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JP-7856782-B2 - Nicotine composition

JP7856782B2JP 7856782 B2JP7856782 B2JP 7856782B2JP-7856782-B2

Inventors

  • アラ・アブラハミアン
  • ヴァヒド・ノウリ

Assignees

  • ハビット ファクトリー イン スウェーデン エービー

Dates

Publication Date
20260511
Application Date
20220315

Claims (20)

  1. a. Nicotine in the form of free base, at a concentration of 0.2% to 5% by weight b. Natural cellulose material in an amount of 35% to 60% by weight, c. Water in an amount of at least 35% by weight, d. One or more pH-controlling salts in an amount of 0.5% to 3% by weight, e. A release control agent comprising 0.1% to 2% by weight of agar and/or an agar derivative, Use of agar as a nicotine release control agent in a composition containing the following , where the weight ratio of agar to nicotine is 0.1:1 to 1.2:1 .
  2. a. Nicotine in the form of free base, at a concentration of 0.2% to 5% by weight b. Natural cellulose material in an amount of 35% to 60% by weight, c. Water in an amount of at least 35% by weight, d. One or more pH-controlling salts in an amount of 0.5% to 3% by weight, e. A release control agent comprising 0.1% to 2% by weight of agar and/or an agar derivative, The use of agar as a nicotine stabilizer in a composition containing the following , where the weight ratio of agar to nicotine is 0.1:1 to 1.2:1 .
  3. The use according to claim 1 or claim 2, wherein the composition further comprises an additional component.
  4. The use according to claim 3, wherein the composition comprises an additional component in an amount of up to 12% by weight.
  5. The use according to claim 3 or 4, wherein the additional component in the composition comprises one or more additives selected from flavorings, flavor enhancers, sweeteners, and preservatives.
  6. The use according to any one of claims 3 to 5, wherein the additional component includes a sweetener.
  7. The use according to claim 6, wherein the sweetener is present in an amount of 1% to 3% by weight.
  8. The use according to claim 6 or 7, wherein the sweetener comprises a compound selected from sugars, sugar alcohols, and/or sugar substitutes.
  9. The use according to claim 8, wherein the sugar is sucrose, fructose, glucose, dextrose, maltose, lactose, or galactose, the sugar alcohol is xylitol, maltitol, sorbitol, or erythritol, and/or the sugar substitute is aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate, or a steviol glycoside.
  10. The use according to any one of claims 6 to 9, comprising less than 3% by weight of a sugar alcohol.
  11. The use according to any one of claims 6 to 10, comprising less than 1% by weight of the sugar substitute.
  12. The use according to claim 10 or 11, wherein the sugar alcohol comprises xylitol and/or the sugar substitute comprises acesulfame K.
  13. The use according to any one of claims 3 to 12, further comprising one or more preservatives selected from calcium chloride, sorbic acid salts, benzoic acid salts, nitrates, nitrites, sulfates, sulfites, and propionates.
  14. The use according to claim 13, wherein the salt of sorbic acid is potassium sorbate, and/or the salt of benzoic acid is sodium benzoate.
  15. The use according to claim 13 or 14, wherein potassium sorbate is present in an amount of less than 1% by weight.
  16. The use according to any one of claims 1 to 14, wherein the pH-controlling salt includes a buffer salt.
  17. The use according to claim 16, wherein the buffer salt is a combination of ammonium chloride and sodium bicarbonate.
  18. The use according to claim 16 or 17, wherein ammonium chloride is present in an amount of 0.05% to 1% by weight.
  19. The use according to any one of claims 1 to 18, wherein sodium bicarbonate is present in an amount of less than 1% by weight.
  20. The use according to any one of claims 1 to 19, comprising more than 40% by weight of water.

