COMPARISON OF THE PHARMACOKINETICS OF 2 NICOTINE TRANSDERMAL SYSTEMS - NICODERM AND HABITROL

This randomized, crossover study compared the nicotine and cotinine ph armacokinetic parameters and plasma concentration profiles of two diff erent nicotine transdermal products: Nicoderm (Alza, Pale Alto, CA; an d Marion Merrell Dow, Kansas City, MO) and Habitrol (Basel Pharmaceuti cals, Summit, ND. The two treatments were randomly assigned to each of 24 male smokers and worn for 24 hours each day for 5 days, with a B-d ay washout between treatments. Plasma nicotine and cotinine concentrat ions were measured on day 1 and day 5 of each treatment. Mean delivere d dose differed significantly between products, and the two products w ere not bioequivalent. The Nicoderm system provided higher mean plasma nicotine concentrations, particularly during the first 8 hours after system application. The mean steady state C-max, AUC, and degree of fl uctuation (DF) values were significantly greater for the Nicoderm syst em than for Habitrol. The mean nicotine t(max) value for the Nicoderm system was significantly shorter (P <.001) than that for Habitrol (2.7 versus 8.6 hours). Steady state cotinine AUC values and plasma concen trations were significantly lower for Habitrol than for the Nicoderm s ystem. The incidence of adverse events was similar for both products.