application):
The aim of this project is to demonstrate episodic delivery from a transdermal patch. In the proposed approach, a meltable transdermal vehicle will be warmed by a small aerobic heat source similar to those used in pocket warmers. Heat generation and the resulting drug delivery can be turned on and off by controlling the availability of air to the heat source, initially by hand, and potentially by a small programmed controller. Nicotine will be used as the demonstration drug because an episodic nicotine patch would be useful for smoking therapy and might facilitate other medical applications of nicotine. BIOTEK has shown that delivery of nicotine from a meltable formulation can be repeatedly increased and decreased by adjusting the temperature just above or below the melting point of the delivery medium. Other experiments have shown that small aerobic heat generators can be turned off and on for many hours while in place on the skin. Phase I will expand this work to show that thermoregulated transdermal delivery can be reproducibly achieved and controlled in both in vitro and in vivo; Phase II will then develop the practical commercial patch design and conduct a Phase I human clinical study of the final design.
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