Physicochemical Characterization, Polymorph Screening,Salt Selection of Oleanolic acid
(0) Preformulation investigations are designed to deliver all necessary data (especially physicochemical, physicomechanical and biopharmaceutical properties of drug substances, excipients and packaging materials) which may influence formulation design, method of manufacture of API and drug product, pharmacokinetic/biopharmaceutical properties of the resulting product, packaging of the product (stability). However, because there are not too many compounds that is under-developed with the authorized intellectual property right, and most of efforts the Chinese pharmaceutical industry have been made focus on generic drug development, Pre-formulation is not very widely performed in China as a drug selection tool. In big pharmaceutical companies, there are a number of guidelines and criteria to determine if the physicochemical properties of a compound are good or not. Among all the important physical-chemical properties, melting point, onset temperature of decomposition, morphology and size of the particles (crystal habit), crystallinity, hygroscopicity, solution/solid stability, solubility and permeability are the most important factors. A simple decision-making index was listed as follows.
Preformulation Polymorph screening Salt selection Oleanolic acid
Shi Bin Chen Longxia Hong Minghuang Zhang Zhiming Li Yuanqiang Lu Wenyun Ji Chongmin Gu Xiping Wei Yan Jiao Yan Guo Linsong
ShangPharm Co., Ltd, Shanghai, 201203, China；Correspondence to: Yuan Qiang Li, Process Chemistry
国际会议
International Symposium on Crystal Engineering and Drug Delivery System 2009(2009晶体工程与药物传送系统国际会议)
天津
英文
180-181
2009-09-05（万方平台首次上网日期，不代表论文的发表时间）