Formulation and Evaluation of Ranolazine Fast Dissolving Tablets Using Various Superdisintegrants

Abstract

Background: This work is envisaged to understand the use of various superdisintegrants and their drug release effect in the formulation of Ranolazine fast-dissolving tablets (FDTs). Materials and Methods: The FDTs were formulated by using direct compression methods using different superdisintegrants like sodium starch glycolate, croscarmellose sodium and crospovidone. The superdisintegrant's effect at different concentrations was studied with help of precompression studies such as Hausner's ratio, compressibility index, differential scanning calorimetry (DSC) and post-compression studies like friability, disintegration and dissolution studies. Results: The effect of various superdisintegrants on desired drug release was studied and its concentrations were optimized. Based on the evaluation results of various trials, the effective concentration was found to be 15mg/tab of crospovidone. It has a disintegration time of 25 sec and a cumulative percentage drug release of 99.77±0.41. Conclusion: In this study, Ranolazine FDTs were developed and successfully optimized. The ideal superdisintegrant and its concentration were selected. Among the various superdisintegrants, crospovidone was more effective compared to other superdisintegrants. Hence, it is recommended to use crospovidone as an ideal superdisintegrant in the Ranolazine FDTs formulations.