In vitro Evaluation of Food Effect on The Bioavailability of Nimesulide and Paracetamol from Fixed Dose Combination of Nimesulide and Paracetamol

Abstract

The present study was undertaken to evaluate the in vitro food effect on the bioavailability of Nimesulide and paracetamol from fixed dose combination. In vitro, effect of food on the bioavailability was studied by simulating in vivo conditions in dissolution fluid. In this study, we assessed the effect of hydrodynamic stress in presence of food and meal composition on Nimesulide containing fixed dose combination formulations by carrying out dissolution at different agitation rates (simulation of fasted and fed state) as well as in the presence of different percentage of oil (fatty food). It was concluded that agitation intensity as well as presence of oil indicates that the food can play an important role on the release of Nimesulide and paracetamol. Nimesulide and paracetamol show delayed release behavior as percentage of oil increased. This formulation had shown delayed release characteristics at all the conditions studied, showed agitation rate dependent release and also release was affected in presence of oil. Further, effect of food on the Nimesulide and paracetamol release was a function of dosage form characteristics such as disintegration time and dissolution rate, which will subsequently affect the release behavior of a formulation in presence of food.