutes at high speed. The total process time was 20 minutes.

[0196] Thereby, mixtures of nicotine and cation exchange resin were produced from the constituents stated in the below tables.

[0197] Premix I:

[0198] Table 1. Ingredients used to manufacture nicotine premix I (5.7% nicotine). % water in obtained nicotine-resin composition: 71.4

[0199] Premix II: Table 2. Ingredients used to manufacture nicotine premix II (13.2% nicotine).

[0200] % water in obtained nicotine-resin composition: 34.1.

[0201] Premix III:

[0202] Table 3. Ingredients used to manufacture nicotine premix III (18.5% nicotine). % water in obtained nicotine-resin composition^.5.

[0203] Premix IV :

[0204] Table 4. Ingredients used to manufacture nicotine premix IV (10% nicotine). % water in obtained nicotine-resin composition: 50.0. Premix V :

[0205] Table 5. Ingredients used to manufacture nicotine premix V (20% nicotine). % water in obtained nicotine-resin composition: 31.5.

[0206] Premix VI:

[0207] Table 6. Ingredients used to manufacture nicotine premix VI (30% nicotine). % water in obtained nicotine-resin composition: 27.5. Premix VII

[0208] Table 7. Ingredients used to manufacture nicotine premix VII (35% nicotine). % water in obtained nicotine-resin composition: 25.6.

[0209] Premix VIII:

[0210] Table 8. Ingredients used to manufacture nicotine premix VIII (42% nicotine). % water in obtained nicotine-resin composition: 22.8.

[0211] Example 3: Preparation of pouch compositions

[0212] Pouches are prepared comprising powdered compositions as outlined in tables 9 - 21. The pouches are made as follows.

[0213] Fibers and water are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients are added subsequently under continuous mixing: first the nicotine (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

[0214] For pouch compositions comprising no or low amounts of water, the pouch compositions may alternatively be made as follows.

[0215] Fibers and other dry ingredients are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients are added subsequently under continuous mixing: first the nicotine (mixed for 2 minutes), then the remaining liquid ingredients if any, except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

[0216] Example 4: Preparation of filled pouches

[0217] The final pouch composition is filled into pouches (target fill weight 500 mg powder per pouch unless specifically noted to be different). The pouch material of example 1A or IB may be used. The powder is filled into pouches and is maintained in the pouch by a sealing.

[0218] Example 5A: Pouches The pouch compositions are prepared from the ingredients in table 9 using preparation method described in example 3.

[0219] The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied). Table 9: Pouch compositions. *=High specific surface area filler

[0220] Pouch content: 600 mg total.

[0221] High specific surface area filler comprising calcium carbonate and tricalcium phosphate was used as a glidant. Applicable high specific surface area fillers include high specific surface area fillers from Omya International, hereunder for example Omyanutra® 300-OG (here used as the High SSA filler), and Omyanutra® 120-TIL. Silicon dioxide was used in some comparative examples as a glidant.

[0222] Oat fiber, trade name “Vitacel HF 600”. Other fibers may be used as well, such as water-insoluble plant fibers, such as wheat fibers (e.g. Vitacel 600 WF plus), pea fibers, rice fiber, maize fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.

[0223] Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

[0224] As flavor, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and / or peppermint or replacing these. The flavor may be liquid or powdered or a combination, i.e. a liquid flavor and a powdered flavor is added.

[0225] Acesulfame potassium and / or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and / or sucralose.

[0226] Potassium sorbate is optionally used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

[0227] Example 5B: Pouches

[0228] The pouch compositions are prepared from the ingredients in table 10 using preparation method described in example 3. The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).

[0229] Table 10: Pouch compositions. *=High specific surface area filler Pouch content: 600 mg total.

[0230] The same ingredients and alternatives as listed under table 9 may be used in this example.

[0231] Example 5C: Pouches The pouch compositions are prepared from the ingredients in table 11 using preparation method described in example 3. The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).

[0232] Table 11 : Pouch compositions. *=High specific surface area filler

[0233] Pouch content: 500 mg total.

[0234] The same ingredients and alternatives as listed under table 9 may be used in this example. Example 5D: Pouches

[0235] The pouch compositions are prepared from the ingredients in table 12 using preparation method described in example 3. The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).

[0236] Table 12: Pouch compositions. *=High specific surface area filler

[0237] Pouch content: 500 mg total.

