Studies in Formulation Development of Itraconazole Granules Using HPMC E 5 and HPC

Abstract

The purpose of this study was to prepare and evaluate immediate release itraconazole granules and comprehensive studies of the same. The Itraconazole granules are prepared using fluid bed processer with different concentration of HPMC E 5 (Hydroxy Propyl Methyl Cellulose) and HPC (Hydroxy Propyl Cellulose). The effect of concentration of HPMC E 5 and HPC studied using 32 full factorial designs. The prepared granules were physically evaluated with size, shape, surface roughness, density, moisture content, assay and drug release etc. Result shown that, both the independent variable the X1 (concentration of HPMC E 5) is more effective than X2 (concentration of HPC) affect on some dependent variable like size distribution, shape and surface roughness, bulk density and drug release. The optimezed batch (HPMC E 5 4 % and HPC 2 % of total weight of granules) give better quality of itraconazole granules.