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Investigator Impact on Reproducibility of Drug Bioavailability in Stratum Corneum Sampling by Tape Stripping

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Abstract

Purpose

Skin sampling by tape stripping measures the local bioavailability of topical drug products in the stratum corneum (SC). The goal of the current study was to evaluate the impact of different investigators in studies that utilize a tape stripping protocol designed to minimize investigator variability.

Methods

Two open-label clinical studies compared two lidocaine patches and a diclofenac patch and solution in twelve healthy volunteers. The mass of drug was determined in SC samples collected on tape strips at three time points following product removal in duplicate by two investigators. Investigator results were compared with each other and with results for the diclofenac solution measured by another laboratory using a similar protocol.

Results

For drug mass, the geometric mean ratio comparing two investigators is within the acceptable bioequivalence interval for most measurement times and drug products. Drug uptake into the SC from the diclofenac solution was not statistically different from that determined in another laboratory. The average flux from the SC over the clearance intervals for the four drug products correspond well with flux measurements from in vitro permeation tests.

Conclusions

Results from different investigators are reproducible within the limitations of measurement variability, which can be managed by increasing volunteer numbers.

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Acknowledgements

This work is supported in part by the University of Maryland Baltimore, School of Pharmacy Mass Spectrometry Center (SOP1841-IQB2014). We thank Drs. Priyanka Ghosh and Sam Raney at the United States Food and Drug Administration for their input into the current study. The views expressed in this manuscript do not reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

Funding

This publication was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] (Research Award U01FD004947) totaling $2,350,000 with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

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Authors and Affiliations

  1. Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, 21201, USA

    Sagar Shukla, Hazem E. Hassan & Audra L. Stinchcomb

  2. Department of Chemical and Biological Engineering, Colorado School of Mines, Golden, CO, 80401, USA

    Annette L. Bunge

  3. Department of Pharmaceutics and Industrial Pharmacy Faculty of Pharmacy, Helwan University, Cairo, Egypt

    Hazem E. Hassan

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  1. Sagar Shukla
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Correspondence to Audra L. Stinchcomb.

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Shukla, S., Bunge, A.L., Hassan, H.E. et al. Investigator Impact on Reproducibility of Drug Bioavailability in Stratum Corneum Sampling by Tape Stripping. Pharm Res 39, 703–719 (2022). https://doi.org/10.1007/s11095-022-03199-w

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