Manufacturing Spray-Dried Dispersions: Process Control Strategies

By Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, PhD

A significant share of current drug development pipelines include active pharmaceutical ingredients (APIs) that fall into BCS (biopharmaceutical classification system) 2 and 4 spaces. These compounds are typically characterized by their lowaqueous solubility and thus poor bioavailability, requiring advanced formulation approaches. Various approaches have been developed to enable these types of compounds, including particle size reduction (eg, micronization), chemical modification (eg, salt forms and pro-drugs), complexing agents, solubilized liquid forms (eg, SEDDS), and solid amorphous dispersions.