Formulation And Evaluation Of Bilayer Tablet Of Eplerenone For The Treatment Of Hypertention

Abstract

The purpose of the current work is to prepare and evaluate the immediate and continuous release of Eplerenone for the treatment of high blood pressure. The Eplerenone Bilayer tablet was prepared by wet granulation using the tablet superdisintegrants (CCS, SLS) and binder (PVPK 30). To expand the release of Eplerenone for a long-term Eplerenone release using hydrophilic polymer (HPMC K10M and HPMC E5) for extended periods, especially for low -soluble drugs. The original purpose is to reduce the frequency of drug administration and reduce the cost of production.

The purpose of the current research is to develope bilayer tablet of immediate release level using superdisintegrants and continuous release levels using hydrophilic polymers. Both immediate and continuous release levels were optimized using 3² factorial designs. For the IR layer selected independent variables are HPMC E3 (X1) and CCS (X2) and for SR layer HPMC K 100M (X1) and HPMC E5 (X2). In both levels, the % of the drug release (Y1) was selected as a dependent variable. Pre -compress and post compression parameters are evaluated. The in-vitro dissolution study was done for 12 hours using a pH 6.8 phosphate buffer. F8 formulation shows 96.9 % drug release at the end of 12 hours and the formulation IR5 showed 96.9 % drug release in 30 minutes. In the vitro release, various release was analyzed according to the kinetic model.

Customized formulation follows the higuchi equation drug release activities. The regression coefficient value(r²) was found to be 0.994.