Optimization of coating film formulation of tamsulosin hydrochloride extended-release pellets by Box-Behnken response surface methodologyChinese Full Text
XIE Xiang-yang;CHEN Chen;LIN Wen;HAN Liang;WANG Tao;Department of Pharmacy,Wuhan General Hospital of Guangzhou Military Command;Department of Clinical Laboratory,Huangshi Love and Health Hospital;PLA Wuhan Sanitarium;
Abstract: OBJECTIVE To optimize the coating film formulation of tamsulosin hydrochloride extended-release pellets by Box-Behnken response surface methodology.METHODS In the Box-Behnken response surface methodology,the ratio of Eudragit RS 30 D to Eudrgit RL 30D（X1） and coat weight gain（X2） were selected as the independent variables,and in vitro accumulated releases from the pellets at 2,6,and 10 h were chosen as dependent variables.The release rate of the extended-release pellets and the reference pellets were compared by calculating the similarity factor f2 value.RESULTS When the ratio of Eudragit RS 30 D to Eudrgit RL 30D（X1） was 30∶70 and coat weight gain（X2） was25%,the accumulative release percentages at 2,6,10 h were consistent with the criterion of USP,The f2 for the extended-release pellets and the reference pellets in dissolution mediums was 69.6.CONCLUSION The Box-Behnken response surface methodology was successfully used to optimize the coating film formulation of tamsulosin hydrochloride extended-release pellets.The release profiles of the pellets complied with requirements of the USP.
Keywords：
Box-Behnken response surface methodology; tamsulosin hydrochloride; extended-release pellets; coating film formulation;
- DOI：
10.13286/j.cnki.chinhosppharmacyj.2014.20.11
- Series：
- Subject：
- Classification Code：
R944
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