Abstract

The objective of the study was to develop and validate the in vitro in vivo correlation models of Ondansetron hydrochloride sustained release tablet. In-vitro test was examined by using the USP XXIII dissolution apparatus (type II, paddle) at 50 and 75 rpm and media used was pH 1.2, 4.5, 5.5, 6.8 and 7.2 buffers. The f2 similarity factor was used to evaluate the In vitro data. Three-way crossover bioavailability study was conducted in six healthy subjects. Pharmacokinetic data were calculated by using non compartment model. The best discrimination was achieved at pH 4.5 buffer at 50 rpm therefore selected as the choice of medium. The formulations were compared using time to reach peak plasma concentration and area under the plasma concentration–time curve while correlation was determined between in-vitro release and in-vivo absorption. An average prediction error for (peak plasma concentration) Cmax was 8.70% and -7.91% for fast and slow release formulation whereas for (area under the plasma concentration curve) AUC it was 9.27% and 8.44% for fast and slow release formulation. The low prediction error of Cmax and AUC shows that IVIVC (in vitro in vivo correlation) model is valid. This study point towards that developed dissolution tests can be used as a surrogate for bioequivalence studies, process development for final products, to ensure batch to batch bioequivalence.