Description:
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