Smokeless tobacco product, smokeless tobacco product in the form of a sheet, extrudable tobacco composition, method for manufacturing a smokeless tobacco product, method for delivering super bioavailable nicotine contained in tobacco to a user, and packaged smokeless tobacco product sheet

• US 9,125,434 B2
• Filed: 05/16/2008
• Issued: 09/08/2015
• Est. Priority Date: 10/11/2007
• Status: Active Grant

• Current Assignee: Philip Morris Products SA (Philip Morris Limited)
• Original Assignee: Philip Morris Products SA (Philip Morris Limited)
• Inventors: Fuisz, Richard C.
• Primary Examiner(s): Crispino, Richard
• Assistant Examiner(s): Mayes, Dionne Walls
• Application Number:
  US12/122,201
• Publication Number:
  US 20090095313A1
• Time in Patent Office: 2,671 Days
• Field of Search: 131/352, 131/347, 131/353
• US Class Current: 1/1
• CPC Class Codes: A23L 27/79 in the form of films
• CPC Class Codes: A24B 13/00 Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff reconstituted tobacco products A24B3/14
• CPC Class Codes: A24B 15/16 of tobacco substitutes
• CPC Class Codes: A24B 15/18 Treatment of tobacco products or tobacco substitutes
• CPC Class Codes: A24B 15/186 by coating with a coating composition, encapsulation of tobacco particles encapsulation of additives other than tobacco : A24B15/283
• CPC Class Codes: A24B 3/18 Other treatment of leaves, e.g. puffing, crimpling, cleaning

Abstract

A nonaqueous, extrudable composition includes at least one thermoplastic polymer in an amount of more than 20 wt % of the whole composition and tobacco. A smokeless tobacco product in the form of a sheet can be made by extruding or hot melt shaping a nonaqueous composition comprising at least one thermoplastic polymer and tobacco, the sheet being soluble in a user'"'"'s mouth and resulting in sustained release of nicotine to the user. The sheet can be in a form that may be placed in the buccal cavity of, on the palate of or sublingually in the user, and have an average dissolution time of 5 to 50 minutes for delivering super bioavailable nicotine to the user.

Claims

1. A smokeless tobacco product comprising a nonaqueous composition comprising at least one thermoplastic polymer and tobacco in a form that may be placed in a buccal cavity, on a palate of a user or sublingually and having an average dissolution time of 5 to 50 minutes, measured for a composition in the form of a sheet having a surface area of approximately 1-1.5 in² and a thickness of approximately 10-40 mil, to dissolve fully in a buccal cavity of a user, wherein the tobacco is present in an amount of less than 100 mg and the product, when used, results in a maximum measured nicotine plasma concentration greater than 4 ng/ml when administered in a single dose.

2. The smokeless tobacco product according to claim 1, wherein the sheet has a rectangular thin strip shape.

3. The smokeless tobacco product according to claim 2, wherein the sheet has a length of 1/16 inch to 4 inches long, a width of 1/16 inch to 4 inches and a thickness of 5 to 50 mils.

4. The smokeless tobacco product according to claim 1, wherein the at least one thermoplastic polymer comprises polyethylene oxide (PEO).

5. The smokeless tobacco product according to claim 1, wherein the at least one polymer thermoplastic comprises hydroxypropyl cellulose (HPC).

6. The smokeless tobacco product according to claim 5, wherein the HPC comprises HPCLF, HPCELF or HPCEF.

7. The smokeless tobacco product according to claim 1, wherein the tobacco is in the form of snuff.

8. The smokeless tobacco product according to claim 1, further comprising a buffering agent for controlling a pH of the composition.

9. The smokeless tobacco product according to claim 8, wherein the buffering agent is present in an amount to provide the product with a pH of 4 to 8 when the composition is present in the user'"'"'s mouth.

10. The smokeless tobacco product according to claim 8, wherein the buffering agent is present in an amount to provide the product with a pH of 6 to 8 when the composition is present in the user'"'"'s mouth.

11. The smokeless tobacco product according to claim 1, wherein the tobacco is a tobacco having a tobacco specific nitrosamine content less than 50 ppm.

12. The smokeless tobacco product according to claim 1, further comprising a mucosal absorbing enhancer.

13. The smokeless tobacco product according to claim 12, wherein the mucosal absorbing enhancer is diethylene glycol monoethyl ether.

14. The smokeless tobacco product according to claim 1, wherein the composition includes less than 4 wt % water.

15. The smokeless tobacco product according to claim 1, further comprising a plasticizer.

16. The smokeless tobacco product according to claim 15, wherein plasticizer is at least one of polypropylene glycol, polyethylene glycol, glycerin and glycerol.

17. The smokeless tobacco product according to claim 16, wherein the plasticizer is present in an amount up to 30% based on the weight of the thermoplastic polymer.

18. The smokeless tobacco product according to claim 15, wherein the plasticizer is present in an amount up to 30% based on the weight of the thermoplastic polymer.

19. The smokeless tobacco product according to claim 1, wherein the sheet has a tensile strength of at least 4 lbs.

20. The smokeless tobacco product according to claim 1, wherein the sheet has a uniformity in the range of ±

10%.

21. The smokeless tobacco product according to claim 1, wherein the at least one thermoplastic polymer is contained in an amount of at least 20 wt % of the whole composition.

22. The smokeless tobacco product according to claim 1, wherein the at least one thermoplastic polymer comprises a water soluble polymer.

23. The smokeless tobacco product according to claim 1, wherein the composition contains less than 80 wt % tobacco.

24. The smokeless tobacco product according to claim 1, wherein the sheet is thicker on one end than another.

25. The smokeless tobacco product according to claim 1, further comprising a flavoring.

26. The smokeless tobacco product according to claim 1, wherein the tobacco is shredded.

27. The smokeless tobacco product according to claim 1, wherein the composition contains less than 50 wt % tobacco.

28. The smokeless tobacco product according to claim 1, wherein the product, when used, results in an area under a mean nicotine plasma concentration versus time curve from zero to infinity greater than 23 ng/ml when administered in a single dose.

29. The smokeless tobacco product according to claim 1, further comprising a water insoluble polymer in an amount to lengthen dissolution time of the product.

30. A method for delivering nicotine from a tobacco product to a user, comprising:

providing a sheet comprising an extruded nonaqueous composition comprising at least one thermoplastic polymer and tobacco in an amount less than 100 mg; and

placing the sheet in the buccal cavity of, on the palate of or sublingually in the user such that the sheet fully dissolves within an average time of 5 to 50 minutes and results in a maximum measured nicotine plasma concentration greater than 4 ng/ml when administered in a single dose.

31. The method according to claim 30, further comprising folding the sheet at approximately a mid-point of its length to form a V-shaped folded sheet before placing the sheet in the buccal cavity.

32. The method according to claim 30, wherein the nonaqueous composition further comprises mint flavoring and the method induces freshened breath in the user for an extended period.