Formulation and evaluation of fast dissolving tablets of Nimesulide and Paracetamol

Abstract

Clinical efficacy is the most important criterion for any novel drug administration. A novel fast dissolving drug formulation has been developed for a combination of Nimesulide and Paracetamol by using a direct compression technique. Nimesulide and paracetamol have an antipyretic as well as analgesic activity. The combination of both these drugs favours the combined effect and also reduces the multiple dosing. Hence, the aim of the current work was to design and evaluate the quick disintegrating tablets of Nimesulide and Paracetamol combination via two super disintegrants named Croscarmellose sodium (CCS) and Sodium Starch Glycolate (SSG), which occur in a different proportion to reduce disintegration time and increase the onset of action of the formulation. In this current study, there are five formulations prepared by utilizing two diverse super disintegrants. The selected formulation batch (F5) which has a 1:1 ratio of two diverse super disintegrants named Croscarmellose sodium (CCS) and Sodium Starch Glycolate (SSG) shows the best dissolution time (only 60 min) while other formulation shows more than 60 min for the complete release. At last, the accelerated stability study was conducted for the optimized formulation (F5) at 45 °C /75%RH (as per the ICH guideline) for 30 days indicated no significant change occur before or after keeping the formulation in an excessively stressed condition. Thus, the prepared formulation (F5) shows rapid absorption, increasing bioavailability, and reducing multiple dosing than the conventional dosage form.