Formulation and Evaluation of Eszopiclone Film Coated Immediate Release Tablets by Direct Compression Method

Abstract

Eszopiclone is a class of drug with hypnotic effect and mainly used in the treatment of Insomnia. The main objective of the present study was to develop a pharmaceutically equivalent, stable, cost effective and quality improved formulation of immediate release tablets of Eszopiclone using different concentration of disintegrants and diluents mainly MCC. Pre formulation studies were performed prior to formulation. The tablets were compressed using lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, anhydrous dibasic calcium phosphate, magnesium stearate and opadry blue (white for 2mg) was used for coating the tablets. The tablets were formulated by direct compression method. And prior to the formulation, the pre formulation parameters analysed are bulk density, tapped density, compressibility index, Hausner's ratio, angle of repose and post compression characteristics like thickness, hardness, friability, disintegration time, drug release and assay. The stability studies were carried out for the reproducible batch F010 (3mg), F009 (1mg) and F010 (2mg) for three months. The results of the present study showed that among all the formulations, F008 for 3mg, F009 for 1mg and F010 for 2mg was better in all terms of pre formulation and post compression parameters and showed comparably a good dissolution profile like that of the marketed product, LUNESTA ®.