Sherif Badawy, Ph.D.

Compaction simulation is widely used in contemporary drug product development. Compaction simulators are used to assess mechanical properties of drug substances, excipients and formulation blends in order to assess the risk associated with the tablet compression unit operation. Both empirical and model based analyses of compaction simulator data have been used to evaluate material properties such as resistance to densification, bonding and elastic recovery. Comprehensive assessment of these properties allows for the prediction of tablet compression risks and tablet defect issues. Compaction simulators are also used as production press replicators in support of the compression unit operation development, scale up and troubleshooting of manufacturing issues. Press replication in the compaction simulator minimizes the need for larger scale studies and serves as a material sparing tool for tablet tooling design evaluation and optimization. The presentation will review the different applications of compaction simulation and provide case studies to illustrate its utility to drug product development.