USP Panel Findings on Development of a Novel In Vitro TDS Adhesion Test


In 2019, the United States Pharmacopeia (USP) created an Expert Panel (New Advancements in Product Performance Testing) to conduct a gap analysis on the need for, and possible creation of, tests and/or standards to characterize the quality or performance of topical and transdermal products. The results of this analysis were described in a 2023 USP Stimuli Article: Advances in Product Quality and Performance Tests for Topical and Transdermal Products - View of the USP Expert Panel, which sought feedback about the need new tests and/or standards in three specific areas:

  • In vitro adhesion tests for transdermal and topical delivery systems (collectively called TDS)
  • In vitro quality and performance tests for microneedle array systems
  • Physicochemical and structural (Q3) characterization tests for topical drug products

The purpose of this webinar is to offer a brief update summarizing the insights and recommendations provided to USP in each of the three specific areas of the stimuli article. Thereafter, the webinar will focus on a deeper dive into the first of these three areas, discussing research activities that have been initiated to develop a new and improved approach to in vitro TDS adhesion testing. The goal of the webinar is to facilitate an interactive dialogue and solicit further input about user requirements and scientific considerations that can guide the development of a novel in vitro test method that is predictive of the in vivo adhesion performance of TDS products. Specifically, input is sought from investigators who work with TDS products to clarify what intrinsic properties and extrinsic factors are most likely to influence in vivo adhesion performance.