Formulation and evaluation of oral dispersible tablet of nimesulide by direct compression method

Abstract

Based on Biopharmaceutics Classification System (BCS), nimesulide is a class II drug, characterized by low solubility and high permeability. Thus, its dissolution represents a limiting step in the drug absorption process which directly affects the bioavailability of the drug. Oral Dispersible tablets (ODTs) of nimesulide overcome the problem related to dissolution by enhancing the rate of dissolution by decreasing the disintegration time and making it easy to administer to patients who refuse to swallow a tablet. In the present study, different formulations of nimesulide were prepared to vary the concentration of superdisintegrants: crospovidone, croscarmellose sodium, sodium starch glycolate along with other excipients: PVP K-30, Aerosil, Mannitol, and Magnesium stearate by direct compression method. Precompression and post-compression parameters were evaluated and also the effect of different concentrations of superdisintegrants on the release profile of Nimesulide ODT was studied. The final data revealed that a combination of 10% crospovidone and 8.33% SSG i.e. formulation B4 was found best combination with the lowest dispersion time of 40 seconds, lowest disintegration time of 19.16 seconds, and lowest wetting time of 15 seconds as compared to other formulations. All other studied parameters were found to be satisfactory for all ODT formulations for Nimesulide. It was concluded that Nimesulide can be successfully formulated as oral dispersible tablets using various superdisintegrants in different concentrations by direct compression method. The optimized batch can be subjected to real-time and accelerated stability studies to determine the shelf life for commercial use.