Comparative Assessment of Critical Quality Attributes of Sildenafil Tablets

IF 1 4区医学 Q4 PHARMACOLOGY & PHARMACY Dissolution Technologies Pub Date : 2021-01-01 DOI:10.14227/DT280121PGC1

Marta I. V. Brevedan, M. A. Varillas, N. L. G. Vidal

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Abstract

Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence. Eight commercial formulations (immediate-release tablets) containing 50 mg of sildenafil were analyzed according to United States and Argentinian Pharmacopoeial guidelines. The assay was performed by UV spectrophotometry in 0.01 N hydrochloric acid. Similar conditions were used for dissolution tests, which were carried out in a basket apparatus at 100 rpm. All samples met pharmacopeial specifications for acceptance (i.e., assay, content uniformity, hardness, friability, disintegration, and in vitro dissolution) for immediate-release dosage forms. When compared to the reference formulation, a statistically significant difference was noted for dissolution efficiency in one case (sample F). Based on the obtained results, it is possible to conclude that the evaluated formulations of sildenafil can be considered pharmaceutical equivalents.

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西地那非片关键质量属性的比较评价

柠檬酸西地那非是5型磷酸二酯酶的选择性抑制剂，用于治疗成人勃起功能障碍和肺动脉高压，主要用于儿童。本研究旨在对在阿根廷销售的西地那非片剂进行比较研究，并建立其药物等效性。根据美国和阿根廷药典指南分析了含有50毫克西地那非的8种商业制剂(速释片)。在0.01 N盐酸中采用紫外分光光度法测定。类似的条件用于溶解试验，这是在一个篮子装置中进行，转速为100 rpm。所有样品均符合药典规定的立即释放剂型验收标准(即测定、含量均匀性、硬度、脆性、崩解性和体外溶出度)。与参考制剂相比，有一个病例(样品F)的溶出效率有统计学显著差异。根据获得的结果，可以得出结论，所评估的西地那非制剂可以被认为是等效药物。

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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.