Spray Drying Process Design: Establishing Links Between Process Parameters and Product Performance

Spray drying or spray congealing is typically used to manufacture a powder for further processing into a final dosage form. Although this operation can profoundly influence the properties and quality of the final product, its contribution is subtle and often incompletely understood due to the impact of subsequent processing steps. Inability to adequately characterize the relationships between the drying or congealing process and the final product can lead to difficulties establishing process and product robustness and reproducibility during late-stage development and scale up. This presentation will provide an overview of how, through a systematic design space and risk assessment approach, key relationships between the powder generation process and the final product have been successfully captured and used to facilitate late-stage development efforts. Two examples are included to illustrate this approach in design of a direct compression tablet and an enteric coated particle blend.