The aim of present investigation was to formulate bilayer tablet of Nitazoxanide by using the wet granulation method. In this formula one layer provided the loading dose by immediate drug release and another layer provided maintenance dose up to 12hrs by controlled release. The drug excipient compatibility study was carried out by FTIR study, there was no interaction found. Sodium stach glycollate was used as superdisintegrant in immediate release layer and controlled release fraction was formulated by using HPMC E 15 polymer. The prepared granules were evaluated for angle of repose, bulk density, tapped density and compressibility index which showed satisfactory result. The prepared bilayer tablets were evaluated for thickness, hardness, friability and in-vitro release studies. In-vitro dissolution study was carried out for 12 hours using USP dissolution apparatus I using phosphate buffer of 1.2 pH and 7.4 pH as dissolution medium. The bilayer tablet showed initial burst release to provide the loading dose of drug followed by controlled release up to 12 hours. Concentration of polymer & superdisintegrant ratio influenced drug release profile. As the polymer concentration was increased in controlled release layer the % drug release decreased whereas on increasing superdisintegrant concentration in immediate release the % drug release increased. The batch F9 showed maximum release of 95% upto 12 hrs and was selected as best formulation. Stability study was carried out for the optimized formulation at 40ºC/75% RH for 3 months; the result shows that there was no significant change in physical and chemical attributes of the tablet.
