药学前沿大讲堂第80讲-Recent Advances in Preformulation Studies for Solid Dosage Forms

报告题目： Recent Advances in Preformulation Studies for Solid Dosage Forms

主 讲 人：　朱海建 博士  

美国Forest Laboratories Inc. 研发总监

主 持 人：  吴传斌 教授   bm11222宝马娱乐网站副院长

讲座时间：  2011年3月28日（星期一）上午10:00

讲座地点：  中山大学东校区药学大楼125讲学厅

朱海建博士简介：

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.

演讲内容摘要：

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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