Spray Drying and Scale‐Up

This chapter discusses amorphous dispersions manufactured using the spray drying process, which are referred to as spray‐dried dispersions (SDDs). It covers key aspects of spray drying equipment, process development, and scale‐up. The spray drying process can be broken down into the following five key steps or focus areas: spray solution preparation; atomization; drying; product collection; and secondary drying. Scalable spray drying process for SDDs is based on integrated consideration of formulation variables and process parameters that control atomization and drying thermodynamics. The chapter lists some of the key formulation selection considerations that have a significant impact on spray drying process development. The goal of scale‐up is often to ensure that the SDD particle attributes (e.g., particle size, density, physical state, and morphology) remain consistent while achieving the necessary throughput to meet clinical and/or commercial demands. This can be achieved by matching droplet size and drying rate during scale‐up.