[0238] The same ingredients and alternatives as listed under table 9 may be used in this example. Example 5E: Pouches The pouch compositions are prepared from the ingredients in table 13 using preparation method described in example 3.

[0239] The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).

[0240] Table 13: Pouch compositions. *=High specific surface area filler

[0241] Pouch content: 600 mg total.

[0242] The same ingredients and alternatives as listed under table 9 may be used in this example.

[0243] High specific surface area filler comprising calcium carbonate and tricalcium phosphate was used. The high SSA filler 2 component has a lower particle size than high SSA filler 1. Applicable calcium carbonate components include calcium carbonate components from Omya International, hereunder for example Omyanutra® 300-OG (here used as High SSA filler 1), and Omyanutra® 120-TIL (here used as High SSA filler 2).

[0244] Example 5F: Pouches The pouch compositions are prepared from the ingredients in table 14 using preparation method described in example 3.

[0245] The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied). Table 14: Pouch compositions. *=High specific surface area filler

[0246] Pouch content: 400 mg total.

[0247] The same ingredients and alternatives as listed under table 9 may be used in this example. Example 5G: Pouches

[0248] The pouch compositions are prepared from the ingredients in table 15 using preparation method described in example 3.

[0249] The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).

[0250] Table 15: Pouch compositions. *=High specific surface area filler

[0251] Pouch content: 600 mg total. The same ingredients and alternatives as listed under table 9 may be used in this example.

[0252] Example 5H: Pouches

[0253] The pouch compositions are prepared from the ingredients in table 15A using preparation method described in example 3.

[0254] The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).

[0255] Table 15 A: Pouch compositions. *=High specific surface area filler Pouch content: 600 mg total.

[0256] The same ingredients and alternatives as listed under table 9 may be used in this example. Example 6: Processability assessment

[0257] Pouch compositions were evaluated with respect to processability, i.e. flowability, by means of a sieving analysis using a sieving tower. The analyses were performed on a Retsch AS 200 control sieve shaker with a sieve of mesh size 1.4 mm. The procedure for the sieving was as follows: A sample of 100 g pouch composition was placed on top of the sieve, the lid was fastened, and the shaker was started. The sample was shaken for 1 min with an amplitude of 0.6 mm.

[0258] The pouch composition fractions (weight %) retained by the sieve after 1 min sieving time were measured, yielding the results as seen in tables 16-18.

[0259] A higher powder fraction passing the sieve during the specified, fixed sieving time indicates an improved processability of the pouch composition. Similarly, a lower retained fraction indicates improved processability of the pouch composition.

[0260] First, comparative pouch composition sample Cl as well as inventive pouch samples PMC41-PMC42 were tested. Results are shown in below table 16.

[0261] Table 16.

[0262] As shown in table 16, the retained fractions for Cl, and PMC41-PMC42 demonstrate how similar processability to the silicon dioxide containing comparative sample Cl could be obtained by 4% high specific surface area filler of PMC41 or even improved by increasing the amount (6%) of high specific surface area filler as in PMC42.

[0263] Then, comparative pouch composition samples C2 and C3 as well as inventive pouch samples PMC11-PMC12 were tested. Results are shown in below table 17.

[0264] Table 17.

[0265] As shown in table 17, the retained fractions for C2, C3, and PMC 11 -PMC 12 demonstrate how similar processability to the silicon dioxide containing comparative sample C3 could be obtained by 4% high specific surface area filler of PMC 11 or even improved by increasing the amount of high specific surface area filler as in PMC 12. This compares with comparative sample C2, a composition without any glidant such as silicon dioxide, that exhibits the poorest flowability properties.

[0266] Also, comparative pouch samples C4 and C5 as well as inventive pouch samples PMC14-PMC17 were tested. Results are shown in below table 18.

[0267] Table 18.

[0268] As shown in table 18, silicon dioxide containing comparative pouch sample C4 has improved processability compared to comparative pouch sample C5 which contains no silicon dioxide or other glidants.

[0269] A comparable processability to the silicon dioxide containing comparative sample C4 was obtained by inventive PMC 16, containing 2% high specific surface area filler. Even better processability was obtained using 6% high specific surface area filler in PMC 14.

[0270] Also, table 18 demonstrates how processability might be further improved by using a combination of alginate and high specific surface area filler in PMC 17 (compare with PMC 16) and PMC 15 (compare with PMC 14). Example 6A: Processability assessment

[0271] Pouch compositions were evaluated with respect to processability, i.e. flowability, by means of a sieving analysis using a sieving tower.

