Volume 26, Issue 142 (11-2016)                   J Mazandaran Univ Med Sci 2016, 26(142): 238-244 | Back to browse issues page

XML Persian Abstract Print


Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:

Ebrahimnejad P, Salehifar E, Kowsaryan M. Post-market Surveillance Study of Osveral, a Branded Generic Formulation of Deferasirox, and the original brand, Exjade. J Mazandaran Univ Med Sci 2016; 26 (142) :238-244
URL: http://jmums.mazums.ac.ir/article-1-8821-en.html
Abstract:   (6297 Views)

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.

Full-Text [PDF 752 kb]   (2375 Downloads)    
Type of Study: Brief Report |

Add your comments about this article : Your username or Email:
CAPTCHA

Send email to the article author


Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

© 2024 CC BY-NC 4.0 | Journal of Mazandaran University of Medical Sciences

Designed & Developed by : Yektaweb