WO2022100805A1 - Composition de sachet de nicotine - Google Patents

Composition de sachet de nicotine Download PDF

Info

Publication number
WO2022100805A1
WO2022100805A1 PCT/DK2021/050334 DK2021050334W WO2022100805A1 WO 2022100805 A1 WO2022100805 A1 WO 2022100805A1 DK 2021050334 W DK2021050334 W DK 2021050334W WO 2022100805 A1 WO2022100805 A1 WO 2022100805A1
Authority
WO
WIPO (PCT)
Prior art keywords
nicotine
pouch
weight
pouch composition
fibers
Prior art date
Application number
PCT/DK2021/050334
Other languages
English (en)
Inventor
Kent Albin Nielsen
Jessie POULSEN
My Ly Lao STAHL
Bine Hare JAKOBSEN
Original Assignee
Ncp Nextgen A/S
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
Priority claimed from US17/099,446 external-priority patent/US20220151292A1/en
Priority claimed from EP20207822.6A external-priority patent/EP4000424B1/fr
Application filed by Ncp Nextgen A/S filed Critical Ncp Nextgen A/S
Priority to CN202180075476.XA priority Critical patent/CN116419682A/zh
Priority to CA3198533A priority patent/CA3198533A1/fr
Priority to JP2023527692A priority patent/JP2023549345A/ja
Publication of WO2022100805A1 publication Critical patent/WO2022100805A1/fr

