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 sodium salt of (1R,2S,5R)-7-oxo-6-sulphooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamide and a compound of Formula (I):
2. The composition according to claim 1 , wherein the composition comprises about 0.05% to about 1.5% of the compound of Formula (I).
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 3 , further comprising an antibacterial agent.
7. The composition according to claim 6 , wherein the antibacterial agent is ceftaroline fosamil.
8. The composition according to claim 7 , comprising about 600 mg sodium salt of (1R,2S,5R)-7-oxo-6-sulphooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamide and 600 mg ceftaroline fosamil.
9. The composition according to claim 6 , wherein the antibacterial agent is ceftazidime.
10. The composition according to claim 9 , comprising about 500 mg sodium salt of (1R,2S,5R)-7-oxo-6-sulphooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamide and about 2 g ceftazidime.