SMOKELESS TOBACCO PRODUCT
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.
1 - 112 . (canceled)
113 . 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.
114 . The smokeless tobacco product according to claim 113 , wherein the at least one polymer comprises hydroxypropyl cellulose (HPC).
115 . The smokeless tobacco product according to claim 114 , wherein the nonaqueous composition does not include a plasticizer.
116 . The smokeless tobacco product according to claim 113 , wherein the tobacco is in the form of snuff.
117 . The smokeless tobacco product according to claim 113 , further comprising a mucosal absorbing enhancer.
118 . The smokeless tobacco product according to claim 113 , further comprising a buffering agent for controlling a pH of the composition.
119 . The smokeless tobacco product according to claim 118 , wherein the buffering agent is present in an amount to provide the product with a pH of 6 to 9.5 when the composition is present in the user's mouth.
120 . The smokeless tobacco product according to claim 113 , further comprising a mucosal absorbing enhancer.
121 . The smokeless tobacco product according to claim 113 , wherein the composition includes less than 6 wt % water.
122 . The smokeless tobacco product according to claim 113 , further comprising a flavoring.
123 . The smokeless tobacco product according to claim 113 , further comprising a plasticizer.
124 . The smokeless tobacco product according to claim 113 , 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 in 2 and a thickness of approximately 10-50 mil, to dissolve fully in a buccal cavity of a user.
125 . The smokeless tobacco product according to claim 113 , wherein the sheet has a tensile strength of at least 4 lbs.
126 . The smokeless tobacco product according to claim 113 , wherein the sheet has a uniformity in the range of +−10%.
127 . The smokeless tobacco product according to claim 113 , wherein the at least one thermoplastic polymer is contained in an amount of at least 20 wt % of the whole composition.
128 . The smokeless tobacco product according to claim 113 , wherein the at least one thermoplastic polymer comprises a water soluble polymer.
129 . The smokeless tobacco product according to claim 113 , wherein the tobacco is present in an amount of less than 100 mg in a single dose of the product such that a user's maximum measured nicotine plasma concentration is greater than 4 ng/ml.
130 . The smokeless tobacco product according to claim 113 , further comprising a water insoluble polymer in an amount to lengthen dissolution time of the product.
131 . The smokeless tobacco product of claim 113 , wherein the absence of tack is sufficient that one strip does not adhere to another when packaged together.