Links

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
    • 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
    • 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
    • A24B15/18—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 present invention relates to a pouch composition
  • a pouch composition comprising a nicotine-ion exchange resin combination, water in an amount of at least 15% by weight of the pouch composition, and inorganic divalent cations.
  • 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 pouch composition 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 ionexchange of the complexed nicotine for the divalent cations during use of a pouch comprising the pouch composition.
  • the amount of inorganic divalent cations may advantageously also decrease the probability of exchanged nicotine from re-complexing with the ionexchange resin, simply by occupying binding sites on the ion-exchange resin during use.
  • 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 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 6 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 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 pouch composition 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.
  • One advantage of the above embodiment may be that including inorganic divalent cations in a not too high amount facilitates a desirable taste and mouthfeel, by avoiding or minimizing undesirable taste and/or mouthfeel, such as undesired salty taste, a local dehydration or even an oral dehydrating sensation.
  • the pouch composition comprises inorganic divalent cations in a molar ratio of between 0.1 and 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 0.1 and 6.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 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. It is noted that in some embodiments, 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 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 pouch composition comprises inorganic divalent cations provided as a water-soluble salt
  • the pouch composition comprises said inorganic divalent cations provided as a water-soluble salt in a molar ratio of between 0.1 and 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 0.1 and 6.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 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 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 as 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 pouch composition comprises inorganic divalent cations provided as an inorganic, water-soluble salt
  • the pouch composition comprises said inorganic divalent cations provided as an inorganic, water- soluble salt in a molar ratio of between 0.1 and 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 0.1 and 6.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 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 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 at least 0.1% by weight, such as least 0.2% by weight of the pouch composition.
  • 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 should have a desirable content of nicotine able to provide the user with a desirable dose of nicotine, while also providing the user with a desirable volume of composition being enclosed in the pouch.
  • the pouch composition comprises nicotine-ion exchange combination in an amount of 0.1 to 20% by weight of the pouch composition.
  • the divalent cations does not form part of the nicotine-ion exchange combination when preparing the pouch composition. If combined before preparation of the pouch composition. A pre-combination may cause stability issues, since the divalent cations could induce a too early release of nicotine from the ionexchange resin. This could in particular be a problem, when incorporating a such combination into a pouch composition having a high water content, such as at least 15% by weight of the pouch composition.
  • the divalent cations are not included in the provided nicotine-ion-exchange combination.
  • the nicotine-ion-exchange combination does not comprise divalent cations.
  • the divalent cations are provided as a salt.
  • 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. In an embodiment of the invention 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 comprises polacrilex resin.
  • 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.
  • 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, such as 25-40% by weight of the composition, such as 25-35% % 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. Also, 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.
  • sugar alcohol may advantageously be used in combination with inorganic divalent cations in order to achieve a desirable release of nicotine, while also a desirable taste is achieved.
  • 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.
  • the pouch composition comprises at least two sugar alcohols.
  • 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 waterinsoluble fiber in an amount between 5 and 50 % by weight of the pouch composition, such as 5-45% by weight of the pouch composition, such as 5-40% by weight of the pouch composition. In an embodiment of the invention, the pouch composition comprises said waterinsoluble 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.
  • An advantage of the above embodiment may be that a residue is left even after use of a nicotine pouch comprising the pouch composition. This may lead to a pleasant perception for users of the nicotine pouch, e.g. due to similarity with tobacco containing products.
  • the water-insoluble fiber may advantageously provide a desirable mouthfeel throughout the use of the pouch.
  • the water-insoluble fiber is a plant fiber.
  • 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.
  • 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 fiber is 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 fiber is 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.
  • the water-insoluble fiber is selected from wheat fibers, oat fibers, or combinations thereof.
  • the water-insoluble fiber is powdered cellulose.
  • Non-limiting examples of usable water-insoluble fibers include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel LOO, 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%.
  • 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%.
  • 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 rnL/g, such as 5.0 - 20 mL/g.
  • the amount of water-insoluble fiber can be reduced without compromising the mouthfeel during use. If an amount of waterinsoluble fiber is substituted for a water-soluble component, the swelling of the waterinsoluble 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/ab sorption 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 basic pH regulating agent, such as a basic buffering agent.
  • the pH regulating agent is a buffering agent, such as a basic buffering agent.
  • the pH regulating agent is water-soluble.
  • the pH regulating agent is having water-solubility of at least 5 gram per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.
  • 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).
  • An advantage of the above embodiment may be that a relatively effective uptake of nicotine is facilitated due to the high pH value obtained.
  • 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. Also, 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-6-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 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, amino acids and phosphate buffer, or any combination thereof.
  • the pH adjusting agent is selected from the group consisting of trometamol and phosphate buffer, or any combination thereof.
  • Trometamol and phosphate buffers have a desirable relative neutral taste, hence the use of these pH regulating agents may not compromise the taste and mouthfeel of the pouch composition.
  • the pH adjusting agent is trometamol.
  • the pH adjusting agent comprises trometamol.
  • the pH adjusting agent is amino acid
  • the pH adjusting agent is phosphate buffer.
  • the pH adjusting agent is phosphate buffer selected from the group consisting of Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, and combinations thereof.
  • the pH regulating agent is an alkali metal phosphate buffer.
  • the phosphate buffer is an alkali metal phosphate buffer.
  • the phosphate buffer is an alkali metal phosphate buffer selected from the group consisting of Sodium orthophosphate, Potassium orthophosphate, Sodium diphosphate, Potassium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, and combinations thereof.
  • the phosphate buffer is provided as a water-soluble composition.
  • the pH adjusting agent does not comprise carbonate and/or bicarbonate.
  • the pH adjusting agent is a non-carbonate and/or non-bicarbonate buffers, or combinations thereof.
  • the humectant is selected from the list of glycerol, propylene glycol, alginate, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.
  • 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 pouch composition is free of humectants selected from the list of glycerol, propylene glycol, alginate, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.
  • humectants selected from the list of glycerol, propylene glycol, alginate, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.
  • 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 a nontobacco 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 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 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
  • 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 pouch composition comprises inorganic divalent cations in a molar ratio of at most 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 6.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 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 pouch composition comprises inorganic divalent cations in a molar ratio of at most 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 6.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as 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 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 waterinsoluble 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 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
  • 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, 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 invention further relates to a pouch composition comprising a nicotine-ion exchange resin combination, and inorganic multivalent 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.
  • pouch composition refers to the composition for use in an oral pouch, i.e. in pouches for oral use.
  • pouch composition refers to the composition enclosed within the pouch.
