Assessment of Drug Release Kinetics and Quality of Naproxen Generic Tablets in Bangladesh

IF 1 4区医学 Q4 PHARMACOLOGY & PHARMACY

Dissolution Technologies Pub Date : 2021-01-01 DOI:10.14227/DT280221P30

Madhabi Lata Shuma, Amrin Jahan, S. Halder

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Abstract

The present study aimed to compare the in vitro equivalence of different generic tablets of naproxen available with the reference brand in the Bangladesh pharmaceutical market. As naproxen belongs to the biopharmaceutics classification system (BCS) class-II drug, interchangeability among commercial products must be demonstrated through in vivo bioequivalence studies. However, in Bangladesh, such studies remain to be performed. An in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and the dissolution profiles of the generic products were compared with the reference brand. Quality assessment parameters including hardness, friability, and disintegration time were also evaluated. Similar dissolution behavior was found with the reference brand using a modeldependent and model-independent approach (f2 > 50, f1 < 15), and there were no statistically significant differences. The best-fit kinetic model was the Korsmeyer-Peppas model, indicating that the mechanism of dissolution is predominantly diffusion. All commercial products complied with the official specifications. The results from this study suggest that the naproxen formulations available in the Bangladesh market could be used interchangeably for optimal therapeutic outcomes.

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萘普生仿制片在孟加拉国的药物释放动力学及质量评价

本研究旨在比较孟加拉国药品市场上不同的萘普生仿制片与参考品牌的体外等效性。由于萘普生属于生物制药分类系统(BCS) ii类药物，必须通过体内生物等效性研究来证明商业产品之间的互换性。但是，在孟加拉国，这类研究仍有待进行。采用美国药典(USP)桨片法进行体外溶出度研究，并将仿制药与参比药的溶出度进行比较。质量评价参数包括硬度、脆性和崩解时间。采用模型依赖和模型独立的方法，参考品牌也发现了类似的溶解行为(f2 bbb50, f1 < 15)，没有统计学上的显著差异。最适合的动力学模型是Korsmeyer-Peppas模型，表明溶解机制以扩散为主。所有商用产品均符合官方规格。这项研究的结果表明，孟加拉国市场上可获得的萘普生配方可以互换使用，以获得最佳的治疗效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Dissolution Technologies 医学-药学

CiteScore

1.20

自引率

33.30%

发文量

审稿时长

3 months

期刊介绍： Dissolution Technologies is a peer reviewed quarterly publication reporting ongoing, useful information on dissolution testing of pharmaceuticals. It provides an international forum for dissolution analysts to receive and exchange information on various dissolution topics. Dissolution Technologies welcomes submissions related to dissolution, in vitro release, and disintegration testing. These topics should be the major focus of the article. Do not submit articles where the focus is formulation development with dissolution testing as one of many tests.