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首页> 外文期刊>American journal of applied sciences >Quality evaluation of Ketoprofen Solid Dosage Forms Available in the Pharma-Market of Bangladesh | Science Publications
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Quality evaluation of Ketoprofen Solid Dosage Forms Available in the Pharma-Market of Bangladesh | Science Publications

机译：孟加拉国药品市场上的酮洛芬固体剂型的质量评估| Business Wire科学出版物

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> Problem statement: Ketoprofen, a widely used analgesic and anti-inflammatory drug, was available in two types of solid dosage forms in the pharma-market of Bangladesh: enteric-coated tablet and capsule of sustained-release pattern. Seven brands of ketoprofen enteric-coated tablets and four brands of ketoprofen sustained release capsules were studied for their in-vitro release behavior as well as potency status. Approach: The studies were carried out to compare with standard sample of ketoprofen sustained-release pellets and that of ketoprofen powder. To determine the release pattern of the preparations, disintegration study and dissolution tests were performed as per the method described in standard pharmacopeial compendia (British Pharmacopoeia or BP and United State Pharmacopoeia or USP respectively). The potency of the samples were determined by the UV spectroscopic method as described in BP. Results: Out of seven samples of tablets, two brands (KT-03 and KT-07) were found noncompliant in respect of disintegration test in acid stage whereas rest of the brands complied with BP specification in buffer stage at pH 6.8. The dissolution study of ketoprofen tablets were carried out in both acid and buffer stages and all the samples satisfied with USP specification in both stages. All of the brands of ketoprofen capsule also complied with the USP specification. Two brands (KT-03 and KT-07) of tablets were found non-compliant whereas rest brands of tablets and all brands of capsules exerted compliance in respect of potency. Conclusion: This study will provide a basis for further in-vivo bioavailability studies of these brands to draw a more conclusive remark regarding quality status of these samples.
机译： > 问题陈述：酮洛芬是一种广泛使用的镇痛和抗炎药，在孟加拉国的药品市场上有两种固体剂型可供选择：肠溶片和胶囊的持续释放模式。研究了七个品牌的酮洛芬肠溶片和四个品牌的酮洛芬缓释胶囊的体外释放行为以及药效状态。 方法：进行了研究，以与酮洛芬缓释微丸和酮洛芬散剂的标准样品进行比较。为了确定制剂的释放方式，按照标准药典（分别为英国药典或BP和美国药典或USP）中描述的方法进行崩解研究和溶出度试验。如BP所述，通过UV光谱法测定样品的效力。 结果：在七个药片样品中，发现两个品牌（KT-03和KT-07）在酸性阶段的崩解试验不合格，而其余品牌在缓冲阶段符合BP规范在pH 6.8下。酮洛芬片剂的溶出度研究在酸阶段和缓冲阶段均进行，所有样品均在两个阶段均符合USP规范。所有酮洛芬胶囊品牌均符合USP规范。发现两个品牌的片剂（KT-03和KT-07）不合规，而其余品牌的片剂和所有品牌的胶囊在效价方面均合规。 结论：该研究将为进一步研究这些品牌的体内生物利用度提供依据，以就这些样品的质量状况做出更结论性的说明。

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