Novel processes for making- and a new crystalline form of-...

C - Chemistry – Metallurgy – 07 – D

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C07D 261/18 (2006.01) A61K 31/42 (2006.01) A61P 19/02 (2006.01) C07D 261/10 (2006.01) C07D 261/12 (2006.01) C07D 261/14 (2006.01)

Patent

CA 2397601

New leflunomide Form III is disclosed, along with processes for preparing it. The present invention also provides an economic process for preparing leflunomide Form II and a process for preparing leflunomide Form I from leflunomide Form III. Pharmaceutical compositions and dosage forms containing the new form and methods of using them for the treatment of rheumatoid arthritis are also disclosed.

La présente invention concerne une nouvelle forme III de léflunomide ainsi que des procédés de préparation de cette dernière; un procédé de préparation peu coûteux de la forme II de léflunomide et un procédé de préparation de la forme I de léflunomide à partir de la forme III de léflunomide. Des compositions pharmaceutiques et des formes posologiques contenant la nouvelle forme et des procédés d'utilisation de ces dernières dans le traitement de l'arthrite rhumatoïde sont également présentés.

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