Safadi, Muhammad,Licht, Daniella,Lovinger, Ioana,Eyal, Aharon M,Fristedt, Tomas,Jansson, Karl
申请号：
ES13187258
公开号：
ES2600920T3
申请日:
2008.12.19
申请国别(地区):
ES
年份:
2017
代理人:
摘要：
A pharmaceutical composition comprising N-ethyl-N-phenyl-1,2-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinolin-3- carboxamide (laquinimod) or a pharmaceutically acceptable salt thereof, less 1% by weight of the oxidation decomposition product of laquinimod, and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is a) in solid form further comprising an agent that reduces oxidation, excluding meglumine, wherein the agent that Reduces oxidation is an antioxidant, a reducing agent, or a chelating agent, and i. wherein, if the oxidation reducing agent is an antioxidant, it is selected from the group consisting of tocopherol, methionine, glutathione, tocotrienol, dimethyl glycine, betaine, butylhydroxyanisole, butylhydroxytoluene, turmerin, vitamin E, ascorbyl palmitate, methylate deteroxime, methylparaben, ethylparaben, propyl gallate, sodium metabisulfite, potassium metabisulfite, sodium sulfite, potassium sulfite, alpha-tocopherol, a derivative of alpha-tocopherol, sodium ascorbate, disodium edetate, butylhydroxyanisole (BHA), a flavonoid, a pharmaceutically acceptable salt or ester thereof, or a mixture thereof, ii. wherein, if the oxidation reducing agent is a reducing agent, it is selected from the group consisting of a compound containing thiol, thioglycerol, mercaptoethanol, thioglycol, thiodiglycol, cysteine, thioglucose, dithiothreitol (DTT), dithio-bis-maleimidoethane (DTME), 2,6-di-tert-butyl-4-methylphenol (BHT), sodium dithionite, sodium bisulfite, sodium metabisulfite formamidine, and ammonium bisulfite, or iii. wherein, if the oxidation reducing agent is a chelating agent, it is selected from the group consisting of penicillamine, trientine, N, N'-diethyldithiocarbamate (DDC), 2,3,2'-tetraamine (2,3,2 '-tet), neocuproin, N, N, N', N'-tetrakis (2-pyridylmethyl) ethylenediamine (TPEN), 1,10-phenanthroline (PHE), tetraethylenepentamine, triethylenetetraamine, tris (2-carboxyethyl) phosphine (TCEP ), ferrioxamine, 1,2-diethyl-3- hyd
