Pharmaceutica Analytica Acta

Design, development and evaluation of immediate release combined dosage form of antihyperlipidemic agents

5^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems

March 16-18, 2015 Crowne Plaza, Dubai, UAE

Pradnya Onkar

Posters & Accepted Abstracts: Pharm Anal Acta

Abstract:

The present study deals with the formulation of film coated immediate release tablet of Atorvastatin and Ezetimibe in combination. Atorvastatin is a selective competitive inhibitor of HMG CoA reductase while Ezetimibe is a lipid lowering drug which acts mainly at intestinal lumen. Atorvastatin reduces total cholesterol, low density lipoprotein (LDL). Both the drugs are of BCS class II, i.e., high permeability and low solubility. The main aim of the study was to decrease the disintegration time and simultaneously increase the dissolution rate of the dosage form. The drug powders were subjected to pre-formulation studies. Drug excipients studies, FT-IR spectroscopic studies and DSC studies revealed that there was no drug ? excipients interaction. In the present study the tablets were prepared by wet granulation method using purified water, calcium carbonate, silicified microcrystalline cellulose, lactose, croscarmellose, sodium bicarbonate, purified talc, magnesium stearate, sodium lauryl sulphate. The prepared tablet formulations were evaluated for various parameters like weight variation, hardness, disintegration time, and drug content. Along with these tests, in-vitro dissolution studies and stability studies were also performed. In-vitro release studies were carried out in USP-XXII tablet dissolution apparatus ?II using 0.05M phosphate buffer pH- 6.8 as dissolution medium and analyzed by HPLC for Atorvastatin and Ezetimibe at 240 nm. The formulated tablet was compared with marketed preparation for all evaluation parameters.