Abstract

Clarithromycin is a macrolide antibiotic. The objective is to design the extended release tablet of Clarithromycin which will exhibit comparative in-vitro and in-vivo drug release profile as that of marketed product. The designed formulation utilizes a combination of Hydroxypropyl Methylcellulose 5 cps and 15 cps as rate controlling polymers for drug release. The process is a wet granulation process using FBP. The finalized extended release tablet showed comparative in vitro and in vivo drug release profile against the marketed product BIAXIN XL FILM TAB®. Also the physico-chemical properties of the finalized extended release tablets of Clarithromycin was found to be stable for 3 months at of 40°C / 75% RH.