格列吡嗪-盐酸二甲双胍聚合物双层基质片的研制及评价

Lakshmana Prabu S
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引用次数: 0

摘要

以HPMC K4M和Eudragit L-100为聚合物基质制备格列吡嗪和盐酸二甲双胍双层片。格列吡嗪和盐酸二甲双胍是一线抗糖尿病药物。采用湿造粒法,以不同比例的HPMC K4M与乌龙茶L-100配制成片剂,考察其理化性质、体外释放特性及稳定性。制备的颗粒理化性能在限定范围内,其硬度、脆度、含量均匀度均在5.1±0.1 ~ 5.9±0.3之间;0.21±0.02和0.49±0.02%;w/w分别为98.99±1.06和100.45±0.52 %。在pH为6.8的磷酸盐缓冲液中,体外释放时间为12小时,并与市场配方进行了比较。盐酸二甲双胍的溶出度与市售制剂相当,差异因子f1和相似因子f2分别为3.75和79.46;格列吡嗪分别为8.74和65.78。根据ICH指南进行了稳定性研究,并对其物理化学性质和体外释放研究进行了测试。稳定性研究结果表明,所制制剂是稳定的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation and Evaluation of Polymeric Bilayer Matrix Tablet Containing Glipizide and Metformin Hydrochloride
The objective of the present study was to develop Bilayer tablets of Glipizide and metformin hydrochloride from polymeric matrices of HPMC K4M and Eudragit L-100. Drugs Glipizide and metformin hydrochloride are frontline anti-diabetic drugs prescribed in combination. Tablets were prepared by wet granulation method using different ratios of HPMC K4M and Eudragit L-100 and evaluated for its physicochemical properties, in vitro release profile and stability studies. The prepared granules physiochemical property results were within the limits and the formulated tablets hardness, friability and content uniformity was found to be between 5.1±0.1 and 5.9±0.3; 0.21 ±0.02 and 0.49±0.02%; 98.99 ±1.06 and 100.45±0.52 %w/w respectively. The invitro release was found to be observed for 12 hours in phosphate buffer pH 6.8 and compared with market formulation. The dissolution release of formulation was comparable with market formulation and the difference factor and similarity factor f1 and f2 were found to be 3.75 and 79.46 for metformin hydrochloride; 8.74 and 65.78 for glipizide respectively. Stability studies were carried out as per ICH guidelines and tested for its physicochemical properties and in vitro release studies. The stability study result reveals that the prepared formulation was stable.
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