SMOKING HAS BEEN DETERMINED TO BE THE CAUSE OF APPROXIMATELY30 PERCENT OF ALL CANCER DEATHS.

SMOKING HAS BEEN DETERMINED TO BE THE CAUSE OF APPROXIMATELY30 PERCENT OF ALL CANCER DEATHS. BUT IT IS VERY HARD TO STOP SMOKING, AND ONLY A FRACTION OF THE INDIVIDUALS WHO TRYSUCCEED. IN RECENT YEARS THE USE OF NICOTINE-CONTAINING CHEWING GUMS HAS BEEN FOUND BENEFICIAL IN SMOKING CESSATION PROGRAMS. THESE FORMULATIONS SEPARATE THE PSYCHOLOGICAL ASPECTS OF ADDICTION FROM THE PHYSIOLOGICAL ASPECTS AND ALLOW EACH TO BE TREATED IN TURN. HOWEVER, THEY HAVE SOME SIDE EFFECTS, DO NOT MAINTAIN A CONSTANT BLOOD LEVEL OF NICOTINE, AND PERMIT THE DOSAGE OF NICOTINE TO BE CONTROLLEDBY THE PATIENT RATHER THAN THE PHYSICIAN. PHASE I RESEARCH WILL DEVELOP A CONTROLLED RELEASE TRANSDERMAL NICOTINE DELIVERY SYSTEM. THIS SYSTEM WOULD DELIVER THE DRUG AS A CONTINUOUS CONSTANT RATE FOR 24 HOURS, AFTER WHICH IT WOULD BE REPLACED WITH A FRESH DEVICE. IT WOULD HAVE AN AREA OF LESS THAN 20 CM2, PREFERABLY 10 CM2. IN THE PHASE I PROGRAM, THE SYSTEM'S FEASIBILITY WOULD BE DEMONSTRATED, ANDPROTOTYPE DEVICES PREPARED. THE DRUG DELIVERY RATE FROM THESE DEVICES AND PERMEABILITY OF SHAVED RAT SKINS TO NICOTINE WOULD BE MEASURED IN VITRO. IN A SUBSEQUENT PHASE II PROGRAM, THE DEVICE DESIGN WOULD BE OPTIMIZED AND ANIMAL AND CLINICAL STUDIES PERFORMED.