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Enhanced Properties of Solid Oral Dosages via API Co-Processing: Dry Coating of APIs and Synergistic Effects

By Prof. Rajesh N. Davé,
Distinguished Professor, Chemical & Materials Engineering,
New Jersey Institute of Technology, Newark, NJ 07102

Distinguished Professor of Chemical, Biological and Pharmaceutical Engineering, Center for Integrated Material Science and Engineering of Pharmaceutical Products (CIMSEPP), New Jersey Institute of Technology, Newark, NJ, 07102, USA Abstract It is often difficult to achieve desirable critical powder material properties via tweaking crystallization processes or by developing a suitable alternate polymorph for many APIs. API co-processing has emerged as a potentially beneficial approach. Co-processing may There are involve wet or dry routes such as, concurrent crystallization/precipitation of the API and nonactive components, controlled crystallization via adsorption/addition of non-actives, adsorption or impregnation of carriers, and dry mechanical coating. This presentation will focus on recent advances in dry co-processing that highlight predictable enhancements in formulations of the APIs co-processed with inert or nonactive materials such as the excipients or additives to achieve better physical properties such as reduced cohesion hence improved flowability, increased bulk density, reduced agglomeration, and enhanced dissolution even when hydrophobic coatings are applied. The synergistic enhancements in the blend or formulation properties will be highlighted including blend uniformity, flowability, compaction properties, and enhanced capability for direct blend direct compaction (DB-DC) tableting at either high or very low drug loadings. The talk will discuss a positive feature for the dry co-processed APIs of model-based predictive enhancements and potential for digital design of their formulations because of the availability and applicability of mechanistic particle contact models.
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