Solid pharmaceutical composition
AssigneeKyorin Pharmaceutical Co., Ltd.
InventorsHiroshi UCHIDA, Masataka HANADA
Life of this patent
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Abstract
[Problem] Provided is a pharmaceutical composition which suppresses gelation of the 7-{(3S,4S)-3-[(cycloproropylamino)methyl]-4-fluoropyrrolidine-1-yl}-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride and which suppresses elution delay. [Solution] This solid pharmaceutical composition is obtained by using crystals (B-form crystals) of a hydrate of 7-{(3S,4S)-3-[(cyclopropylamino)methyl]-4-fluoropyrrolidine-1-yl}-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride, having peaks at 9.4 and 17.7 degrees (±0.2 degrees for each angle) as 2θ diffraction angles in X-ray powder diffraction using CuKα emission.
Claims8
A solid pharmaceutical composition comprising a crystal of a hydrate of 7-{(3S,4S)-3-[(cyclopropylamino)methyl]-4-fluoropyrrolidine-1-yl}-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride having peaks at 9.4 degrees and 17.7 degrees (±0.2 degrees for each angle) as 2θ diffraction angles in X-ray powder diffraction using CuKα c radiation, wherein the solid pharmaceutical composition is obtained by compression-molding.
A method for suppressing delayed dissolution of 7-{(3S,4S)-3-[(cyclopropylamino)methyl]-4-fluoropyrrolidine-1-yl}-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride contained in a tablet, the method comprising:
- allowing the tablet to contain a crystal of a hydrate of 7-{(3S,4S)-3-[(cyclopropylamino)methyl]-4-fluoropyrrolidine-1-yl}-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride having peaks at 9.4 degrees and 17.7 degrees (±0.2 degrees for each angle) as 2θ diffraction angles in X-ray powder diffraction using CuKα radiation as the 7-{(3S,4S)-3-[(cyclopropylamino)methyl]-4-fluoropyrrolidine-1-yl}-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride.
A solid pharmaceutical composition comprising:
- a granular substance containing a crystal of a hydrate of 7-{(3S,4S)-3-[(cyclopropylamino)methyl]-4-fluoropyrrolidine-1-yl}-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride having peaks at 9.4 degrees and 17.7 degrees (±0.2 degrees for each angle) as 2θ diffraction angles in X-ray powder diffraction using CuKα radiation;
- and
- a disintegrant.
Dependencies are inferred from the claim text.