The mechanical development of a novel pulsed transdermal therapeutic system (TTS) is described in this proposal. The TTS will utilize Intelimer TM polymeric membranes, proprietary to Landec Labs., and a thermal signal generator to drive them. Because the membranes have a very low permeability to a variety of drugs below a """"""""switch temperature"""""""" and a very high permeability above that temperature, the release of a drug can activated and controlled by a small heat stimulus to change the state of the membrane. The system has potential for many dosing regimens. Benefits derived from such a system include the reduction of tolerance, improved patient compliance, and patient controlled therapy. This proposal focused on the development of a system to provide the heat stimulus required to activate the Intelimer TM membrane. The research will encompass a review of heating technologies appropriate to this concept. A prototype using the most appropriate heating method will be constructed using the Intelimer TM polymers. This prototype will be evaluated with respect to response time, temperature control, and other parameters. Finally, the thermal heating prototype will be laminated into a transdermal device complete with a drug reservoir. The release profile of a drug as it responds to the heat stimulus will be monitored in vitro.
