Release and stability studies of mesalamine delayed-release formulations

• Main Authors: Ying-Chih Tsai, 蔡穎芝
• Other Authors: Kuo-Chun Sung
• Format: Others
• Language: zh-TW
• Published: 2014
• Online Access: http://ndltd.ncl.edu.tw/handle/fnee8w

碩士 === 嘉南藥理大學 === 藥學系 === 102 === Controlled release system has a number of advantages, however various excipients and storage conditions might affect release characteristics as well as chemical structure integrity, and thus many affect system quality. The purpose of this study is to investigates stability of mesalamine by using forced-degradation, and then to study effects of core and coating excipients on drug release. Different percentages of povidone K30 and sodium starch glycolate were used in the core tablet. Various percentages of Eudragit S100 and Povidone K30 were coated on the core tablet to produce delayed-release formulations. The chemical stability of the coated tablet under accelerated stability condition was also evaluated. In summary, the forced degradation tests demonstrate that mesalamine is very stable in acid, UV and heat, but not stable in the base and H2O2. The dissolution results show that mesalamine release rates from core tablet can be controlled by binder and disintegrant. Different percentages and thickness of Eudragit S100 and Povidone K30 coating may control the release profile of the delayed-release formulations. By using accelerated stability condition, we can observe limited of mesalamine degradation and is acceptable according to ICH Q3B.