Jim Jingjun Huang

Poor water solubility of more than 60% of new chemical entity present a major hurdles in the design of suitable drug delivery systems for the market dosage form. Current controlled-release drug technologies for water insoluble drug are summarized. The key considerations in design of controlled release dosage forms, such as drug physic-chemical and biopharmaceutical properties, in-vitro and in-vivo correlation, and key material and process attributes for the robust manufacturing and reproducible performance of the product are presented. The multidisciplinary collaboration between CMC, biopharm, clinical, M&S, and marketing teams were found critical for the successful development of controlled release dosage forms with enhanced bioavailability.