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<p>While external factors can significantly influence the rate and extent of drug absorption from transdermal products, some of these factors are not typically accounted for in the development process. In this study, oxybutynin gel (OXY GEL) was used as a model formulation to understand the impact of a short 3&#xa0;h occlusion period on the oxybutynin absorption profile both <i>in vitro</i> and <i>in vivo</i>. Using the <i>in vitro</i> permeation test (IVPT) design with skin from 4 human donors, OXY GEL provided significantly greater flux and cumulative amounts of oxybutynin after occlusion was applied, as compared to the unoccluded formulation. These results were in agreement with the clinical pharmacokinetic (PK) study conducted with 12 healthy volunteers when temperature, dosing, and timepoints were harmonized between <i>in vitro</i> and <i>in vivo</i> studies to help develop an <i>in vitro-in vivo</i> correlation (IVIVC). Described herein are the IVPT and clinical PK study methods and results used to establish the Level A IVIVC.</p> Graphical Abstract <p></p>

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The Influence of Occlusion on Oxybutynin Absorption from Gel-Deposited Excipients Using Ex Vivo Skin and Healthy Human Volunteers

  • 期刊论文

  • 发表日期：

    2026年3月13日

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  • Bianca Reginauld,
  • Sherin Thomas,
  • Vijaya Kumari Karra,
  • Danielle Fox,
  • Dana C. Hammell,
  • Maureen Kane,
  • Audra L. Stinchcomb

摘要

While external factors can significantly influence the rate and extent of drug absorption from transdermal products, some of these factors are not typically accounted for in the development process. In this study, oxybutynin gel (OXY GEL) was used as a model formulation to understand the impact of a short 3 h occlusion period on the oxybutynin absorption profile both in vitro and in vivo. Using the in vitro permeation test (IVPT) design with skin from 4 human donors, OXY GEL provided significantly greater flux and cumulative amounts of oxybutynin after occlusion was applied, as compared to the unoccluded formulation. These results were in agreement with the clinical pharmacokinetic (PK) study conducted with 12 healthy volunteers when temperature, dosing, and timepoints were harmonized between in vitro and in vivo studies to help develop an in vitro-in vivo correlation (IVIVC). Described herein are the IVPT and clinical PK study methods and results used to establish the Level A IVIVC.

Graphical Abstract