Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability, and Dosage Form

Amorphous dispersions enable progression of low-solubility compounds and open multiple opportunities for optimization and understanding during formulation and process development. This technical article describes the development and use of amorphous spray-dried dispersions (SDDs) and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and final dosage-form selection. Innovative models and tools are used to predict and select the optimum formulation and process early in the development process. Use of guidance maps, process-development flowcharts, in vitro tests, and models are used to ensure efficient and successful formulation development.

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