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Last Updated: April 23, 2024

Claims for Patent: 9,504,691

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Summary for Patent: 9,504,691

Title:	Finafloxacin suspension compositions
Abstract:	The present invention relates to methods for treating an ophthalmic, otic, or nasal infection comprising treating the infected tissue with a suspension composition comprising finafloxacin or a finafloxacin derivative. The present invention also relates to antimicrobial compositions comprising finafloxacin free base or a finafloxacin derivative. The compositions are suitable for the treatment of ophthalmic, otic, or nasal infections.
Inventor(s):	Boudreaux; Brent G. (Irving, TX), Bridle; Mark J. (Keller, TX), Huynh; Bryan H. (Fort Worth, TX), Ghosh; Malay (Fort Worth, TX), Chowhan; Masood A. (Arlington, TX), Alani; Laman (Fort Worth, TX), Kabra; Bhagwati P. (Euless, TX)
Assignee:	Alcon Research, Ltd. (Fort Worth, TX)
Application Number:	14/086,651
Patent Claims:	1. A topical suspension composition comprising finafloxacin, a solubilizer, and a suspending agent, and wherein said finafloxacin is finafloxacin free base form A, said solubilizer is magnesium salt at a concentration of 0.98 to 4.9 mM, and said suspending agent is hydroxyethylcellulose at a concentration of 0.1 to 0.3 w/v %, and wherein said composition maintains substantial uniformity for greater than 8 hours at 25.degree. C., and wherein said composition has a pH of 5.8 to 6.2 and said concentration of finafloxacin is 0.15 to 2.0 w/v %. 2. A composition according to claim 1, said composition having a ratio of suspended to solubilized finafloxacin between 18:1 and 1:1. 3. A composition according to claim 1, wherein said solubilizer is magnesium chloride at a concentration of 0.05 to 0.07 w/v %. 4. A composition according to claim 1, further comprising an anti-inflammatory agent. 5. A composition according to claim 4, wherein said anti-inflammatory agent is dexamethasone. 6. A composition according to claim 5, wherein said composition comprises dexamethasone at a concentration of 0.05 to 1.0 w/v %. 7. A method for treating an ophthalmic, otic, or nasal infection comprising: treating the infection with a pharmaceutically effective amount of a composition according to claim 1. 8. A method according to claim 7 wherein said infection is acute otitis externa or acute otitis media with tympanostomy tubes. 9. A method for preparing a finafloxacin suspension of claim 1 comprising: producing a finafloxacin slurry by adding finafloxacin free base, a milling agent, and milling beads together with water to form an aqueous slurry; and heating the slurry to form finafloxacin free base form A. 10. A method for preparing a finafloxacin suspension comprising: producing a finafloxacin slurry by adding finafloxacin free base, a milling agent, and milling beads together with water to form an aqueous slurry; and heating the slurry to form finafloxacin free base form A. 11. A method according to claim 10 wherein said finafloxacin slurry further comprises one or more anti-inflammatory agents. 12. A method according to claim 11 wherein said finafloxacin slurry further comprises dexamethasone.

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