Preparation and Characterization of Spherical Agglomerates of Gliclazide

Gliclazide, an antidiabetic drug, exhibit poor water solubility and micromeritic properties. Thus the aim of present study was to improve the dissolution rate and micromeritic properties of gliclazide by spherical agglomeration method in the presence of hydrophilic polymer such as PVP K30 and PEG 4000. Crystallization medium for the spherical agglomerates of gliclazide consist of ethanol (good solvent), water (poor solvent) and chloroform (bridging liquid) in the ratio of 20:65:15 mL. The prepared spherical agglomerates were evaluated for micromeritic properties, solubility, dissolution rate and compare with pure drug. Also agglomerates were characterized by Scanning electron microscopy, Infrared Spectroscopy, Differential scanning calorimetry and X-ray Diffractometry. The spherical agglomerate showed improved in the micromeritic properties compare to pure drug. The four fold increased in the solubility and thus increased the dissolution rate of spherical agglomerates than that of pure drug. The Infrared spectroscopy indicate that there is no significant interaction between the drug and polymer.The data of DSC showed that there is slight changes in the melting point of spherical agglomerates.  The agglomerate posses nearly spherical shape and smooth surface. The XRD spectra indicate the decrease in the crystallinity of agglomerates. This could be due to polymorphic changes in the spherical agglomerates.