EP4000424B1 - Nikotinbeutelzusammensetzung - Google Patents

Nikotinbeutelzusammensetzung Download PDF

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Publication number
EP4000424B1
EP4000424B1 EP20207822.6A EP20207822A EP4000424B1 EP 4000424 B1 EP4000424 B1 EP 4000424B1 EP 20207822 A EP20207822 A EP 20207822A EP 4000424 B1 EP4000424 B1 EP 4000424B1
Authority
EP
European Patent Office
Prior art keywords
nicotine
fibers
pouch
weight
composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20207822.6A
Other languages
English (en)
French (fr)
Other versions
EP4000424A1 (de
Inventor
Kent Albin Nielsen
Jessie POULSEN
My Ly Lao STAHL
Bine Hare JAKOBSEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Philip Morris Products SA
Original Assignee
Philip Morris Products SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Philip Morris Products SA filed Critical Philip Morris Products SA
Priority to DK20207822.6T priority Critical patent/DK4000424T3/da
Priority to EP20207822.6A priority patent/EP4000424B1/de
Priority to PCT/DK2021/050334 priority patent/WO2022100805A1/en
Priority to CN202180075476.XA priority patent/CN116419682A/zh
Priority to JP2023527692A priority patent/JP2023549345A/ja
Priority to CA3198533A priority patent/CA3198533A1/en
Publication of EP4000424A1 publication Critical patent/EP4000424A1/de
Application granted granted Critical
Publication of EP4000424B1 publication Critical patent/EP4000424B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10—Chemical features of tobacco products or tobacco substitutes
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/42—Treatment of tobacco products or tobacco substitutes by chemical substances by organic and inorganic substances

