A comparative study on the dissolution profiles and Equivalent assessment of some the generics of Aceclofenac tablets available in Lagos Nigeria
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Abstract
The dissolution behavior of a reference standard brand and four generic equivalent brands of Aceclofenac tablets purchased from the Lagos metropolis was compared in this study. A variation of excipients is contained in the different formulations, influences of these on the release characteristics of the varying aceclofenac brands was evaluated in gastric pH (1.2), and intestinal pH (4.5 and 6.8). Physicochemical parameters such as hardness, disintegration, friability and content uniformity, were assessed in comparison with the reference standard brand coded RS-1. The studied formulations reflected a dissolution profile exhibiting variations in the release characteristics among the different brands. Only one of the generic brands had a > 80% of aceclofenac released within 60 minutes in SIF complying with the United States pharmacopeia in vitro dissolution specifications for drug release. The study showed that only one of the generic brands was similar to the reference standard brand f2 being 66 in SIF dissolution media, and can thus be used interchangeably with the reference standard brand, the other two brands had dissimilar dissolution patterns. There is the need for constant market vigilance to ensure that products marketed are similar to innovator products to facilitate ease of interchangeability by health care providers.
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