With the collaboration of Teledyne Hanson Research and RaDes GmbH from Germany a webinar with the title: “Introduction to IVRT: Fundamentals of In Vitro Release Testing of Semisolid Dosage Forms” will be presented on Wednesday, June 9, 2021. The webinar is free but registration is needed for the attendance on the 45-minute presentation plus interactive Q&A session.
14:00 / 2 PM CEST
20:00 / 8 PM CEST
3:00 / 3:00 AM CEST, June 10
Evaluating release characteristics of active pharmaceutical ingredient (API) from a semisolid dosage form, whether for product development or quality control purposes, is best accomplished using vertical diffusion cell (VDC) instruments and methods. Obtaining test results that are meaningful for product development and acceptable by regulatory agencies requires a strong understanding of the factors affecting the accuracy and precision of in vitro release testing (IVRT). In this introductory-level webinar moderated by Keith Hamman, Vice President & General Manager of Teledyne Hanson, RaDes GmbH’s Sascha Gorissen, Lab Operations Manager, and Michael Herbig, CEO, will provide details on IVRT methods and best practices to ensure high quality results that fully comply with industry guidance, such as USP <1724> Semisolid Drug Products – Performance Tests.
Topics of discussion:
- What is diffusion and how is it calculated?
- Release test (IVRT) vs. permeation test (IVPT)
- IVRT receptor cell media and “back diffusion”
- IVRT test setup: membrane selection
- Determining API release rate
- IVRT method validation: sensitivity, linearity, specificity, and robustness
- Data validation: two-stage comparison testing of reference drug (R) vs. test formulation (T)