U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Generic Drug User Fee Amendments
  5. FY2015 Regulatory Science Research Report: Transdermal Drug Products
  1. Generic Drug User Fee Amendments

FY2015 Regulatory Science Research Report: Transdermal Drug Products

Introduction

To ensure the quality and performance of generic transdermal delivery systems (TDS) products and their robust therapeutic equivalence, several initiatives are underway to support research in this area. One of these initiatives characterizes the potential difference in heat effects in brand-name vs. generic TDS products. TDS products that are bioequivalent to the reference listed drug (RLD) under normal conditions may deliver drug(s) at a higher rate than the RLD when both are exposed to the same elevated heat conditions that can occur during the normal course of product wear, such as from heating blankets, hot showers, and saunas.

Research

Two grants supporting research in this area provide the comparative assessment of TDS heat effects in vitro as well as in vivo. The goals of this research are to develop appropriate and relevant study conditions under which to evaluate TDS heat effects and to develop predictive in vitro methodologies to evaluate the effects of elevated heat on the unintentional increase in transdermal delivery of drug(s) from TDS.

ORS staff facilitating research in this area

  • Sam Raney, Priyanka Gosh, Bryan Newman

Projects and Collaborators

  • Tiered Testing Strategy for Assessing Thermal Effects on Transdermal Products
    • Site PI: Kevin Li
    • Grant #: 1U01FD004942-01
  • Heat Effect on Generic Transdermal Drug Delivery Systems
    • Site PI: Audra Stinchcomb
    • Grant #: 1U01FD004955-01

Publications and Presentations

  • Murawsky MK, Zhang Q, La Count T, Hao J, Newman B, Ghosh P, Raney SG, Lionberger R, Kasting G, Li S. An in vitro test method for evaluating the effect of heat on TDDS performance. Poster presentation at Innovation@CDER (September 10, 2014)
  • Shin SH, Hassan HE, Stinchcomb AL, Ghosh P, Newman B, Raney SG, Lionberger R. Influence of heat on reference and generic transdermal drug delivery systems. Poster presentation at Innovation@CDER (September 10, 2014)
  • Murawsky MK, Zhang Q, La Count T, Hao J, Newman B, Ghosh P, Raney SG, Lionberger R, Kasting G, Li S (2014) An In Vitro Test Method for Evaluating the Effect of Heat on TDDS Performance. Poster presentation at Marshall University School of Pharmacy Research Day on October 27, 2014.
  • Abdallah I, Ghosh P, Newman B, Raney SG, Stinchcomb A, Hassan H. LC-MS/MS determination of nicotine and its metabolite cotinine in human plasma. Poster presentation at the AAPS Annual Meeting (November 4, 2014)
  • Murawsky MK, Zhang Q, La Count T, Hao J, Newman B, Ghosh P, Raney SG, Lionberger R, Kasting G, Li S. Skin temperature under transdermal patch with heat application. Poster presented at the AAPS Annual Meeting (November 4, 2014)
  • Shin SH, Thomas S, Aballah I, Raney SG, Ghosh P, Newman B, Hammell D, Hassan HE, Stinchcomb AL. Evaluation of Bioavailability and In Vitro/In Vivo Correlation of Nicotine Transdermal Drug Delivery Systems Under the Influence of Heat. Poster presentation at the Barrier Function of Mammalian Skin Gordon Research Conference (August 18, 2015)

Outcomes

  • Research projects in progress

ResourcesForYou

 
Back to Top