报告题目:晶体工程和颗粒工程联合使用加速片剂产品的开发
主讲人:Changquan Calvin Sun, Ph.D., University of Minnesota, USA
时间:12月26日(星期四)下午3:20-4:30
地点:邵科馆二楼国际会议厅
报告内容简介:
The development of a quality pharmaceutical tablet product is a complex process, involving informed decisions on the type and amount of excipients and several process parameters. Owning to the level of complexity, tablet development has been empirical. Generally, a significant amount of active pharmaceutical ingredient (API) and a long time is required before a scalable formulation is identified. Unfortunately, problems during manufacturing still occur frequently for such empirically developed tablet formulations. In contrast, formulation development guided by Materials Science Tetrahedron (MST) is efficient. Robust tablet formulation and manufacturing process can be developed quickly and using a small amount of API. The MST guided approach starts from identifying problems that affect tablet quality. Structural origin of each problem is then understood and appropriate engineering strategies are developed to modify structure. This leads to efficient development of high performance tablets. Assisted by predictive characterization tools, such as shear cell tester, compaction simulator, and artificial stomach, scalable high quality tablet formulation can be developed using a small amount of API. This talk will cover useful particle and engineering strategies. Case studies will be discussed to demonstrate the benefits of integrated crystal and particle engineering in the expedited development of robust tablet formulations.
主讲人简介:
孙常全博士是明尼苏达大学药剂学教授,现为研究生工作部主任和药剂系执行主任。自2000年在明尼苏达大学取得博士学位后, 先后在多个著名制药企业从事工业药剂学的研究工作八年,于2008年回到明尼苏达大学担任教授。孙博士的研究重点是应用材料科学和工程科学的策略来促进片剂的处方开发,包括:1)利用晶体工程和颗粒工程来改善粉末的流动性和可压性;2)混合、制粒和压片等单元操作的理解和控制。孙博士是固态科学、片剂处方设计和粉末技术的资深专家,已发表相关研究论文170多篇。目前为J. Pharm. Sci.、Int. J. Pharm. Tablets and Capsules、Crystals 、Chemical & Pharmaceutical Bulletin等杂志的编委会成员或顾问,是美国药典物性分析专家委员会委员和粉末分会主席。