Novel oral biopharmaceutics tools (EU project OrBiTo)

Wednesday 30 September 2015
14:30-17:30
A6, 3 hours

Organised by the FIP SIG on Regulatory Sciences and the FIP Clinical Biology Section 

Introduction

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.


Learning objectives

Knowledge-based session

At the conclusion of this session, participants will be able to:

  1. Evaluate latest progress in the area of in vitro and in silico predictive tools for oral absorption reducing the need for in vivo studies.
  2. Outline new physiological information of relevance for oral absorption.
  3. Describe possible future direction for increased opportunites for biowaivers by enhanced use of predictive tools.
  4. Distinguish the aims and plans within the IMI project OrBiTo.
  5. Specify progress and plans to influence further work in OrBiTo.

Chairs: Xavier Pepin (AstraZeneca, France) and Jennifer Dressman (Goethe University Frankfurt am Main, Germany)

Programme

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)

15:45 Break

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)