[0272] The analyses were performed on a Retsch AS 200 control sieve shaker with a sieve of mesh size 1.7 mm. The procedure for the sieving was as follows: A sample of 100 g pouch composition was placed on top of the sieve, the lid was fastened, and the shaker was started. The sample was shaken with an amplitude of 0.6 mm until no further powder was passing the sieve, i.e. until the retained fraction remains constant.

[0273] The pouch composition fractions (weight %) retained by the sieve after sieving were measured, yielding the results as seen in table 18 A.

[0274] A higher powder fraction passing the sieve during the sieving indicates an improved processability of the pouch composition. Similarly, a lower retained fraction indicates improved processability of the pouch composition.

[0275] At the same time, a shorter sieving time until the retained fraction is constant indicates an improved processability of the pouch composition. Similarly, a longer sieving time indicates poorer processability, i.e. poorer flow properties, of the pouch composition.

[0276] First, comparative pouch composition sample C6 as well as inventive pouch samples PMC71-PMC72 were tested. Results are shown in below table 18 A.

[0277] Table 18 A. N / A = not measured As shown in table 18 A, inventive pouch PMC71 shows improved processability over silicon dioxide containing comparative sample C6. PMC72, comprising an increased amount of high specific surface area filler compared to PMC71 showed even further improved processability.

[0278] Then, inventive pouch samples PMC73-PMC77 were tested. Results are shown in below table 18B.

[0279] Table 18B.

[0280] As shown in table 18B, gradually increasing the content of high specific surface area filler from 5.0% by weight in PMC73 to 8.0% by weight in PMC76 resulted in correspondingly gradual improvements of the processability, as can be seen both from the gradually shorter sieving time and the gradually lower retained fraction.

[0281] Also, when increasing the amount of water, from 28% by weight in PMC76 to 34% by weight in PMC77, a further increase in the processability was observed, as confirmed by both the shorter sieving time and the lower retained fraction. This was quite unexpected, as increased amount of water typically results in a lower processability, and this unexpected result demonstrates the robustness of the inventive use of the high specific surface area filler even when using the increased high amount of water as in PMC77.

[0282] Example 7: Release

[0283] Pouch samples were subjected to an in vitro release test to determine release profile of nicotine over a time range of 7 to 60 minutes.

[0284] Test method 10 L chewing buffer pH 7.4 was degassed and heated to 38 °C with a Dissolution Media Preparation Station.

[0285] 900 mL chewing buffer pH 7.4 was transferred to each vessel in the USP Dissolution Apparatus 1. Inside the vessels, the chewing buffer pH 7.4 was adjusted to 37 °C.

[0286] Weight measured pouches were transferred to baskets and the dissolution apparatus was started.

[0287] Sampling times of buffer were set to different times, occasionally covering the time span of different times such as 7, 14, 21, 30 and 60 min. Rotational speed was set to 100 rpm.

[0288] Release samples at all time points were taken automatically with the dissolution apparatus.

[0289] All samples were filtered and prepared for HPLC analysis.

[0290] For each sample release measurements were repeated for 6 individual pouches.

[0291] Results

[0292] Results are shown in below table 19.

[0293] Table 19. As shown in table 19, the results demonstrated how in vitro nicotine release from inventive composition PMC 16 was significantly improved at all measured time points over comparative silicon dioxide containing composition C4. The results are also illustrated in figure 1.

[0294] Also, inventive composition PMC 17 showed decreased release compared to PMC 16 due to the presence of alginate.

[0295] Example 8: Sensory evaluation

[0296] The produced pouches of the invention were evaluated with respect to perceived nicotine effect and flavor intensity.

[0297] Nicotine effect was evaluated using a panel of six users evaluating all samples twice.

[0298] Each user assessed the nicotine effect, i.e. the perceived effect of nicotine stimulating the body on a scale from 0 to 5, where 0 is no effect at all and 5 is the most intense nicotine effect perceived. The average perceived effect of nicotine during 10 minutes of use for comparative pouches C4 and C5 as well as inventive pouch PMC 16 is indicated in table 20.

[0299] Table 20. Perceived nicotine effect

[0300] As shown in table 20, comparative pouch C4, including silicon dioxide, results in a decreased perceived nicotine effect compared to comparative pouch C5, without silicon dioxide. Furthermore, inventive pouch PMC 16 has a nicotine effect comparable to C5, without silicon dioxide.

[0301] Flavor intensity was evaluated using a panel of six users evaluating all samples twice.

