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Biorelevant Dissolution Testing

16 January 2023

Biorelevant in vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behavior. An in vitro performance test which mimics the intraluminal performance of an oral dosage form is termed biorelevant. Biorelevant tests have been utilized to decrease the number of in vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies.

Prediction of intraluminal performance of an orally administered dosage form and the active pharmaceutical ingredient with biorelevant in vitro performance testing requires appropriate simulation of luminal conditions. Key luminal parameters to be simulated may vary with the process to be simulated, the structure of the active pharmaceutical ingredient and the type of dosage form. A variety of biorelevant media have been proposed, making it now possible to simulate most regions in the gastrointestinal tract in both prandial states. The levels of biorelevance and accompanying decision tree may serve as a useful tool during formulation development, in order to ensure high quality, predictive performance results without unnecessary complexity of media.

• Participants will be introduced in biorelevant dissolution testing
• Participants will be informed on dissolution media that simulates the physicochemical characteristics of the contents of the gastrointestinal lumen
• Participants will be informed on the in vitro methodologies that have been shown to be useful in simulating the intraluminal environment

- Horst-Dieter Friedel, FIP Chair Regulatory Sciences and Quality, Director Former at Bayer AG, Germany

- Christos Reppas, Professor in Pharmaceutics National and Kapodistrian University of Athens, Greece

- Maria Vertzoni, Associate Professor in Pharmaceutical Technology and Biopharmaceutics National and Kapodistrian University of Athens, Greece