FIELD: medicine; pharmaceutics.
SUBSTANCE: first invention of a group is a stable pharmaceutical composition for oral administration, including 4-(2-fluoro-4-(3-(2-phenylacetyl)thioureido)phenoxy)-7-methoxy-N-methylquinoline-6-carboxamide or its pharmaceutically acceptable salt and hydroxypropyl-β-cyclodextrin, where hydroxypropyl-β-cyclodextrin is contained in the amount of 3-5.5 weight parts per 1 weight part of 4-(2-fluoro-4-(3-(2-phenylacetyl)thioureido)phenoxy)-7-methoxy-N-methylquinoline-6-carboxamide or its pharmaceutically acceptable salt. The second invention of the group is the specified pharmaceutical composition that is obtained by physical mixing, i.e., by a method not including a stage, at which 4-(2-fluoro-4-(3-(2-phenylacetyl)thioureido)phenoxy)-7-methoxy-N-methylquinoline-6-carboxamide or its pharmaceutically acceptable salt is converted into a solution. The third invention of the group is a method for the production of the specified compositions, including physical mixing of 4-(2-fluoro-4-(3-(2-phenylacetyl)thioureido)phenoxy)-7-methoxy-N-methylquinoline-6-carboxamide or its pharmaceutically acceptable salt and hydroxypropyl-β-cyclodextrin, where the method does not include a stage, at which 4-(2-fluoro-4-(3-(2-phenylacetyl)thioureido)phenoxy)-7-methoxy-N-methylquinoline-6-carboxamide or its pharmaceutically acceptable salt is converted into a solution.
EFFECT: group of inventions provides for an increase in stability, disintegration and absorption of the composition.
35 cl, 11 dwg, 12 tbl, 9 ex
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