[0302] Each user assessed the flavor intensity on a scale from 0 to 5, where 0 is no intensity at all and 5 is the most intense flavor perceived. The average flavor effect during 10 minutes of use for comparative pouches C4 and C5 as well as inventive pouch PMC 16 is indicated in table 21.

[0303] Table 21. Flavor intensity

[0304] As shown in table 21, comparative pouch C4, including silicon dioxide, results in a decreased flavor intensity compared to comparative pouch C5, without silicon dioxide. Furthermore, inventive pouch PMC 16 has a flavor intensity comparable to C5, without silicon dioxide.

Claims

CLAIMS1. A nicotine pouch composition, the pouch composition comprising nicotine, water-insoluble fiber, water in an amount of at least 5% by weight of the pouch composition, and at least 1 % by weight of a particulate inorganic mineral filler comprising calcium carbonate, the inorganic mineral filler having a BET specific surface area of at least 15 m2 / g.

2. The nicotine pouch composition according to claim 1, wherein the pouch composition comprises at least 2% by weight of the inorganic mineral filler, such as at least 4% by weight of the inorganic mineral filler, such as at least 6% by weight of the inorganic mineral filler.

3. The nicotine pouch composition according to claims 1 or 2, wherein the inorganic mineral filler comprises a natural calcium carbonate and / or a precipitated calcium carbonate.

4. The nicotine pouch composition according to any of claims 1-3, wherein the inorganic mineral filler has a BET specific surface area of at least 20 m2 / g, such as at least 25 m2 / g, such as at least 30 m2 / g, such as at least 40 m2 / g, such as at least 50 m2 / g.

5. The nicotine pouch composition according to any of claims 1-4, wherein the inorganic mineral filler has a BET specific surface area of no more than 300 m2 / g, such as no more than 250 m2 / g, such as no more than 200 m2 / g, such as no more than 150 m2 / g, such as no more than 100 m2 / g, such as no more than 75 m2 / g.

6. The nicotine pouch composition according to any of claims 1-5, wherein the inorganic mineral filler comprises calcium carbonate in an amount of at least 30% byweight of the inorganic mineral filler, such as at least 40% by weight of the inorganic mineral filler, such as at least 50% by weight of the inorganic mineral filler.

7. The nicotine pouch composition according to any of claims 1-6, wherein at least 50% by weight of the inorganic mineral filler has a particle size below 10 microns, such as below 8 microns.

8. The nicotine pouch composition according to any of claims 1-7, wherein the pouch composition comprises less than 0.1% by weight of silicon dioxide, such as being substantially free of silicon dioxide, such as free of silicon dioxide.

9. The nicotine pouch composition according to any of claims 1-8, wherein the inorganic mineral filler comprises phosphate.

10. The nicotine pouch composition according claim 9, wherein the phosphate is provided as a calcium salt.

11. The nicotine pouch composition according to any of claims 1-10, wherein the inorganic mineral filler comprises tricalcium phosphate.

12. The nicotine pouch composition according to any of claims 1-11, wherein the inorganic mineral filler is substantially composed of a combination of calcium carbonate and tricalcium phosphate.

13. The nicotine pouch composition according to any of claims 1-12, wherein the inorganic mineral filler comprises the phosphate containing calcium salt in an amount of at least 10% by weight of the inorganic mineral filler, such as at least 15% by weight of the inorganic mineral filler, such as at least 20% by weight of the inorganic mineral filler, such as at least 30% by weight of the inorganic mineral filler, such as at least 40% by weight of the inorganic mineral filler.

14. The nicotine pouch composition according to any of claims 1-13, wherein the pouch composition comprises at least one sugar alcohol.

15. The nicotine pouch composition according to any of claims 1-14, wherein 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.

16. The nicotine pouch composition according to any of claims 1-15, wherein 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.

17. The nicotine pouch composition according to any of claims 1-16, wherein the pouch composition comprises said at least one sugar alcohol in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.

18. The nicotine pouch composition according to any of claims 1-17, wherein the pouch composition comprises water in an amount of at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition, such as at least 30% by weight of the pouch composition.

19. The nicotine pouch composition according to any of claims 1-18, wherein the pouch composition comprises water-insoluble fiber.

20. The nicotine pouch composition according to any of claims 1-19, wherein the water-insoluble fiber is a plant fiber.

21. The nicotine pouch composition according to any of claims 1-20, wherein the pouch composition comprises said water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition.

