Claims for Patent: 9,827,235

Summary for Patent: 9,827,235

Title:	Pharmaceutical compositions comprising antibacterial agents
Abstract:	Pharmaceutical compositions comprising cefepime or a pharmaceutically acceptable derivative, and a compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof are disclosed.
Inventor(s):	Sachin Bhagwat, Mahesh Vithalbhai Patel
Assignee:	Wockhardt Ltd
Application Number:	US15/030,526
Patent Claims:	1. A pharmaceutical composition comprising: (a) cefepime or a pharmaceutically acceptable derivative thereof, and (b) a compound of Formula (I): or a stereoisomer or a pharmaceutically acceptable derivative thereof; wherein the compound of Formula (I) or a stereoisomer or the pharmaceutically acceptable derivative thereof is present in the composition in an amount from about 0.25 gram to about 4 grams per gram of cefepime or a pharmaceutically acceptable derivative thereof. 2. The pharmaceutical composition according to claim 1, wherein the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof is present in the composition in an amount from about 0.01 gram to about 10 grams. 3. The pharmaceutical composition according to claim 1, wherein the cefepime or a pharmaceutically acceptable derivative thereof is present in the composition in an amount from about 0.01 gram to about 10 grams. 4. The pharmaceutical composition according to claim 1, comprising: (a) the cefepime or a pharmaceutically acceptable derivative thereof, and (b) the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, in any of the following amounts: (i) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (ii) about 2 grams of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (iii) about 0.5 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (iv) about 0.25 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (v) about 0.5 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (vi) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (vii) about 2 grams of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; or (viii) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 0.5 gram of the cefepime or a pharmaceutically acceptable derivative thereof. 5. The pharmaceutical composition according to claim 1, wherein the compound of Formula (I) is: “trans-sulphuric acid mono-[2-(N′—[(R)-piperidin-3-carbonyl]-hydrazinocarbonyl)-7-oxo-1,6-diaza-bicyclo[3.2.1]oct-6-yl] ester”, “(2S,5R)-sulphuric acid mono-[2-(N′—[(R)-piperidin-3-carbonyl]-hydrazinocarbonyl)-7-oxo-1,6-diaza-bicyclo[3.2.1]oct-6-yl] ester”, “(1R,2S,5R)-1,6-Diazabicyclo[3.2.1]octane-2-carboxylic acid, 7-oxo-6-(sulfooxy)-, 2-[2-[(3R)-3-piperidinylcarbonyl]hydrazide]”, sodium salt of “(1R,2S,5R)-1,6-Diazabicyclo[3.2.1]octane-2-carboxylic acid, 7-oxo-6-(sulfooxy)-, 2-[2-[(3R)-3-piperidinylcarbonyl]hydrazide]”, potassium salt of “(1R,2S,5R)-1,6-Diazabicyclo[3.2.1]octane-2-carboxylic acid, 7-oxo-6-(sulfooxy)-, 2-[2-[(3R)-3-piperidinylcarbonyl]hydrazide]” or a stereoisomer or a pharmaceutically acceptable derivative thereof. 6. The pharmaceutical composition according to claim 1, wherein the composition is formulated into a dosage form such that the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and the cefepime or a pharmaceutically acceptable derivative thereof, are present in the composition as an admixture or as separate components. 7. The pharmaceutical composition according to claim 1, wherein the composition is in form of a powder or a solution. 8. The pharmaceutical composition according to claim 7, wherein the composition is in the form of a powder or a solution that can be reconstituted by addition of a compatible reconstitution diluent for use in parenteral administration. 9. The pharmaceutical composition according to claim 1, for use in treatment of a bacterial infection. 10. A method for treating a bacterial infection in a subject, said method comprising administering to said subject the pharmaceutical composition according to claim 1. 11. A method for treating a bacterial infection in a subject, wherein said method comprising administering to the subject an effective amount of: (a) cefepime or a pharmaceutically acceptable derivative thereof, and (b) a compound of Formula (I): or a stereoisomer or a pharmaceutically acceptable derivative thereof; wherein the amount of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof administered is from about 0.25 gram to about 4 gram per grams of the cefepime or a pharmaceutically acceptable derivative thereof. 12. The method according to claim 11, wherein the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof is administered in an amount from about 0.01 gram to about 10 grams. 13. The method according to claim 11, wherein the cefepime or a pharmaceutically acceptable derivative thereof is administered in an amount from about 0.01 gram to about 10 grams. 14. The method according to claim 11, wherein the cefepime or a pharmaceutically acceptable derivative thereof, and the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, is administered in any of the following amounts: (i) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (ii) about 2 grams of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (iii) about 0.5 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (iv) about 0.25 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (v) about 0.5 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (vi) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (vii) about 2 grams of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; or (viii) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 0.5 gram of the cefepime or a pharmaceutically acceptable derivative thereof. 15. The method according to the claim 11, wherein the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, is administered before, after or simultaneously with the administration of the cefepime or a pharmaceutically acceptable derivative thereof. 16. The method according to claim 11, wherein the compound of Formula (I) is: “trans-sulphuric acid mono-[2-(N′—[(R)-piperidin-3-carbonyl]-hydrazinocarbonyl)-7-oxo-1,6-diaza-bicyclo[3.2.1]oct-6-yl] ester”, “(2S, 5R)-sulphuric acid mono-[2-(N′—[(R)-piperidin-3-carbonyl]-hydrazinocarbonyl)-7-oxo-1,6-diaza-bicyclo[3.2.1]oct-6-yl] ester”, “(1R,2S,5R)-1,6-Diazabicyclo[3.2.1]octane-2-carboxylic acid, 7-oxo-6-(sulfooxy)-, 2-[2-[(3R)-3-piperidinylcarbonyl]hydrazide]”, sodium salt of “(1R,2S,5R)-1,6-Diazabicyclo[3.2.1]octane-2-carboxylic acid, 7-oxo-6-(sulfooxy)-, 2-[2-[(3R)-3-piperidinylcarbonyl]hydrazide]”, potassium salt of “(1R,2S,5R)-1,6-Diazabicyclo[3.2.1]octane-2-carboxylic acid, 7-oxo-6-(sulfooxy)-, 2-[2-[(3R)-3-piperidinylcarbonyl]hydrazide]” or a stereoisomer or a pharmaceutically acceptable derivative thereof. 17. A method for increasing antibacterial effectiveness of cefepime or a pharmaceutically acceptable derivative thereof in a subject, the method comprising co-administering the cefepime or a pharmaceutically acceptable derivative thereof, with a compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof. 18. A method for increasing antibacterial effectiveness of cefepime or a pharmaceutically acceptable derivative thereof in a subject, the method comprising co-administering the cefepime or a pharmaceutically acceptable derivative thereof, with a compound of Formula (I): or a stereoisomer or a pharmaceutically acceptable derivative thereof; wherein the amount of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof administered is from about 0.25 gram to about 4 grams per gram of the cefepime or a pharmaceutically acceptable derivative thereof. 19. The method according to claim 18, wherein the cefepime or a pharmaceutically acceptable derivative thereof, and the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, is administered in any of the following amounts: (i) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (ii) about 2 grams of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (iii) about 0.5 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 2 grams of the cefepime or a pharmaceutically acceptable derivative thereof; (iv) about 0.25 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (v) about 0.5 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (vi) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; (vii) about 2 grams of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 1 gram of the cefepime or a pharmaceutically acceptable derivative thereof; or (viii) about 1 gram of the compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof, and about 0.5 gram of the cefepime or a pharmaceutically acceptable derivative thereof.