Definitions

  • the present invention relates to pouch compositions and an oral pouched nicotine product according to the claims.
  • a further challenge in the prior art is that the desired release of nicotine should be attractive to the user of the pouch from a user perspective.
  • pouches as delivery vehicle for nicotine may be somewhat costly and thereby impose restrictions on the way pouches are designed in order to keep manufacturing costs in check.
  • the product comprises a filling material comprising a particulate non-tobacco material, a nicotine source, 1-15 wt% water, a pH adjusting agent selected from Na2C03, K2C03, NaHC03 and/or KHC03, as well as a salt of Formula M 2+ (A n- ) m , wherein the M 2+ is selected from Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+ and Fe 2+ .
  • the particulate non-tobacco material may comprise sugar alcohol.
  • the filling material may comprise water insoluble fiber.
  • the nicotine source may be a nicotine salt and/or nicotine base.
  • the nicotine source such as nicotine base may be bound to an ion exchange resin.
  • the pouch contains a matrix composition comprising a combination of nicotine and a water-soluble composition.
  • the present invention relates to a pouch composition
  • a pouch composition comprising
  • One advantage of the present invention may be that a relatively high stability of the provided nicotine may be obtained, while at the same time obtaining a relatively fast nicotine release. Obtaining a high stability may lead to nicotine being bound too effectively e.g. to a carrier and therefore lead to slow release.
  • the claimed pouch composition including combination of a water content of at least 15% by weight of the composition and divalent inorganic cations, a high stability yet fast release is facilitated, while also having a very desirable mouthfeel and taste.
  • the high water content facilitates effective release of nicotine during use.
  • One advantage of the invention is that a relatively fast release rate of nicotine from the pouch composition may be obtained due to the presence of the divalent cations. At the same time a desirable moist mouthfeel is provided, due to the high water content, which also facilitate fast nicotine release.
  • the invention may advantageously provide a more effective release of nicotine during use of a pouch comprising the pouch composition. Obtaining an effective release of nicotine may enable a lower total dose of nicotine with the same amount of nicotine released, due to a minimization of any residual nicotine not released from the pouch composition.
  • the solid oral nicotine formulation comprises inorganic divalent cations in molar ratio of at least 0.1 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at least 0.25 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at least 0.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.
  • the amount of divalent cations should advantageously be high enough to enable ion-exchange of the complexed nicotine for the divalent cations during use of a pouch comprising the pouch composition.
  • the amount of inorganic divalent cations may even prevent exchanged nicotine from re-complexing with the ion-exchange resin during use.
  • the amount of inorganic divalent cations may decrease the probability of any uncomplexed nicotine, such as free base nicotine and/or exchanged nicotine from complexing/re-complexing with the ion-exchange resin during use.
  • the solid oral nicotine formulation comprises inorganic divalent cations in a molar ratio of at most 3.75 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 2.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.
  • the pouch composition comprises inorganic divalent cations in a molar ratio of between 0.1 and 5.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 4.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 3.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 2.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 1.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination.
  • the pouch composition comprises inorganic divalent cations in a molar ratio of between 0.1 and 5.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.5 and 5.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.75 and 5.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 1.0 and 4.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 2.0 and 4.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination.
  • the pouch composition comprises inorganic divalent cations in a molar ratio of between 0.01 and 5.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.01 and 4.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.01 and 3.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.01 and 2.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.01 and 1.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination.
  • the molar ratio refers to the molar content of divalent cations divided by the molar content of nicotine.
  • the inorganic divalent cations are selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.
  • the inorganic divalent cations are selected from the group consisting of divalent cations of calcium and magnesium.
  • the inorganic divalent cations are provided as a salt comprising inorganic or organic anions.
  • 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.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition.
  • the organic anions are selected from the group consisting of carboxylates, such as acetate, lactate, oxalate, propionate, levulinate; organic sulfonate; organic sulfate; organic phosphate; and any combination thereof.
  • the inorganic divalent cations are provided as an inorganic salt.
  • the inorganic divalent cations are provided as an inorganic salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition.
  • the inorganic divalent cations are provided as an inorganic salt in the amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition.
  • the inorganic divalent cations are provided as an inorganic salt in the amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 7.0% by weight of the composition, such as between 0.1 and 7.0% by weight of the composition, such as between 0.5 and 5.0% by weight of the composition, such as between 0.5 and 4.0% by weight of the composition.
  • 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.
  • the inorganic anions may be combined e.g. such that the cations form separate salts with two different types of anions.
  • One example could e.g. be magnesium chloride combined with magnesium bromide.
  • inorganic divalent cations are provided as an inorganic salt comprising inorganic anions are selected from the group consisting of chloride, bromide, sulfate, hydrogen carbonate, and any combination thereof.
  • inorganic divalent cations are provided as an inorganic salt comprising inorganic anions are selected from the group consisting of chloride, bromide, sulfate, and any combination thereof.
  • inorganic divalent cations are provided as an inorganic salt comprising inorganic anions are selected from the group consisting of chloride, bromide, and any combination thereof.
  • the inorganic anions comprise chloride.
  • the inorganic cations are magnesium and/or calcium and the anions comprise chloride.
  • the inorganic anions are chloride.
  • the inorganic cations are magnesium and/or calcium and the anions are chloride.
  • the inorganic divalent cations are provided as an inorganic salt selected from the group consisting of calcium chloride or magnesium chloride, or combinations thereof.
  • the divalent cations are provided as a pharmaceutically acceptable salt.
  • the divalent cations are provided as a pharmaceutically acceptable inorganic salt.
  • the inorganic divalent cations are provided as a hydrated inorganic salt.
  • the divalent cations are provided as an alimentary acceptable salt.
  • the divalent cations are provided as an alimentary acceptable inorganic salt.
  • the divalent cations are provided as a water-soluble salt having a water-solubility of at least 5 gram per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.
  • atmospheric pressure is understood a pressure around 101.3 kPa or a pressure within the range of 90 to 110 kPa.
  • the inorganic divalent cations are provided as a water-soluble salt in the amount of between 0.1 and 15.0% by weight of the composition.
  • the divalent cations are provided an inorganic and water-soluble salt having a water-solubility of at least 5 gram per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.
  • the inorganic divalent cations are provided as a water-soluble salt in the amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 7.0% by weight of the composition, such as between 0.1 and 7.0% by weight of the composition, such as between 0.5 and 5.0% by weight of the composition, such as between 0.5 and 4.0% by weight of the composition.
  • the inorganic divalent cations are provided as an inorganic and water-soluble salt in the amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 7.0% by weight of the composition, such as between 0.1 and 7.0% by weight of the composition, such as between 0.5 and 5.0% by weight of the composition, such as between 0.5 and 4.0% by weight of the composition.
  • the inorganic cations are added to the composition as a salt.
  • the dissolution of the salt into cations could advantageously be faster and more effective, whereby relative fast release of nicotine could be achieved.
  • the pouch composition comprises nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition.
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition.
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition, such as 1.0 to 15% by weight of the pouch composition, such as 3.0 to 15% by weight of the pouch composition, such as 5.0 to 15% by weight of the pouch composition.
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition, such as 1.0 to 15% by weight of the pouch composition, such as 1.0 to 10% by weight of the pouch composition, such as 3.0 to 10% by weight of the pouch composition.
  • the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight.
  • 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.
  • the nicotine-ion exchange resin combination consists of nicotine complexed with ion exchange resin, wherein the nicotine constitutes an amount of between 10 and 50% by weight of nicotine-ion exchange resin combination, such as between 10 and 40% by weight of nicotine-ion exchange resin combination, such as. between 10 and 30% by weight of nicotine-ion exchange resin combination, such as between 10 and 25% by weight of nicotine-ion exchange resin combination.
  • the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 50% by weight of nicotine-ion exchange resin combination.
