C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 307/88 (2006.01)
Patent
CA 2537958
The present invention relates to a new and economically attractive process for the production of mycophenolate mofetil in a high degree of pharmaceutically acceptable purity, which comprises the reaction of a reactive derivative of mycophenolic acid with 4-(2-hydroxyethyl)morpholine under acidic reaction conditions and the subsequent extraction of the pure mycophenolate mofetil through salt formation and release of the free base. A further aspect of the invention relates to the purification of mycophenolate mofetil by removing its by products, in particular its dimeric by-products, by means of treatment with a primary or secondary amine.
La présente invention concerne un procédé attractif, nouveau et économique de production de mycophénolate mofétil ayant un haut degré de pureté pharmaceutiquement acceptable. Ce procédé consiste à faire réagir un dérivé réactif d'acide mycophénolique avec de la 4-(2-hydroxyéthyl)morpholine dans des conditions de réaction acides puis à extraire le mycophénolate mofétil pur par la formation de sel et la libération de la base libre. Un autre aspect de l'invention concerne la purification de mycophénolate mofétil par le retrait de ses produits, notamment de ses sous-products dimériques, par un traitement avec une amine primaire ou secondaire.
Greil Julia
Ludescher Johannes
Wolf Siegfried
Goudreau Gage Dubuc
Sandoz Ag
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