Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-Diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
The present invention relates to novel crystalline forms of sodium salt of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide (e.g., NXL-104) thereof. The present invention relates to compositions comprising a crystalline form of sodium salt of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide (e.g., NXL-104) alone or in combination with an antibacterial agent (e.g., ceftaroline fosamil). Processes for the preparation of the crystalline forms and methods of treating bacterial infections by administering the crystalline forms alone or in combination with an antibacterial agent (e.g., ceftaroline fosamil) are also described.
1. A pharmaceutical composition comprising a crystalline form of sodium salt of (1R,2S,5R)-7-oxo-6-sulphooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamide and ceftaroline fosamil, wherein the composition comprises less than about 1.5% of a compound of Formula (XIII):
2. The composition according to claim 1 , wherein the composition comprises about 0.05% to about 1.5% of the compound of Formula (XIII).
3. The composition according to claim 1 , comprising about 100 mg to about 800 mg sodium salt of (1R,2S,5R)-7-oxo-6-sulphooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamide.
4. The composition according to claim 1 , comprising about 500 mg sodium salt of (1R,2S,5R)-7-oxo-6-sulphooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamide.
5. The composition according to claim 1 , comprising about 600 mg sodium salt of (1R,2S,5R)-7-oxo-6-sulphooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamide.
6. The composition according to claim 5 , comprising about 600 mg ceftaroline fosamil.
7. The composition according to claim 1 , comprising about 100 mg to 1200 mg ceftaroline fosamil.
8. The composition according to claim 1 , comprising about 400 mg ceftaroline fosamil.
9. The composition according to claim 1 , comprising about 600 mg ceftaroline fosamil.