12th International Conference of Pharmaceutical Sciences

The aim of this study was establish an in vitro-in vivo correlations using computer simulations and selected the best in vitro release methodology for nimesulide oral suspensions (1). The dissolution behavior of the nimesulide powder were measured in different media: water, pH 6.8, 7.4, 0.5 and 1% sodium lauryl sulfate, 1 and 2% polysorbate 80, both in aqueous solution, pH 6.8 and 7.4. The USP apparatus 2 was used with rotation speed of 50, 75 and 100 rpm (2). Bioavailability data were extracted using Web Plot Digitizer and with the PKPlusTM module, selected a compartmental pharmacokinetic model (3). The 2% polysorbate 80 aqueous solution showed significant differences between the nimesulide powder varying particle size and recristalization process. Formulations A, B, C and D showed a correlation coefficients of 0.954, 0.927, 0.913 and 0.879, respectively. Indicating the method as a surrogate for human bioequivalence studies of the nimesulide oral suspension formulation.