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.
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.
Achievements & News
OrBiTo Open Science Day 1st July – ‘Beyond the BCS based biowaivers’
The OrBiTo project plans an Open Science Day with a regulatory focus entitled ‘Beyond the BCS based biowaivers’. The event takes place Wednesday 1st July, 09.00-18.30 in Chilly Mazarin, France, during the three day 2015 OrBiTo annual meeting. ###Participants will come from EFPIA partners, universities and SMEs as well as scientists from outside of OrBiTo and regulatory agencies. 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. More information about the Open Science Day is available through the following sources:
- Event flyer and speakers list
- 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
- Simcyp Limited , Sheffield, UK
- Sirius Analytical Ltd, Forest Row, UK
- Simulations Plus, Inc., Lancaster, US
Facts & Figures
|IMI funding||8 975 392|
|EFPIA in kind||11 556 863|
|Other||3 962 626|
|Total cost||24 494 881|
Tel: +46 31 7761262
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