Pharmaceutical Research

, Volume 16, Issue 9, pp 1325–1330

Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products

  • Gordon L. Flynn
  • Vinod P. Shah
  • Srinivas N. Tenjarla
  • Michael Corbo
  • David DeMagistris
  • Terry G. Feldman
  • Thomas J. Franz
  • Deborah R. Miran
  • David M. Pearce
  • Joel A. Sequeira
  • James Swarbrick
  • Jonas C. T. Wang
  • Avaraham Yacobi
  • Joel L. Zatz


The FDA recently issued a guidance covering practices of scaleup and post approval changes with semisolids (SUPAC-SS). This guidance outlines the steps that must be taken by a company to maintain certification of its semisolid dermatological products after quantitative changes have been made in their compositions and/or after changes have been made in the sourcing of their key ingredients, in their processing, in their batch sizes, and/or after their site of manufacture has been relocated. A key element within the guidance is a release test to be used to determine if the diffusional release of a drug found in a formulation is the same after changes have been made to the formulation as it was prior to implementing the changes. The AAPS-FDA sponsored workshop was set up to explore this qualifying test. The stated aims of the workshop were: a) to illustrate the methodology and techniques of in vitro release testing, b) to show the sensitivity of in vitro release with respect to manufacturing variables and to variations in components and composition (of specific formulations), c) to recognize in vitro release testing as a useful procedure for SUPAC documentation, d) to highlight and evaluate other applications of in vitro release testing, e) to explore the degree to which in vitro release testing and bioavailability may be related, and f) to evaluate the role of in vitro release testing of topical dosage forms as a tool to improve product quality.

SUPAC-SS topical delivery systems dermatologicals release testing FDA guidances 


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Copyright information

© Plenum Publishing Corporation 1999

Authors and Affiliations

  • Gordon L. Flynn
    • 1
  • Vinod P. Shah
    • 2
  • Srinivas N. Tenjarla
    • 3
  • Michael Corbo
    • 4
  • David DeMagistris
    • 5
  • Terry G. Feldman
    • 6
  • Thomas J. Franz
    • 7
  • Deborah R. Miran
    • 8
  • David M. Pearce
    • 9
  • Joel A. Sequeira
    • 10
  • James Swarbrick
    • 11
  • Jonas C. T. Wang
    • 12
  • Avaraham Yacobi
    • 13
  • Joel L. Zatz
    • 14
  1. 1.College of PharmacyUniversity of MichiganAnn Arbor
  2. 2.FDA-Office of Pharmaceutical Science, CDER/OPS ---Rockville20857
  3. 3.Southern School of PharmacyMercer UniversityAtlanta
  4. 4.R. W. Johnson PRIRaritan
  5. 5.Glaxo, Inc.
  6. 6.Taro PharmaceuticalsBramptonCanada
  7. 7.Kinetics Corp.Palo Alto
  8. 8.Miran Consulting, Inc.Lutherville
  9. 9.Altana Inc.Melville
  10. 10.Schering-Plough ResearchKenilworth
  11. 11.AAI, Inc.Wilmington
  12. 12.Johnson & Johnson Consumer ProductsSkillman
  13. 13.Taro Pharmaceuticals USA, Inc.Hawthorn
  14. 14.College of PharmacyRutgers UniversityPiscataway

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