Tanzania
Research Article
Capecitabine: An In-vitro Comparison between the Branded Xeloda® 500 Mg and its Intended Copy Capeda 500 Mg
Author(s): Mubarak Nasser AlAmeri, Simon Abi Aad, Arthur Tucker and Atholl JohnstonMubarak Nasser AlAmeri, Simon Abi Aad, Arthur Tucker and Atholl Johnston
Introduction: Dissolution is an example of in-vitro test which can be used to identify formulations that may present potential bioequivalence problems. It is defined as the amount of substance that goes into solution per unit time under standardised conditions of liquid/solid interface, solvent composition and temperature. It is considered one of the most important tools to predict the in-vivo bioavailability and in some cases replacing clinical studies to determine bioequivalence. Aim: To compare the differences in the dissolution behaviour between two anticancer formulations, Xeloda® 500 mg (reference product) and Capeda 500 mg (test product). Methods: Four replicates for each batch of the tested medicines were carried out using a PT-DT70 dissolution tester (Pharma Test) to detect any differences in their dissolution behaviour. Samples at nine time intervals were tested accordin.. Read More»
DOI:
10.4172/2161-0444.1000125
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