C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 311/20 (2006.01) C07D 311/46 (2006.01)
Patent
CA 2439489
The present invention is a method for producing warfarin sodium from warfarin sodium 2-propanol clathrate by thermal, nondestructive solvent expulsion. The solvent expulsion is conducted under conditions of controlled heat transfer whereby the 2-propanol is expelled from the warfarin sodium 2-propanol clathrate without decomposition of warfarin sodium or the clathrate. Heating is conducted the clathrate at a temperature from about 100 ~C to about 170 ~C in an active oven under air or in an inert atmosphere and at partial pressures ranging from that of a relative vacuum to atmospheric pressure. The invention also relates to pure warfarin sodium prepared according to the method of the invention and pharmaceutical compositions containing warfarin sodium.
L'invention concerne un procédé servant à préparer warfarine sodium à partir de warfarine sodium 2-propanol clathrate par expulsion thermique non destructive au solvant. On exécute cette expulsion au solvant dans des conditions de transfert thermique contrôlées, ce qui permet d'expulser 2-propanol du warfarine sodium 2-propanol clathrate sans décomposer ni warfarine sodium, ni clathrate. On effectue le réchauffement de clathrate à une température entre 100 ·C et 170 ·C dans un four actif dans une atmosphère inerte ou dans l'air et à des pressions partielles situées dans une plage s'étendant entre un vide relatif et la pression atmosphérique. L'invention concerne également warfarine sodium pur préparé d'après ce procédé, ainsi que des compositions pharmaceutiques contenant warfarine sodium.
Bercovici Sorin
Chernyak Shimon
Ulanenko Konstantin
Johnston Wassenaar Llp
Taro Pharmaceutical Industries Ltd.
Taro Pharmaceuticals U.s.a. Inc.
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