Quality evaluation of Ketoprofen Solid Dosage Forms Available in the Pharma-Market of Bangladesh

Abstract

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.