FORMULATION OF EPLERENONE MINI TABLETS - A NOVEL APPROACH IN DESIGNING SUSTAINED RELEASE MATRIX TABLETS

Abstract

The intention of present study was to adopt a novel approach in designing sustained release matrix tablets of Eplerenone a water soluble drug, using Cellulose polymers as release modifiers in the form of matrix mini tablets filled in ‘00’ size transparent hard gelatin capsules. Matrix mini tablets containing cellulose polymers like HPMC K4M, HPMC K15M, were prepared by wet granulation technique using PVP K60 as a tablet binder. The optimized formulation (F1) contains 1: 1 ratio (drug to HPMC K4M ratio) and (F4) contains 1:0.7 ratio (drug and HPMC K15M) respectively. The in vitro release kinetic studies of prepared matrix mini tablets with both the polymers revealed that the amount of Eplerenone released from the matrix mini tablets at different time intervals was matched with theoretical release profile of drug for a period of 12 h. The kinetic treatment illustrate that the optimized formulation (F1 and F4) followed zero order kinetics with release exponent (n) 0.83. Drug content in the tablets and amount of drug released in different time points were estimated by reported HPLC method. The FT-IR and DSC studies did not show any interaction between Eplerenone, polymers and with the excipients used in the formulation. The results clearly indicated that the adopted novel approach in designing controlled release formulations of Eplerenone in the form of matrix mini tablets could be successfully fabricated using an appropriate ratio of cellulose polymers like HPMC K15M & HPMC K4M.