The effect of binders on the bioavailability of ofloxacin tablets in animal model.

Present study was undertaken to evaluate the effect of binders on the bioavailability of the drug. Two formulations of ofloxacin were manufactured with two different binders, i.e. gelatin and starch, which were analyzed by different in vitro tests such as dissolution test using USP apparatus II (paddle method) by using 0.1 M HCl solution. For in vivo studies, blood samples were collected through the heparinized syringe at zero time (before dosing) and at 0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0 hours after the dosing of ofloxacin tablets to 24 rabbits and analyzed by high performance liquid chromatography. Mobile phase consisted of distilled water, acetonitrile and triethylamine (700 : 300 : 1.4, v/v/v). The pH of the mobile phase was adjusted at 2.4 with orthophosphoric acid. The maximum plasma concentration attained after the administration of formulation 1 (containing gelatin) was 7.56 +/- 0.835 microg/mL (the mean +/- SEM) and of formulation 2 (containing starch) was 3.4417 +/- 1.16 microg/mL (the mean +/- SEM). There is also statistically significant difference between the volume of distribution and total body clearance of both formulations. Therefore, formulation 1 is more bioavailable than formulation 2. Thus it can be concluded that binder can affect the bioavailability and pharmacokinetics of a drug.