IN VITRO BIOEQUIVALENCE STUDY OF OFLOXACIN GENERIC AND INNOVATOR BRAND

RATNAPURI, PRIMA HAPPY IN VITRO BIOEQUIVALENCE STUDY OF OFLOXACIN GENERIC AND INNOVATOR BRAND. IN VITRO BIOEQUIVALENCE STUDY OF OFLOXACIN GENERIC AND INNOVATOR BRAND.

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Official URL: http://farmasi.unpad.ac.id/ispst2016/

Abstract

Bioequivalence studies are the commonly accepted methods describing therapeutic equivalence between two products. Brands are available in the market at significant price differences. The aim of present study was to compare the dissolution profiles between Ofloxacin (200 mg) tablets and innovator brand. Two brands of Ofloxacin 200 mg tablets have been evaluated using several quality control parameters, such as weight variation, friability, hardness, disintegration and dissolution test. Dissolution profiles were compared through three model independent methods: difference factor (f1), similarity factor (f2) and efficiency dissolution. All the tested brands released more than 80% drug in 30 minutes and met the requirement of the official specifications for uniformity of weight, friability, hardness and disintegration time. Based on f1 and f2, the results indicated that generic product could be used as substitute for the innovator product. Keywords : Ofloxacin, Bioequivalence, In vitro, Dissolution profile

Item Type: Article
Subjects: Q Science > QH Natural history > QH301 Biology
Depositing User: Mr Arief Mirathan - Eka Setya Wijaya
Date Deposited: 06 Dec 2016 07:14
Last Modified: 17 Mar 2017 02:54
URI: http://eprints.unlam.ac.id/id/eprint/1408

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