Last Updated: May 10, 2026

Claims for Patent: 12,138,257

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Summary for Patent: 12,138,257

Title:	Antimicrobial compositions
Abstract:	The present invention relates to antimicrobial compositions and more specifically compositions of quinolone carboxylic acid derivatives. These compositions have improved solubility, stability, and tolerability. These compositions are useful for intravenous administration for treating, preventing, or reducing the risk of infection.
Inventor(s):	Danping Li, Eric S. Burak, David S. Dresback, Danielle B. LORD
Assignee:	Melinta Subsidiary Corp
Application Number:	US16/425,580
Patent Claims:	1. An intravenous pharmaceutical composition comprising: (a) a quinolone carboxylic acid derivative or a pharmaceutically acceptable salt or ester thereof, wherein the quinolone carboxylic acid derivative corresponds to the following compound (A): (b) meglumine; (c) a SBE-7-β-CD; and (d) disodium EDTA. 2. The intravenous pharmaceutical composition according to claim 1, wherein the quinolone carboxylic acid derivative is a D-glucitol,1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoro-2-pyridinyl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxy-1-azetidinyl)-4-oxo-3-quinolinecarboxylate (salt). 3. The intravenous pharmaceutical composition according to claim 2 wherein said quinolone carboxylic acid derivative is a crystalline D-glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoro-2-pyridinyl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxy-1-azetidinyl)-4-oxo-3-quinolinecarboxylate (salt) characterized, when measured at about 25° C. with Cu-Ka radiation, by the powder diffraction pattern shown in FIG. 1 . 4. The intravenous pharmaceutical composition according to claim 1, wherein the quinolone carboxylic acid derivative has a measurable improvement in solubility compared to the quinolone carboxylic acid derivative in water, and/or the composition has improved stability, and/or the composition provides a measurable enhancement in venous toleration. 5. The intravenous pharmaceutical composition according to claim 1 which is in the form of a lyophile. 6. The intravenous pharmaceutical composition according to claim 1, wherein the cyclodextrin comprises from 0.01% to 50% by weight of the composition. 7. The intravenous pharmaceutical composition according to claim 6, wherein the cyclodextrin comprises from 10% to 30% by weight of the composition. 8. The intravenous pharmaceutical composition according to claim 1, wherein the composition has a pH from 7 to 11. 9. The intravenous pharmaceutical composition according to claim 8, wherein the composition has a pH from 8 to 10. 10. The intravenous pharmaceutical composition according to claim 9, wherein the composition has a pH from 8.5 to 9.5. 11. The intravenous pharmaceutical composition according to claim 10, wherein the composition has a pH from 8.8 to 9.2. 12. The intravenous pharmaceutical composition according to claim 11, wherein the composition has a pH of 9.0. 13. An intravenous pharmaceutical composition comprising: (a) from 100 mg to 500 mg of delafloxacin, (b) from 15 mg to 125 mg meglumine, (c) from 500 mg to 5000 mg of a SBE-7-β-CD; and (d) from 0 mg to 4 mg disodium EDTA. 14. The intravenous pharmaceutical composition according to claim 13 comprising: (a) 100 mg of delafloxacin; (b) 19.52 mg of meglumine; (c) 800 mg of the SBE-7-β-CD; and (d) 0.44 mg of disodium EDTA. 15. The intravenous pharmaceutical composition according to claim 13 comprising: (a) 300 mg of delafloxacin; (b) 58.56 mg of meglumine; (c) 2400 mg of the SBE-7-β-CD; and (d) 1.32 mg of disodium EDTA. 16. The intravenous pharmaceutical composition according to claim 13 comprising: (a) 500 mg of delafloxacin; (b) 97.6 mg of meglumine; (c) 4000 mg of the SBE-7-β-CD; and (d) 2.2 mg of disodium EDTA. 17. The intravenous pharmaceutical composition according to claim 13 which is in the form of a lyophile. 18. The intravenous pharmaceutical composition according to claim 13, wherein the quinolone carboxylic acid derivative has a measurable improvement in solubility compared to the quinolone carboxylic acid derivative in water, and/or the composition has improved stability, and/or the composition provides a measurable enhancement in venous toleration. 19. The intravenous pharmaceutical composition according to claim 13, wherein the composition has a pH from 7 to 11. 20. An intravenous pharmaceutical composition comprising: (a) from 100 mg to 500 mg of delafloxacin meglumine, (b) from 15 mg to 125 mg meglumine, (c) from 500 mg to 5000 mg of the SBE-7-β-CD; and (d) from 0 mg to 4 mg disodium EDTA.

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