FIELD: chemical-pharmaceutical industry.
SUBSTANCE: group of inventions relates to the pharmaceutical industry and is a lyophilized composition, having inhibitory activity against PI3 kinase and mTOR, obtained by freeze-drying the pharmaceutical composition in the form of an aqueous solution, containing 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazine-2-yl)phenyl]urea or its lactate at a concentration of less than 6 mg/ml, lactic acid in an amount, sufficient to provide a clear solution, and water; or 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazine-2-yl)phenyl]urea or its phosphate at a solution concentration of less than 4 mg/ml, orthophosphoric acid in an amount sufficient to provide a clear solution; and water. Inventions are also represented by pharmaceutical compositions in the form of aqueous solutions obtained in the form of clear solutions by reconstituting or dissolving the lyophilized composition described above. Invention includes a method of treating cancer in a mammal through these compositions.
EFFECT: lyophilized composition is chemically stable when stored in combination with the possibility of its recovery to produce a clear solution suitable for intravenous administration.
31 cl, 4 dwg, 4 ex
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AQUEOUS COMPOSITION CONTAINING 1-(4-{[4-(DIMETHYLAMINO)PIPERIDINE-1-YL]CARBONYL} PHENYL)-3-[4-(4,6- DIMORPHOLINE-4-YL-1,3,5-TRIAZINE-2-YL)PHENYL]UREA | 2019 |
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Authors
Dates
2018-11-20—Published
2015-12-10—Filed