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US 2008/0176905 A1Published application
Polymorphic forms of rosiglitazone hydrobromide and processes for preparation thereof
OwnerSantiago Ini, Kobi Chen +1inventors
InventorsSantiago Ini, Kobi Chen, Michal Rafilovich
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Abstract
The present invention presents crystal forms of Rosiglitazone hydrobromide, denominated Form I and Form II, methods of their preparation, as well as pharmaceutical compositions comprising these crystalline forms.
Claims51
Rosiglitazone hydrobromide having a water content of between 1 and 4.1% by weight.
A Rosiglitazone hydrobromide crystalline form, characterized by at least one of data selected from the group consisting of:
- a powder XRD pattern having peaks at about 15.2, 17.8, 22.9 and 24.5±0.2 degrees two-theta;
- a solid-state 13C-NMR spectrum having chemical shift resonances at about 169.7, 156.5, 135.7, 118.3 and 115.6±0.2 ppm;
- a solid-state 13C NMR spectrum having chemical shift differences between the lowest ppm resonance in the chemical shift area of 100 to 180 ppm and another in the chemical shift area of 100 to 180 ppm of about 59.5, 46.3, 25.5, 8.1 and 5.4±0.1 ppm;
- an X-ray diffractogram substantially as depicted in FIG. 1;
- and a solid-state 13C-NMR substantially as depicted in FIG. 2 or 3.
2 more elements
A Rosiglitazone hydrobromide crystalline form characterized by a powder XRD pattern with peaks at about 4.6, 9.3, 15.3, 16.3 and 18.3±0.2 degrees two-theta.
Dependencies are inferred from the claim text.