Active Biotech Ab

Teva Pharmaceutical Industries Limited

Tomas Fristedt

Anders Bjoerk

Karl Jansson

Hans Waennman

Karl Erik Jansson

Aharon Eyal

Muhammad Safadi

Daniella Licht

Ioana Lovinger

Hans Wännman

Anders Björk

Anders K Bjork

The subject invention provides a pharmaceutical composition comprising N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide or the salt thereof; a pharmaceutically acceptable carrier; and not more than 0.5% w/w relative to N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide of 2-Chloro-6-(1-ethyl-N-methyl-2-oxoindoline-3-carboxamido)benzoic acid, 1H,3H-spiro[5-chloro-1-methylquinoline-2,4-dione-3,3'-[1]ethylindolin-[2]-one], or 5-Chloro-N-ethyl-3-hydroxy-1-methyl-2,4-dioxo-N-phenyl-1,2,3,4-tetrahydro-quinoline-3-carboxamide.

Stable laquinimod preparations

A stable solid pharmaceutical composition consisting essentially of an effective amount of a crystalline salt of formula (II) together with an alkaline-reacting component maintaining the pH preferably above 8, or a salt with a divalent metal cation; andat least one pharmaceutical excipient;said salt of formula (II) being essentially stable during storage at room temperature for a period of at least 3 years. A process for stabilizing the salt of formula (II). A crystalline salt of formula (II) and a process for preparing said salt.

Crystalline salts of quinoline compounds and methods for preparing them

A stable solid pharmaceutical composition consisting essentially of an effective amount of a salt of formula (II)  A crystalline salt of formula (II) and a process for preparing said salt.

Compositions containing quinoline compounds

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Helsingborg, Sweden

Tomas Fristedt