PHARMACEUTICAL EVALUATION OF DIFFERENT BRANDS OF LEVOFLOXACIN TABLETS (500MG) AVAILABLE IN PAKISTAN

This investigation has been conducted to evaluate the quality of commonly prescribed flouroquinolones antibiotic, Levofloxacin tablets and examine the possibility of biopharmaceutical classification system biowaiver. As Levofloxacin is important antibiotic for resistant bacteria and price fluctuation of Levofloxacin tablet brands in a Pakistani community were analyzed .The possibility of biowaiver on brand level was also examined. Ten generic brands and the innovator brand were compared on friability, hardness, disintegration and dissolution. In vitro testing shows less variation in case of hardness, disintegration. In vitro dissolution testing was carried out in three different Medias including 0.1 N HCl, PH 4.5 acetate buffer and PH 6.8 phosphate buffer while the samples were taken after every 5 min for up to 30 min. Ten brands of Levofloxacin (500 mg) and 6 dosage units of each brand were randomly selected for study. A total of about 1000 dissolution tests were performed. And all the samples were analyzed by a validated UV spectrophotometer at 293 nm wave length. The dissolution test results obtained were recorded and graphs were prepared for comparison. The dissolution data obtained revealed that though the brands of Levofloxacin tablet manufactured in Pakistan have met the minimum pharmacopoeial requirements but still efforts are certainly further needed to get close to the innovator brand and to meet the requisite criteria for getting the biowaiver status as different brands showed variable results in different dissolution medias. The significance of the observed in vitro differences may be further evaluated and confirmed by in vivo bioequivalence studies.