  • the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 50% by weight of nicotine-ion exchange resin combination, such as between 10 and 50% by weight of nicotine-ion exchange resin combination, such as between 20 and 50% by weight of nicotine-ion exchange resin combination, such as between 25 and 50% by weight of nicotine-ion exchange resin combination, such as between 25 and 45% by weight of nicotine-ion exchange resin combination.
  • the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 40% by weight of nicotine-ion exchange resin combination, such as between 10 and 40% by weight of nicotine-ion exchange resin combination, such as between 10 and 35% by weight of nicotine-ion exchange resin combination, such as between 10 and 25% by weight of nicotine-ion exchange resin combination, such as between 10 and 15% by weight of nicotine-ion exchange resin combination.
  • the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight.
  • the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight.
  • the nicotine-ion exchange resin combination comprises nicotine in an amount of between 10 and 30% by weight and ion-exchange resin in an amount between 20 and 90% by weight.
  • the nicotine-ion exchange resin combination consist of nicotine in an amount of between 10 and 30% by weight and ion-exchange resin in an amount between 70 and 90% by weight.
  • the nicotine-ion exchange resin combination is substantially free of water.
  • the nicotine-ion exchange resin combination further comprising a C3 sugar alcohol.
  • the C3 sugar alcohol may be selected from glycerol, propylene glycol, and any combination thereof.
  • the nicotine-ion exchange resin combination further comprises glycerol.
  • the nicotine-ion exchange resin combination further comprises glycerol in an amount of 0.1 to 50% by weight, such as 5 to 40% by weight, such as 5 to 30% by weight.
  • the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 20 and 75% by weight.
  • the nicotine-ion exchange resin combination comprises water in an amount of no more than 75% by weight, such as no more than 50% by weight, such as no more than 40% by weight, such as no more than 30% by weight, such as no more than 20% by weight, such as no more than 10% by weight, such as no more than 5% by weight.
  • the ion exchange resin comprises one or more resin(s) selected from the group consisting of:
  • the ion exchange resin is polacrilex resin.
  • the ion exchange resin is polacrilex resin.
  • the polacrilex resin comprises or is Amberlite ® IRP64.
  • the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin.
  • the nicotine-ion exchange resin combination is nicotine complexed with ion exchange resin.
  • the nicotine-ion exchange resin combination consists of nicotine complexed with ion exchange resin.
  • the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin.
  • One advantage of the above embodiment may be providing sustained release of nicotine. At the same time, the release rate of nicotine is not too slow to give the user the craving relief desired.
  • the nicotine-ion exchange resin combination is free-base nicotine mixed with ion exchange resin.
  • the pouch composition comprises further nicotine.
  • the pouch composition comprises further nicotine selected from the group consisting of a nicotine salt, nicotine free base, nicotine bound to an ion exchanger, such as an ion exchange resin, such as nicotine polacrilex resin, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites; nicotine bound to cellulose, such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.
  • an ion exchanger such as an ion exchange resin, such as nicotine polacrilex resin, a nicotine inclusion complex or nicotine in any non-covalent binding
  • nicotine bound to zeolites nicotine bound to cellulose, such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.
  • the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.
  • the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 20-65% by weight of the composition, such as 25-65% by weight of the composition.
  • the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 15-40% by weight of the composition.
  • the pouch composition comprises water in an amount of 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 15-40% by weight of the composition, such as 15-30% by weight of the composition.
  • the pouch composition comprises water in an amount of 15-40% by weight of the composition.
  • the water may be added as a separate component to be fully or partly mixed into other components, such as fibers.
  • a significant amount of water of the final pouch composition may come from the this mixture.
  • the final amount pouch composition comprises 5% water from the nicotine-ion exchange resin combination, then up to one third of the water in the pouch composition derives from the nicotine-ion exchange resin combination.
  • the pouch composition comprises at least one sugar alcohol.
  • xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof is used as the at least one sugar alcohol.
  • the at least one sugar alcohol may also comprise further sugar alcohols.
  • hydrogenated starch hydrolysates may be used, which comprises a mixture of sorbitol, maltitol and further sugar alcohols.
  • Sugar alcohols may advantageously facilitate and induce salivation of the pouch composition, whereby dissolution of the inorganic divalent cations are achieved, and release of nicotine is obtained, such as release of nicotine from the ion-exchange resin and release of nicotine from the pouch.
  • Sugar alcohols may advantageously be used to further increase the nicotine release from the pouch.
  • sugar alcohols may advantageously be used for obtaining a desirable mouthfeel by increasing salivation and thereby counteract any local dehydration or oral dehydrating sensation experienced by the user of the pouch.
  • the at least one sugar alcohol is selected from sugar alcohols having at least 4 carbon atoms.
  • the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.
  • sugar alcohols may be applied for the purpose of taste and salivation, where the sugar alcohol composition is made of different sugar alcohols having different properties with respect to storage, bacteria growth, processability and/or taste.
  • the at least two sugar alcohols are selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.
  • the pouch composition comprises sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition, such as at least 15% by weight of the composition.
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 10 to 70% by weight of the composition, such as 10 to 60% by weight of the composition, such as 15 to 60% by weight of the composition, such as 20 to 60% by weight of the composition, such as 20 to 50% by weight of the composition.
  • the pouch composition comprises at least one water-insoluble fiber.
  • the pouch composition comprises said water-insoluble fiber in an amount between 5 and 50 % by weight of the pouch composition, such as 10-45% by weight of the pouch composition, such as 15-40% by weight of the pouch composition.
  • the pouch composition comprises said water-insoluble fiber in an amount between 5 and 50 % by weight of the pouch composition, such as 10-50% by weight of the pouch composition, such as 15-50% by weight of the pouch composition.
  • the water-insoluble fiber may advantageously provide a desirable mouthfeel throughout the use of the pouch.
  • Powdered cellulose within the scope of the invention is understood to be cellulose prepared by processing alpha-cellulose obtained as a pulp from strains of fibrous plant materials, such as wood pulp.
  • the water-insoluble fiber comprises or consists of cereal fibers.
  • the water-insoluble fiber comprises or consists of fruit and/or vegetable fibers.
  • the water-insoluble composition comprises or consists of water-insoluble fiber selected from wheat fibers, oat fibers, pea fibers, powdered cellulose, or combinations thereof.
  • the water-insoluble composition comprises or consists of water-insoluble fiber selected from wheat fibers, oat fibers, pea fibers, or combinations thereof.
  • the water-insoluble composition comprises or consists of water-insoluble fiber selected from wheat fibers, oat fibers, or combinations thereof.
  • Non-limiting examples of usable water-insoluble fibers include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel L00, Vitacel Erbsenmaschine EF 150, Vitacel bamboo fiberbaf 90, Vitacel HF 600, Vitacel Cellulose L700G, Vitacel PF200, Vitacel potatofiber KF200, Vitacel bamboo fiberhaf BAF40, Vitacel Hafermaschine/oat fiber HF-401-30 US.
  • Non-limiting examples of usable powdered cellulose include Vitacel L 00, Vitacel Cellulose L700G, Vitacel LC1000, Vitacel L600-20, Vitacel L600 etc.
  • the powdered cellulose is chemically unmodified.
  • powdered cellulose may be chemically unmodified cellulose fibers, which do not include e.g. microcrystalline cellulose (MCC).
  • MMC microcrystalline cellulose
  • the water-insoluble fiber has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.
  • An advantage of the above embodiment may be that the high water-binding capacity enables pouch compositions having a high water-content.
  • the pouches having a high water-content where found to have a desirable texture and mouthfeel may while still being able to store manufactured pouches together in abutment e.g. in cans etc. without sticking too much together to result in ruptures of the pouches when being removed.
  • water-insoluble fibers having a high water-binding capacity may reduce any nicotine exchange induced by the divalent cations happening prior to the pouch being used.
  • pouches comprising water-insoluble fibers having a high water-binding capacity could advantageously have a decreased relative standard deviation (RSD) on the nicotine content.
  • RSS relative standard deviation
  • the content of nicotine between a series of at least 10 oral pouches comprising said pouch composition holds a relative standard deviation (RSD) below 10%, preferably below 8%, more preferably at most 6%, even more preferably at most 4%, most preferably at most 2%.
  • RSS relative standard deviation
  • the content of the nicotine between a series of at least 10 oral pouches comprising said pouch composition holds a relative standard deviation (RSD) of 0.1 - 10%, preferably 0.1 - 8%, more preferably 0.1 - 6%, even more preferably 0.1 - 4%, and most preferably 0.1 - 2%.
  • RSS relative standard deviation
  • the water-insoluble fiber has a water binding capacity of 300 to 1500%, such as 400 to 1300%.
  • the water-insoluble fiber has a water binding capacity of 200% to 1500%, such as 300 to 1300%, such as 200 to 800%, such as 300 to 800%, such as 400 to 600%.
  • the water-insoluble fiber has a water binding capacity of 200 to 1500%, such as 300 to 1300%, such as 300 to 900%, such as 300 to 700%, such as 400 to 700%.
  • the water-insoluble fiber has a water binding capacity of 200 to 1500%, such as 400 to 1500%, such as 500 to 1500%, such as 500 to 1200%, such as 500 to 1000%.
  • the water-insoluble fiber has a swelling capacity of at least 5.0 mL/g, such as 5.0 - 20 mL/g.
