Abstract:
Irbesartan was practically insoluble in water. The aim of the present work is to increase the solubility of drug and bioavailability without modifying the properties of drug. In this present work solubility was increased by spherical crystallization method and converted into a tablet. Various solvents like N, N dimethyl formamide as a good solvent, bridging solvent chloroform & bad solvent water were selected. Spherical crystals are prepared by using β-cyclodextrin and HP-β-cyclodextrin in various ratios by quasi emulsion solvent diffusion method. Spherical agglomerates are prepared and converted into orodispersible tablets by direct compression technique. Various super disintegrating agents (SSG and Croscarmalose and crospovidone) batch F36 of 1:3 rations shown high dissolution efficiency of 98.09% and when compared with the marketed product shown better dissolution value. NOVA significance value of P<0.05 which will indicates the co-processing parameters variability within the specified limits. F36 shown higher plasma concentration which will indicates the increased bioavailability. When F36 batch execute in pilot plant scale will increases the production rate and available the tablet in affordable cost to the poor people.

Keywords: Irbesartan, β-cyclodextrin, HP-β-cyclodextrin, SSG, Croscarmalose.