TRANSDERMAL NICOTINE-AN AID TO SMOKING CESSATION

NICOTINE SUBSTITUTION OR MAINTENANCE HAS BEEN SHOWN TO BE ANEFFECTIVE AID FOR CEASING SMOKING. THE OVERALL GOAL OF THIS PROGRAM IS TO DEVELOP A TRANSDERMAL NICOTINE DELIVERY SYSTEM AS AN AID TO CESSATION OF SMOKING BASED ON BIOTEK, INC.'S DERMAPATCH CONCEPT AND SYSTEM FOR PREPARING SUSTAINED-RELEASE PREPARATIONS OF LIQUID MATERIALS. THIS SYSTEM, CALLED NICOPATCH, WILL BE DESIGNED TO DELIVER NICOTINE FOR AT LEAST 24 HOURS AT A DOSE SUFFICIENT TO MAINTAIN A BLOOD NICOTINE LEVEL OF ABOUT 20 NG/ML. IN PRELIMINARY STUDIES, SUSTAINED-RELEASE MATRIXES WERE PRODUCED AND TESTED. A PROTOTYPE VEHICLE HAS BEEN SHOWN TO DELIVER NICOTINE TRANSERMALLY IN VITRO. THE OBJECTIVE OF THE PHASE I STUDY IS TO DEMONSTRATE THE FEASIBILITY OF THIS SYSTEM. SPECIFICALLY, A SUSTAINED-RELEASE, NICOTINE DERMAPATCH MATRIX WILL BE DEVELOPED AND CHARACTERIZED BY IN VITRO DRUG-RELEASE RATES. UTILIZING NUDE MOUSE SKIN IN VITRO, TRANSDERMAL DIFFUSION OF NICOPATCH FORMULATIONS WILL BE EVALUATED. THE RATE OF DELIVERY OF NICOTINE AND THE BLOOD LEVELS ACHIEVED WILL BE ESTIMATED BY IN VIVO STUDIES IN GUINEA PIGS AND RABBITS. DURING PHASE II, FURTHER IN VITRO AND IN VIVO TESTING WILL BE REQUIRED TO OPTIMIZE THE FORMULATION. TOXICOLOGY STUDIES WILL BE CONDUCTED AND AN INVESTIGATIONAL NEW DRUG APPLICATION FILED WITH THE FDA. BASED ON THESE STUDIES, INDUSTRIAL SUPPORT WILL BE SOUGHT FOR COMMERCIALIZING THE SYSTEM.