IP Library Granted Patent US 11,547,660
Granted Patent B2
US 11,547,660 · App. 17/458,997 · Granted Jan 10, 2023

Snuff composition

Inventors: Anders Axelsson (Bjärred, SE); Arne Kristensen (Helsingborg, SE); Henri Hansson (Helsingborg, SE)
Assignee: Niconovum USA, Inc.
A61K9/0056A24B13/00A24B15/14A61K9/009A61K31/465A61K9/146
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Quick Facts
Patent No.
US 11,547,660
App. No.
17/458,997
Granted
Jan 10, 2023
Kind
B2
Abstract

Use of a nicotine-cellulose combination for the preparation of a snuff composition for achievement of a fast onset of action of nicotine after application of the snuff composition to the oral cavity of a subject, wherein the composition has a high release rate so that when subjected to an in vitro dissolution test about 45% or more of the total content of nicotine is released within 30 minutes. Moreover, the invention relates to an improved snuff composition for application to the oral cavity.

Claims (47)

1. A product for delivery of an oral composition, the product comprising:

(a) a composition that includes:

a cellulose material; and

nicotine, at least a portion of the nicotine being sorbed to at least a portion of the cellulose material so as to be in the form a nicotine-cellulose combination and such that the nicotine-cellulose combination forms at least 45% by weight of the total weight of the composition; and (b) a pouch enclosing the composition.

2. The product of claim 1 , wherein the nicotine-cellulose combination forms at least 80% to 98% by weight of the total weight of the composition.

3. The product of claim 1 , wherein the nicotine is nicotine free base or a pharmaceutically acceptable salt, solvate, complex, or derivative thereof.

4. The product of claim 1 , wherein the nicotine is in the form of a nicotine salt.

5. The product of claim 4 , wherein the nicotine salt is nicotine bitartrate.

6. The product of claim 1 , wherein the nicotine is present in a total amount of about 0.5 mg to about 10 mg.

7. The product of claim 1 , wherein the composition includes a further cellulose in addition to the cellulose material.

8. The product of claim 1 , wherein the composition includes at least one sugar alcohol.

9. The product of claim 8 , wherein the sugar alcohol includes maltitol.

10. The product of claim 1 , wherein the composition includes at least one artificial sweetener.

11. The product of claim 10 , wherein the at least one artificial sweetener includes acesulfame.

12. The product of claim 1 , wherein the composition includes one or both of sodium carbonate and sodium hydrogen carbonate.

13. The product of claim 1 , wherein the composition includes at least one flavoring.

14. The product of claim 1 , wherein the nicotine and the cellulose material are combined such that, when subjected to an in vitro dissolution test using UV detection, about 30% or more of the total content of the nicotine is released from the composition within 30 minutes.

15. The product of claim 1 , wherein the pouch is formed of cellulose.

16. The product of claim 1 , wherein at least a portion of the nicotine is absorbed into at least a portion of the cellulose material.

17. The product of claim 1 , wherein at least a portion of the nicotine is adsorbed onto at least a portion of the cellulose material.

18. A product for delivery of an oral composition, the product comprising:

(a) a composition that includes:

a cellulose material;

nicotine in a total amount of about 0.5 mg to about 10 mg, at least a portion of the nicotine being sorbed to at least a portion of the cellulose material so as to be in the form a nicotine-cellulose combination and such that the nicotine-cellulose combination forms at least 45% by weight of the total weight of the composition;

one or both of sodium carbonate and sodium bicarbonate;

one or more sweeteners; and

one or more flavorings; and

(b) a pouch enclosing the composition;

wherein the nicotine and the cellulose material are combined such that, when subjected to an in vitro dissolution test using UV detection, about 30% or more of the total content of the nicotine is released from the composition within 30 minutes.

19. The product of claim 18 , wherein the nicotine-cellulose combination forms at least 80% to 98% by weight of the total weight of the composition.

20. The product of claim 18 , wherein the nicotine is nicotine free base or a pharmaceutically acceptable salt, solvate, complex, or derivative thereof.

21. The product of claim 18 , wherein the nicotine is in the form of a nicotine salt.

22. The product of claim 21 , wherein the nicotine salt is nicotine bitartrate.

23. The product of claim 18 , wherein the composition includes a further cellulose in addition to the cellulose material.

24. The product of claim 18 , wherein the nicotine and the cellulose material are combined such that, when subjected to an in vitro dissolution test using UV detection, about 45% or more of the total content of the nicotine is released from the composition within 20 minutes.

25. The product of claim 18 , wherein the pouch is formed of cellulose.

26. A product for delivery of a composition to an oral cavity, the product comprising:

(a) a composition that includes:

a cellulose material;

nicotine bitartrate in a total amount of about 1.5 mg to about 7.5 mg, at least a portion of the nicotine bitartrate being sorbed to at least a portion of the cellulose material so as to be in the form a nicotine-cellulose combination and such that the nicotine-cellulose combination forms at least 45% by weight of the total weight of the composition;

one or both of sodium carbonate and sodium bicarbonate;

one or more sweeteners including at least maltitol and acesulfame; and

one or more flavorings; and

(b) a pouch enclosing the composition.

27. The product of claim 26 , wherein the nicotine bitartrate and the cellulose material are combined such that, when subjected to an in vitro dissolution test using UV detection, about 30% or more of the total content of the nicotine is released from the composition within 30 minutes.

28. The product of claim 26 , wherein the nicotine-cellulose combination forms at least 80% to 98% by weight of the total weight of the composition.

29. The product of claim 26 , wherein the pouch is formed of cellulose.

Priority Claims (2)
DK 2006 00375 · Mar 16, 2006 · national
DK 2006 00376 · Mar 16, 2006 · national
Continuity (6)
Continuation 16194969 · Nov 19, 2018
Continuation 13690531 · Nov 30, 2012
Continuation 12225262
Provisional Application 60782977 · Mar 16, 2006
Provisional Application 60782903 · Mar 16, 2006
Related Publication 20210386662A1 · Dec 16, 2021
Cited By (1)
US 12,219,983