(640e) Methodology to Rapidly Screen Lyophilization Formulations

Formulation screening can take significant time and resource to identify viable excipient combinations. The proposed methodology allows for hundreds of formulations to be screened within a single lyophilization cycle to identify viable formulations. Manufacturability of the formulations was determined by evaluating the primary drying glass transition temperature (Tg’) and commercial equipment limitations. The lyophilization cycle was determined via an automated end point using a pressure differential between the capacitance manometer and the Pirani gauge. A scoring criterion was then adopted to evaluate the appearance, dispersibility, and other quality critical attributes. The methodology resulted in a reduction in development time from months to less than two weeks.