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ORBITO

Oral biopharmaceutics tools

Summary

Most drugs are taken orally, as tablets or capsules for example. However, designing these pharmaceutical products in such a way that the active ingredient is absorbed at an appropriate rate and extent by the gut is far from easy. The ORBITO project aims to enhance our understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients.

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Predicting performance

The majority of drug products are administered orally, yet designing oral formulations and determining dosages involves a lot of trial and error. Current laboratory tests do not mimic accurately the highly variable and dynamic environment of the human gut, and so their ability to predict the performance of an orally-administered drug in the human body is limited. As a result, researchers rely heavily on tests in animals and clinical studies in humans to verify drug performance, rendering the entire process rather lengthy and expensive. 

The issue is likely to become even more pressing in the future as new drug discovery technologies are increasingly delivering active drugs that are very hard to put into simple oral formulations, for example because they are hydrophobic, have low aqueous solubility, and/or variable uptake in large intestine.

There is therefore an urgent need for improved tools to predict the performance of orally-administered drugs.

From trial and error to rational models

The ORBITO project aims to tackle this problem at all levels, beginning with improving our fundamental understanding of the gastro-intestinal absorption process. This information will be integrated into the development of new (or refinement of existing) laboratory tests and computer-based methods that will deliver more accurate predictions of drug product behaviour in real life. The new methods will be validated with the use of industrial data and material. Crucially, the project will set up a framework to guide the use of these new tools in drug development.

What sets ORBITO apart from other projects is the way it will integrate data from many existing studies while also initiating new studies that will generate better data. By combining existing data with new data, and by bringing together so many different partners, it has a good chance of achieving its goals.

Ultimately, the project will help to facilitate and speed up the formulation development process and significantly reduce the need for animal experiments in this area as well as for human clinical studies in the future.

For patients, the main benefit will be in the form of high quality medicines where the dose required is well calculated and is released in a way that consistently provides an optimal clinical effect.

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Participants

EFPIA

  • AstraZeneca AB, Sodertalje, Sweden
  • AbbVie Deutschland GmbH & Co. KG, Wiesbaden-Delkenheim, Germany
  • Bayer Pharma AG, Berlin, Germany
  • Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • GlaxoSmithKline Research and Development Ltd, Brentford, UK
  • H. Lundbeck A/S, Valby, Denmark
  • Janssen Pharmaceutica NV, Beerse, Belgium
  • Merck Sharp & Dohme Corp, Rahway, US
  • Novartis Pharma AG, Basel, Switzerland
  • Orion Corporation, Espoo, Finland
  • Pfizer Ltd, Sandwich, UK
  • Sanofi-Aventis Research and Development, Chilly-Mazarin, France

Universities, research organisations, public bodies, non-profit groups

  • Uppsala Universitet, Uppsala, Sweden
  • Copenhagen University , Copenhagen, Denmark
  • Ernst Moritz Arndt University Greifswald, Greifswald, Germany
  • Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany
  • Johannes Gutenberg Universität Mainz, Mainz, Germany
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • Medical Products Agency, Uppsala, Sweden
  • National and Kapodistrian University of Athens, Athens, Greece
  • Netherlands Organization for Applied Scientific Research TNO, Delft, Netherlands
  • University of Manchester, Manchester, UK
  • University of Strathclyde, Glasgow, UK

SMEs

  • Simcyp Limited , Sheffield, UK
  • Sirius Analytical Ltd, Forest Row, UK
  • Simulations Plus, Inc., Lancaster, US

Facts & Figures

Start date  01/10/2012
Duration  60 months
   
Contributions   €
IMI funding   9 000 000
EFPIA in kind 11 500 000
Other   4 000 000
Total cost 24 500 000

Links and Documents

Project website:
www.orbitoproject.eu

IMI funding per project participant

 

Contact

Project Coordinator
Bertil Abrahamsson

AstraZeneca AB
Tel: +46 31 7761262
E-mail: bertil.abrahamsson[AT]astrazeneca.com

Managing Entity
Hans Lennernäs

Uppsala Universitet
Tel: +46 18 471 4317
E-mail: hans.lennernas[AT]farmaci.uu.se