PTH shows great promise as a treatment for osteoporosis when delivered in pulsatile dosing regimens. The development of a simple and economical on-demand transdermal system for delivery of parathyroid hormone (PTH) is proposed. Preliminary clinical results have demonstrated the ability of a prototype system to rapidly and controllably deliver therapeutically significant levels of PTH into the bloodstream. The PTH is delivered through 100 micron diameter pores, which are formed in the skin through a patented, non-traumatic, instantaneous thermal process. The system couples a low iontophoretic current with the pores to achieve a delivery rate which is several orders of magnitude faster than conventional iontophoresis. The pharmacokinetics observed are more rapid than subcutaneous injection and without the undesirable depot effect. The goal of this Phase I effort is to analyze the feasibility of the system on ten subjects by delivering short pulses of PTH and measuring the subsequent PTH blood levels produced. Ultimately, this system could be incorporated into a personal, portable device used for treatment of osteoporosis through the therapeutic administration of PTH without the pain, inconvenience and low compliance associated with injections. PROPOSED COMMERCIAL APPLICATIONS: The ultimate goal is the development of a cost effective transdermal delivery system for parathyroid hormone. The entire system could be made to be worn like a pager electrically connected to a disposable transdermal patch. Alternately, a small hand held unit could be briefly connected to a transdermal patch to create the thermal micropores once every twenty-four hours, and then a small processor in the patch could control the PTH delivery profile.
