[learn_more caption=”Sherif Badawy, Ph.D.”] Sherif Badawy, Ph.D., is a Research Fellow in the Drug product Science and Technology of the Bristol-Myers Squibb Company. He received his B.S. in Pharmacy and M.S. in Pharmaceutics from Cairo University, and his Ph.D. in Pharmaceutics from Duquesne University. He has more than 18 years of industrial experience in drug product development. His current responsibilities at Bristol-Myers Squibb include formulation and process development and scale-up of commercial oral solid and liquid dosage forms. His areas of research interest include high shear wet granulation, tablet compaction, stability of solid dosage forms and bioavailability enhancement of poorly water-soluble compounds. He authored 30 manuscripts and numerous abstracts and presentations in those areas.[/learn_more]
Empirical methods have been traditionally used to assess compaction behavior of pharmaceutical materials. As a result, compaction issues have been difficult to predict in development and are often identified only after scale up of the compaction process. The presentation describes the application of a physical model to determine relevant material mechanical properties and identify potential risk to the tablet compaction process. A database of the Drucker-Prager Cap (DPC) model parameters of several excipients, active compounds and formulations was established. Various trends in the DPC parameters of the different materials were identified and assessed in light of known compaction issues for these materials. Examining model parameters was shown to provide insight into material compaction behavior. The development of this approach will enable the evaluation of compaction risk using a small amount of material, and minimize the need for larger scale studies.