Novel oral biopharmaceutics tools (EU project OrBiTo)
Wednesday 30 September 2015
A6, 3 hours
Organised by the FIP SIG on Regulatory Sciences and the FIP Clinical Biology Section
OrBiTo (www.orbitoproject.eu) is a new European project within the IMI programme in the area of oral biopharmaceutics tools that includes leading international scientists from nine European universities, one regulatory agency, one non-profit research organisation, four SMEs together with scientists from twelve pharmaceutical companies. The OrBiTo project will address key gaps in our knowledge of gastrointestinal (GI) drug absorption and deliver a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. Among other benefits, the tools emerging from OrBiTo is expected to reduce the number of human bioequivalence setting a foundation for increased use of biowaivers.
The aim of this session is to provide an update of plans and progress of this project as well as setting outcome in a broader perspective of more efficient development of better products to the patient.
At the conclusion of this session, participants will be able to:
- Evaluate latest progress in the area of in vitro and in silico predictive tools for oral absorption reducing the need for in vivo studies.
- Outline new physiological information of relevance for oral absorption.
- Describe possible future direction for increased opportunites for biowaivers by enhanced use of predictive tools.
- Distinguish the aims and plans within the IMI project OrBiTo.
- Specify progress and plans to influence further work in OrBiTo.
Chairs: Xavier Pepin (AstraZeneca, France) and Jennifer Dressman (Goethe University Frankfurt am Main, Germany)
14:30 1) Introduction to OrBiTo
Xavier Pepin (AstraZeneca, France)
14:45 2) Screening drugs for supersaturation potential and precipitation risks
Anette Müllertz (Copenhagen University, Denmark)
15:15 3) Biopharmaceutical tools to predict the impact of supersaturation and precipitation on oral drug absorption
Edmund Kostewicz (Goethe University, Germany)
16:00 4) Gastrointestinal evaluation of enabling formulations in humans to understand intraluminal supersaturation and precipitation
Joachim Brouwers (Catholic University Leuven, Belgium)
16:30 5) Modelling the dynamics of fluids, pH and bile salts in the upper GI tract: towards adequate estimates of luminal drug concentration and supersaturation
Xavier Pepin (Sanofi-Aventis, France)
17:00 6) Interactions during oral drug absorption
Elin Lindhagen (Swedish Medical Product Agency, Sweden)