Physical Identification of Binary System of GliclazideHydrophilic Polymers Using X-Ray Diffraction


The formation of binary system in pharmaceutical solid state is aimed to improve the physicochemical
characteristics of active compound, such as its solubility. To identify the physical change of the binary system including
crystallinity or particle morphology, there are many methods can be applied. In present report, we study the physical
interaction of the binary system of gliclazide and hydrophilic polymers. In this binary system, gliclazide was either
dispersed or mixed with polyvinyl pirrolidone (PVP K30) or polyethylene glycol (PEG 6000). The dispersion system of
gliclazide in the polymeric carriers was prepared by solvation-evaporation method, using dichloromethane/methylene
chloride as an organic solvent. The physical characterization of both dispersed and mixed of gliclazide was studied using
X-ray diffraction at interval 6-50°/28. As a comparison, the same procedure was performed for pure gliclazide. To
confirm the diffractogram of this binary system, Fourier Transform Infrared (FT-IR) spectroscopy was carried out as
well. Both diffarctogram and FT-IR spectra revealed that there was no new compound formed in the solid dispersion
system of gliclazide:PEG 6000 and gliclazide:PVP K30. In contrast, the solubility as well as the dissolution rate of
gliclazide in the presence of both hydrophilic polymers was increased as compared to pure gliclazide. We conclude
therefore that solvatation followed by evaporation of gliclazide in the presence of either PEG 6000 or PVP K30 did not
alter its crystalline characteristic. The improved of gliclazide solubility in the binary system might due to other
mechanism 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, dissolutionH. Rachmawati, Yatinasari, Faizatun, S. A. Syarie
Research Group of Pharmaceutics, Institut Teknologi Bandung, Bandung 40/32 Indonesia