  • An advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without compromising the mouthfeel during use. If an amount of water-insoluble fiber is substituted for a water-soluble component, the swelling of the water-insoluble fiber will during use counteract the dissolution of the water-soluble component, thereby the user will not experience any decrease in pouch content during use.
  • the water-insoluble fibers are selected from pea fibers, powdered cellulose, and combinations thereof, and wherein the pouch composition comprises flavor in an amount of no more than 10% by weight of the pouch composition.
  • the pouch composition comprises water-insoluble fibers selected from pea fibers and powdered cellulose, or a combination thereof, and flavor in an amount of 0.01 - 10% by weight of the pouch composition.
  • the water-insoluble fiber has a density of 50 to 500 gram per Liter, such as 100 to 400 gram per Liter, such as 200 to 300 gram per Liter.
  • water-insoluble fiber having a relatively low bulk density will provide not only a good mouthfeel, but also an effective release from the pouch, due to the fact that a relatively low bulk density promotes effective salivation, thereby dissolution and release of water-soluble ingredients of the composition.
  • the pouch composition comprises a pH regulating agent.
  • the pouch composition comprises pH regulating agent in an amount between 0.01 and 15% by weight of the pouch composition, such as between 0.5 and 10% by weight of the pouch composition, such as between 1 and 10% by weight of the pouch composition, such as between 5 and 10% by weight of the pouch composition.
  • Obtaining a relatively fast release rate of nicotine and an effective uptake/absorption may be desirable as this ensures a fast effect for the user, i.e. craving relief.
  • the combination of having an effective release and an effective absorption advantageously enables a relative high exploitation of the nicotine dose within the pouch.
  • Having a relative high exploitation of the nicotine dose within the pouch may further provide a reduction of necessary nicotine dose of the pouch, without compromising the resulting effect.
  • a lower nicotine dose may in tern result in a reduction in production cost, as nicotine may be relatively expensive, but may also assist users who want to lower their intake of nicotine.
  • the pH regulating agent is a buffering agent, such as a basic buffering agent.
  • the pouch composition is adapted to give a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 gram of pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to 7.4).
  • a further advantage of the above embodiment may be that the need for preservative may be decreased or even eliminated and that low amounts of such preservatives may be used if not absent.
  • the high pH value obtained may advantageously provide for a tingling sensation in the mouth which may be perceived as a desirable mouthfeel, e.g. due to resemblance with tobacco-based pouch products.
  • the pH regulating agent is selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono- ⁇ -lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potasium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.
  • the pH regulating agent is selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof.
  • the pouch composition comprises inorganic divalent cations, which may be provided as a water soluble salt, and in addition thereto a pH regulating agent selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof.
  • a pH regulating agent selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof.
  • the pH adjusting agent is selected from the group consisting of trometamol.
  • the pH adjusting agent is trometamol. +wherein the pouch composition comprises humectant.
  • the humectant is or comprises humectant in an amount of 0.5 to 10%, such as 0.5 to 5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition.
  • the humectant is or comprises alginate, such as sodium alginate, e.g. in an amount of 0.5 to 10%, such as 0.5 to 5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition.
  • the pouch composition is free of alginate.
  • the pouch composition is free of humectants consisting of alginate, pectin and xanthan gum.
  • the pouch composition is adapted to release at least 30% nicotine within 10 minutes when exposed to in vitro conditions described in example 7A.
  • the pouch composition is adapted to release at least 25% more nicotine within 5 minutes compared to a corresponding pouch composition without divalent cations when exposed to the in vitro conditions described in example 7A.
  • the pouch composition comprises sodium chloride in an amount of 0.0-3.0% by weight of the pouch compositions, such as 0.05 - 1.0% by weight of the pouch composition, such as 0.1 - 1.0% by weight of the pouch composition.
  • Sodium chloride may advantageously be added in small amounts, i.e. 0.0-3.0% by weight as a flavor enhancer. Adding higher amounts of sodium chloride could induce an undesirable taste or mouthfeel.
  • the pouch composition further comprises a preservative.
  • the preservative may help to preserve the pouch composition against undesirable microbiological growths.
  • the pouch composition further comprises a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition, such as 0.1 to 0.2% by weight of the pouch composition.
  • Non-limiting examples of usable preservatives within the scope of the invention includes sorbic acid (E200) and salts thereof (e.g. sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and salts thereof (e.g. sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213)).
  • sorbic acid E200
  • salts thereof e.g. sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)
  • benzoic acid (E210) and salts thereof e.g. sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213).
  • the pouch composition comprises less than 0.1% by weight of preservatives, such as less than 0.05% by weight of preservatives.
  • the pouch composition may comprise preservatives in an amount of 0 to 0.1 % by weight of preservatives, such as in an amount of 0 to 0.05% by weight of preservatives.
  • preservatives in an amount of 0 to 0.1 % by weight of preservatives, such as in an amount of 0 to 0.05% by weight of preservatives.
  • the low amount or even absence of preservative may be realized by obtaining a relatively alkaline environment, particularly by the use of free-base nicotine.
  • the pouch composition is free of preservatives.
  • the pouch composition is a non-tobacco pouch composition.
  • the pouch composition comprises less than 2.0% by weight of tobacco, such as less than 1.0% by weight of tobacco, such as less than 0.5% by weight of tobacco, such as 0.0% by weight of tobacco.
  • the pouch composition comprises a non-tobacco fiber.
  • the pouch composition is a powdered composition.
  • the invention further relates to an oral pouched nicotine product comprising a saliva-permeable pouch and the pouch composition of according to the invention or any of its embodiments enclosed in said pouch.
  • the pouched nicotine product comprises nicotine in an amount of 0.5 to 20 mg, such as 1.0 to 20 mg, such as 5.0 to 15 mg.
  • the pouched nicotine product comprises nicotine-ion exchange combination in an amount of 1 to 100 mg per pouch.
  • the pouched nicotine product comprises nicotine-ion exchange combination in an amount of 1 to 100 mg per pouch, such as 10 to 90 mg per pouch, such as 10 to 80 mg per pouch, such as 20 to 80 mg per pouch, such as 30 to 80 mg per pouch, such as 40 to 80 mg per pouch, such as 50 to 80 mg per pouch.
  • the pouched nicotine product comprises nicotine-ion exchange combination in an amount of 1 to 100 mg per pouch, such as 10 to 80 mg per pouch, such as 10 to 60 mg per pouch, such as 20 to 60 mg per pouch, such as 20 to 50 mg per pouch.
  • the divalent cations are provided as a salt having a water-solubility of 5 - 500 grams per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0, such as 5 - 350 grams per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition, and the inorganic divalent cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of chloride, bromide, hydrogen carbonate, sulfate, and any combination thereof
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition, and the divalent cations are provided as a water-soluble salt having a water-solubility of at least 5 gram per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.
  • the inorganic divalent cations are provided as an inorganic salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition, and the water-soluble salt has a water-solubility of at least 5 gram per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition and the pouch composition comprises nicotine in an amount of at least 0.1% by weight, such as least 0.2% by weight of the pouch composition.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition
  • the pouch composition comprises nicotine in an amount of at least 0.1% by weight, such as least 0.2% by weight of the pouch composition
  • the solid oral nicotine formulation comprises inorganic divalent cations in a molar ratio of at most 5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 3.75 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 2.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition, and the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition
  • the solid oral nicotine formulation comprises inorganic divalent cations in a molar ratio of at most 5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 3.75 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 2.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.
  • the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight, and the ion exchange resin is polacrilex resin.
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition, and the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight, and the ion exchange resin is polacrilex resin.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition
  • the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.
  • the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition
  • the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition, and the pouch composition comprises said water-insoluble fiber in an amount between 5 and 50 % by weight of the pouch composition, such as 10-45% by weight of the pouch composition, such as 15-40% by weight of the pouch composition.
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition, and the pouch composition comprises said water-insoluble fiber in an amount between 5 and 50 % by weight of the pouch composition, such as 10-45% by weight of the pouch composition, such as 15-40% by weight of the pouch composition, and the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.
