Abstract

PHARMACEUTICAL QUALITY EVALUATION OF CEFUROXIME AXETIL TABLETS AVAILABLE IN DRUG MARKET OF BANGLADESH

*Farzana Hasin, Md. Mofazzal Hossain, Milon Kumar Ghosh, Samir Paul, Mahfujur Rahman and Md. Forhad Ahmad

ABSTRACT

The purpose of this Post-Marketing Pharmaceutical Quality Evaluation of Cefuroxime Axetil 500 mg tablets to evaluate the quality standards of different marketed brands with various price ranges, collected from retail drug stores of Bangladesh. The brands were tested for physicochemical evaluation and in-vitro dissolution studies as per US FDA dissolution database recommendation (The dissolution profiles showed release of drug at 10, 15, 30, 45 and 60 minutes time point, Apparatus 2 at 100 revolutions per minute, 0.07 NHCl media at volume900 ml) and model independent (difference f1, similarity f2) concepts were applied to different dissolution profile of all brands. From research results it is established that collected Cefuroxime brands of Bangladesh market found similar in physicochemical quality parameters like same active ingredient(s) with identical in strength or concentration, same dosage form as well as same route of administration with reference innovator and meet the exact compendial quality standard. Other quality parameters of these Cefuroxime tablets like thickness, length, hardness, disintegration time, weight variation were also evaluated properly and the test results were found within the compendial limit. Besides the in-vitro dissolution analysis indicated that these collected brands are considered Pharmaceutical equivalents in compared to innovators according to FDA Orange Book. According to FDA classification, and based on this research results it is suggested that Pharmaceutical Equivalents could be considered as Therapeutic Equivalents. So all collected Cefuroxime Axetil brands can be considered as Pharmaceutical Equivalents to Innovator drug, and also could be prescribed by physicians to patients as the Therapeutic Equivalents for Innovator drug in-case of high price or unavailability of Innovator drugs.

Keywords: Pharmaceutical Quality Evaluation, In-vitro Dissolution Study, Physicochemical Parameter.