盐酸二甲双胍与辛伐他汀缓释片配方设计与表征

S. Dhobale, Sayali Nilakh, S. Jadhav
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摘要

本研究的目的是开发药物组合剂型,用于同时治疗伴有冠心病相关合并症高风险的2型糖尿病患者。降糖药物二甲双胍用于治疗糖尿病患者,与HMG-CoA还原酶抑制剂辛伐他汀联合治疗高危冠心病。在该配方中,采用直接压缩法制备了三批。预处方参数,如鉴定、溶解度、熔点、相容性研究;预压缩参数,如堆积密度、抽头密度、休止角、豪斯纳比、可压缩性指数;后压缩参数,如重量均匀性、硬度、药物含量、厚度、体外药物释放。所有制剂B1、B2和B3在0.1N HCl中体外释放2h,在磷酸盐缓冲液(pH 6.8)溶出介质中体外释放10h。其中,B3为最佳配方。B3制剂在12小时内,盐酸二甲双胍的药物释放率为85%,辛伐他汀的药物释放率为93%。©2022全球研究与出版基金会。版权所有。
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Design and Characterization of Sustained Release Tablet Formulation Containing Metformin Hydrochloride and Simvastatin
The aim of the present work was to develop pharmaceutical combinational dosage form for simultaneous treatment of patients with type 2 diabetes with at high-risk of coronary disease associated co-morbidities. Metformin, an antidiabetic drug is used to treat the diabetic patient and combined with Simvastatin which is HMG-CoA reductase inihibitor drug to treat the high-risk coronary disease simultaneously. In this formulation, three batches were prepared by the direct compression method. Preformulation parameters such as identification, solubility, melting point, compatibility studies, Pre-compression parameters such as bulk density, tapped density, angle of repose, Hausner ratio, compressibility index, and Post-compression parameters like weight uniformity, hardness, drug content, thickness, in-vitrodrug release. In-vitrodrug release of all formulations, B1, B2, and B3 was carried out in 0.1N HCl for 2hrs and 10 hrs in phosphate buffer (pH 6.8) dissolution media. Among all the formulations, B3 was an optimized batch. B3 formulations showed drug release of 85% for Metformin Hydrochloride and 93% for Simvastatin over a period of 12hrs.©2022iGlobal Research and PublishingFoundation. All rights reserved.
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