Crystalline form i of 2-methyl-4-(4-methyl-1-piperazinyl)...

Details Crystalline form i of 2-methyl-4-(4-methyl-1-piperazinyl)... Crystalline form i of 2-methyl-4-(4-methyl-1-piperazinyl)...

C - Chemistry, Metallurgy

07

D

C07D 495/04 (2006.01) A61K 31/55 (2006.01)

Patent

CA 2471341

A novel crystalline form of a known substance cannot be characterized in a sufficient clear and concise manner - distinguishing it form prior art compounds - by a vague property ("having a stable colour upon storage at ambient conditions") or by the giving of infrared absorbance bands alone. Only the characterisation by certain x-ray powder diffraction peaks seems to be sufficient (and a combination of such peaks with IR absorbance bands). For this reason, claims 1 and 3 (and claims 22-23 as far as they refer to claim 1 or 3) are not searchable. Further, the characterization of a novel product by its preparation process (see product-by-process claims 4-21) is not allowable, because such a characterization is only allowable in cases where no other possibility of characterizing a product is possible (which is not the case for the new compound of the present application).

L'invention concerne une forme cristalline I de 2-méthyl-4-(4-méthyl-1-pipérazinyl)-10H-thiéno[2,3-b][1,5]benzodiazépine, caractérisée par des pics de diffraction de rayons X sur poudres approximativement aux valeurs suivantes : 9.94, 8.53, 8.19, 6.86, 6.35, 5.47, 4.83, 4.71, 4.53, 4.22, 4.08, 3.82, 3.75, 3.69, 3.50, 3.34, 3.11, 2.94, 2.82, 2.76, 2.59, 2.34, 2.03, 1.92 d (écartement des plans) ; par des bandes d'absorbance infrarouge approximativement aux valeurs suivantes : 1456, 1365, 905, 757, 662 & 604 cm-1 et en ce qu'elle présente une coloration stable aux conditions ambiantes de conservation. L'invention concerne en outre un procédé de préparation du composé précité,caractérisé en ce qu'on effectue au moins deux étapes de cristallisation répétitives par un ou plusieurs solvants organiques en dissolvant la 2-méthyl-4-(4-méthyl-1-pipérazinyl)-10H-thiéno[2,3-b][1,5]benzodiazépine dans ledit solvant, en ce qu'on laisse ensuite le produit cristalliser, et en ce que, dans au moins une étape, la solution est purifiée par traitement par un produit adsorbant solide et filtration ; et en ce que, dans la dernière étape, le produit cristallisé est séché.

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