N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide, preparation and uses thereof
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsVladimir Ioffe, Konstantin Ulanenko, Avital Laxer, Muhammad Safadi, Danit Licht, Ioana Lovinger, Ulf Tomas Fristedt
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Abstract
The subject invention provides a pharmaceutical composition containing laquinimod or a pharmaceutically acceptable salt thereof, and a compound of N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide or a salt thereof.
Claims17
A pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof, and 1) N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide or a salt thereof, wherein N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide is present in the composition in an amount greater than about 0.02% and less than about 0.50%, by weight, relative to the amount of laquinimod, based on a determination by an HPLC method;
- or 2) at least one pharmaceutically acceptable carrier, and a light-resistant coating wherein the coating is resistant to light with wavelength in the range of 310-400 nm.
A process for preparing a pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof, comprising:
- admixing laquinimod or a pharmaceutically acceptable salt thereof with at least one pharmaceutically acceptable carrier in a low-light environment to form the pharmaceutical composition, wherein the pharmaceutical composition further comprises N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide in an amount of less than 0.5% by weight relative to the amount of laquinimod.
A process for preparing a validated pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier, comprising:
- a) obtaining a batch of laquinimod or a pharmaceutically acceptable salt thereof;
- b) determining the amount of N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide in the batch using a suitable apparatus;
- and
- c) preparing the pharmaceutical composition from the batch only if the batch is determined to have less than about 0.50% N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide by weight relative to the amount of laquinimod.
A process for preparing a packaged pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof comprising:
- a) obtaining a pharmaceutical composition of laquinimod or a pharmaceutically acceptable salt thereof;
- b) analyzing the pharmaceutical composition for the presence of N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide;
- and
- c) packaging the pharmaceutical composition in a light-resistant packaging only if the content of N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide is less than about 0.50% by weight relative to the amount of laquinimod.
A process of distributing a validated batch of a pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable carrier, comprising:
- a) obtaining a batch of the pharmaceutical composition;
- b) performing stability testing with a sample of the batch;
- c) determining the total amount of N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide in the sample of the batch by a suitable apparatus after stability testing;
- d) validating the batch for distribution only if the sample of the batch after stability testing is determined to have less than about 0.50% by weight of N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide relative to the amount of laquinimod;
- and
- e) distributing the validated batch.
Dependencies are inferred from the claim text.