A medicated oral patch has been developed which has good adhesion to the gingival mucosa. The objective of this program is to extend this concept to the delivery of nystatin. This is the drug of choice for the treatment of oral candidiasis, which is very prevalent in HIV infected patients and must be treated aggressively to prevent a life-threatening infection. Compared to present therapy, this patch will deliver the drug for a longer period of time (6 vs 1/2 hour), deliver more directly to the infected area, and be more palatable than the present nystatin lozenge therapy. In Phase I an active nystatin patch will be developed and tested in vitro. Testing will include drug release profile (simulating release to the underlying tissue and to the bathing saliva), demonstration of mucosal adhesion, and stability of the patch to typical storage conditions. The most appropriate research preparation methods will then be converted for use with a laboratory model of a commercial coater/dryer. This coater will then be used to prepare material for clinical testing.
