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 20090095313A1
• Filed: 05/16/2008
• Published: 04/16/2009
• 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.
• Granted Patent: US 9,125,434 B2
• Time in Patent Office: Days
• US Class Current: 131/290
• 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 nonaqueous, extrudable composition comprising at least one thermoplastic polymer in an amount of more than 20 wt % of the whole composition and tobacco.

2. The nonaqueous, extrudable composition according to claim 1, wherein the at least one thermoplastic polymer comprises hydroxypropyl cellulose (HPC).

3. The nonaqueous, extrudable composition according to claim 2, wherein the HPC comprises HPCLF, HPCELF or HPCEF.

4. The nonaqueous, extrudable composition according to claim 1, wherein the at least one polymer comprises at least one polymer selected from the group consisting of cellulose ethers, polyethylene oxide, polymethacrylates, poloxamers, extrudable carbohydrates, polyethylene glycols, PVP, poly vinyl alcohol, acrylates, ethyl cellulose, cellulose acetate butyrate, poly(ethylene-co-vinyl acetate), poly vinyl acetate, poly(methylvinyl ether/maleic anhydride) co-polymer, pullulan and hydroxypropyl methylcellulose (HPMC).

5. The nonaqueous, extrudable composition according to claim 1, wherein the at least one thermoplastic polymer comprises polyethylene oxide (PEO).

6. The nonaqueous, extrudable composition according to claim 1, wherein the tobacco is in the form of snuff.

7. The nonaqueous, extrudable composition according to claim 1, further comprising a mucosal absorbing enhancer.

8. The nonaqueous, extrudable composition according to claim 7, wherein the mucosal absorbing enhancer is polyethylene glycol.

9. The nonaqueous, extrudable composition according to claim 1, further comprising a buffering agent for controlling a pH of the composition.

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

11. The nonaqueous, extrudable composition according to claim 9, wherein the buffering agent is present in an amount to provide the composition with a pH of 6 to 8 when the composition is present in a user'"'"'s mouth.

12. The nonaqueous, extrudable composition according to claim 1, wherein the tobacco is a tobacco having a tobacco specific nitrosamine content less than 50 ppm.

13. The nonaqueous, extrudable composition according to claim 1, wherein the composition includes less than 10 wt % water.

14. The nonaqueous, extrudable composition according to claim 1, wherein the tobacco comprises a tobacco extract.

15. The nonaqueous, extrudable composition according to claim 1, further comprising a flavoring.

16. The nonaqueous, extrudable composition according to claim 1, further comprising a plasticizer.

17. The nonaqueous, extrudable composition according to claim 16, wherein the plasticizer is at least one of polypropylene glycol, polyethylene glycol, glycerin, glycerol and a water soluble edible polyol.

18. The nonaqueous, extrudable composition according to claim 17, wherein the plasticizer is present in an amount up to 30% based on the weight of the thermoplastic polymer.

19. The nonaqueous, extrudable composition according to claim 16, wherein the at least one polymer comprises HPC, and the plasticizer comprises polyethylene oxide.

20. The nonaqueous, extrudable composition according to claim 1, wherein the at least one thermoplastic polymer comprises a water soluble polymer.

21. The nonaqueous, extrudable composition according to claim 1, wherein the at least one thermoplastic polymer is contained in an amount of at least 30 wt % of the whole composition.

22. The nonaqueous, extrudable composition according to claim 1, wherein the at least one thermoplastic polymer is contained in an amount of at least 40 wt % of the whole composition.

23. A smokeless tobacco product comprising a sheet made by extruding or hot melt shaping a nonaqueous composition comprising at least one thermoplastic polymer and tobacco, the sheet comprising a matrix comprising the at least one thermoplastic polymer and the tobacco distributed in the matrix, the matrix being soluble in a user'"'"'s mouth and resulting in sustained release of nicotine to the user.

24. The smokeless tobacco product according to claim 23, wherein the sheet has a rectangular thin strip shape.

25. The smokeless tobacco product according to claim 24, 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.

26. The smokeless tobacco product according to claim 23, wherein the at least one polymer comprises polyethylene oxide (PEO).

27. The smokeless tobacco product according to claim 23, wherein the at least one polymer comprises hydroxypropyl cellulose (HPC).

