In vitro assessment of pharmaceutical equivalence and analysis of drug release kinetics of Domperidone 10mg tablets available in Bangladesh market

Background: The aim of this study was to evaluate the pharmaceutical equivalence of different brands of Domperidone tablets marketed in Bangladesh and study their release kinetics model. Methods: Five different brands of Domperidone tablets were purchased from different pharmacies from Dhaka, Bangladesh. The quality control parameters of domperidone tablets were determined by identification, weight variation, disintegration, assay and dissolution tests and the results were compared with USP and BP pharmacopoeia standards. Difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements. Finally, drug release kinetics were studied through model-dependent calculative methods. Results: The results of assay, weight variation and disintegration tests indicated that all samples complied with USP specification limits. The active pharmaceutical ingredients quantitative assay showed that all the brands of domperidone tablets were between the 95% and 105% limit of the label claim met the range of f1 (0-15) and f2 (>50). All brands best fitted in Korsmeyer-Peppas model indicating diffusion mediated release and also shown low AIC in Hixson-Crowell model assuming the release governed by velocity of dissolution. Conclusion: This study revealed that all the domperidone brands met the quality specification of weight variation, disintegration, assay and dissolution. The study also indicated similarity in the dissolution profile of the brands of domperidone tablets with the reference product. Hence, selected generic brands could be substituted with the reference product in clinical practice.