A Study on Screening Polymorphs of Drug Substances

• Main Authors: Chine-Ming Chen, 陳建銘
• Other Authors: 魏正琪
• Format: Others
• Language: zh-TW
• Published: 2010
• Online Access: http://ndltd.ncl.edu.tw/handle/hn4y5n

碩士 === 國立臺北科技大學 === 化學工程研究所 === 98 === The purpose of this study is to screen polymorphic forms of drug substances by using systematic crystallization techniques. In this study, sulfathiazole was used as a model drug and two different approaches of crystallization methods including cooling crystallization and salting out crystallization were used to search for various polymorphs. XRD, DSC, FTIR, TGA and SEM were employed to characterize the polymorphic forms. In cooling crystallization, water and twelve organic solvents of different functional groups and polarity were chosen for systematic screening with three cooling modes. In salting out crystallization,toluene and heptane were used as anti-solvents while the other organic solvents were used as good solvents. The results show that various polymorphs including formⅠ, formⅢ, formⅣ, formⅤ and mixing form(formⅠ+formⅣ) were found. It is validated in this study that various polymorphic forms appear with this screening methodology through which the manufacturing processes and the quality of drug products are enhanced in the pharmaceutical industry.