Abstract
Dovitinib is a small molecule kinase inhibitor (KI) that is practically insoluble in water but demonstrates high antitumor activity. The aqueous solubility of dovitinib can be improved through formation of water-soluble γ-cyclodextrin (γCD) complexes. However, the very low intrinsic solubility hammers the complex formation. The aim of the present study was to investigate dovitinib binary and ternary complexes with both γCD and hexadimethrine bromide (HDMBr) in both aqueous solution and the solid state. The phase-solubility diagrams of dovitinib were of Bs-type. Addition of HDMBr to the complexation media, that is formation of ternary dovitinib/γCD/HDMBr complex, resulted in four-fold increase in the complexation efficacy (CE). The enhanced CE can decrease the amount of γCD needed to solubilize given amount of dovitinib. The solid dovitinib complexes were characterized by differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), Fourier transform infrared spectroscopy (FTIR), and in vitro dissolution. The dissolution test showed that γCD did stabilize supersaturated dovitinib solution.
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