US2016279137A1PendingUtilityA1

Finafloxacin suspension compositions

Assignee: ALCON RES LTDPriority: Dec 6, 2012Filed: Jun 3, 2016Published: Sep 29, 2016

Est. expiryDec 6, 2032(~6.4 yrs left)· nominal 20-yr term from priority

Inventors:Brent G. Boudreaux Mark J. Bridle Bryan H. Huynh Malay Ghosh Masood A. Chowhan Laman Alani Bhagwati P. Kabra

A61P 9/00A61P 31/04A61P 27/02A61P 29/00A61P 27/16A61P 31/00A61P 11/02A61K 47/38A61K 31/573A61K 9/0048A61K 9/0043A61K 9/10A61K 47/02A61K 9/0046A61K 31/5383

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References

Claims

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.

Claims

exact text as granted — not AI-modified

What is claimed is: 
     
         1 . A topical suspension composition comprising finafloxacin, a solubilizer, and a suspending agent, and wherein said finafloxacin is finafloxacin free base. 
     
     
         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 the soluble concentration of finafloxacin is greater than 0.05 w/v %. 
     
     
         4 . A composition according to  claim 1 , wherein said finafloxacin is finafloxacin free base at a concentration of 0.15 to 2.0 w/v %. 
     
     
         5 . A composition according to  claim 1 , wherein said finafloxacin is finafloxacin free base form A. 
     
     
         6 . A composition according to  claim 1  comprising finafloxacin or a pharmaceutically acceptable salt thereof at a concentration of 0.15 to 2.0 w/v %. 
     
     
         7 . A composition according to  claim 1 , said composition having a pH of 5.8 to 6.2. 
     
     
         8 . A composition according to  claim 1 , wherein said solubilizer is magnesium salt at a concentration of 0.98 to 4.9 mM. 
     
     
         9 . A composition according to  claim 1 , wherein said solubilizer is magnesium chloride at a concentration of 0.05 to 0.07 w/v %. 
     
     
         10 . A composition according to  claim 1  wherein said suspending agent is hydroxyethylcellulose. 
     
     
         11 . A composition according to  claim 10 , wherein 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° C. 
     
     
         12 . A composition according to  claim 1 , further comprising an anti-inflammatory agent. 
     
     
         13 . A composition according to  claim 12 , wherein said anti-inflammatory agent is dexamethasone. 
     
     
         14 . A composition according to  claim 13 , wherein said composition comprises dexamethasone at a concentration of 0.05 to 1.0 w/v %. 
     
     
         15 . 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 .   
     
     
         16 . A method according to  claim 15  wherein said infection is acute otitis externa or acute otitis media with tympanostomy tubes. 
     
     
         17 . A method according to  claim 15 , said method comprising instilling the composition into the affected tissue once a day.

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