# US 2021/0329962 A1 · Nicotine pouch composition and pouch comprising such

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- Number: US 2021/0329962 A1
- Document ID: US20210329962A1
- Status: Published application
- Kind: A1
- Application number: 17/370,641
- Filed: 2021-07-08
- Published: 2021-10-28
- Earliest claimed: 2019-06-07
- Assignees: NCP NextGen A/S
- Applicants: NCP NextGen A/S
- Inventors: My Ly Lao Stahl; Heidi Ziegler Bruun; Bruno Provstgaard Nielsen; Bine Hare Jakobsen
- Web page: https://patentgrep.com/patent/US20210329962A1

## CPC

- A24B 15/16: of tobacco substitutes
- A24B 13/00: Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff (reconstituted tobacco products A24B3/14)
- A24B 15/10: Chemical features of tobacco products or tobacco substitutes
- A24B 15/14: made of tobacco and a binding agent not derived from tobacco
- A24B 15/243: {Nicotine}
- A24B 15/281: {the action of the chemical substances being delayed}
- A24B 15/30: by organic substances {(A24B15/281 takes precedence)}
- A24B 15/302: {by natural substances obtained from animals or plants}
- A24B 15/303: {Plant extracts other than tobacco}
- A24B 15/32: by acyclic compounds
- A24B 15/385: {in a five-membered ring}
- A24B 15/403: {having only oxygen as hetero atoms}
- A24B 15/42: by organic and inorganic substances {(A24B15/281 takes precedence)}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/009: {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)}
- A61K 31/465: Nicotine; Derivatives thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/38: Cellulose; Derivatives thereof
- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A24B: MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A nicotine pouch composition is disclosed, the pouch composition comprising free-base nicotine and having a water content of at least 15% by weight of said pouch composition. Furthermore, an oral nicotine pouch product comprising the pouch composition and a method for manufacturing the oral nicotine pouch product is disclosed.

## Claims

### Claim 1

A nicotine pouch composition comprising a free-base nicotine mixture, and sugar alcohol, said pouch composition having a water content of at least 15% by weight of said pouch composition,
wherein the free-base nicotine mixture comprises at least one selected from the group consisting of free-base nicotine mixed with ion exchange resin, free-base nicotine mixed with a water-soluble substance, and combinations thereof.

### Claim 2 (depends on 1)

The nicotine pouch composition according to claim 1, wherein said sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, and any combination thereof.

### Claim 3 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition comprises sugar alcohol in an amount of 5-70% by weight of the pouch composition.

### Claim 4 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises a pH-regulating agent.

### Claim 5 (depends on 4)

The nicotine pouch composition according to claim 4, wherein the pouch composition comprises pH-regulating agent in an amount of between 0.01 and 15% by weight of the pouch composition

### Claim 6 (depends on 4)

The nicotine pouch composition according to claim 4, wherein the pH regulating agent is a basic pH regulating agent.

### Claim 7 (depends on 4)

The nicotine pouch composition according to claim 4, wherein the pH regulating agent is selected from the group consisting of Sodium carbonate, Sodium bicarbonate, Potassium carbonate, Potassium bicarbonate, Magnesium carbonate, and combinations thereof.

### Claim 8 (depends on 4)

The nicotine pouch composition according to claim 4, wherein the nicotine pouch composition comprises an acidic pH regulating agent.

### Claim 9 (depends on 8)

The nicotine pouch composition according to claim 8, wherein the nicotine pouch composition further comprises an alkaline pH regulating agent and wherein the pouch composition is adapted to give a pH of at least 8.0

### Claim 10 (depends on 8)

The nicotine pouch composition according to claim 8, wherein the acidic pH regulating is selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-δ-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Carbonic acid, Benzoic acid, and salts thereof.

### Claim 11 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises a humectant.

### Claim 12 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition is free of silicon dioxide.

### Claim 13 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises a water-insoluble composition in an amount of between 5 and 50% by weight of the pouch composition.

### Claim 14 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition further comprises an amount of a water-insoluble composition, wherein the water-insoluble composition comprises or consists of water-insoluble fiber.

### Claim 15 (depends on 14)

The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber is selected from the group consisting of wheat fibers, oat fibers, pea fibers, rice fiber, maize fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fiber, powdered cellulose, bamboo fibers, bran fibers and combinations thereof.

### Claim 16 (depends on 14)

The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber comprises microcrystalline cellulose.

### Claim 17 (depends on 14)

The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber comprises powdered cellulose.

### Claim 18 (depends on 14)

The nicotine pouch composition according to claim 14, wherein the water-insoluble fiber comprises at least two different types of fibers.

### Claim 19 (depends on 18)

The nicotine pouch composition according to claim 18, wherein the water-insoluble fiber comprises powdered cellulose

### Claim 20 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition has a water content of 15 to 70% by weight of said pouch composition.

### Claim 21 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition comprises nicotine in an amount corresponding to 0.5 to 20 mg per pouch.

### Claim 22 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the pouch composition is free of tobacco, tobacco fibers and fibers derived from tobacco.

### Claim 23 (depends on 1)

The nicotine pouch composition according to claim 1, wherein the composition comprises flavor.

### Claim 24 (depends on 1)

An oral nicotine pouch product comprising a pouch and an amount of the nicotine pouch composition according to claim 1 enclosed in said pouch.

### Claim 25 (depends on 24)

The oral nicotine pouch product according to claim 24, wherein the pouch composition is a non-tobacco pouch composition,
wherein the nicotine pouch composition comprises sugar alcohol in an amount of 10-60% by weight of the pouch composition, said sugar alcohol being selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, and combinations thereof,
wherein the pouch composition comprises pH regulating agent in an amount of 0.01 and 15% by weight of the pouch composition, and
wherein the pouch composition comprises water-insoluble fiber in an amount of 10-50% by weight of the pouch composition.

### Claim 26

A nicotine pouch composition comprising free-base nicotine and sugar alcohol, said pouch composition having a water content of at least 15% by weight of said pouch composition.
