"Formulation, Evaluation and Development of Immediate Release Film Coated Tablets of Atorvastatin and Sustained Release Film Coated Tablets of Ezetimibe in Capsules Form Usp"

The present study deals with the formulation of film coated immediate release tablet of Atorvastatin and sustained release tablet of ezetimibe. Atorvastatin is a selective competitive inhibitor of HMG CoA reductase while Ezetimibe is a lipid lowering drug. Atorvastatin reduces total cholesterol, low density lipoprotein (LDL). HMG CoA reductase catalyzes the HMG CoA to mevolanate, which is the limiting step in cholesterol biosynthesis. It also reduces the VLDL cholesterol and triglyceride. The drug powders were subjected to preformulation studies. The drug and excipients compatability were carried out by FT-IR studies and DSC studies. In the present study the tablets were prepared by wet granulation method using binding agents like polyvinyl pyrolidone(K30), sodium sulphate, microcrystalline cellulose, Crospovidone, Croscarmellose sodium and magnesium stearate. The prepared tablet formulations were evaluated for various parameters like weight variation, hardness, friability, disintegration time, and drug content. Along with these drug excipients interaction, In-vitro dissolution studies and stability studies also performed. Drug excipients studies, FT-IR spectroscopic studies and DSC studies revealed that there are no drug – excipients interaction. In-vitro release studies were carried out in USP-XXII tablet dissolution apparatus –II using 0.05M phosphate buffer pH-6.4 and 0.5% SLS in acetate buffer as dissolution medium and HPLC analyzed for Atorvastatin at 242nm and Ezetimibe at 232nm.