FORMULATION AND EVALUATION OF FEBUXOSTAT FAST DISSOLVING TABLETS USING STERCULIA FOETIDA SEED STARCH AS EXCIPIENT BY LYOPHILIZATION TECHNIQUE

The present work is focused on the formulation of Febuxostat fast dissolving tablets by lyophilization technique using natural starch extracted from Sterculia foetida seeds. Starches were extracted using the alkali method, i.e., sodium hydroxide at 0.1%, 0.25%, and 0.5% concentrations and water from Sterculia foetida seed powder. These starches were evaluated for phytochemical and physicochemical tests. Tablets were prepared using Febuxostat, Sterculia foetida seed starch, and croscarmellose sodium in various concentrations using direct compression technique. Various pre and post-compression parameters were performed along with in vitro drug release studies, characterization studies like FTIR, DSC, SEM, XRD, and accelerated stability studies. Phytochemical tests revealed the presence of only starch in all the extracts. The starch prepared from 0.1% sodium hydroxide (SFS2) showed the best physicochemical properties. From in vitro dissolution studies, it was observed that formulations FS6 and FS12 containing 15% w/w of SFS2 and 15% w/w of croscarmellose sodium respectively showed faster disintegration and enhanced dissolution rate compared with other formulations. Febuxostat tablets were further prepared by lyophilization technique. The lyophilized product FSL5 containing 12.5% w/w of SFS2 showed more drug release when compared to FS6. Fourier Transform Infra-Red (FT-IR) spectroscopy and Differential Scanning Calorimetry (DSC) studies revealed that there were no major interactions between the drug and excipients. X-Ray Diffraction (XRD) studies revealed the nature of formulations. Thus the tablets prepared using Sterculia foetida seed starch by lyophilization technique revealed the super disintegrant property of starch.