Physical Identification of Binary System of Gliclazide-Hydrophilic Polymers Using X-Ray Diffraction


The formation of binary system in pharmaceutical solid state is aimed to improve the physicochemicalcharacteristics of active compound, such as its solubility. To identify the physical change of the binary system includingcrystallinity or particle morphology, there are many methods can be applied. In present report, we study the physicalinteraction of the binary system of gliclazide and hydrophilic polymers. In this binary system, gliclazide was eitherdispersed or mixed with polyvinyl pirrolidone (PVP K30) or polyethylene glycol (PEG 6000). The dispersion system ofgliclazide in the polymeric carriers was prepared by solvation-evaporation method, using dichloromethane/methylenechloride as an organic solvent. The physical characterization of both dispersed and mixed of gliclazide was studied usingX-ray diffraction at interval 6-50°/28. As a comparison, the same procedure was performed for pure gliclazide. Toconfirm the diffractogram of this binary system, Fourier Transform Infrared (FT-IR) spectroscopy was carried out aswell. Both diffarctogram and FT-IR spectra revealed that there was no new compound formed in the solid dispersionsystem of gliclazide:PEG 6000 and gliclazide:PVP K30. In contrast, the solubility as well as the dissolution rate ofgliclazide in the presence of both hydrophilic polymers was increased as compared to pure gliclazide. We concludetherefore that solvatation followed by evaporation of gliclazide in the presence of either PEG 6000 or PVP K30 did notalter its crystalline characteristic. The improved of gliclazide solubility in the binary system might due to othermechanism such as increased in the wettability and the hydrophylicity effect of the polymers.Keywords: Solid dispersion, gliclazide, binary system, X-ray diffractometry, FT-IR spectroscopy, solubility, dissolution. H. Rachmawati, Yatinasari, Faizatun, S. A. SyarieResearch Group of Pharmaceutics, Institut Teknologi Bandung, Bandung 40/32 Indonesia