Biopharmaceutics risk assessment via gastrointestinal modelling

The biopharmaceutics performance of drug products can depend on multiple factors, including drug substance physicochemical properties, particle size distribution, patient physiology and dosage form composition. Even to the most experienced investigators, the interplay of these factors is not intuitive.

In silico modelling allows for the low cost, rapid identification of risk factors affecting drug absorption. Formulators can then develop risk mitigation strategies before clinical trials, allowing them to design clinical studies to understand, confirm and mitigate the predicted risks.

Topics covered

This webinar demonstrates the investigation of several pharmaceutical compounds using mechanistic oral absorption models. Detailed analysis identified rate limiting processes of absorption for four structurally diverse model drugs representing:

• An acidic salt (Diclofenac)
• A basic salt (Ziprasidone HCl)
• A neutral compound (Fluconazole)
• An ampholyte compound

The simulation modelled the human body's dynamic response to feeding using transitive physiological states. This showed significantly different biopharmaceutics performance when compared to simulations using static physiological parameters.

Presenter(s)

Dan Braido, Senior Consultant, PSE

Dan Braido is a Senior Consultant with PSE's Life Sciences business unit. Dan is the lead developer of gCOAS and works interactively with major pharmaceutical companies to improve and expand the toolset. Dan completed his PhD in Chemical and Biochemical Engineering at Rutgers University.