نظارت بعد از ورود به بازار داروی اسورال، یک فرمولاسیون تجاری از داروی دفرازیروکس با داروی مرجع Exjade®

Background and purpose: Exjade® is developed by Novartis pharmaceutical company and contains the active substance deferasirox, an orally active iron chelator for treatment of chronic iron overload following blood transfusions such as beta thalassemia. The aim of this study was to compare the physicochemical characteristics of branded generic product of deferasirox, Osveral®, produced by Osveh pharmaceutical company (in Iran) with the original brand. Materials and methods: Three doses (125, 250 and 500 mg) of deferasirox reference tablets (Exjade®) were compared with the same doses of Osveral®. Three batches of each product were randomly selected and physicochemical evaluations including appearance, disintegration time, hardness, assay, in vitro drug release and content uniformity were determined. Also, the similarity factor was calculated based on ICH (International Conference Harmonization) and Food and Drug Administration (FDA) guidelines. The drug entrapped in the tablets was determined by HPLC. The dissolution rates were measured in solution media (phosphate buffered and sodium Lauryl sulfate at 37 ºC) within 30 min by USP apparatus II (Paddle) at 50 RPM speed after 5, 10, 20 and 30 min intervals. Results: The results indicated that physicochemical properties of Osveral® were similar to those of Exjade®. Disintegration time for both products was less than 1 min and drug assay was between 90 – 110%. In addition, the similarity factor was more than 50% for all doses. Conclusion: Osveral® is a reliable branded generic formulation of deferasirox for treatment of chronic iron overload states.