Nicotine pouch filler and method of preparing the same

Patent metadata

Field	Value
Publication number	US-2025072468-A1
Application number	US-202418818012-A
Country	US
Kind code	A1
Filing date	Aug 28, 2024
Priority date	Aug 31, 2023
Publication date	Mar 6, 2025
Grant date	—

Abstract

Provided is a nicotine pouch filler including nicotine, a release control excipient including at least one or more selected from a group consisting of cellulose and sugar alcohol, a binder, a pH adjuster, and a flavoring agent, wherein a content of the nicotine is 2.5 to 10 wt % with respect to a weight of total solid contents of the nicotine pouch filler, and a content of the release control excipient is 5.5 to 36 times the content of the nicotine.

First claim

What is claimed is:

1 . A nicotine pouch filler comprising:
nicotine; a release control excipient comprising at least one or more selected from a group consisting of cellulose and sugar alcohol; a binder; a pH adjuster; and a flavoring agent, wherein a content of the nicotine is 2.5 to 10 wt % with respect to a weight of total solid contents of the nicotine pouch filler, and wherein a content of the release control excipient is 5.5 to 36 times the content of the nicotine.

2 . The nicotine pouch filler of claim 1 , wherein
the nicotine comprises nicotine salt, and the nicotine salt comprises at least one or more selected from a group consisting of nicotine salt benzoate, nicotine salt tartrate, nicotine salt malate, and nicotine salt salicylate.

3 . The nicotine pouch filler of claim 1 , wherein
the release control excipient comprises cellulose, and the nicotine is contained in the cellulose.

4 . The nicotine pouch filler of claim 1 , wherein the cellulose comprises one or more of microcrystalline cellulose and methyl cellulose.

5 . The nicotine pouch filler of claim 1 , wherein a content of the cellulose is 5 to 20 wt % with respect to a weight of total solid contents of the nicotine pouch filler.

6 . The nicotine pouch filler of claim 1 , wherein the sugar alcohol comprises at least one or more selected from a group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomaltol.

7 . The nicotine pouch filler of claim 1 , wherein a content of the sugar alcohol is 50 to 70 wt % with respect to a weight of total solid contents of the nicotine pouch filler.

8 . The nicotine pouch filler of claim 1 , wherein
the binder comprises at least one or more selected from a group consisting of Povidone K-25, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, hydroxypropylmethyl cellulose (HPMC), and carboxymethylcellulose (CMC), and a content of the binder is 8 to 10 wt % with respect to a weight of total solid contents of the nicotine pouch filler.

9 . The nicotine pouch filler of claim 1 , wherein the pH adjuster comprises one or more of sodium bicarbonate and sodium carbonate.

10 . The nicotine pouch filler of claim 9 , wherein
the pH adjuster comprises sodium bicarbonate and sodium carbonate, and a weight ratio of the sodium bicarbonate and the sodium carbonate is 7:3 to 6:4.

11 . The nicotine pouch filler of claim 1 , wherein a pH of the nicotine pouch filler is 8.3 to 8.5.

12 . The nicotine pouch filler of claim 1 , wherein the nicotine pouch filler has nicotine elution performance of 15% to 25% within 4 minutes, and nicotine elution performance of 70% to 80% within 20 minutes.

13 . A nicotine pouch comprising:
a nicotine pouch filler; and a packaging material, wherein the nicotine pouch filler comprises:
nicotine;
a release control excipient comprising at least one or more selected from a group consisting of cellulose and sugar alcohol;
a binder;
a pH adjuster; and
a flavoring agent,
wherein a content of the nicotine is 2.5 to 10 wt % with respect to a weight of total solid contents of the nicotine pouch filler, and wherein a content of the release control excipient is 5.5 to 36 times the content of the nicotine.

14 . A method of preparing a nicotine pouch filler, the method comprising:
step S1 of mixing at least one or more selected from a group consisting of nicotine, a release control excipient, a binder, a pH adjuster, and a flavoring agent; step S2 of spraying a solvent; and step S3 of performing granulation, wherein, in step S1, the release control excipient comprises at least one or more selected from a group consisting of cellulose and sugar alcohol, wherein, in step S2, the solvent comprises at least one or more selected from a group consisting of water and alcohol, wherein a content of the solvent is 10 to 60 wt % of a content of the cellulose, and wherein an L/S ratio is 8% to 15%.

Assignees

• Kt & G Corp

Inventors

• Jeoung Eun Mi
• Ki Sung Jong
• Cha Sung Je
• Shin Jun Won

Classifications

• A61K9/009

  Sachets, pouches characterised by the material or function of the envelope (with gastric retention A61K9/0065; sachets which are not administered but function merely as a container are classified according to the content, e.g. sachets comprising powder for reconstitution of a drink A61K9/0095) · CPC title

• A61K9/006

  Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays · CPC title

• A61K31/465 Primary

  Nicotine; Derivatives thereof · CPC title

• A24B15/38

  having only nitrogen as hetero atom · CPC title

• A24B15/285

  characterised by structural features, e.g. particle shape or size · CPC title