COMPARATIVE IN VITRO QUALITY ASSESSMENT OF DIFFERENT BRANDS

ABSTRACT

INTRODUCTION: The safety and efficacy of pharmaceutical products can be guaranteed when their quality is reliable and reproducible from batch to batch. To ensure the requisite quality of drug, manufacturers are required to test their products during and after manufacturing at their various intervals during the shelf life of their products. The aim of this study is to assess the quality and compare the physiochemical equivalence of fifteen (15) different brands of Metformin Hydrochloride tablets marketed by registered pharmacies in Benin city, Edo state , Nigeria METHODOLOGY : Fifteen (15) different brands of metformin hydrochloride were purchased from registered pharmaceutical outlets in Benin City, Edo State and they were subjected to preliminary examination of their organoleptic properties such as colour ,shape and the presence or absence of surface coating as well as the manufacturers’ label information. Physiochemical evaluations such as weight uniformity, content uniformity, hardness, friability, disintegration and dissolution tests were carried out in accordance with the recommended specifications of the British and United States Pharmacopoeia. RESULTS AND DISCUSSION: The fifteen brands of Metformin Hydrochloride tablets employed in the study were found to be within the recommended shelf life periods. They were all duly registered by the National Agency for Food and Drug Administration and Control (NAFDAC). Their Organoleptic properties indicated that there were no signs of spoilage and decoration . All fifteen brands passed the tests for Uniformity of weight, content and percentage friability. Met 7, Met 10, Met 11, Met 14 failed the hardness test as they did not break even upon maximum load of 15kpa. However Met 10, Met 11 and Met 14 passed the tests for disintegration suggesting that a super-disintegrant may have been incorporated into the formula. All other brands well found to have a disintegration time of between 8 to 12 mins which is in accordance with the British Pharmacopoeia and United State specification for the disintegration time for conventional tablets, however, Met 4 and Met 7 did not disintegrate even after a test period of 45mins. CONCLUSION: it can be concluded from the study that current available brands of Metformin Hydrochloride tablets obtainable in registered pharmaceutical outlets in Benin City, meets the quality control and quality assurance standards and can be considered safe for generic prescription and /or substitution