C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 215/56 (2006.01) A61K 31/4704 (2006.01)
Patent
CA 2552463
A stable solid pharmaceutical composition consisting essentially of an effective amount of a salt of formula (II) together with an alkaline-reacting component maintaining the pH preferably above 8, or a salt with a divalent metal cation; and at least one pharmaceutical excipient; said salt of formula (II) being essentially stable during storage at room temperature for a period of at least 3 years. A process for stabilizing the salt of formula (II). A crystalline salt of formula (II) and a process for preparing said salt.
L'invention concerne une composition pharmaceutique solide stable consistant essentiellement en une quantité efficace d'un sel représenté par la formule (II), ainsi qu'un composant de réaction alcalin maintenant le pH de préférence au-dessus de 8, ou un sel à cation métallique divalent; ainsi qu'au moins un excipient pharmaceutique; ce sel de formule (II) étant essentiellement stable durant le stockage à température de laboratoire pour une période d'au moins trois ans. L'invention concerne également un procédé destiné à stabiliser le sel de formule (II). L'invention concerne enfin un sel cristallin de formule (II) et un procédé de préparation dudit sel.
Bjoerk Anders
Fristedt Tomas
Jansson Karl
Waennman Hans
Active Biotech Ab
Smart & Biggar
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