盐酸维拉帕米基质片的处方及体外生物等效性评价

I. Bashir, A. Sethi, M. Zaman, Junaid Qureshi, R. M. Sarfraz, Asif Mahmood, M. Sajid, Talha Jamshaid, M. Akram
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引用次数: 4

摘要

采用天然聚合物制备盐酸维拉帕米(VH)缓释片,并与国内知名品牌Searle Pharmaceuticals的Calan SR进行比较。采用不同浓度的黄芪胶和果胶。预压缩研究,即休止角,体积密度,抽头密度,卡尔压缩指数和豪斯纳比也进行了并发现在药典限制内。采用直接压缩法制备了(VH)的8个配方(f1 ~ f8)。压缩后的研究,即厚度,硬度,直径,脆性和溶解研究进行。采用零阶、一阶、Highuchi模型和Korsmeyer Peppas模型研究了不同的释放模式,并计算了相似指数。在pH为6.8的磷酸盐缓冲液中进行溶出研究表明,聚合物浓度越高的配方(F4和F8)缓药效果越好。F5与参考产品最具可比性。按照Higuchi模型观察盐酸维拉帕米释放量呈非粘性扩散。
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 in-vitro bioequivalence evaluation of verapamil hydrochloride matrix tablets with Calan R
The purpose of the current work was to formulate Verapamil Hydrochloride (VH) sustained release matrix tablets by using natural polymers and comparison with leading national brand Calan SR of Searle Pharmaceuticals. Tragacanth and pectin were used in various concentrations. Pre compression studies i.e. angle of repose, bulk density, tapped density, Carr’s compressibility index and Hausner’s ratio were also performed and found within the Pharmacopoeial limits. Eight formulations (F1-F8) of (VH) were prepared by direct compression method. Post compression studies i.e. Thickness, Hardness, Diameter, Friability and Dissolution studies were conducted. Different kinetic models i.e. zero order, first order, Highuchi model and Korsmeyer Peppas were applied to study release patterns and similarity index was calculated. Dissolution studies were carried out in phosphate buffer of pH 6.8 showed that formulations (F4 and F8) formulated with higher polymers concentration showed comparatively better drug retardation. F5 was the most comparable with the reference product. Verapamil hydrochloride released was observed non-fickian as diffusion following Higuchi model.
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