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.