Crystalline and amorphous solids of pantoprazole and...

C - Chemistry – Metallurgy – 07 – D

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Details

C07D 401/12 (2006.01) A61B 1/04 (2006.01) A61K 31/4439 (2006.01)

Patent

CA 2518999

The present invention relates to a polymorphic form (Form I) of pantoprazole and a processes of making same. Form I has a PXRD pattern with characteristic peaks at 6.6, 13.2, 13.7, 15.7, 23.1, and 23.4 .plusmn. 0.2 ~20 and a FTIR spectrum with characteristic bands at 1385, 1264, 1244, 1180, and 1027 at cm- 1. The process of making Form I includes crystallizing pantaoprazole or forming slurry from amorphous pantoprazole. The present invention also relates to another polymorphic form (Form II) of pantoprazole and a process of making the same. Form II has a PXRD pattern with characteristic peaks at 5.8, 7.5, 9.3, 15.0, 22.0, and 22.6 .plusmn. 0.2 ~20 and a FTIR spectrum with characteristic bands at 3195, 1196, and 1584 at cm-1. The process of making Form II includes forming a slurry from amorphous pantoprazole.

Cette invention se rapporte à une forme polymorphe (forme I) de pantoprazole et à un procédé de fabrication de cette forme. La forme I possède un diagramme PXRD (diagramme de diffraction des rayons X sur poudre) ayant des crêtes caractéristiques à 6.6, 13.2, 13.7, 15.7, 23.1, et 23.4 .plusmn. 0.2 ·2.theta. et un spectre FTIR (spectre infrarouge à transformée de Fourier) ayant des bandes caractéristiques à 1385, 1264, 1244, 1180, et 1027 à cm?-1¿. Le procédé de fabrication de la forme I consiste à cristalliser du pantoprazole ou à former une suspension épaisse à partir de pantoprazole amorphe. Cette invention concerne également une autre forme polymorphe (forme II) de pantoprazole et à un procédé de fabrication de cette forme. La forme II possède un diagramme PXRD ayant des crêtes caractéristiques à 5.8, 7.5, 9.3, 15.0, 22.0, et 22.6 .plusmn. 0.2 ·2.theta. et un spectre FTIR ayant des bandes caractéristiques à 3195, 1196, et 1584 à cm?-1¿. Le procédé de fabrication de la forme II consiste à former une suspension épaisse à partir de pantoprazole amorphe.

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