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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 2
First page : ( 532) Last page : ( 536)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00099.9

In Vitro Bioequivalence for three Products of Warfarin Sodium in Syrian Market

Naddour Roula Faek*, Kaddar Nisrin Ali

Department of Pharmaceutics, Faculty of Pharmacy, Tishreen University, Latakia, Syria

*Corresponding Author E-mail: roula.naddour@hotmail.com

Online published on 12 June, 2018.

Abstract

Three generic warfarin sodium 5mg tablets from different manufacturers had been evaluated to assess their bioequivalence in vitro. Other general quality assessments of these tablets like weight variation, content uniformity, hardness, friability and disintegration time were carried out and all these generic tablets passed these specification tests. To compare the dissolution profiles of all the tablet formulation withthe innovator brand, a model independent approach of difference factor (f1) and similarity factor (f2) was employed with all points included in the in vitro dissolution studies. These results showedthat all generic warfarin sodium tablets included in thisinvestigation were not bioequivalent with the chosen innovator brand, but two generic tablets were bioequivalent between each other.

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Keywords

Warfarin sodium, in vitro bioequivalence, dissolution profile, similarity factor, difference factor.

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