Ciprofloxacin polymorph and its use

Abstract

The present disclosure relates to ciprofloxacin polymorphs and their use in treating infections.

1 .- 11 . (canceled) 
     
     
         12 . The composition of  claim 36 , wherein the particles have a mean particle size (volume-based distribution) in the range of about 0.5 μm to about 10 μm. 
     
     
         13 . The composition of  claim 12 , wherein the particles have a mean particle size (volume-based distribution) in the range of about 0.5 μm to about 7 μm; or in the range of about 1 to about 5 μm. 
     
     
         14 . The composition of  claim 36 , wherein the particles are uncoated. 
     
     
         15 . The composition of  claim 36 , wherein the composition comprises dry powder or aerosol droplets of the particles, wherein the dry powder or aerosol droplets have a mass median aerodynamic diameter (MMAD) of between about 0.5 μm to about 6 μm diameter, or between about 1 μm to about 3 μm diameter, or between about 2 μm to about 3 μm diameter. 
     
     
         16 . A pharmaceutical composition comprising:
 (a) the composition of  claim 36 ; and   (b) a pharmaceutically acceptable carrier.   
     
     
         17 . A method for treating a bacterial infection, comprising administering to a subject in need thereof an amount effective to treat the bacterial infection of the composition of  claim 36 . 
     
     
         18 . The method of  claim 17 , wherein the bacterial infection comprises a bacterial infection selected from the group consisting of infections of bones and joints, endocarditis, gastroenteritis, malignant otitis externa, respiratory tract infections, cellulitis, infectious diarrhea, urinary tract infections, typhoid fever, prostatitis, anthrax, and chancroid. 
     
     
         19 . The method of  claim 17 , wherein the bacterial infection comprises a respiratory tract infection. 
     
     
         20 . The method of  claim 19 , wherein the respiratory tract infection comprises bronchitis and/or pneumonia. 
     
     
         21 . The method of  claim 17 , wherein the polymorph, composition, or pharmaceutical composition thereof is delivered via pulmonary administration. 
     
     
         22 . (canceled) 
     
     
         23 . The composition of  claim 36 , wherein the composition comprises a dry powder or aerosol droplets having a mass median aerodynamic diameter (MMAD) of between about 0.5 μm to about 6 μm diameter, or between about 1 μm to about 3 μm diameter, or about 2 μm to about 3 μm diameter. 
     
     
         24 . A method of preparing ciprofloxacin hydrochloride particles, comprising
 (a) obtaining a solution or a suspension of 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid in a solvent or mixture of solvents;   (b) feeding and spraying said solution or suspension into a pressurized chamber to obtain a stream of atomized droplets; and   (c) removing the solvent or mixture of solvents from said droplets to form the ciprofloxacin hydrochloride particles.   
     
     
         25 .- 35 . (canceled) 
     
     
         36 . A composition, comprising particles including at least 95% by weight of ciprofloxacin hydrochloride, or a pharmaceutically acceptable salt thereof, wherein the particles have a specific surface area (SSA) of at least 12.9 m 2 /g.