Pharmaceutical compositions of nicotine and methods of use...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...

Reexamination Certificate

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C514S343000

Reexamination Certificate

active

07387788

ABSTRACT:
The present invention comprises non occlusive compositions for transdermal delivery of nicotine, and more particularly pharmaceutically acceptable salts thereof, and methods of making same. The composition may, for example, be a gel suitable for transdermal or transmucosal applications. The compositions of the present invention typically comprise a mixture of water and alcohol, and a solvent system having a mono alkyl ether of diethylene glycol and a glycol present in specified ratios and in specific amounts, wherein the pH of the gel is usually between a pH of 5.5 and 7. The compositions may include further components, for example, the hydroalcoholic vehicle may further comprise additional penetration enhancer(s), buffering agent(s), antioxidant(s), stabilizer(s) and/or gelling agent(s). The invention also relates to a method for the sustained delivery of nicotine pharmaceutically acceptable salts to treat a variety of conditions and disorders.

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