Heated Spray Drying Process and Formulation Development for a SDD

A tablet formulation based on a spray dried dispersion (SDD) of a low solubility oncology compound in vinylpyrrolidone-vinyl acetate copolymer (PVP-VA) has been developed to increase solubility and reduce variability of exposure.  Initial SDD pre-clinical and clinical supplies were spray dried at 10wt% solids in a ternary tetrahydrofuran (THF)-methanol-water solution due to solubility limitations in preferred solvent systems.  The purpose of this body of work was to identify a solvent system and spray drying process to increase throughput and eliminate the use of THF, and to manufacture SDD intermediate and tablets with performance and stability equivalent to the initial materials.

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