Geoff Mckee^a Efren Alvidrez^a and Naimah Majeed-SloanEl^a

^a Pfizer Inc.(235 E 42nd St, New York, NY 10017)

Compaction Simulators are key pieces of equipment in the development of a formulation. One of the challenges that we have in development is the limited amount of Active we can have available initially. With a Simulator a material sparing approach was applied to design the fit-for-purpose formulation and process to achieve clinical timeline. As the project progressed, larger quantity of API is available, the formulation and manufacturing process was able to be finalized. Using the Compaction Simulator each compression step was evaluated and were able to recommend manufacturing parameters. With additional Active supply the formulation was able to be adjusted based on compression results and tablet properties.