以HPMC为缓释剂的格列美脲与芒果胶配速释层与盐酸二甲双胍缓释层双层片的研制及评价

S. Hemalatha, P. Srikanth, G. Sai
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引用次数: 0

摘要

本研究以芒果胶(MIG)和HPMC为缓释层聚合物,设计并制备格列美脲-二甲双胍双层片剂。格列美脲和二甲双胍是一种降低血糖水平的口服降糖药,已被选择制成双层片。采用MIG湿造粒法制备格列美脲速释层,采用HPMC干造粒法制备二甲双胍缓释层。对制备的双层片进行了厚度、直径、重量变化、硬度、脆性、崩解度和体外释放度等参数的评价。所制片剂表面光滑,质构美观。片剂质量范围为540±0.551 mg。片剂厚度范围为4±0.05mm。药物含量均匀性研究表明,在97.16±0.50%范围内,药物在整个制剂中分散均匀。硬度范围为4.0±0.5 kg/cm2,脆性范围为0.67±0.06%。通过零阶、一阶、Higuchi和peppas方程对数据进行处理,对双层片进行模型拟合分析,了解其缓释顺序和释药机理。制备的糖苷酸双层片与上市的糖苷酸双层片的生物等效性研究表明,红外层的相似系数为70.120,SR层的相似系数为57.689。
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Formulation and Evaluation of Bilayered Tablets Containing Immediate Release Layer of Glimepiride Complexed with Mangifera indica Gum and Sustained Release Layer Containing Metformin HCL by Using HPMC as Release Retardant
In present investigation an attempt has been made to design and develop the Bilayered tablet of Glimepiride and Metformin using Mangifera Indica Gum (MIG) and HPMC as Immediate Release and Sustained Release Layer polymers. Glimepiride and Metformin are oral-hypoglycaemic drugs which lower blood glucose level and have been selected to prepare Bilayered tablets. Glimepiride immediate release layer was prepared using MIG by wet granulation technique and Metformin sustained release layer was prepared using HPMC by dry granulation technique. Prepared Bilayered tablets were evaluated for parameters like thickness, diameter, weight variation, hardness, friability, disintegration and in-vitro release studies. All the prepared tablets were of smooth surface and elegant texture. The weights of the tablets were in the range of 540±0.551 mg. The thicknesses of the tablet were in the range of 4±0.05mm. The drug content uniformity study showed uniform dispersion of drug throughout the formulation in the range of 97.16±0.50%. The hardness was in the range of 4.0±0.5 kg/cm2 and friability is in the range of 0.67±0.06%. The bilayered tablets were also subjected to model fitting analysis to know the order and mechanism of drug release from the formulation by treating the data according to zeroorder, first-order, Higuchi and peppas equations.The bioequivalence studies conducted between prepared and marketed (Glycomate) bilayered tablet showed the similarity factor value of 70.120 for IR layer and 57.689 for SR layer.
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