Spray drying is a process used in the pharmaceutical industry to formulate amorphous solid dispersions (ASDs) composed of a homogeneous mixture of drug substance and polymer. Pharmaceutical ASDs are used in drug product manufacturing to improve the solubility and dissolution behavior of poorly soluble drug substances. Designing a robust spray drying process with a sufficiently wide operating space at commercial scale is important in the highly regulated pharmaceutical industry. Defining a scale independent process design space capable of producing comparable ASDs across multiple equipment sets and scales is important to ensure a robust supply chain. A case study will be presented confirming the desired ASD quality attributes were achieved across multiple equipment sets when operating within the spray drying process design space.