22. The nicotine pouch composition according to any of claims 1-21, wherein the water-insoluble fiber comprises one or more selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, microcrystalline cellulose, and any combination thereof.

23. The nicotine pouch composition according to any of claims 1-22, wherein the water-insoluble fiber comprises microcrystalline cellulose.

24. The nicotine pouch composition according to any of claims 1-23, wherein the water-insoluble fiber is free of microcrystalline cellulose.

25. The nicotine pouch composition according to any of claims 1-24, wherein the pouch composition comprises flavor.

26. The nicotine pouch composition according to any of claims 1-25, wherein the pouch composition comprises flavor in an amount of at least 0.1% by weight of the pouch composition.

27. The nicotine pouch composition according to any of claims 1-26, wherein the water-insoluble fiber is a non-tobacco fiber.

28. The nicotine pouch composition according to any of claims 1-27, wherein the pouch composition comprises tobacco in an amount of no more than 5% by weight of the pouch composition, such as no more than 2% by weight of the pouch composition, such as no more than 1% by weight of the pouch composition, such as no more than 0.5% by weight of the pouch composition, such as no more than 0.1% by weight of the pouch composition.

29. The nicotine pouch composition according to any of claims 1-28, wherein the pouch composition is free of tobacco fibers.

30. The nicotine pouch composition according to any of claims 1-29, wherein the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, a nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites, nicotine bound to cellulose, such as microcrystalline cellulose, starch microspheres, and mixtures thereof.

31. The nicotine pouch composition according to any of claims 1-30, wherein the nicotine comprises nicotine free base.

32. The nicotine pouch composition according to any of claims 1-31, wherein the nicotine comprises nicotine mixed with ion exchange resin.

33. The nicotine pouch composition according to any of claims 1-32, wherein the nicotine comprises free-base nicotine mixed with ion exchange resin in a weight ratio between the free-base nicotine and the ion exchange resin of 0.1 to 2.0, preferably from 0.5 to 2.0, and most preferred about 0.67 to 1.0.

34. The nicotine pouch composition according to any of claims 1-33, wherein the nicotine comprises nicotine bound to an ion exchange resin.

35. The nicotine pouch composition according to any of claims 1-34, wherein the nicotine comprises a nicotine salt, such as nicotine bitartrate.

36. The nicotine pouch composition according to any of claims 1-35, wherein the nicotine does not comprise a premix of nicotine free base mixed with calcium carbonate.

37. The nicotine pouch composition according to any of claims 1-36, wherein the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.25% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1.0% by weight of the pouch composition, such as at least 2.0% by weight of the pouch compositions, such as at least 4.0% by weight of the pouch compositions.

38. The nicotine pouch composition according to any of claims 1-37, wherein the pouch composition comprises a pH regulating agent, such as an alkaline pH regulating agent, such as an alkaline buffering agent.

39. The nicotine pouch composition according to any of claims 1-38, wherein the pH regulating agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, amino acids, trometamol, or any combination thereof.

40. The nicotine pouch composition according to any of claims 1-39, wherein the pouch composition comprises pH regulating agent in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 3% by weight of the pouch composition.

41. The nicotine pouch composition according to any of claims 1-40, wherein the pouch composition comprises humectant.

42. The nicotine pouch composition according to any of claims 1-41, wherein the pouch composition comprises alginate.

43. The nicotine pouch composition according to any of claims 1-42, wherein the pouch composition is free of alginate.

44. The nicotine pouch composition according to any of claims 1-43 wherein the pouch composition is a powdered composition.

45. A nicotine pouched product comprising a pouch composition, the pouch composition comprising nicotine, water-insoluble fiber, water in an amount of at least 5% by weight of the pouch composition, and at least 1 % by weight of a particulate inorganic mineral filler comprising calcium carbonate, the inorganic mineral filler having a BET specific surface area of at least 15 m2 / g.

46. The nicotine pouched product according to claim 45, wherein the pouched product comprises said pouch composition in an amount of at least 50 mg, such as at least 100 mg, such as at least 150 mg, such as at least 200 mg, such as at least 300 mg, such as at least 400 mg, such as at least 500 mg.

47. The nicotine pouched product according to claim 45 or 46, wherein the pouched product comprises nicotine in an amount of at least 1 mg, such as at least 2 mg, such as at least 4 mg, such as at least 6 mg.

48. The nicotine pouched product according to any of claims 45-47 comprising a pouch composition according to any of claims 1-44.

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