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Determination of Microstructural Impact on the Release of Drug from Hydroxypropyl Cellulose Gel by Validated In Vitro Release Test Method
ASSAY and Drug Development Technologies ( IF 1.6 ) Pub Date : 2021-12-08 , DOI: 10.1089/adt.2021.078
Sharda Gurram 1 , Devanshi S Shah 1 , Durgesh K Jha 1 , Purnima D Amin 1
Affiliation  

Microstructure of a semisolid system is greatly influenced by the formulation composition and the processing parameters. Different polymers exhibit different three-dimensional structure and these have a great impact on the drug release properties. The current research focuses on studying the impact of hydroxypropyl cellulose gel microstructure on the release properties of chlorhexidine gluconate (CHX G). The two main investigating methods of microstructure were used namely, rheology and texture analysis to determine the differences in the formulations studied. The CHX G drug release study was performed using a developed and validated in vitro release test method, which is reproducible, discriminative, and robust to detect the formulation differences. The drug release results showed that there was appreciable difference in the release rates of the different formulations. The rheology and texture analysis data correlated well with the difference in the release rates. The formulations differences were further confirmed by a statistical approach using analysis of variance.

中文翻译:

通过验证的体外释放测试方法测定微观结构对羟丙基纤维素凝胶中药物释放的影响

半固体体系的微观结构很大程度上受配方组成和加工参数的影响。不同的聚合物表现出不同的三维结构,这些对药物释放性能有很大的影响。目前的研究重点是研究羟丙基纤维素凝胶微观结构对葡萄糖酸氯己定(CHX G)释放性能的影响。使用了两种主要的微观结构研究方法,即流变学和织构分析来确定所研究配方的差异。CHX G 药物释放研究是使用开发和验证的体外释放测试方法,该方法具有可重复性、鉴别性和鲁棒性,可检测配方差异。药物释放结果表明,不同制剂的释放速率存在明显差异。流变学和质地分析数据与释放速率的差异有很好的相关性。通过使用方差分析的统计方法进一步证实了制剂的差异。
更新日期:2021-12-10
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