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In-Vitro Release Testing of Semisolid Topical Dosage Forms

5 September 2023

The semisolid topical dosage forms include creams, ointments, and gels. They are special dosage forms with particular compositions, structures, transformations at the site of administration and mechanisms of release. In vitro release test (IVRT) is a simple, reliable and reproducible tool utilized for the assessment of the performance of these complex formulations. The applications of IVRT gradually evolved from screening of the impact of scale up post approval changes (variations) to comparative evaluations of multisource drug products. The presentation will focus on the particularities and relevance of IVRT, the role of critical assessment of qualitative / quantitative composition for appropriate interpretation, the current applications and possible extension.

- Horst-Dieter Friedel, Former Director, retired Worked for Bayer AG, Germany

- Flavian Stefan Radulescu, Assoc.Prof. University of Medicine and Pharmacy Carol Davila Bucharest - Romania
- Xiao Yu Xie, Head of laboratory Eurofins PHAST Development GmbH & Co. KG - Germany