R Sailaja, G Tejasri, K Amrutha Reddy and Jagadeesh Panda
Background: The aim of this study was to evaluate the pharmaceutical equivalence of different brands of Domperidone tablets available in local pharmacies of Visakhapatnam, Andhra Pradesh, India, and study their kinetics models.
Methods: Two different brands of Domperidone tablets were purchased from different pharmacies in Visakhapatnam. The quality control parameters of Domperidone tablets were evaluated for weight variation, friability, hardness, wetting time, disintegration, assay, and dissolution test. 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 (Zero order and first order).
Results: The results of assay, weight variation, friability, hardness, disintegration tests and dissolution of tablets 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 have good pharmacokinetics and bioequivalence.
Conclusion: This study revealed that all the Domperidone brands met the quality specifications of the tests performed. The study also indicated a similarity in the dissolution profile of the brands of Domperidone tablets. The pharmaceutical bioequivalence of Domperidone tablets has met their needed specifications.
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