IP Library Granted Patent US 10,219,999
Granted Patent B2
US 10,219,999 · App. 13/690,531 · Granted Mar 5, 2019

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 10,219,999
App. No.
13/690,531
Granted
Mar 5, 2019
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 (53)

1. A snuff composition comprising:

(a) about 80% to about 98% by weight, based on the weight of the snuff composition, of a solid nicotine-cellulose combination formed of porous cellulose having the nicotine sorbed into the pores thereof, the nicotine being present at a concentration of about 0.1% to about 10% by weight, based on the weight of the snuff composition;

(b) a flavoring agent; and

(c) a buffering agent;

wherein the composition is enclosed in a bag, pouch, or membrane.

2. The snuff composition of claim 1 , wherein the nicotine and cellulose 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.

3. The snuff composition of claim 2 , wherein about 45% or more of the total content of the nicotine is released from the composition within 30 minutes.

4. The snuff composition of claim 2 , wherein about 50% or more of the total content of the nicotine is released from the composition within 30 minutes.

5. The snuff composition of claim 2 , wherein about 60% or more of the total content of the nicotine is released from the composition within 30 minutes.

6. The snuff composition of claim 2 , wherein about 70% or more of the total content of the nicotine is released from the composition within 30 minutes.

7. The snuff composition of claim 1 , wherein the nicotine and cellulose 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.

8. The snuff composition of claim 1 , wherein the nicotine and cellulose are combined such that, when subjected to an in vitro dissolution test using UV detection, about 20% or more of the total content of the nicotine is released from the composition within 10 minutes.

9. The snuff composition of claim 1 , wherein the composition comprises about 85% to about 98% by weight of the nicotine-cellulose combination.

10. The snuff composition of claim 1 , wherein the composition comprises about 90% to about 98% by weight of the nicotine-cellulose combination.

11. The snuff composition of claim 1 , wherein the cellulose is derived from a source selected from the group consisting of a plant, an algae, a bacterium, a fungi, and combinations thereof.

12. The snuff composition of claim 1 , wherein the cellulose is crystalline.

13. The snuff composition of claim 12 , wherein the cellulose is microcrystalline cellulose.

14. The snuff composition of claim 13 , wherein the microcrystalline cellulose is synthetic or semi-synthetic.

15. The snuff composition of claim 13 , wherein the microcrystalline cellulose is derived from natural cellulose.

16. The snuff composition of claim 1 , wherein the cellulose has a surface area of at least 0.7 m 2 /g.

17. The snuff composition of claim 1 , wherein the cellulose has a mean particle size of about 500 μm or less.

18. The snuff composition of claim 1 , wherein the cellulose has a mean particle size of about 400 μm or less.

19. The snuff composition of claim 1 , wherein the cellulose has a mean particle size of about 300 μm or less.

20. The snuff composition of claim 1 , wherein the cellulose has a mean particle size of about 40 μm to about 300 μm.

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

22. The snuff composition of claim 1 , wherein the composition comprises about 0.1% to about 8% by weight of the nicotine.

23. The snuff composition of claim 1 , wherein the composition comprises about 0.1% to about 5% by weight of the nicotine.

24. The snuff composition of claim 1 , wherein the composition comprises about 0.1% to about 4% by weight of the nicotine.

25. The snuff composition of claim 1 , wherein composition comprises about 1% to about 15% by weight, based on the weight of the snuff composition, of the flavoring agent.

26. The snuff composition of claim 25 , wherein the composition comprises about 1.5% to about 8% by weight of the flavoring agent.

27. The snuff composition of claim 1 , wherein the composition comprises about 0.1% to about 5% by weight, based on the weight of the snuff composition, of the buffering agent.

28. The snuff composition of claim 27 , wherein the composition comprises about 0.5% to about 2% by weight of the buffering agent.

29. The snuff composition of claim 1 , wherein the composition is enclosed in the membrane, and wherein the membrane is formed of a natural material.

30. The snuff composition of claim 1 , wherein the composition is enclosed in the membrane, and wherein the membrane is formed of a synthetic or semi-synthetic material.

31. The snuff composition of claim 1 , wherein the composition is enclosed in the membrane, and wherein the membrane is formed of a hydrophilic material.

32. The snuff composition of claim 1 , wherein the composition is enclosed in the membrane, and wherein the membrane is formed of a hydrophobic material.

33. The snuff composition of claim 1 , wherein the composition is enclosed in the membrane, and wherein the membrane is formed from one or more biocompatible and physiologically acceptable polymeric materials.

34. The snuff composition of claim 1 , wherein the composition is enclosed in the membrane, and wherein the membrane comprises a material selected from the group consisting of cellulose acetate and derivatives thereof, carboxymethyl cellulose, polycellulose ester, ethylcellulose, propylcellulose, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinyl acetate, acrylate polymers, methacrylate polymers, natural rubber, polycarbonate, polyethylene terephthalate, polyester, polyamide, and nylon.

35. The snuff composition of claim 1 , wherein the composition is enclosed in the bag or pouch, and wherein the bag or pouch is a woven material, a non-woven material, or a polymeric material.

36. The snuff composition of claim 1 , further comprising a sweetener.

37. The snuff composition of claim 36 , wherein the composition comprises about 0.01% to about 0.2% by weight, based on the weight of the snuff composition, of the sweetener.

38. The snuff composition of claim 1 , further comprising an antioxidant.

39. The snuff composition of claim 38 , wherein the composition comprises about 0.4% to about 2.4% by weight, based on the weight of the snuff composition, of the antioxidant.

40. A snuff composition comprising:

(a) about 90% to about 98% by weight, based on the weight of the snuff composition, of a solid nicotine-cellulose combination formed of:

(i) porous microcrystalline cellulose having a mean particle size of about 40 μm to about 300 μm; and

(ii) nicotine at a concentration (calculated as free base) of about 0.1% to about 5% by weight, based on the weight of the snuff composition, the nicotine being sorbed into pores of the microcrystalline cellulose;

(b) about 1.5% to about 8% by weight, based on the weight of the snuff composition, of a flavoring agent;

(c) about 0.5% to about 2% by weight, based on the weight of the snuff composition, of a buffering agent;

(d) about 0.01% to about 0.2% by weight, based on the weight of the snuff composition, of a sweetener; and

(e) about 0.4% to about 2.4% by weight, based on the weight of the snuff composition, of an antioxidant;

wherein the composition is enclosed in a bag, pouch, or membrane; and

wherein the nicotine and cellulose 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.

Assignments (2)
CHANGE OF NAME Recorded May 19, 2020
From: NICONOVUM USA, INC.
To: MODORAL BRANDS INC.
Reel/Frame 052698/0836 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2016
From: NICONOVUM AB
To: NICONOVUM USA, INC.
Reel/Frame 037813/0678 →
Priority Claims (2)
DK 200600375 · Mar 16, 2006 · national
DK 200600376 · Mar 16, 2006 · national
Continuity (4)
Continuation 12225262
Provisional Application 60782903 · Mar 16, 2006
Provisional Application 60782977 · Mar 16, 2006
Related Publication 20130160782A1 · Jun 27, 2013
Cited By (3)
US 12,219,983 US 12,295,412 US 12,484,617