  • the terms “pouch composition”, “nicotine pouch composition” and “solid oral nicotine formulation” are used interchangeably, when referring to the composition being enclosed within the pouch.
  • 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.
  • nicotine-ion exchange resin combination refers to a combination comprising nicotine complexed with ion exchange resin and/or free- base nicotine mixed with ion exchange resin.
  • nicotine complexed with ion-exchange resin refers to nicotine bound to an ion exchange resin.
  • 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 ionexchange 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-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. Therefore, compositions or substances having a water-solubility of between 0.1 and 5 gram per of composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH of 7.0 are considered neither water-soluble nor water-insoluble, but having an intermediate water-solubility.
  • 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.
  • 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-6- 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, trometamol, phosphate buffers, amino acids, 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.
  • 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.
  • 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.
  • 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.
  • the flavors can be natural or synthetic flavors.
  • the pouch composition comprises flavor.
  • Flavor may typically be present in amounts between 0.01 and 15% by weight of the total composition of the pouch, such as between 0.01 and 5% by weight of the total composition.
  • 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, according to various embodiments, be selected group consisting of metallic stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, silicates dioxide, talc, magnesium stearates, calcium stearates, fumed silica, powdered hydrogenated cottonseed oils, hydrogenated vegetable oils, hydrogenated soya oil, emulsifiers, triglycerides, and mixtures thereof.
  • metallic stearates such as magnesium stearate, may be advantageous.
  • 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.
  • 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.
  • 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.
  • % water in obtained nicotine-resin composition 34.1.
  • Pouches are prepared comprising powdered compositions as outlined in table 9 - 21.
  • the pouches are made as follows.
  • the final pouch composition is filled into pouches (target fill weight 500 mg powder per pouch).
  • the pouch material of example 1A or IB may be used.
  • the powder is filled into pouches and is maintained in the pouch by a sealing.
  • Pouch content 500 mg total, i.e. nicotine cone 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 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.
  • 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 5B The pouch compositions are prepared from the ingredients in table 10 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).
  • **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 cone 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.
  • **Multivalent 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.
  • 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 1 A was used, but IB could also have been applied).
  • **Multivalent 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.
  • 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 13 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).
  • Table 13 Pouch compositions. *The inorganic divalent cations are presented as equivalents relative to nicotine in nicotine ion-exchange combination.
  • **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 cone 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 1 A was used, but IB could also have been applied).
  • **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 cone 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 1 A was used, but IB could also have been applied).
  • **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 cone 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.
  • Example 5H The pouch compositions are prepared from the ingredients in table 16 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).
  • **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 cone 19.2 mg/g.
  • Powdered cellulose trade name “Vitacel LOO” or “Vitacel L700G”.
  • Oat fiber trade name “Vitacel HF 600”.
  • Pea fiber trade name “Vitacel EFl 50”.
  • 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.
  • 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 17 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).
  • **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 cone 19.2 mg/g.
  • Powdered cellulose trade name “Vitacel LOO” or “Vitacel L700G”.
  • Oat fiber trade name “Vitacel HF 600”.
  • Pea fiber trade name “Vitacel EFl 50”.
  • 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.
  • 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 18 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).
  • **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 cone 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 1 A was used, but IB could also have been applied).
  • **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 cone 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 20 using preparation method described in example 3.
  • the pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1 A was used, but IB could also have been applied).
  • **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 cone 19.2 mg/g (16 mg/g for samples Pl 16, P117 and C12).
  • Wheat fiber trade name “Vitacel 600 WF plus”. Powdered Cellulose, trade name “Powdered Cellulose L700G”.
  • Other fibers may be used as well, such as waterinsoluble 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, bran fibers, bamboo fibers, and cellulose fiber.
  • waterinsoluble 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, bran fibers, bamboo fibers, and cellulose fiber.
  • 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 1 A was used, but IB could also have been applied).
  • inorganic divalent cations are presented as equivalents relative to nicotine in nicotine ion-exchange combination.
  • **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 cone 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.
  • Example 6A Release experiment and varying salts.
  • the release experiment was performed by adding an amount of NPR (16%) and varying equivalent of CaCh to 900 mL of water corresponding to a nicotine concentration of 28 mg/L.
  • the equivalents of CaCh 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 ionexchange resin.
  • Table 22 Release of nicotine over time in the presence of varying salts and varying equivalents of cations.
  • Example 6B Release experiment using NPR and varying equivalents of CaCh.
  • the release experiment was performed by adding NPR (16%) and varying equivalent of CaCh to a volume of water corresponding to a nicotine concentration of 28 mg/L.
  • the equivalents of CaCh 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 ionexchange resin.
  • Table 23 Shows the percentage of nicotine released from NPR at different timepoints in the presence of varying equivalent of CaCh.
  • Example 6C Release experiment using NPR and varying equivalents of MgCh.
  • the release experiment was performed by adding NPR (16%) and varying equivalents of MgCh to a volume of water corresponding to a nicotine concentration of 28 mg/L.
  • the equivalents of MgCh 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 ionexchange resin.
  • Table 24 Shows the percentage of nicotine released from NPR at different timepoints in the presence of varying equivalents of MgCh.
  • Example 6D Release experiment using 1 equivalent of CaCh and nicotine premix having varying content of nicotine.
  • the release experiment was performed by adding nicotine premix having varying content of nicotine and 1 equivalent of CaCb to a volume of water, whereby a corresponding nicotine concentration of 28 mg/L is obtained.
  • the equivalent of CaCh 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.
  • Table 25 Shows the percentage of nicotine released from nicotine premix at different timepoints in the presence of 1 equivalent of MgCh.
  • the release experiment was performed by adding NPR (16%) and 1 equivalent of A1CE 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 ionexchange resin.
  • Table 24 Shows the percentage of nicotine released from NPR at different timepoints in the presence of 1 equivalent of AlCh.
  • Example 7A Pouch release experiments (in vitro) The release properties of the pouches were tested in an in vitro experiment.
  • Reaction tubes having a diameter approx. 2 cm and containing 10 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to 7.4) were warmed to 37 degrees Celsius. One reaction tuber per timepoint was used.
  • a pouch was submerged in the buffer of the first reaction tube using tweezers. After a specified time period, the pouch was captured with the tweezer and gently swirled in the buffer before being removed from the first reaction tube and added to the next reaction tube, representing the next time point. The procedure was repeated until the desired number of time points had been tested. 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 A Shows the percentage of nicotine released from nicotine pouches at different timepoints in the presence of varying equivalents of CaCh.
  • Table 27B Shows the percentage of nicotine released from nicotine pouches at different timepoints in the presence of varying equivalents of CaCh.
  • 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 products P03, P44 and Pl 17 were evaluated with respect to perceived effect from nicotine and mouthfeel. Evaluation of perceived effect from nicotine and mouthfeel is performed as described in the following.
  • 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,P44 and Pl 17 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 Pl 27, 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.
  • Pouches comparable to P127 but comprising higher amounts of flavor were also evaluated, i.e. P128 and P129. Despite their increased flavor levels compared to P127, these pouches were also perceived as being dry and adhering to the oral mucosa. Furthermore, the taste was also for these pouches found to be less desirable, as notes of saltiness were still perceived and the flavor profile was perceived as imbalanced.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Toxicology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Manufacture Of Tobacco Products (AREA)