  • the pouch composition comprises said water-insoluble fiber in an amount between 5 and 50 % by weight of the pouch composition, such as 10-45% by weight of the pouch composition, such as 15-40% by weight of the pouch composition, and the water-insoluble fiber is selected from 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.
  • the inorganic divalent cations are provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition, such as between 0.1 and 10.0% by weight of the composition, such as between 0.5 and 10.0% by weight of the composition
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition
  • the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition
  • the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition
  • the pouch composition comprises said water-insoluble fiber in an amount between 5 and 50 % by weight of the pouch composition, such as 10-45% by weight of the
  • the pouch composition comprises pH regulating agent in an amount between 0.01 and 15% by weight of the pouch composition, such as between 0.5 and 10% by weight of the pouch composition, such as between 1 and 10% by weight of the pouch composition, such as between 5 and 10% by weight of the pouch composition, and the pH regulating agent is selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof.
  • the pouch composition comprises pH regulating agent in an amount between 0.01 and 15% by weight of the pouch composition, such as between 0.5 and 10% by weight of the pouch composition, such as between 1 and 10% by weight of the pouch composition, such as between 5 and 10% by weight of the pouch composition, and the pH regulating agent is selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof, and the divalent cations are provided as a water-soluble salt having a water-solubility of at least 5 gram per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.
  • the pH regulating agent is selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof, and the divalent cations are provided as a water-soluble salt having a
  • the pouch composition comprises pH regulating agent in an amount between 0.01 and 15% by weight of the pouch composition, such as between 0.5 and 10% by weight of the pouch composition, such as between 1 and 10% by weight of the pouch composition, such as between 5 and 10% by weight of the pouch composition, and the pH regulating agent is selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof, and the inorganic divalent cations are provided as an inorganic salt comprising inorganic anions selected from the group consisting of chloride, bromide, hydrogen carbonate, sulfate, and any combination thereof.
  • a pouch composition comprising
  • the multivalent cations are selected from the group consisting of Ca2+, Mg2+, Zn2+, Ba2+, Fe2+, Fe3+, Fe4+, Al3+, Mn2+, Mn4+, Cu4+, and any combination thereof.
  • the multivalent cations are selected from the group consisting of trivalent cations of aluminum, divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.
  • the multivalent cations are trivalent cations.
  • the trivalent cation is aluminum.
  • the multivalent cations comprise aluminum chloride
  • the multivalent cations are selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.
  • the multivalent cations are selected from the group consisting of divalent cations of calcium, magnesium, and any combination thereof.
  • the term "pouch composition” refers to the composition for use in an oral pouch, i.e. in pouches for oral use. Also, the terms “pouch composition” and “nicotine pouch composition” is used interchangeably.
  • 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 refers to the amount of pure nicotine.
  • Nicotine also covers nicotine not obtained from tobacco, often referred to as synthetic nicotine.
  • a molar ratio refers to the ratio of the molar content of the first component divided by the molar content of the second component.
  • the relative content between the first component and the second component may also be presented as equivalents of the first component relative to the second component.
  • a pouch comprising divalent cations in a molar ratio of 0.1 relative to the amount of nicotine in the nicotine-ion exchange resin combination may also be presented as a pouch comprising 0.1 eq. of divalent cations relative to the amount of nicotine in the nicotine-ion exchange resin combination, i.e. a pouch comprising 0.1 eq. of divalent cations and 1 eq. of nicotine in the nicotine-ion exchange resin combination.
  • 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.
  • 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.
  • 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.
  • nicotine complexed with ion-exchange resin refers to nicotine bound to an ion exchange resin.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 alginate, propylene glycol, hydroxypropyl cellulose, and glycerol.
  • glycerol when included as a humectant, the glycerol is added as free glycerol and therefore liquid at room temperature.
  • humectants include triacetin, modified starch, pectin, xanthan gum, etc.
  • the term humectant does not refer to sugar alcohols comprising 4 or more carbons.
  • 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.
  • 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.
  • water-soluble is meant, unless otherwise stated.
  • 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.
  • insoluble water-insoluble is meant unless otherwise stated.
  • 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.
  • 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.
  • fast release or “fast release period” may refer to the initial 2 minutes of the nicotine release profile, whereas the term “sustained release period refers” to the subsequent period of the release profile until end of experiment or end of use.
  • fast release rate refers to the released nicotine per minute within the initial 2 minutes.
  • the term “effective release” refers to the total release of nicotine over the release period of the experiment or the use period.
  • solvent is the process where a solid substance enters a solvent (such as oral saliva or water within the pouch) to yield a solution.
  • 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 an water-insoluble composition, inside the pouch during use.
  • the material for the pouch may be selected accordingly, e.g. comprising e.g. woven and/or non-woven fabric.
  • 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.
  • 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.
  • 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.
  • 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.
  • the pouch composition may further comprise one or more additives.
  • said additives are selected from the group consisting of bile salts, cetomacrogols, chelating agents, citrates, cyclodextrins, detergents, enamine derivatives, fatty acids, labrasol, lecithins, phospholipids, syntetic and natural surfactants, nonionic surfactants, cell envelope disordering compounds, solvents, steroidal detergents, chelators, solubilization agents, charge modifying agents, pH regulating agents, degradative enzyme inhibitors, mucolytic or mucus clearing agents, membrane penetration-enhancing agents, modulatory agents of epithelial junction physiology, vasodilator agents, selective transport-enhancing agents, or any combination thereof.
  • pH regulating agents include buffers.
  • said additives are selected from the group consisting of cetylpyridinium chloride (CPC), benzalkonium chloride, sodium lauryl sulfate, polysorbate 80, Polysorbate 20, cetyltrimethylammonium bromide, laureth 9, sodium salicylate, sodium EDTA, EDTA, aprotinin, sodium taurocholate, saponins, bile salt derivatives, fatty acids, sucrose esters, azone emulsion, dextran sulphate, linoleic acid, labrafil, transcutol, urea, azone, nonionic surfactants, sulfoxides, sauric acid/PG, POE 23 lauryl ether, methoxysalicylate, dextran sulfate, methanol, ethanol, sodium cholate, Sodium taurocholate, Lysophosphatidyl choline, Alkylglycosides, polysorbates, Sorbit
  • 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.
  • pH regulating agents may be acids and bases, including acidic buffering agents and alkaline buffering agents.
  • pH regulating agents does not including substances and compositions that can only affect the pH by dilution.
  • pH regulating agents does not include e.g. flavoring, fillers, etc.
  • said pH-regulating agents are selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono- ⁇ -lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potasium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.
  • 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.
  • the pouch composition comprises high intensity sweetener.
  • 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.
  • 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.
  • the pouch composition comprises bulk sweeteners including sugar and/or sugarless components.
  • 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.
  • 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, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.
  • 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, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.
  • 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.
  • sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.
  • 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.
  • 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.
  • 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.
  • composition modifiers may be added to the pouch composition in various ways.
  • composition modifiers may be added by full powder mixture during the last few minutes of the final mixing.
  • composition modifiers may be added after granulation steps on a granulation premix.
  • composition modifier such as magnesium stearate
  • the composition modifier may have a sealing effect and can be used to control the release of the nicotine and the solubility of the pouch.
  • the pouch composition comprises polyvinylpyrrolidone (PVP).
  • PVP polyvinylpyrrolidone
  • 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.
  • Example 1A Preparation of pouches designed for administration of nicotine
  • 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.
  • the powder is filled into pouches and is maintained in the pouch by a sealing.
  • Example 1B Preparation of pouches designed for administration of nicotine
  • 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.
  • the powder is filled into pouches and is maintained in the pouch by a sealing.
  • 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.
  • Pouches are prepared comprising powdered compositions as outlined in table 9 - 21.
  • the pouches are made as follows.
  • Fibers and water are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: first the nicotine-ion exchange combination (NPR or premix) (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.
  • the pouch compositions are prepared from the ingredients in table 9 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 9 Pouch compositions.
