藥學前沿大講堂第80講-Recent Advances in Preformulation Studies for Solid Dosage Forms

報告題目： Recent Advances in Preformulation Studies for Solid Dosage Forms

主 講 人：　朱海建 博士  

美國Forest Laboratories Inc. 研發總監

主 持 人：  吳傳斌 教授   太阳集团1088vip副院長

講座時間：  2011年3月28日（星期一）上午10:00

講座地點：  中山大學東校區藥學大樓125講學廳

朱海建博士簡介：

Dr. Zhu is currently Director of Pharmaceutical R&D at Forest Laboratories, Inc. in New York. Prior to joining Forest Laboratories, Dr. Zhu has worked at GlaxoSmithKline for 8 years as a Manager of Strategic Technologies and Team Leader within the Pharmaceutics Department.  His research interests include solid state characterization, crystallization/polymorph screening, solubilization, oral absorption simulation/modeling and novel drug delivery technologies. He has more than 80 publications and presentations including several book chapters and multiple patents. Dr. Zhu obtained his Ph.D. (1996) in Pharmaceutics from the College of Pharmacy at University of Minnesota under the tutelage of Late Professor David J.W. Grant.  His doctoral research involved in investigating the physicochemical properties and crystal structures of pharmaceutical solids. Dr. Zhu also holds a B.S. (1986) in Pharmacy, as well as a M.S. degree (1989) in Biopharmaceutics both from China Pharmaceutical University.

演講内容摘要：

The preformulation function is constantly evolving. It plays an important role in drug discovery support by screening initial physical and chemical properties, assessing its developability and helping selecting new chemical entity for clinical studies. Key physicochemical properties such as pKa, partition coefficient, solubility and solution stability are increasingly addressed earlier in the discovery and early development stage. This has resulted in a shift in focus for preformulation activities towards solid state investigations, including polymorph/salt/co-crystal screenings, solid state compatibility testings, physical/chemical stability studies and mechanical properties evaluation. Preformulation is essential in drug product development to realize the quality in built - not tested -  into the product or Quality by design (QbD). This presentation includes multiple case studies addressing the challenges faced in the design of the solid dosage forms.

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