Nicotine pharmacokinetics of Nicoderm (nicotine transdermal system) in women and obese men compared with normal-sized men.

This study examined the effect of gender and body weight on the pharmacokinetic properties of the Nicotine Transdermal System (NTS) (Nicoderm). This NTS was applied for 24 hours to 13 normal-sized men, 13 women, and 13 obese men, all of whom were smokers who had abstained from cigarettes for the previous 24 hours. Pharmacokinetic parameters were determined during a single application of the system. The mean nicotine maximal plasma concentration (Cmax) and area under the curve (AUC) values for women did not differ significantly from those for normal-sized men. Nicotine Cmax and AUC values, however, were significantly lower in obese compared with normal-sized men; nicotine AUC was strongly correlated to body weight and body mass index. Mean apparent nicotine elimination rate constant values were not significantly different between normal-sized and obese men, but the apparent elimination rate constant value was significantly higher in women. The possible clinical significance of the differences in nicotine AUC values with body weight is discussed.

Single- and multiple-dose pharmacokinetics of Nicoderm (Nicotine Transdermal System).

The pharmacokinetics and tolerability of single and multiple applications of Nicotine Transdermal Systems (NTS), designed to deliver 14 mg of nicotine per 24 hours, were investigated in 20 healthy adult male smokers. After a single application, mean Cmax and tmax for plasma nicotine were 12.2 ng/mL and 4.4 hours, respectively. Plasma nicotine concentrations rose rapidly and then remained steady between 12 and 24 hours after application. The apparent nicotine half-life (t1/2) after system removal was 3.2 hours. Steady state was attained by the second day of multiple application, and mean steady-state nicotine Cavg was 25% higher on day 5 compared with the first NTS application. Steady-state plasma cotinine was reached by the fourth day of multiple application and, as with nicotine, Cavg and Cmax increased, tmax decreased, and t1/2 did not change compared with single application. The mean ratios of cotinine-to-nicotine area under the curve (AUC) values for single and multiple NTS applications were 14.0 and 15.8, respectively. The pharmacokinetics of nicotine and cotinine were linear between single and multiple NTS applications. The nicotine transdermal systems were generally well tolerated.