BIOPHARMACEUTICAL STABILITY OF THE GLIBORNURIDE BETA-CYCLODEXTRIN INCLUSION COMPLEX AFTER ONE-YEAR OF STORAGE

Dissolution characteristics and X-ray powder diffraction patterns remained unchanged after storing the glibornuride/beta-cyclodextrin (1/1) inclusion complex for 2, 4, 6 and 12 months under laboratory conditions. The bioavailability of an orally-administered complex in rabbits (expressed as serum glucose coefficient), in spite of the large inter-individual variability, proved to be higher than that of glibornuride or its physical mixture with beta-cyclodextrin. The serum variation coefficients, 4 h after administration, were 18.9 +/- 6.5,13.5 +/- 7.7 and 33.8 +/- 8.7 respectively for glibornuride, the mixture and the complex. According to both in vitro and in vivo studies, the biopharmaceutical properties of glibornuride/beta-cyclodextrin remain unaltered for at least one year under the studied conditions.