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Randomized Controlled Trial
. 2018 Jun;7(5):506-512.
doi: 10.1002/cpdd.431. Epub 2018 Feb 2.

Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

Scott Rasmussen  1 , Kathleen Halabuk Horkan  2 , Mitchell Kotler  3
Affiliations
Randomized Controlled Trial

Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

Scott Rasmussen et al. Clin Pharmacol Drug Dev. 2018 Jun.

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 Cmax and AUC0-t . In addition, the parameters Tmax and t1/2 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.

Keywords: bioequivalence; nicotine replacement therapy; nicotine transdermal system; smoking cessation; tobacco dependence.

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Figures

Figure 1
Figure 1
Baseline‐adjusted mean plasma nicotine concentration follows a similar trend over time after the application of both the test and reference patches (per‐protocol population; n = 38 for each treatment). Arithmetic means are plotted; error bars represent standard deviation. All values below the limit of quantitation were considered to be 0. For baseline adjustment, nicotine levels at time 0 were adjusted for the apparent terminal elimination rate constant calculated for each subject and subtracted from the observed nicotine concentration at each time.
See this image and copyright information in PMC

References

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