Abstract

Une composition de sachet est divulguée, la composition de sachet comprenant une combinaison de résine échangeuse d'ions de nicotine, de l'eau en une quantité d'au moins 15 % en poids de la composition de sachet et des cations divalents inorganiques. En outre, un produit de nicotine en sachet oral comprenant un sachet perméable à la salive et la composition de sachet dans ledit sachet, et une composition de sachet sont également divulgués.
PCT/DK2021/050334 2020-11-16 2021-11-16 Composition de sachet de nicotine WO2022100805A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN202180075476.XA CN116419682A (zh) 2020-11-16 2021-11-16 尼古丁袋组合物
CA3198533A CA3198533A1 (fr) 2020-11-16 2021-11-16 Composition de sachet de nicotine
JP2023527692A JP2023549345A (ja) 2020-11-16 2021-11-16 ニコチンパウチ組成物

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US17/099,446 US20220151292A1 (en) 2020-11-16 2020-11-16 Nicotine pouch composition
EP20207822.6 2020-11-16
US17/099,446 2020-11-16
EP20207822.6A EP4000424B1 (fr) 2020-11-16 2020-11-16 Composition de poche à nicotine

Publications (1)

Publication Number Publication Date
WO2022100805A1 true WO2022100805A1 (fr) 2022-05-19

Family

ID=78676251

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2021/050334 WO2022100805A1 (fr) 2020-11-16 2021-11-16 Composition de sachet de nicotine

Country Status (4)

Country Link
JP (1) JP2023549345A (fr)
CN (1) CN116419682A (fr)
CA (1) CA3198533A1 (fr)
WO (1) WO2022100805A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023106407A1 (fr) * 2021-12-09 2023-06-15 日本たばこ産業株式会社 Composition pour cavité buccale et produit en sachet pour cavité buccale

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018197454A1 (fr) * 2017-04-24 2018-11-01 Swedish Match North Europe Ab Produit humide et aromatisé à base de nicotine sous forme de sachet pour administration orale comprenant un triglycéride
WO2018233795A1 (fr) * 2017-06-23 2018-12-27 Fertin Pharma A/S Poche à nicotine
WO2020157280A1 (fr) * 2019-02-01 2020-08-06 Swedish Match North Europe Ab Produit oral à base de nicotine comprenant un agent d'ajustement du ph

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018197454A1 (fr) * 2017-04-24 2018-11-01 Swedish Match North Europe Ab Produit humide et aromatisé à base de nicotine sous forme de sachet pour administration orale comprenant un triglycéride
WO2018233795A1 (fr) * 2017-06-23 2018-12-27 Fertin Pharma A/S Poche à nicotine
WO2020157280A1 (fr) * 2019-02-01 2020-08-06 Swedish Match North Europe Ab Produit oral à base de nicotine comprenant un agent d'ajustement du ph

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023106407A1 (fr) * 2021-12-09 2023-06-15 日本たばこ産業株式会社 Composition pour cavité buccale et produit en sachet pour cavité buccale

Also Published As

Publication number Publication date
CA3198533A1 (fr) 2022-05-19
JP2023549345A (ja) 2023-11-24
CN116419682A (zh) 2023-07-11

Similar Documents

Publication Publication Date Title
US11096412B2 (en) Nicotine pouch composition and pouch comprising such
US11406630B2 (en) Nicotine pouch
US11963944B2 (en) Cannabinoid pouch
US11166935B2 (en) Cannabinoid pouch
DK180339B1 (en) Nicotine pouch composition and pouch comprising such
WO2022100805A1 (fr) Composition de sachet de nicotine
EP4000424B1 (fr) Composition de poche à nicotine
US20220151292A1 (en) Nicotine pouch composition

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21810282

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2023527692

Country of ref document: JP

ENP Entry into the national phase

Ref document number: 3198533

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21810282

Country of ref document: EP

Kind code of ref document: A1