Pharmaceutical compositions comprising sulbactam and beta-lactamase inhibitor

Patent metadata

Field	Value
Publication number	US-9744160-B2
Application number	US-201114112156-A
Country	US
Kind code	B2
Filing date	Oct 4, 2011
Priority date	Jul 26, 2011
Publication date	Aug 29, 2017
Grant date	Aug 29, 2017

Abstract

Pharmaceutical compositions and methods for treating or preventing bacterial infections are disclosed. The pharmaceutical compositions typically comprise pharmaceutically effective amount of: (a) sulbactam or a pharmaceutically acceptable salt thereof, and (b) at least one beta-lactamase inhibitor or a pharmaceutically acceptable salt thereof, with the provision that the beta-lactamase inhibitor is not sulbactam.

First claim

The invention claimed is:

1. A pharmaceutical composition for parenteral administration, comprising active ingredients, said active ingredients consisting of: (a) sulbactam or a pharmaceutically acceptable salt thereof, and (b) trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide or a pharmaceutically acceptable salt thereof, for treating a bacterial infection caused by an Acinetobacter species.

2. The pharmaceutical composition according to claim 1 , wherein the composition is in the form of powder or a solution.

3. The pharmaceutical composition according to claim 1 , wherein sulbactam or a pharmaceutically acceptable salt thereof is present in an amount from about 0.01 to about 10 gm.

4. The pharmaceutical composition according to claim 1 , wherein trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide or pharmaceutically acceptable salt thereof is present in an amount from about 0.01 to about 10 gm.

5. The pharmaceutical composition according to claim 1 , wherein the composition is formulated into a dosage form such that the sulbactam or pharmaceutically acceptable salt thereof, and the trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide or pharmaceutically acceptable salt thereof, are present in admixture or as separate components.

6. The pharmaceutical composition according to claim 1 , wherein the composition is in the form of a powder that can be reconstituted by addition of a compatible reconstitution diluent prior to parenteral administration.

7. The pharmaceutical composition according to claim 1 , wherein the composition is in the form of a frozen composition that can be diluted with a compatible diluent prior to parenteral administration.

8. The pharmaceutical composition according to claim 1 , wherein the composition is in a form ready to use composition for parenteral administration.

9. A method for treating a bacterial infection caused by an Acinetobacter species in a subject, said method comprising administering parenterally to said subject a pharmaceutically effective amount of active ingredients, said active ingredients consisting of: (a) sulbactam or a pharmaceutically acceptable salt thereof, and (b) trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide or a pharmaceutically acceptable salt thereof.

10. A method for treating a bacterial infection in a subject, said infection being caused by an Acinetobacter species of bacteria producing one or more beta-lactamase enzymes, said method comprising administering parenterally to said subject a pharmaceutically effective amount of active ingredients, said active ingredients consisting of: (a) sulbactam or a pharmaceutically acceptable salt thereof, and (b) trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide or a pharmaceutically acceptable salt thereof, as active ingredients.

11. The pharmaceutical composition according to any one of claims 1 to 8 , wherein the sulbactam is present as sulbactam sodium.

12. The pharmaceutical composition according to any one of claim 1 - 4 , or 5 - 8 , wherein the trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide is present as sodium salt of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide.

13. The method according to any one of the claim 9 or 10 , wherein the sulbactam is administered as sulbactam sodium.

14. The method according to any one of the claim 9 or 10 , wherein the trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide is administered as a sodium salt of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo-[3.2.1]-octane-2-carboxamide.

15. The pharmaceutical composition according to claim 1 , wherein the bacterial infection is caused by Acinetobacter baumannii.

Assignees

• Bhagwat Sachin Subhash
• Patel Mahesh Vithalbhai
• Wockhardt Ltd

Inventors

• Bhagwat Sachin Subhash
• Patel Mahesh Vithalbhai

Classifications

• A61K31/4188 Primary

  condensed with other heterocyclic ring systems, e.g. biotin, sorbinil · CPC title

• A61K31/43

  Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems · CPC title

• A61K31/439 Primary

  the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46) · CPC title

• A61K31/424

  condensed with heterocyclic ring systems, e.g. clavulanic acid · CPC title

• A61K9/08

  Solutions {(composition of solutions A61K47/00)} · CPC title