Expedited and Material-Sparing Tablet Development
Changquan Calvin Sun, PhD (University of Minnesota)
The tablet is the most common commercial dosage form for oral drug delivery. It is desirable to use tablets in an early phase of clinical trials, which minimizes the need to bridge clinical data for product approval because of little, if any, formulation changes throughout the clinical testing. However, the development of a scale-up ready tablet formulation and manufacturing process usually requires a long time and a large amount of active pharmaceutical ingredient (API) that is typically not available before Phase II clinical trials begin. Using predictive tools for assessing the manufacturability of a formulation, i.e., flowability and tabletability, and through appropriate API engineering, it is possible to efficiently develop a scale-up ready tablet formulation. Efficient and material-sparing development of a high-quality tablet product requires an understanding of the fundamental physics that determines the compaction process, tablet strength, and powder properties. This will be demonstrated in this talk using a few case studies.
Date and Location
Thurs April 15th, 20214:00 - 5:00 PM |
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About the speaker
Dr. Sun is a Professor of Pharmaceutics and Director of Graduate Studies at the Department of Pharmaceutics, University of Minnesota (UMN). After receiving his Ph.D. in Pharmaceutics from UMN, he worked in the pharmaceutical industry for 8 years before joining the UMN in 2008. Dr. Sun’s research focuses on formulation development of tablet products through appropriate application of materials science and engineering principles. Two active lines of research in his lab are 1) crystal and particle engineering for superior powder flow, compaction, and dissolution performance; 2) understanding and optimizing pharmaceutical unit operations, e.g., blending, granulation, and tableting.
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