Amorphous spray-dried dispersions (SDDs) have gained considerable traction with the commercialization of numerous products to address low-solubility compounds. This technical article describes a model-based SDD product development methodology, as well as a control strategy that is based upon fundamental understanding of the formulation and the process. Key to this development strategy is the early identification of critical SDD attributes and process parameters, which contributes to the development program and facilitates identification of functional relationships between key material attributes and their controlling parameters. This understanding can later be translated into a robust control strategy for commercial manufacture.

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

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