Design, Formulation And Evaluation Of Ranolazine Solid Dispersions And Orodispersible Tablets Using Natural Seed Starch As Superdisintegrant

The objective of the study was to enhance the solubility and dissolution rate of Ranolazine, which is a drug that has low water solubility. This was achieved by utilizing solid dispersions and orodispersible tablets made from pregelatinized Entada scandens seed starch. The starches were extracted using water and alkali as solvents. The study evaluated the chemical composition and physical properties of seed starches.The solid dispersions were made utilizing a modifiedsolvent evaporation method with Entada scandensseed starch as carrier in various amounts using pre-gelatinization technique. The direct compressiontechnique to make tablets with optimized solid dispersions of Ranolazine andvarious quantities of croscarmellose sodium (CCS) and sodium starch glycolate (SSG). The optimized solid dispersions and orodispersible tablets were also subjected for characterization studies like Fourier Transform Infra Red (FTIR) and Scanning Electron Microscopy (SEM).  These findings indicated that the starch derived from pregelatinized Entada scandens seeds, which was produced using suitable solvent (ESPS), demonstrated superior physicochemical characteristics compared to other starches. The solid dispersions made with (ESPS- RPS2) exhibited more drug release. The optimized dispersion RPS2 was employed for preparation of orodispersible tablets with CCS and SSG.  The prepared tablets exhibited pre and post compression parameters with in specified limits. The in- vitro drug release studies exhibited release of drug at a faster rate. The FTIR studies revealed that there is no drug - excipient interaction and SEM images showed well distribution of spherical Entada scandens starch granules and crystalline form of Ranolazine.The accelerated stability studies performed for 3 and 6 months have also indicated no change in physical and dissolution parameters of Ranolazine orodispersible formulations which indicated their high stability.Thus from the present study it was concluded that the Ranolazine solid dispersions prepared with ESPS as polymer by modified solvent evaporation method enhanced drug release, indicating its potential application in developing an innovative formulation for the treatment of angina utilizing Ranolazine.