Predictive Models for Advancing Amorphous Dispersions of Poorly-Bioavailable Compounds from Drug Discovery to Commercial Product

March 20, 2013 - 8:40am


A significant fraction of active pharmaceutical ingredients (APIs) currently being developed by the pharmaceutical industry have low aqueous solubility and require enabling formulations to achieve acceptable oral absorption. Amorphous solid dispersions—prepared by spray-drying, hot-melt extrusion or precipitation—are often enabling formulations for such compounds.

This talk will focus on predictive methodologies covering performance, stability and manufacturability of amorphous solid dispersions. Topics presented will include predictive bio-performance and physical stability of the amorphous dispersions, and science-of-scale to allow production of dispersions in milligram quantities of API for discovery support up to multiple metric ton quantities for commercial production. 

Presented by David Lyon, Ph.D.

Bioavailability Enhancement