DESIGN AND EVALUATION OF A NEW FORMULATION OF ENALAPRIL MALEATE TABLET

Abstract

Enalapril maleate, one of the Angiotensin converting enzyme (ACE) inhibitor is effective in the treatment of hypertension. Enalapril maleate is selected for the present study. The aim of this study was to develop a new formulation of Enalapril maleate tablet and its comparative evaluation with other formulations of Enalapril maleate tablet that are listed in the local index of registered pharmaceutical products. To accomplish this task, a new formulation of Enalapril maleate tablet has been developed by direct compression method. All formulation tablets with 5mg potency were selected and the new formulation tablets were also developed with 5mg potency. For new formulation as well as for six available formulations of Enalapril maleate tablets, various pharmaceutical parameters namely weight variation, thickness, hardness test; friability test, disintegration test, dissolution test and pharmaceutical assay were performed in accordance with United States Pharmacopeias (USP). The results of all the above tests were within the specified limits as mentioned in USP, whereas hardness test results for two formulations were deviated from the specified limits. It is concluded that direct compression can be used as an alternate method for the manufacture of Enalapril maleate tablet.