Premium
Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Author(s) -
Rasmussen Scott,
Horkan Kathleen Halabuk,
Kotler Mitchell
Publication year - 2018
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.431
Subject(s) - bioequivalence , medicine , nicotine replacement therapy , cmax , nicotine patch , nicotine , tolerability , pharmacokinetics , pharmacology , transdermal , adhesive , smoking cessation , transdermal patch , crossover study , adverse effect , placebo , pathology , chemistry , alternative medicine , organic chemistry , layer (electronics)
Abstract Smoking continues to be a major preventable cause of early mortality worldwide, and nicotine replacement therapy has been demonstrated to increase rates of abstinence among smokers attempting to quit. Nicotine transdermal systems (also known as nicotine patches) attach to the skin via an adhesive layer composed of a mixture of different‐molecular‐weight polyisobutylenes (PIBs) in a specific ratio. This randomized, single‐dose, 2‐treatment, crossover pharmacokinetic (PK) trial assessed the bioequivalence of nicotine patches including a replacement PIB adhesive (test) compared with the PIB adhesive historically used on marketed patches (reference). The test and reference patches were bioequivalent, as determined by the PK parameters of C max and AUC 0–t . In addition, the parameters T max and t 1/2 did not significantly differ between the 2 patches, supporting the bioequivalence finding from the primary analysis. The tolerability profiles of the patches containing the replacement and previously used PIB adhesives were similar; application‐site adverse events did not significantly differ between test and reference patches. Overall, these data establish the bioequivalence of the nicotine patch with the replacement PIB adhesive formulation and the previously utilized PIB adhesive formulation.