Preparation and Characterization of Esomeprazole Sodium Enteric-Coated Solid Dispersion Tablets
JIAO Dong-mei1, SUN Jing-meng2, WANG Dan1, ZHANG Wei-yu1*
1. School of Pharmacy, Changchun University of Chinese Medicine, Changchun 130117, China; 2. The First Hospital of Jilin University, Changchun 130021, China
Abstract：OBJECTIVE To prepare esomeprazole sodium(Es) enteric solid dispersion tablets (E-ESSDT), improve the wettability, thermal instability and oral acid degradation of esomeprazole sodium. METHODS Based on the concept of quality derived from design, fishbone analysis diagram was used to screen the key quality attributes of E-EsSDT, and single-factor investigation method, Plackett-Burman design and Box-Behnken design were used to optimize and characterize the E-EsSDT. RESULTS The optimal formula was that the ratio of water to hydoxpropylmethylcellulose succinate-LG(AS-LG) was 3∶22, the ratio of Es to AS-LG was 1∶3.5, and the shear break time was 44 seconds.The stability test results showed that the Es content, moisture absorption and weight gain and acid resistance of E-EsSDT were all in accordance with the regulations.Characterization analysis showed that Es existed in amorphous form in solid dispersion. CONCLUSION The preparation of E-EsSDT solves the problems of moisture absorption, thermal instability and acid degradation of Es by oral administration.
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2021, Vol. 56 
