Extrudable and Extruded Compositions for Delivery of Bioactive Agents, Method of Making Same and Method of Using Same
First Claim
1. A nonaqueous, extrudable composition comprising at least one thermoplastic polymer in an amount of more than 20 wt % of the whole composition and a bioactive agent other than tobacco, the composition not containing polycarbophil.
3 Assignments
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Accused Products
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. An extruded bioactive 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 a bioactive agent, the sheet being soluble in a user'"'"'s mouth and resulting in sustained release of bioactive to the user. The sheet can be in a form that may be placed in contact with the mucosa of the user, and have an average dissolution time of 5 to 50 minutes for delivering the bioactive to the user.
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Citations
126 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 a bioactive agent other than tobacco, the composition not containing polycarbophil.
- 30. An extruded bioactive product comprising a sheet made by extruding or hot melt shaping a nonaqueous composition comprising at least one thermoplastic polymer and a bioactive agent other than tobacco, the composition not containing polycarbophil, the sheet comprising a matrix comprising the at least one thermoplastic polymer and the bioactive agent distributed in the matrix, the matrix being soluble in the mucosa of a user and resulting in sustained release of the bioactive agent to the user.
- 60. An extruded bioactive product comprising a nonaqueous composition comprising at least one thermoplastic polymer and a bioactive agent other than tobacco, the composition not containing polycarbophil, in a form that may be placed on mucosal tissue 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 consequent with comfort and bioactive loading and a thickness of approximately 10-50 mil.
- 71. An extruded bioactive product in the form of an extruded sheet, comprising at least one thermoplastic polymer and a bioactive material comprising a bioactive agent other than tobacco and an ion exchange resin.
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73. A an extruded bioactive nicotine containing product comprising a thermoplastic polymer matrix and nicotine and having a maximum measured nicotine plasma concentration greater than 4 ng/ml when administered in a single dose.
- 74. A method for making a dosage unit, comprising extruding a nonaqueous composition comprising at least one thermoplastic polymer in an amount of more than 20 wt % the whole composition and a bioactive agent other than tobacco, the composition not containing polycarbophil, through an extruder to form an extruded sheet of the nonaqueous composition.
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113. A method for delivering nicotine from a bioactive product to a user, comprising:
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providing a sheet of a bioactive product comprising an extruded nonaqueous composition comprising at least one thermoplastic polymer and nicotine; and placing the sheet in the buccal cavity of, on the palate of or sublingually in the user. - View Dependent Claims (114, 115, 116, 117, 118, 119)
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120. A method for administering a clotting agent, comprising:
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providing a sheet of a bioactive product comprising an extruded nonaqueous composition comprising at least one thermoplastic polymer and a clotting agent; and placing the sheet on or in a wound user. - View Dependent Claims (121, 122, 123, 124, 125)
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126. A single use package, comprising sheet of a bioactive product comprising an extruded nonaqueous composition comprising at least one thermoplastic polymer and a bioactive agent other than tobacco, the sheet being of a size to administer a single dose of the bioactive agent to a user, and a package in which the sheet is sealed.
Specification