FORMULATION AND EVALUATION OF CHEWABLE TABLETS OF RALTEGRAVIR POTASSIUM

The present study was undertaken to formulate and evaluate Raltegravir potassium chewable tablets using different superdisintegrants to identify an optimized formulation with satisfactory physicochemical properties and improved in vitro drug release. Nine formulations (F1–F9) were prepared using Primojel, Ac-Di-Sol, and crospovidone at different concentrations. The prepared powder blends were evaluated for pre-compression parameters, including angle of repose, bulk density, tapped density, Carr’s index, and Hausner’s ratio. The formulated chewable tablets were evaluated for physical appearance, average weight, hardness, friability, thickness, drug content, disintegration time, wetting time, and in vitro drug release. The calibration curve of Raltegravir potassium was prepared in pH 6.8 phosphate buffer containing 0.25% sodium lauryl sulfate (SLS), demonstrating good linearity with a reported coefficient of determination of approximately 0.998. The drug content of the prepared formulations ranged from 96.25% to 99.36%, while hardness ranged from 4.15 to 4.96 kg/cm² and friability ranged from 0.22% to 0.86%. The disintegration time ranged from 21 to 52 seconds, and the wetting time ranged from 30 to 59 seconds. Among the nine formulations, F3 containing Primojel was identified as the optimized formulation based on the reported evaluation results. It exhibited a disintegration time of 21 seconds, a wetting time of 30 seconds, and a maximum in vitro drug release of 98.12% at 45 minutes. FTIR analysis of the pure drug and optimized formulation did not indicate any apparent drug–excipient incompatibility based on the reported observations. Overall, the results suggest that the F3 formulation demonstrated promising physicochemical characteristics, rapid disintegration, and improved in vitro drug release compared with the other formulations investigated. Further stability studies and additional evaluations are recommended to establish the long-term stability and suitability of the optimized formulation. Keywords: Raltegravir potassium, chewable tablets, superdisintegrants, Primojel, Ac-Di-Sol, crospovidone, pre-compression parameters, in vitro drug release, FTIR analysis.