28. The smokeless tobacco product according to claim 27, wherein the HPC comprises HPCLF, HPCELF or HPCEF.

29. The smokeless tobacco product according to claim 23, wherein the tobacco is in the form of snuff.

30. The smokeless tobacco product according to claim 23, further comprising a mucosal absorbing enhancer.

31. The smokeless tobacco product according to claim 23, further comprising a buffering agent for controlling a pH of the composition.

32. The smokeless tobacco product according to claim 31, 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.

33. The smokeless tobacco product according to claim 31, 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.

34. The smokeless tobacco product according to claim 23, wherein the tobacco is a tobacco having a tobacco specific nitrosamine content less than 50 ppm.

35. The smokeless tobacco product according to claim 23, further comprising a mucosal absorbing enhancer.

36. The smokeless tobacco product according to claim 35, wherein the mucosal absorbing enhancer is diethylene glycol monoethyl ether.

37. The smokeless tobacco product according to claim 23, wherein the composition includes less than 4 wt % water.

38. The smokeless tobacco product according to claim 23, further comprising a flavoring.

39. The smokeless tobacco product according to claim 23, further comprising a plasticizer.

40. The smokeless tobacco product according to claim 39, wherein plasticizer is at least one of polypropylene glycol, polyethylene glycol, glycerin and glycerol.

41. The smokeless tobacco product according to claim 40, wherein the plasticizer is present in an amount up to 30% based on the weight of the thermoplastic polymer.

42. The smokeless tobacco product according to claim 39, wherein the plasticizer is present in an amount up to 30% based on the weight of the thermoplastic polymer.

43. The smokeless tobacco product according to claim 42, wherein the sheet has an average dissolution time of 5 to 50 minutes, measured for 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.

44. The smokeless tobacco product according to claim 23, wherein the sheet has a tensile strength of at least 4 lbs.

45. The smokeless tobacco product according to claim 23, wherein the sheet has a uniformity in the range of ±

10%.

46. The smokeless tobacco product according to claim 23, wherein the at least one thermoplastic polymer is contained in an amount of at least 20 wt % of the whole composition.

47. The smokeless tobacco product according to claim 23, wherein the at least one thermoplastic polymer comprises a water soluble polymer.

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

49. The smokeless tobacco product according to claim 23, wherein the sheet is thicker on one end than another.

50. The smokeless tobacco product according to claim 23, wherein the tobacco is present in an amount of less than 100 mg and the product has a maximum measured nicotine plasma concentration greater than 4 ng/ml when administered in a single dose.

51. The smokeless tobacco product according to claim 23, wherein the tobacco is present in an amount of less than 100 mg and the product has an area under a nicotine plasma concentration versus time curve from zero to infinity greater than 23 ng/ml when administered in a single dose.

52. A combination of the smokeless tobacco product according to claim 23, wherein the sheet is formed into a continuous rolled sheet, and a package within which the rolled sheet is provided, the package having an opening for removing a desired length of the rolled sheet and a cutting edge for cutting the desired length of the rolled sheet from a remaining portion of the rolled sheet provided in the package.

53. 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.

54. The smokeless tobacco product according to claim 53, further comprising a flavoring.

55. The smokeless tobacco product according to claim 53, wherein the tobacco product is in the form of a sheet.

56. The smokeless tobacco product according to claim 53, wherein the tobacco product is shredded.

57. The smokeless tobacco product according to claim 53, wherein the composition contains less than 50 wt % tobacco.

58. The smokeless tobacco product according to claim 53, wherein the tobacco is present in an amount of less than 100 mg and the product has a maximum measured nicotine plasma concentration greater than 4 ng/ml when administered in a single dose.

59. The smokeless tobacco product according to claim 53, wherein the tobacco is present in an amount of less than 100 mg and the product has an area under a nicotine plasma concentration versus time curve from zero to infinity greater than 23 ng/ml when administered in a single dose.

60. A smokeless tobacco product comprising a matrix and tobacco in an amount of less than 100 mg and having a maximum measured nicotine plasma concentration greater than 4 ng/ml when administered in a single dose.

61. A smokeless tobacco product comprising a matrix and tobacco in an amount of less than 100 mg and having an area under a nicotine plasma concentration versus time curve from zero to infinity greater than 23 ng/ml when administered in a single dose.

