Florentin Lukas Holzem

ESR 11: Integrating in vitro dissolution-permeation data with biopharmaceutical models to predict the in vivo performance of drug formulations

University of Southern Denmark

Supervisor: Anette Bauer-Brandl

Planned secondments: Roche (Purpose: Formulation manufacturing; in vitro characterization; in silco modelling)             NKUA (Purpose: Evaluation of alternative in vitro model (BioGIT)

Project Description

The aim of the project is to benchmark a range of dissolution/permeation methods and to develop integrated PBPK models with increasing levels of complexity using a variety of enabling formulations. Hence, a main goal is to establish an approach for integrating in vitro dissolution/permeation data with in silico PBPK models and verify the predictions by comparison with in vivo reference data. Based on this project, a new guide on optimal selection of in vitro dissolution-permeation methods and in silico tools during formulation development for poorly soluble drugs should be developed.

Background

Florentin Lukas Holzem (ESR 11) has a Diploma in Pharmacy and a bachelor’s degree in Biology from the University of Greifswald. During his Diploma thesis at Roche, Florentin was able to get insights into the pharmaceutical industry and the biopharmaceutical characterization of supersaturating systems. His research project within InPharma will focus on different Dissolution-Permeation tools and the integration of resulting data into biopharmaceutical models. Florentin is currently hosted at the University of Southern Denmark and will spend half of his project at Roche in Basel.