PSE

Process Systems Enterprise (PSE), the Advanced Process Modelling company, today announced its new gCOAS® product for computational oral absorption at the Drug Development and Formulation Summit in Düsseldorf.

gCOAS, co-developed with Pfizer Inc. within the Systems-based Pharmaceutics (SbP) Alliance, is an analysis tool for a priori prediction of drug absorption in the human intestine under different drug substance and product formulations or ingestion conditions.

It provides formulation scientists with a tool that allows them to easily and quickly screen the performance of new formulations. The ultimate objective is to design a good dosage form in terms of amount of active pharmaceutical ingredient (API), particle size distribution of the API crystals, and other relevant attributes.

Using gCOAS helps reduce the number of trials, making it possible to bring new and better drugs to market earlier with less risk to volunteers.

Dr Ravi Shanker, Senior Research Fellow at Pfizer and a key mover behind the Systems-based Pharmaceutics developments, says “gCOAS gives us unprecedented confidence in the accuracy of predictions of fractions absorbed using basic compound data, prior to – and indeed, removing the need for – extensive trials. This has allowed us to design better formulations while shortening the critical field trial cycle.”

Unlike existing computational oral absorption tools, which use data fitting techniques, gCOAS inputs are directly measurable material physicochemical properties such as intrinsic solubility, permeability, pK_a , and logP. This not only makes it much easier for formulation scientists to set up analyses, it also provides them with much higher quality predictions going into first-in-human (FIH) trials.

gCOAS is a key component in Pfizer and PSE’s developments in Systems-based Pharmaceutics, in which the formulation and manufacturing decisions are based on their effect on the efficacy of the drug. Says Shanker, “the ultimate goal of SbP is to identify the drug formulation that gives you the desired bioavailability while satisfying manufacturing constraints such as flowability, etc. as early as possible in the development cycle. This is what SbP is all about.”

‘About’ information: www.psenterprise.com/news/pr150210.html

Contact:

Process Systems Enterprise
Kate Burness
+44-20-8563-0888
k.burness@psenterprise.com

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