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Stable laquinimod preparations

  • US 8,178,127 B2
  • Filed: 12/19/2008
  • Issued: 05/15/2012
  • Est. Priority Date: 12/20/2007
  • Status: Active Grant
First Claim
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1. A process for validating a batch of a pharmaceutical product containing N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide or a salt thereof and a pharmaceutically acceptable carrier for distribution comprisinga) subjecting a sample of the batch to stability testing;

  • b) determining the total amount of an oxidation decomposition product in the sample of the batch after stability testing; and

    c) validating the batch for distribution only if the sample of the batch after stability testing contains not more than a total of 0.5% w/w relative to N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide of the oxidation decomposition products of N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide, wherein the oxidation decomposition product is 2-Chloro-6-(1-ethyl-N-methyl-2-oxoindoline-3-carboxamido) benzoic acid, 5-Chloro-N-ethyl-3-hydroxy-1-methyl-2,4-dioxo-N-phenyl-1,2,3,4-tetrahydro-quinoline-3-carboxamide or 1H,3H-spiro[5-chloro-1-methylquinoline-2,4-dione-3,3′

    -[1]ethylindolin-[2]-one], or a mixture thereof.

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