Heated Spray-Drying Process and Formulation Development For A Spray-Dried Dispersion

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 preclinical and clinical supplies were spray-dried at 10-wt% 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 (1) to identify a solvent system and spray-drying process to increase throughput and eliminate the use of THF and (2) to manufacture SDD intermediate and tablets with performance and stability equivalent to the initial materials.

Topics: 
Bioavailability Enhancement