POST-MARKET SURVEILLANCE STUDY OF OSVERAL, A BRANDED GENERIC FORMULATION OF DEFERASIROX, AND THE ORIGINAL BRAND, EXJADE

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EBRAHIMNEJAD PEDRAM; SALEHIFAR EBRAHIM; KOSARYAN MEHRNOUSH

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Journal: JOURNAL OF MAZANDARAN UNIVERSITY OF MEDICAL SCIENCES Year:2016 | Volume:26 | Issue:142 Page(s): 238-244

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Title

POST-MARKET SURVEILLANCE STUDY OF OSVERAL, A BRANDED GENERIC FORMULATION OF DEFERASIROX, AND THE ORIGINAL BRAND, EXJADE

Author(s)

EBRAHIMNEJAD PEDRAM | SALEHIFAR EBRAHIM | KOSARYAN MEHRNOUSH | Issue Writer Certificate

Keywords

DEFERASIROXQ2

THALASSEMIAQ3

OSVERALQ1

EXJADEQ1

POSTMARKETINGQ1

DRUG SURVEILLANCEQ1

Abstract

Background and purpose: EXJADEÒ 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, OSVERALÒ, 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 (ExjadeÒ) were compared with the same doses of OSVERALÒ. 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 37oC) 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 OSVERALÒ were similar to those of EXJADEÒ. 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: OSVERALÒ is a reliable branded generic formulation of DEFERASIROX for treatment of chronic iron overload states.

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APA: Copy

EBRAHIMNEJAD, PEDRAM, SALEHIFAR, EBRAHIM, & KOSARYAN, MEHRNOUSH. (2016). POST-MARKET SURVEILLANCE STUDY OF OSVERAL, A BRANDED GENERIC FORMULATION OF DEFERASIROX, AND THE ORIGINAL BRAND, EXJADE. JOURNAL OF MAZANDARAN UNIVERSITY OF MEDICAL SCIENCES, 26(142), 238-244. SID. https://sid.ir/paper/45944/en

Vancouver: Copy

EBRAHIMNEJAD PEDRAM, SALEHIFAR EBRAHIM, KOSARYAN MEHRNOUSH. POST-MARKET SURVEILLANCE STUDY OF OSVERAL, A BRANDED GENERIC FORMULATION OF DEFERASIROX, AND THE ORIGINAL BRAND, EXJADE. JOURNAL OF MAZANDARAN UNIVERSITY OF MEDICAL SCIENCES[Internet]. 2016;26(142):238-244. Available from: https://sid.ir/paper/45944/en

IEEE: Copy

PEDRAM EBRAHIMNEJAD, EBRAHIM SALEHIFAR, and MEHRNOUSH KOSARYAN, “POST-MARKET SURVEILLANCE STUDY OF OSVERAL, A BRANDED GENERIC FORMULATION OF DEFERASIROX, AND THE ORIGINAL BRAND, EXJADE,” JOURNAL OF MAZANDARAN UNIVERSITY OF MEDICAL SCIENCES, vol. 26, no. 142, pp. 238–244, 2016, [Online]. Available: https://sid.ir/paper/45944/en

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