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EP-4510847-B1 - A POUCHED PRODUCT

EP4510847B1EP 4510847 B1EP4510847 B1EP 4510847B1EP-4510847-B1

Inventors

  • NIELSEN, KENT ALBIN
  • PEDERSEN, Kim Bøgh
  • JAKOBSEN, Bine Hare

Dates

Publication Date
20260513
Application Date
20240202

Claims (20)

  1. A nicotine pouched product comprising a pouch composition and a saliva-permeable pouch enclosing said pouch composition, the pouch composition comprising nicotine and a pouch substrate, the pouch substrate comprising water-insoluble fiber, wherein said pouch composition comprises nicotine in an amount of at least 0.25% by weight of the pouch composition, wherein said pouch composition further comprises one or more alkaline pH regulating agents, wherein the pouched product comprises said pouch composition in an amount of no more than 200 mg, and wherein the pouch is insoluble in water.
  2. The nicotine pouched product according to claim 1, wherein the pouched product comprises said pouch composition in an amount of no more than 150 mg, such as no more than 100 mg, such as no more than 50 mg.
  3. The nicotine pouched product according to claims 1 or 2, wherein the water-insoluble fiber is a non-tobacco fiber.
  4. The nicotine pouched product according to any of claims 1-3, wherein the pouch composition is free of tobacco fibers.
  5. The nicotine pouched product according to any of claims 1-4, wherein the pouch has a maximum dimension of no more than 30 mm, such as no more than 25 mm, such as no more than 20 mm.
  6. The nicotine pouched product according to any of claims 1-5, wherein the pouch composition comprises at least one sugar alcohol.
  7. The nicotine pouched product according to any of claims 1-6, wherein pouch composition comprises said at least one sugar alcohol in an amount of at least 1% by weight of the pouch composition, such as at least 2% by weight of the pouch composition, such as at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
  8. The nicotine pouched product according to any of claims 1-7, wherein said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combinations thereof.
  9. The nicotine pouched product according to any of claims 1-8, wherein said at least one sugar alcohol comprises one or more from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combinations thereof.
  10. The nicotine pouched product according to any of claims 1-9, wherein the pouch composition comprises said water-insoluble fiber in an amount of at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition.
  11. The nicotine pouched product according to any of claims 1-10, wherein the water-insoluble fiber comprises one or more selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof.
  12. The nicotine pouched product according to any of claims 1-11, wherein the water-insoluble fiber comprises microcrystalline cellulose.
  13. The nicotine pouched product according to any of claims 1-12, wherein the pouch composition comprises water in an amount of at least 10% by weight of the pouch composition, such as at least 15% by weight of the pouch composition, such as at least 20% by weight of the pouch composition.
  14. The nicotine pouched product according to any of claims 1-13, wherein the pouch composition has a weight ratio of water-insoluble fiber to sugar alcohol, said weight ratio being from 0.1 to 10, such as from 0.2 to 5, such as from 0.3 to 4, such as from 0.5 to 2.
  15. The nicotine pouched product according to any of claims 1-14, wherein the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, a nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites; nicotine bound to cellulose, such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.
  16. The nicotine pouched product according to any of claims 1-15, wherein the nicotine comprises a nicotine salt.
  17. The nicotine pouched product according to any of claims 1-16, wherein the pH regulating agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate, potassium bicarbonate, trometamol, phosphate buffer, or any combination thereof.
  18. The nicotine pouched product according to any of claims 1-17, wherein the pouched product has a Surface Area to Volume (SAV) ratio of at least 0.6, such as at least 0.65, such as at least 0.7, such as at least 0.8, such as at least 1, such as at least 2, such as at least 3.
  19. The nicotine pouched product according to any of claims 1-18, wherein the pouch composition further comprises one or more solubilizers, such as copovidone.
  20. A nicotine pouched product according to any of claims 1-19 for use in alleviation of nicotine craving.