Description

This invention relates to a nicotine composition that is tobacco-free or low in tobacco. The composition is preferably for human consumption and can be delivered orally, for example, by placing a permeable pouch filled with the composition into the user's mouth. Nicotine-free or low-nicotine pouches are alternative products that can help reduce cravings associated with smoking cigarettes, cigars, or other nicotine delivery products. When smoking a cigarette or using an inhalation-based nicotine delivery system, i.e., vaping, nicotine vapor is rapidly absorbed into the bloodstream through the lungs and reaches the brain within 10 seconds of inhalation. The brain produces an almost instantaneous feeling of satisfaction, which lasts for some time after smoking/inhaling. Nicotine-free or low-nicotine pouches are intended for oral use by placing the pouch under the lips, thereby allowing for the release and absorption of nicotine through the oral mucosa. The pouches typically contain a saliva-permeable membrane material and other components such as particulate fillers, nicotine or nicotine derivatives, and flavorings. The particulate matter may, among other things, include polysaccharides or cellulose. Nicotine is an alkaloid, traditionally derived from tobacco leaves, but is now sometimes available in a completely synthetic form. It can be obtained as free base nicotine or in the form of various nicotine salts produced from the interaction of nicotine with acids. Common nicotine salts include chlorides, sulfates, benzoates, and tartrates. It is known to provide tobacco-free or low-tobacco pouches in which nicotine is supplied in the form of a salt in a powder formulation. Providing nicotine salts in such formulations is partly driven by the high stability of the system against chemical decomposition and/or evaporation. To release free base nicotine from a nicotine salt-containing formulation, the formulation contains a significant amount of buffer salt to increase its alkalinity. As alkalinity increases, the dissociation constant of nicotine changes, resulting in the generation of free base nicotine from its ionic form in the salt within the solution (such as in the user's mouth). Uncharged free base nicotine has higher permeability through the oral mucosa into the bloodstream compared to its ionic form, which is important for consumer use. In particular, the pH of nicotine-containing, non-tobacco pouches is typically in the range of 6.9–10.1, with undissociated free base nicotine levels ranging from 7.7–99.2% (Stanfil et al. Nicotine & Tobacco Research, 2021, 1590–1596). Therefore, nicotine salt preparations tend to be characterized by a low moisture content, i.e., less than 10% by weight (e.g., 1-8% by weight). This is because a high moisture content promotes the formation of free base nicotine in situ, which reduces product stability because free base nicotine is volatile and unstable to oxidative degradation. When nicotine oxidizes, it turns yellowish-brown, which is often unattractive to consumers and also produces an unpleasant taste. In fact, some preparations contain large amounts of sweeteners (such as maltitol) to stimulate saliva secretion. However, excessive saliva secretion can lead users to spit or swallow, which affects nicotine intake. Furthermore, product degradation exhibits reactivity in the system, which can lead to the presence of undesirable (and potentially toxic) compounds. These requirements present problems for users. Formulations with low moisture content can feel hard and unpleasant to the mouth, while high alkalinity (especially above approximately 9 pH) can irritate the user's gums. In contrast, moist nicotine products offer improved palatability when used in the mouth, meaning they are softer and more pleasant. Nicotine-containing pouches, including free base nicotine products, are supplied with moisture levels exceeding 35% by weight. However, this type of formulation requires stabilization to prevent nicotine degradation, as well as ingredients to prevent moisture loss during storage. Therefore, wet free base nicotine products tend to require a greater number and quantity of additives than products containing nicotine salts. International Publication Nos. 2010/104464 and 2010/0114445 disclose compositions of free base nicotine that can be stabilized using a salt of alginate, such as sodium alginate (e.g., Protanal LFR 5/60). The amount of sodium alginate used as a stabilizer is substantial, typically corresponding to a nicotine:Protanal ratio of 1:2 (by weight). International Publication No. 2020244721 discloses a composition of free base nicotine, in which the free base nicotine is stabilized using an ion exchange resin, such as a Polarcrilex resin, such as Amberlite IRP64 (a methacrylic acid polymer containing divinylbenzene, or a potassium salt of divinylbenzene). The amount of Polarcrilex resin used as a nicotine stabilizer is a nicotine-to-resin ratio that can vary between