  • Pouches P01 P02 P03 P04 P05 P06 P07 P08 C1 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt%] 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 Inorganic divalent cations [eq] ⁇ 0.5 0.75 1 1.5 2 3 4 7.5 - Raw material Content in weight percent NPR (16%) 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 CaCl 2 ⁇ 0.7 1.0 1.3 2.0 2.6 3.9 5.2 10.0 - Xylitol 18.2 17.9 17.6 16.9 16.3 15.0 13.7 8.9 18.9 Purified water 25
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • 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 1A was used, but 1B could also have been applied).
  • Table 10 Pouch compositions.
  • Pouches P1 1 P12 P13 P14 P15 P16 P17 P18 C2 C3 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt%] 15 25 30 35 30 30 30 10 25 25 Inorganic divalent cations [eq] ⁇ 1.0 1.0 1.0 1.0 1.5 2.0 1.0 - - Raw material Content in weight percent NPR (16%) 12.
  • Divalent cations may be provided as a hydrated salt, such as dihydrate, tetrahydrate, hexahydrate etc.
  • the weight% in the table are based on the non-hydrated salt.
  • ⁇ Corresponds to 1 eq of NaCl relative to nicotine in nicotine ion-exchange combination.
  • ⁇ Corresponds to 10 eq of NaCl relative to nicotine in nicotine ion-exchange combination.
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 11 using preparation method described in example 3.
  • Pouch content 500 mg total.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • 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 1A was used, but 1B could also have been applied).
  • Table 12 Pouch compositions.
  • Pouch content 500 mg total.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 13 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 13 Pouch compositions.
  • Pouches P40 P41 P42 P43 P44 P45 C4 C5 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt%] 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 Inorganic divalent cations [eq] ⁇ 0.
  • Divalent cations may be provided as a hydrated salt, such as dihydrate, tetrahydrate, hexahydrate etc.
  • the weight% in the table are based on the non-hydrated salt.
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 14 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 14 Pouch compositions.
  • Pouches P50 P51 P52 P53 P54 P55 C6 C7 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt%] 15 25 40 30 30 10 30 30 30 Inorganic divalent cations [eq] ⁇ 1.0 1.0 1.0 1.0 1.0 1.0 - - Raw material Content in weight percent Premix VI 6.4 6.4 6.4 - - 6.4 - - Premix VII - - - 5.5 - - 5.5 - Premix VIII - - - - 4.6 CaCl 2 ⁇ 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 - - Xylitol 45.3 25.3 4.3
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 15 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 15 Pouch compositions.
  • Pouches P60 P61 P62 P63 P64 P65 P66 P67 C8 C9 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt%] 27 27 27 27 27 35 30 30 30 30 Inorganic divalent cations [eq] ⁇ 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 - - Raw material Content in weight percent Premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 CaCl 2 ⁇ 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 16 using preparation method described in example 3.
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Pea fiber trade name "Vitacel EF150”.
  • fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, powdered cellulose, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, bran fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, powdered cellulose, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, bran fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 17 using preparation method described in example 3.
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Pea fiber trade name "Vitacel EF150”.
  • Fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, powdered cellulose, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, bran fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 18 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 18 Pouch compositions.
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 19 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 19 Pouch compositions.
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • the pouch compositions are prepared from the ingredients in table 20 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 20 Pouch compositions.
  • Pouches P110 P111 P112 P113 P114 P115 C10 C11 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt%] 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 Inorganic divalent cations [e
  • Pouch content 500 mg total, i.e. nicotine conc 19.2 mg/g.
  • 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.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • the pouch compositions are prepared from the ingredients in table 21 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
  • Table 21 Pouch compositions.
  • Pouches P120 P121 P122 P123 P124 P125 P126 P127 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt%] 30 30 30 30 30 27 27 Inorganic divalent cations [eq] ⁇ 2.0 3.0 4.0 2.0 3.0 4.0 7.5 7.5 Raw material Content in weight percent Premix II 14.6 14.6 14.6 - - - 14.6 - Premix VI - - 6.4 6.4 - 6.4 CaCl 2 ⁇ 2.6 3.9 5.2 2.6 3.9 5.2 10.0 10.0 Xylitol 8.8 7.5 6.2 14.0 12.7 11.4 7.4 12.6 Purified water 25 25 25 28 28 28 22 25 Wheat fiber 30 30 30 30 30 30 30 30 30 30 30 30 30 27 27
  • Wheat fiber trade name "Vitacel 600 WF plus”.
  • Other fibers may be used as well, such as water-insoluble plant fibers, such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • water-insoluble plant fibers such as oat 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, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.
  • Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants.
  • Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.
  • Flavor example 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 flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
  • 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.
  • Potassium sorbate is used as a preservative.
  • Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
  • Silicon dioxide is used as a glidant.
  • Other possible glidants include e.g. magnesium stearate, starch and talc.
  • Example 6A Release experiment and varying salts.
  • the release experiment was performed by adding an amount of NPR (16%) and varying equivalent of CaCl 2 to 900 mL of water corresponding to a nicotine concentration of 28 mg/L.
  • the equivalents of CaCl 2 are relative to nicotine.
  • the temperature of the water was 25 degrees Celsius throughout the experiment and stirring of 100 rpm was applied throughout the experiment. pH was measured at experiment start and end. The pH was in all experiments below 7.0 at both the start and end of the experiment.
  • a relative low nicotine concentration is used in order to reduce the impact of equilibrium on both the release rate and effective release of nicotine from the ion-exchange resin.
  • Example 6B Release experiment using NPR and varying equivalents of CaCl 2 .
  • a relative low nicotine concentration is used in order to reduce the impact of equilibrium on both the release rate and effective release of nicotine from the ion-exchange resin.
  • Example 6C Release experiment using NPR and varying equivalents of MgCl 2 .
  • a relative low nicotine concentration is used in order to reduce the impact of equilibrium on both the release rate and effective release of nicotine from the ion-exchange resin.
  • the release experiment was performed by adding nicotine premix having varying content of nicotine and 1 equivalent of CaCl 2 to a volume of water, whereby a corresponding nicotine concentration of 28 mg/L is obtained.
  • the equivalent of CaCl 2 is relative to nicotine.
  • the temperature of the water was 25 degrees Celsius throughout the experiment and stirring of 150 rpm was applied throughout the experiment. pH was measured at experiment start and end. The pH was in all experiments below 7.0 at both the start and end of the experiment.
  • a relative low nicotine concentration is used in order to reduce the impact of equilibrium on both the release rate and effective release of nicotine from the ion-exchange resin.
  • Example 6E Release experiment using 1 equivalent of AlCl 3 or 1 equivalent of MgO.
  • the release experiment was performed by adding NPR (16%) and 1 equivalent of AlCl 3 to a volume of water corresponding to a nicotine concentration of 28 mg/L. The equivalents are relative to nicotine.
  • the temperature of the water was 25 degrees Celsius throughout the experiment and stirring of 150 rpm was applied throughout the experiment. pH was measured at experiment start and end. The pH was in all experiments below 7.0 at both the start and end of the experiment.
  • a relative low nicotine concentration is used in order to reduce the impact of equilibrium on both the release rate and effective release of nicotine from the ion-exchange resin.
  • Example 6E falls outside the scope of claim 1.
  • the whole release experiment was performed at 37 degrees Celsius. No stirring or shaken was applied during the release experiment.
  • the amount of release nicotine was determined by analyzing the buffer samples at the different timepoints using standard HPLC.
  • Table 27 Shows the percentage of nicotine released from nicotine pouches at different timepoints in the presence of varying equivalents of CaCl 2 .
  • Pouch C4 P40 P42 C5 P43 P45 C10 P110 C11 P113 Premix II II II VI VI II II VI CaCl 2 - 0.75 eq 1.5 eq - 0.75 eq 1.5 eq - 0.75 eq - 0.75 eq NaCl 2.9 eq - - 2.9 eq - - - - - - Min.
  • Example 9A User evaluation.
  • the produced pouches of the invention were evaluated and found highly suitable as delivery vehicles of nicotine in that they provide a favorable release of nicotine and at the same time are pleasant to the user, e.g. with respect to a desirable mouthfeel such as a moist and moldable texture and a desirable taste.
  • Example 9B User evaluation.
  • the pouch product P03 and P44 was evaluated with respect to perceived effect from nicotine and mouthfeel.
  • Perceived effect from nicotine and mouthfeel was evaluated by a test panel of 4 trained assessors. Each assessor evaluates all samples twice. Average evaluations are estimated.
  • the pouch product P03 and P44 were evaluated to have a fast onset of action and a high perceived effect from nicotine by all four assessors. Also, all four assessors evaluated the pouch products to have a desirable mouthfeel, i.e. the pouches were found to be moist and have a desirable taste.
  • the pouches, P08 and P127 were evaluated. These pouches were evaluated to have a fast onset of action and a high perceived effect from nicotine by all four assessors. However, the pouches were found to provide a less desirable mouthfeel, the pouches being perceived as somewhat dry, adhering to the oral mucosa and/or as having a poor taste or less desirable taste, i.e. too salty.

