FIELD: medicine.
SUBSTANCE: group of inventions relates to medicine, in particular, to oncology, and is intended for treating cancer. The pharmaceutical aqueous composition contains a compound of 1-(4-{[4-(dimethylamino)piperidine-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholine-4-yl-1,3,5-triazine-2-yl)phenyl]urea, or a pharmacologically acceptable salt thereof with an organic or inorganic acid, a pharmacologically acceptable organic or inorganic acid, pharmacologically acceptable beta- or gamma-cyclodextrins and water, and is in the form of a transparent solution. The group of inventions also relates to a lyophilised composition of the compound; to a pharmaceutical composition in the form of an aqueous solution, containing the lyophilised composition; and to an application of the composition for treating cancer.
EFFECT: implementation of the invention allows for production of a chemically and physically stable pharmaceutical composition of 1-(4-{[4-(dimethylamino)piperidine-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholine-4-yl-1,3,5-triazine-2-yl)phenyl]urea at 25°C with a relative humidity of 60%, and also provides a possibility of facilitating effective intravenous or parenteral administration by creating a more convenient dosage form, namely a vial containing a single dosage of the composition.
34 cl, 1 dwg, 4 tbl, 6 ex
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Authors
Dates
2022-05-18—Published
2019-06-04—Filed