Description

FIELD OF INVENTION The invention relates to a nicotine pouched product according to the claims, in particular to non-tobacco nicotine pouched products. BACKGROUND In the latest years a wide range of nicotine products having a reduced tobacco content or without tobacco has been seen, also within the field of pouched products or pouches. Yet for pouched products, it remains a desire to provide a faster nicotine release in order to give the user an improved experience by means of faster craving relief. Certain pouched products are known. For example, WO 2022/224196 A1 (to Nicoventures Trading Limited) discloses an oral product in the form of an edible film, which is orally dissolvable. The oral product may be in the form of a pouched product comprising the edible film. The oral product may comprise an oral composition, which may comprise nicotine. Another example is WO 2022/219310 A1 (to Zanoprime Lifesciences Limited), which discloses a composition comprising nicotine and/or nicotine salt, and calcium silicate, wherein the composition is in a pouch. SUMMARY The invention relates to a nicotine pouched product comprising a pouch composition and a saliva-permeable pouch enclosing said pouch composition, the pouch composition comprising nicotine and a pouch substrate, the pouch substrate comprising water-insoluble fiber,wherein said pouch composition comprises nicotine in an amount of at least 0.25% by weight of the pouch composition,wherein said pouch composition further comprises one or more alkaline pH regulating agents,wherein the pouched product comprises said pouch composition in an amount of no more than 200 mg, andwherein the pouch is insoluble in water. One advantage of the invention may be that an unexpectedly fast release of nicotine may be obtained from the pouched product. Thereby, the use of the pouched product may facilitate a surprisingly but highly desirable fast nicotine craving relief. A further advantage of the invention may be that a discreet pouch product may be obtained, i.e. a pouched product which may be used without other people noticing such use. In order to obtain a discreet pouched product, the present inventors found that a product with a smaller amount of pouch composition was desirable. At the same time, having a relatively high nicotine content was important to still provide efficient nicotine craving relief. However, it was surprisingly found that the decrease of the pouch substrate content in fact led to a faster release of nicotine, whereby faster nicotine craving relief was facilitated. In other words, despite reducing the content of the nicotine releasing pouch substrate, a faster release was obtained. In the present context the term "discreet" refers to a pouch which appears small, before and/or during use. In more detail, a small looking pouch may thus have a reduced size and to appear small before use and during inserting into the mouth but may alternatively or in combination be smaller to make the use of the pouch less obvious for others, in particular by being thinner during use. In the present context, the term "pouch substrate" refers to components of the pouch composition excluding the nicotine component. The nicotine component may in some embodiments be e.g. nicotine free base or may include a carrier, a salt counter ion or other components provided together with the nicotine, e.g. in the form of an ion exchange resin. Thus, the pouch substrate includes, besides the water-insoluble fiber, other non-nicotine components, if present, such as sugar alcohol, water, pH regulating agent, flavor, glidant, humectant, etc. In the present context, the term "pouch composition" refers to the content of the pouch, i.e. the composition enclosed in the saliva-permeable pouch. Sometimes, the pouch composition may be referred to simply as the "composition", and thus when referring to "composition", this refer to the "pouch composition", unless otherwise specified. In an advantageous embodiment of the invention, the pouched product comprises said pouch composition in an amount of no more than 150 mg, such as no more than 100 mg, such as no more than 50 mg. An advantage of the above embodiment may be that a discreet product with a fast release of nicotine may be obtained. In an embodiment of the invention, the pouched product comprises said pouch composition in an amount of 150-200 mg. In an embodiment of the invention, the pouched product comprises said pouch composition in an amount of 40-200 mg, such as 40-150 mg, such as 40-100 mg, such as 75-100 mg. In an advantageous embodiment of the invention, the pouched product comprises said pouch composition in an amount of at least 40 mg, such as at least 75 mg, such as at least 100 mg, such as at least 125 mg, such as at least 150 mg. In an embodiment of the invention, the water-insoluble fiber comprises a non-tobacco fiber. In an advantageous embodiment of the invention, the water-insoluble fiber is a non-tobacco fiber. In an advantageous