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Claims (17)

  1. Beutelzusammensetzung, umfassend
    eine Nikotin-Ionenaustauschharz-Kombination,
    Wasser in einer Menge von wenigstens 15 Gew.-% der Beutelzusammensetzung, und
    anorganische zweiwertige Kationen, wobei die feste orale Formulierung von Nikotin anorganische zweiwertige Kationen in einem Molverhältnis von höchstens 5, bezogen auf die Menge an Nikotin in der Nikotin-Ionenaustauschharz-Kombination, aufweist.
  2. Beutelzusammensetzung nach Anspruch 1, wobei die feste orale Nikotinformulierung anorganische zweiwertige Kationen in einem Molverhältnis von wenigstens 0,1, bezogen auf die Menge an Nikotin in der Nikotin-Ionenaustauschharz-Kombination, wie wenigstens 0,25, bezogen auf die Menge an Nikotin in der Nikotin-Ionenaustauschharz-Kombination, wie wenigstens 0,5, bezogen auf die Menge an Nikotin in der Nikotin-Ionenaustauschharz-Kombination, aufweist.
  3. Beutelzusammensetzung nach Anspruch 1 oder 2, wobei die feste orale Nikotinformulierung anorganische zweiwertige Kationen in einem Molverhältnis von höchstens 3,75, bezogen auf die Menge an Nikotin in der Nikotin-Ionenaustauschharz-Kombination, wie höchstens 2,5, bezogen auf die Menge an Nikotin in der Nikotin-Ionenaustauschharz-Kombination, aufweist.
  4. Beutelzusammensetzung nach einem der Ansprüche 1 bis 3, wobei die anorganischen zweiwertigen Kationen aus der Gruppe ausgewählt sind bestehend aus zweiwertigen Kationen von Kalzium, Magnesium, Eisen, Zink und jeder Kombination davon, wie beispielsweise ausgewählt aus der Gruppe bestehend aus zweiwertigen Kationen von Kalzium und Magnesium.
  5. Beutelzusammensetzung nach einem der Ansprüche 1 bis 4, wobei die anorganischen zweiwertigen Kationen als ein Salz vorgesehen sind, das Anionen aufweist, die ausgewählt sind aus der Gruppe bestehend aus Carboxylaten, wie Acetat, Lactat, Oxalat, Propionat oder Levulinat; organischem Sulfonat; organischem Sulfat; organischem Phosphat; Chlorid, Bromid, Nitrat, Sulfat, Hydrogenphosphat, Oxid und jeder Kombination davon.
  6. Beutelzusammensetzung nach einem der Ansprüche 1 bis 5, wobei die anorganischen zweiwertigen Kationen als Salz in einer Menge zwischen 0,1 und 15,0 Gew.-% der Zusammensetzung, wie zwischen 0,1 und 10,0 Gew.-% der Zusammensetzung, wie zwischen 0,5 und 10,0 Gew.-% der Zusammensetzung, vorgesehen sind.
  7. Beutelzusammensetzung nach einem der Ansprüche 1 bis 6, wobei die anorganischen zweiwertigen Kationen als ein anorganisches Salz vorgesehen sind, das anorganische Anionen umfasst, die ausgewählt sind aus der Gruppe bestehend aus Chlorid, Bromid, Nitrat, Sulfat, Hydrogencarbonat, Hydrogenphosphat, Oxid, Hydroxid, und jede Kombination davon, wie beispielsweise ausgewählt aus der Gruppe bestehend aus Chlorid, Bromid, Hydrogencarbonat, Sulfat und jeder Kombination davon, wie beispielsweise ausgewählt aus der Gruppe bestehend aus Chlorid, Bromid und jeder Kombination davon, wie beispielsweise, wobei die anorganischen Anionen Chlorid aufweisen.
  8. Beutelzusammensetzung nach einem der Ansprüche 1 bis 7, wobei die zweiwertigen Kationen als wasserlösliches Salz mit einer Wasserlöslichkeit von wenigstens 5 Gramm pro 100 ml Wasser, gemessen bei 25 Grad Celsius, Atmosphärendruck und pH 7,0, vorgesehen sind.
  9. Beutelzusammensetzung nach einem der Ansprüche 1 bis 8, wobei die Beutelzusammensetzung eine Nikotin-Ionen-Austauschkombination in einer Menge von 0,1 bis 20 Gew.-% der Beutelzusammensetzung aufweist.
  10. Beutelzusammensetzung nach einem der Ansprüche 1 bis 9, wobei die Nikotin-Ionenaustauschharz-Kombination Nikotin umfasst, das mit Ionenaustauschharz komplexiert ist, und wobei das Ionenaustauschharz Polacrilexharz ist.
  11. Beutelzusammensetzung nach einem der Ansprüche 1 bis 10, wobei die Nikotin-Ionenaustauschharz-Kombination Nikotin auf freier Basis aufweist, das mit Ionenaustauschharz gemischt ist, und wobei das Ionenaustauschharz Polacrilexharz ist.
  12. Beutelzusammensetzung nach einem der Ansprüche 1 bis 11, wobei die Beutelzusammensetzung wenigstens einen Zuckeralkohol aufweist.
  13. Beutelzusammensetzung nach einem der Ansprüche 1 bis 12, wobei der wenigstens eine Zuckeralkohol ausgewählt ist aus Xylit, Maltit, Mannit, Erythrit, Isomalt, Sorbit, Lactit und Mischungen davon.
  14. Beutelzusammensetzung nach einem der Ansprüche 1 bis 13, wobei die Beutelzusammensetzung wenigstens eine wasserunlösliche Faser, wie wenigstens eine wasserunlösliche Pflanzenfaser, aufweist.
  15. Beutelzusammensetzung nach einem der Ansprüche 1 bis 14, wobei die wasserunlösliche Faser ausgewählt ist aus Weizenfasern, Erbsenfasern, Reisfasern, Maisfasern, Haferfasern, Tomatenfasern, Gerstenfasern, Roggenfasern, Zuckerrübenfasern, Buchweizenfasern, Kartoffelfasern, Zellulosefasern, Apfelfasern, Kakaofasern, Zellulosefasern, Kleiefasern, Bambusfasern, pulverisierter Zellulose und Kombinationen davon.
  16. Beutelzusammensetzung nach einem der Ansprüche 1 bis 15, wobei die Beutelzusammensetzung ein pH-regulierendes Mittel aufweist.
  17. Orales Nikotinprodukt in einem Beutel, umfassend einen speicheldurchlässigen Beutel und die in diesem Beutel eingeschlossene Beutelzusammensetzung nach einem der Ansprüche 1 bis 16.
EP20207822.6A 2020-11-16 2020-11-16 Nikotinbeutelzusammensetzung Active EP4000424B1 (de)

