ABSTRACT

The current research work was aimed at improving the solubility of dolutegravir sodium (BCS class II) by utilizing the approach of co-crystallization and formulating orodispersible tablets of chosen cocrystals to maximize the therapeutic use of dolutegravir sodium. Co-crystals were prepared by the solvent evaporation method. Thus prepared co-crystals were subjected to solubility analysis, melting point determination, FTIR, DSC and PXRD analysis. Co-crystals prepared using various co-formers showed an increment in solubility. Dolutegravir sodium - maltitol co-crystals demonstrated four times higher solubility than the primary drug, which is profound among all the co-crystals. Co-crystal formation has been confirmed by FTIR, DSC and PXRD studies. All the parameters of the orodispersible tablet were found to be within the acceptable range. The optimized formulation of the co-crystals has shown profound drug release compared with the pure drug formulation. The optimized formulation was stable for six months of storage.