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首页> 美国卫生研究院文献>Journal of Basic and Clinical Pharmacy >FORMULATION AND EVALUATION OF ENTERIC COATED TABLETS OF PROTON PUMP INHIBITOR
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FORMULATION AND EVALUATION OF ENTERIC COATED TABLETS OF PROTON PUMP INHIBITOR

机译：质子泵抑制剂肠溶片的研制与评价

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The present study was an attempt to formulate and evaluate enteric coated tablets for esomeprazole magnesium trihydrate. Different core tablets were prepared and formulation (F-1) was selected for further enteric coating, based on the disintegration time. Seal coating was applied to achieve 3% weight gain using opadry®. Enteric coating was carried out using different polymers like Eudragit L-30 D-55, hydroxy propyl methylcellulose phthalate, cellulose acetate phthalate and Acryl-EZE® to achieve 5% weight gain. Disintegration studies showed that the formulations failed in 0.1 N HCl media. Hence the quantity of enteric coating was increased to 8% w/w. In vitro analysis of the developed tablets was carried out. Results from disintegration time and dissolution rate studies indicate that all the esomeprazole enteric tablets prepared possess good integrity, desirable for enteric coated tablets. Among the polymers studied, the methacrylic polymers exhibited better dissolution rate than the cellulose polymers. Stability studies indicate that the prepared formulations were stable for a period of three months. This study concluded that enteric coated tablets of esomeprazole can be prepared using any of the enteric coating polymer studied using a minimal weight gain of 8%.
机译：本研究是试图配制和评估艾索美拉唑三水合镁的肠溶片。制备了不同的片芯，并基于崩解时间选择制剂（F-1）用于进一步的肠溶衣。使用opadry®施加密封涂层，以使重量增加3％。使用不同的聚合物（例如Eudragit L-30 D-55，羟丙基甲基纤维素邻苯二甲酸酯，乙酸纤维素邻苯二甲酸酯和Acryl-EZE®）进行肠溶衣，以实现5％的增重。崩解研究表明，该制剂在0.1 N HCl介质中失效。因此，肠溶衣的量增加到8％w / w。对开发的片剂进行了体外分析。崩解时间和溶出度研究的结果表明，所有制备的埃索美拉唑肠溶片均具有良好的完整性，这对于肠溶衣片是理想的。在研究的聚合物中，甲基丙烯酸聚合物的溶解速率比纤维素聚合物好。稳定性研究表明，所制备的制剂在三个月内稳定。这项研究得出的结论是，埃索美拉唑的肠溶衣片可以使用任何研究的肠溶衣聚合物制备，其最小增重为8％。

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