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PHARMACOKINETICS

Effect of Application Sites and Multiple Doses on Nicotine Pharmacokinetics in Healthy Male Japanese Smokers Following Application of the Transdermal Nicotine Patch

Satoshi Sobue, PhD, Kaneo Sekiguchi, PhD, Hironori Kikkawa, PhD and Shin Irie, MD

From Pfizer Global R&D, Tokyo Laboratories, Pfizer Japan, Inc, Tokyo, Japan (Dr Sobue, Dr Sekiguchi, Dr Kikkawa) and Kyushu Clinical Pharmacology Research Clinic, Fukuoka, Japan (Dr Irie).

The transdermal nicotine patch, which contains 25 mg nicotine per 30 cm2, is designed to deliver approximately 15 mg nicotine to the blood circulation in 16 hours of application for the treatment of smoking cessation. It was applied to 3 different skin sites (upper arm, abdomen, and back) to examine regional variations in percutaneous nicotine absorption in a single-dose, 3-period, crossover study involving 9 healthy male Japanese smokers. Nicotine pharmacokinetics during once-daily application of the transdermal nicotine patch for 5 days was also investigated in 10 healthy smokers. There were statistically significant effects of application sites on percutaneous nicotine absorption. The ratios (90% confidence intervals) of AUC and Cmax for comparison to the upper arm were 102% (88, 117%) and 106% (95, 119%) for the back and 75% (65, 87%) and 75% (66, 84%) for the abdomen, respectively. These suggest that systemic exposure after application to the upper arm was greater compared with the abdomen but equivalent to the back. Following multiple doses, linear pharmacokinetics and no significant accumulation of nicotine concentrations were observed, and steady state was reached by day 2. Only mild itching and erythema were observed at the application sites. The transdermal nicotine patchwas well tolerated in both studies.

Key Words: Nicotine • transdermal • pharmacokinetics • application site • multiple dose

Address for reprints: Satoshi Sobue, Department of Clinical Pharmacology, Pfizer Global R&D, Tokyo Laboratories, Pfizer Japan Inc, Shinjuku Bunka Quint Bldg. 3-22-7, Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan; e-mail: Satoshi.Sobue{at}pfizer.com.


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