Formulation Development And Evaluation Of Bilayer Tablets Of Lisinopril For Immediate Release And Simvastatin For Sustained Release

Abstract

The development of innovative combination therapy is highly desired to deliver Lisinopril and Simvastatin for to prepare bilayer tablets that can perform as quick/slow biphasic release systems of a poorly soluble drug[1]. This formulation approach is of particular interest for treatments that require a rapid action followed by sustained therapeutic levels[2]. Lisinopril one of the most widely prescribed angiotensin –converting enzyme inhibitor for hypertension therapy was used as a model of a BCS III drug. The Sodium Starch Glycolate was chosen various concentration of (2%,3%,4%)[3] in the rapid release layer, HPMC K4M,HPMC K100M,was tested as controlled release agent in the sustained release layer and Sodium starch glycolate was utilizing as super in disintegrant in the rapid release layer and magnesium state was applied anti-adhered lubricant in both layer. In bilayer tablets[4] were characterized through several technique. The result feasibility of the preparation method of wet granulation with sodium starch glycolate in the rapid release to achieve fast dissolution for the first 45 minutes and HPMC K4M,HPMC K100M as a controlling agent in the sustained release layer of the bilayer tablets[5] to obtain a prolonged release during 1440 min.In conclusion, combinations of Sodium starch glycolate and HPMC K4M,HPMC K100M may help addressing the formulation of poorly soluble drugs in bilayer tablets as a fast/slow biphasic release system[6].