NYSTATIN/CLOTRIMAZOLE DEVICE FOR ORAL CANDIDIASIS

THE OBJECTIVE OF THIS PROGRAM IS TO DEVELOP A DEVICE FOR ORAL DELIVERY OF NYSTATIN AND CLOTRIMAZOLE. THESE DRUGS AREPRESENTLY USED 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 DEVICE WILL DELIVER THE DRUG FOR A LONGER PERIOD OF TIME (6 HOURS VS. 1/2 HOUR), DELIVER MORE DIRECTLY TO THE INFECTED AREA, AND SHOULD BE MORE PALATABLE AND HAVE FEWER SIDE EFFECTS THAN THE PRESENT DRUG THERAPY. IN PHASE I, AN ACTIVE NYSTATIN PATCH WILL BE DEVELOPED AND TESTED IN VITRO. TESTING WILL INCLUDE A DRUG RELEASE PROFILE (SIMULATING RELEASE TO THE UNDERLYING TISSUE AND TO THE BATHING SALIVA), DEMONSTRATION OF MUCOSAL ADHESION, AND STABILITY OF THE DEVICE IN TYPICAL STORAGE CONDITIONS. THE MOST APPROPRIATE RESEARCH PREPARATION METHODS WILL THEN BE CONVERTED FOR USE WITH A LABORATORY MODEL OF PRODUCTION EQUIPMENT. FINALLY, THIS EQUIPMENT WILL BE USED TO PREPARE MATERIAL FOR CLINICAL TESTING.