Priority Applications (6)

Application Number Priority Date Filing Date Title
DK20207822.6T DK4000424T3 (da) 2020-11-16 2020-11-16 Sammensætning af nikotinpose
EP20207822.6A EP4000424B1 (de) 2020-11-16 2020-11-16 Nikotinbeutelzusammensetzung
PCT/DK2021/050334 WO2022100805A1 (en) 2020-11-16 2021-11-16 Nicotine pouch composition
CN202180075476.XA CN116419682A (zh) 2020-11-16 2021-11-16 尼古丁袋组合物
JP2023527692A JP2023549345A (ja) 2020-11-16 2021-11-16 ニコチンパウチ組成物
CA3198533A CA3198533A1 (en) 2020-11-16 2021-11-16 Nicotine pouch composition

Applications Claiming Priority (1)

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EP20207822.6A EP4000424B1 (de) 2020-11-16 2020-11-16 Nikotinbeutelzusammensetzung

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024208402A1 (en) * 2023-04-03 2024-10-10 Fertin Pharma A/S Pouch with crosslinked alginate

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114740103B (zh) * 2022-03-16 2023-06-23 天津键凯科技有限公司 一种聚多卡醇低聚物分布检测方法

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US11717017B2 (en) * 2017-04-24 2023-08-08 Swedish Match North Europe Ab Flavoured moist oral pouched nicotine product comprising triglyceride
WO2018233795A1 (en) * 2017-06-23 2018-12-27 Fertin Pharma A/S NICOTINE POCKET
KR20210122776A (ko) * 2019-02-01 2021-10-12 스웨디쉬 매치 노스 유럽 에이비 pH 조절제를 포함하는 경구 니코틴 제품

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024208402A1 (en) * 2023-04-03 2024-10-10 Fertin Pharma A/S Pouch with crosslinked alginate

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