By Amber Broadbent, Ph.D., Director of Engineering and Nathan Bennette, Senior Research Chemist, Bend Research, a division of Capsugel Dosage Form Solutions
A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classification System (BCS) class II and IV space, which includes compounds that are dissolution rate, solubility or permeability limited to absorption, or all three. As portfolios across the industry are increasingly focused on these compounds, the need for enabling technologies continues to grow.
Many technologies exist to address issues of oral delivery of BCS II and IV active pharmaceutical ingredient (API), and selecting the right strategy depends on the physical chemical properties of the drug and the final product concept. Solid amorphous dispersion is one technology approach that has a broad range of applicability to BCS II compounds.