In vitro - In vivo Correlation (IVIVC) of Immediate Release (IR) Levofloxacin Tablet

Abstract

The aim of this study was to examine the in vitro - in vivo correlation (IVIVC) of two immediate
release formulations of levofloxacin 250 mg film coated tablet. In vitro release data were obtained for each
formulation by using the USP apparatus II, in 0.1N HCl of pH 2.0. Twelve healthy subjects were randomly chosen
for in vivo study. Blood samples were collected over 24 hour period and analyzed by validated HPLC method with
UV detection to establish a correlation between in vitro release and in vivo absorption. f2 and f1 were determined for
the time intervals of 5, 10, 15, 20, 25, 30, 45 and 60 minutes and the obtained values were 65.72, 77.38, 61.93, 53.75,
55.36, 58.59, 60.23 and 61.16 percent for f2 and 11.00, 4.35, 8.30, 12.15, 5.59, 1.82, 0.06 and 0.11 percent for f1 at
respective time intervals. Mean dissolution times (MDT) for local and reference products were obtained at 7.69 and
9.55 minutes respectively. The values of mean absorption time (MAT) were obtained at 8.27 and 27.96 minutes for
local and reference products respectively. For in vitro and in vivo correlation, level A type was also done for both
products. In case of level A correlation, a non linear type of relation was established which is typical for immediate
release formulations.