FIELD: medicine; pharmaceuticals.
SUBSTANCE: invention relates to crystalline vinorelbine monotartrate, presented in form of a solvate, where said crystalline vinorelbine monotartrate contains an organic solvent, selected from acetone and isopropanol or where said crystalline vinorelbine monotartrate is a hydrate, where said acetone solvate of crystalline vinorelbine monotartrate is characterized by X-ray powder diffraction X-ray diffraction pattern, containing peaks at average diffraction angles (2Θ) 7.9°; 9.5°; 10.1°; 13.2°; 13.4°; 14.4°; 16.7°; 16.9°; 19.1° and 20.7° (each ± 0.2°); said crystalline vinorelbine isopropanol solvate of monotartrate is characterized by an X-ray powder diffraction pattern comprising peaks at average diffraction angles (2Θ) 8.0°; 9.2°; 10.3°; 10.8°; 10.9°; 13.4°; 14.6°; 16.9°; 19.3° and 22.9° (each ± 0.2°); said hydrate of crystalline vinorelbine monotartrate is characterized by an X-ray powder diffraction pattern comprising peaks at mean diffraction angles (2Θ) 7.9°; 9.5°; 10.3°; 10.8°; 13.4°; 13.6° and 14.5° (each ± 0.2°), measured by nCu-Kα1 radiation at wavelength of 1.54056 Å (0.154056 nm). Invention also relates to methods of producing crystalline vinorelbine monotartrate represented by a solvate and a hydrate.
EFFECT: crystalline vinorelbine monotartrate according to the invention is meant for preventing and/or treating cancer, wherein said cancer is non-small-cell lung cancer and/or breast cancer.
17 cl, 17 tbl, 14 ex, 11 dwg
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