Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions

September 1, 2015

Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersion

Authored by Devon DuBose, Dana Settell, Nathan Bennette and Amber Broadbent of Bend Research



Drug Development & Delivery - September 2015, Vol. 15 No. 7 – 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 low-aqueous solubility and thus poor bioavailability, requiring advanced formulation approaches.1 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.


In recent years, amorphous dispersions manufactured via spray drying have gained considerable traction with the commercialization of numerous products. Additionally, increased access to and familiarity with small-scale spray drying equipment has enabled formulation scientists to include spray-dried dispersions (SDDs) early in compound screening and drug development. With greater use of SDDs as an integral part of the formulation toolbox, and a considerable portfolio of SDDs progressing toward commercialization, adoption of a Quality-by-Design (QbD)-based development approach can help streamline scale-up and regulatory approval in bringing these compounds to market.


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