Prof. Jean-Michel Cardot
Pharm D, Ph. D.
Consultant for SAS Borvo
France
2023 Presentation
The objective of this presentation is to explore the proposed recommendation of the current EMA guidelines on local availability and to extend this one step further to an IVIVC, to estimate the similarities in the quantity of active ingredients released over time from sugar-free and sugared CPC/benzocaine (1.4 mg/10 mg) lozenges, based on the in vivo mass loss and the in vitro mass loss correlated with drug release.
That was done through indirect measurement of the local availability. First the quantity of active ingredient released, at selected time points in an in vitro dissolution study was related to the in vitro mass loos. Second a clinical in vivo study was performed to measure mass loss over time.
Based on the in vitro outcome it was possible to translate the in vivo mass loss to in vivo release of active ingredients and investigate potential for equivalence between lozenges.
2022 Presentation
EMA published some new requirements for dissolution in the two last years. The description of the new requirements for delayed release formulation and for F2 calculation are presented associated with examples and impact on dossier submission.
Since the publication of the guidelines on LALA in GIT Q&A and product specific guidance were published. The description of the requirements are presented. Three examples: lozenges, antiacid drug, and drug acting through chelation are presented to illustrate the current requirement. A specific point will be made on the difference between EMA and FDA on acceptance criteria.
About the speaker:
He was Professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology from the Auvergne University, France from 2002 to 2021. Before joining University, he was in research department of pharmaceutical industries in Switzerland and in France.
His research fields are Biopharmaceutical development of drugs, in vitro dissolution and in vivo bioequivalence and in vitro-in vivo correlation.