Pyridone derivative pharmaceutical composition and preparation method thereof
AssigneeJiangsu Hengrui Medicine Co., Ltd.
InventorsHuan DING, Daimei ZHANG
Life of this patent
Estimating the term…
Abstract
Provided are a pyridone derivative pharmaceutical composition and a preparation method thereof. In particular, provided are a pharmaceutical composition containing a pyridone derivative or a pharmaceutically acceptable salt thereof and the preparation method thereof. The pharmaceutical composition contains an active ingredient 2-((2-fluoro-4-iodophenyl)amino)-1-methyl-4-((6-methylpyridin-3-yl)oxy)-6-oxo-1,6-di hydropyridine-3-carboxamide or a pharmaceutically acceptable salt thereof, and hydroxypropyl methylcellulose, and the pharmaceutical composition has good dissolution.
Claims20
An oral solid pharmaceutical composition, comprising 2-((2-fluoro-4-iodophenyl)amino)-1-methyl-4-((6-methylpyridin-3-yl)oxy)-6-oxo-1,6-dihydropyridine-3-carboxamide or a pharmaceutically acceptable salt thereof, and hydroxypropyl methylcellulose, wherein the pharmaceutical composition has a content of 0.01-10% by weight of 2-((2-fluoro-4-iodophenyl)amino)-1-methyl-4-((6-methylpyridin-3-yl)oxy)-6-oxo-1,6-dihydropyridine-3-carboxamide or the pharmaceutically acceptable salt thereof, relative to a weight of the pharmaceutical composition.
An oral solid pharmaceutical composition, comprising:
- a) 0.1-5% by weight of 2-((2-fluoro-4-iodophenyl)amino)-1-methyl-4-((6-methylpyridin-3-yl)oxy)-6-oxo-1,6-dihydropyridine-3-carboxamide or a pharmaceutically acceptable salt thereof,
- b) 2-15% by weight of a disintegrant, wherein the disintegrant is at least one selected from the group consisting of croscarmellose sodium, sodium carboxymethyl starch, crospovidone and low-substituted hydroxypropyl cellulose,
- c) 50-94% by weight of a filler, wherein the filler is at least one selected from the group consisting of mannitol and microcrystalline cellulose,
- d) 1.5-3% by weight of hydroxypropyl methylcellulose, and
- e) 0.5-3% by weight of a lubricant, wherein the lubricant is at least one selected from the group consisting of magnesium stearate, stearic acid, palmitic acid, calcium stearate, talc, carnauba wax and sodium stearyl fumarate.
An oral solid pharmaceutical composition, comprising 2-((2-fluoro-4-iodophenyl)amino)-1-methyl-4-((6-methylpyridin-3-yl)oxy)-6-oxo-1,6-dihydropyridine-3-carboxamide or a pharmaceutically acceptable salt thereof, mannitol and microcrystalline cellulose, wherein a weight ratio of the mannitol to the microcrystalline cellulose is 1.5:1-10:1.
Dependencies are inferred from the claim text.