C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 401/12 (2006.01) A61K 31/47 (2006.01) C07D 217/04 (2006.01) C07D 401/14 (2006.01) C07D 405/04 (2006.01) C07D 409/14 (2006.01) C07D 495/04 (2006.01)
Patent
CA 2485430
A hydrate of an acid addition bis-salt of an anthranilic acid derivative of formula (I) (see formula I) is produced by a process, which comprises: (a) combining, in any order, the anthranalic acid derivative, a pharmaceutically acceptable organic solvent, an excess of water and a pharmaceutically acceptable strong acid to form a mixture; (b) warming the mixture until a clear solution forms; (c) filtering the solution while it is warm, to yield a filtrate; and (d) recovering the hydrate as defined above from the filtrate. The hydrate has a defined number of moles of water of crystallisation and possesses better storage stability and dissolution characteristics than conventionally produced hydrates of such acid addition bis-salts.
L'invention concerne un hydrate d'un bis-sel d'addition d'acides d'un dérivé d'acide anthranilique produit par un procédé consistant (a) à combiner, dans un ordre quelconque, le dérivé d'acide anthranilique, un solvant organique, acceptable sur le plan pharmaceutique, un excès d'eau et un acide fort, acceptable sur le plan pharmaceutique, afin de former un mélange, (b) à chauffer ce mélange jusqu'à formation d'une solution claire, (c) à filtrer la solution encore chaude afin d'obtenir un filtrat, et (d) à récupérer l'hydrate, tel que défini ci-dessus, à partir du filtrat. Cet hydrate possède un nombre défini de moles d'eau de cristallisation, possède de meilleures caractéristiques de dissolution et se conserve mieux que les hydrates produits classiquement de ces bis-sels d'addition d'acides.
Hayman David Frank
Wright Michael
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
Xenova Limited
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