Application of 22 Level Factorial Design in Formulation and Evaluation of Spherical Agglomerates by Solvent Change Method

Candesartan cilexetil is an antihypertensive drug, which exhibit poor water solubility, poor flowability and poor dissolution. The main aim of study was to improve the dissolution of Candesartan cilexetil. Spherical agglomerates containing Candesartan cilexetil were prepared by solvent change method. By using ternary phase diagram ratio of solvent addition was maintained. Drug was dissolved in solvent blend of methanol (good solvent), water (poor solvent), dichloromethane (bridging liquid). The formulated agglomerates were characterized by scanning electron microscopy (SEM), differential scanning calorimeter (DSC), x-ray diffraction (XRD), Fourier transform infrared spectroscopy (FT-IR) and In-vitro dissolution studies. It was found that the B2 batch has shown better results with respect to all the parameters. Spherical agglomeration and crystallization process can be used to enhance water solubility, flowability and thereby dissolution.