Abstract

Objective: To assess the in vitro-in vivo correlation of immediate release formulation of pioglitazone 30 mg film coated tablet. Methods: In vitro release data were obtained for test and reference formulation using the USP paddle method (Apparatus 2) at 50 r/min and with the temperature of 37 °C in the dissolution medium of 0.1 mol/L hydrochloric acid of pH 1.2. Twelve healthy volunteers were administered both test and reference pioglitazone 30 mg tablet orally and blood samples were collected over 24 h period. In vivo drug concentrations were analyzed by a simple, fast and precise reverse phase binary HPLC method with UV detection to establish a correlation between in vitro release and in vivo absorption data. Results: Similarity factor (f2) and dissimilarity factor (f1) were determined for the time intervals of 5, 10, 15, 30, 45, 60, 75, 90, 105 and 120 min and the obtained values were 65.17%, 59.37%, 63.62%, 66.61%, 68.89%, 70.73%, 72.27%, 73.59%, 74.65% and 75.67% for f2 and 9.43%, 9.00%, 5.42%, 3.86%, 3.07%, 2.56%, 2.20%, 1.94%, 1.82% and 1.65% for f1 at respective time intervals. Mean dissolution time for test and reference products were obtained at 3.06 and 3.40 min respectively. f2 and f1 values obtained were within the acceptable range f2 (50%-100%) and f1 (<15%). Conclusions: Comparison of dissolution profiles corroborate that the test and reference formulations are similar and there is no linear in vitro-in vivo correlation.

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