62. A method for making a tobacco product, comprising extruding a nonaqueous composition comprising at least one thermoplastic polymer in an amount of more than 20 wt % the whole composition and tobacco through an extruder to form an extruded sheet of the nonaqueous composition.

63. The method according to claim 62, wherein the extruding of the composition is carried out without injecting gas into the composition.

64. The method according to claim 62, wherein the at least one polymer comprises polyethylene oxide (PEO).

65. The method according to claim 62, wherein the at least one polymer comprises hydroxypropyl cellulose (HPC).

66. The method according to claim 62, wherein the extruded sheet has a thickness of 5 to 50 mils.

67. The method according to claim 62, wherein the composition is extruded at a temperature sufficiently low and for a time sufficiently short to not substantially increase a tobacco specific nitrosamine content thereof.

68. The method according to claim 62, wherein the composition is extruded at a temperature of less than 200°

F.

69. The method according to claim 62, wherein the composition is extruded at a temperature of 350°

F. or lower and for a time of 2 minutes or less.

70. The method according to claim 62, wherein the composition is extruded at a temperature of 400°

F. or lower and for a time of 2 minutes or less.

71. The method according to claim 62, wherein the nonaqueous composition further comprises flavoring.

72. The method according to claim 71, wherein the nonaqueous composition flavoring is in liquid form and the extruder is vented.

73. The method according to claim 62, wherein the extruder is vented.

74. The method according to claim 62, the nonaqueous composition further comprises a plasticizer.

75. The method according to claim 74, wherein plasticizer is at least one of polypropylene glycol, polyethylene glycol, glycerin, glycerol and a water soluble edible polyol.

76. The method according to claim 75, wherein the plasticizer is present in an amount up to 30% based on the weight of the thermoplastic polymer.

77. The method according to claim 74, wherein the plasticizer is present in an amount up to 30% based on the weight of the thermoplastic polymer.

78. The method according to claim 62, further comprising cutting the extruded sheet to form a plurality of smaller sheets.

79. The method according to claim 78, wherein each of the smaller sheets has a rectangular thin strip shape or an ovoid shape.

80. The method according to claim 79, wherein the sheet has a rectangular thin strip shape having 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.

81. The method according to claim 78, further comprising recycling any discarded portions of the extruded sheet to an inlet of the extruder.

82. The method according to claim 62, further comprising winding the extruded sheet about a roll to form a roll of the extruded sheet.

83. The method according to claim 62, further comprising passing the extruded sheet around a portion of at least one roller.

84. The method according to claim 83, wherein the at least one roller is smooth.

85. The method according to claim 83, wherein the at least one roller is textured to provide a textured surface on at least one side of the extruded sheet.

86. The method according to claim 83, wherein the at least one roller is graveured to provide a design on a surface on at least one side of the extruded sheet.

87. The method according to claim 62, wherein the extruder is a single screw extruder.

88. The method according to claim 87, wherein the nonaqueous composition is extruded through the single screw extruder.

89. The method according to claim 62, wherein the extruder is a double screw extruder with a pump to pump the nonaqueous composition through a die thereof at constant pressure.

90. The method according to claim 62, wherein the extruder comprises a die and a pump to control pressure on the die.

91. The method according to claim 62, further comprising shredding the sheet to form a shredded tobacco product and providing the shredded tobacco product in a package.

92. The method according to claim 62, wherein the composition is exposed to heat in processing for less than 90 seconds to reduce formation of tobacco specific nitrosamines.

93. 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; and

placing the sheet in the buccal cavity of, on the palate of or sublingually in the user.

94. The method according to claim 93, 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.

95. The method according to claim 93, wherein the nonaqueous composition further comprises mint flavoring and the method induces freshened breath in the user for an extended period.

96. A co-packaged product comprising a first package containing at least one extruded tobacco product comprising a sheet made of a nonaqueous composition comprising at least one thermoplastic polymer and tobacco and a second package containing at least one cigarette, the first and second packages being co-packaged together in an outer package.

97. The co-packaged product according to claim 96, wherein the sheet has a rectangular thin strip shape.

98. The co-packaged product according to claim 96, 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.

99. The co-packaged product according to claim 96, wherein the outer package is transparent.

100. The smokeless tobacco product according to claim 23, further comprising a water insoluble polymer in an amount to lengthen dissolution time of the product.