Aerosol fluoroquinolone formulations for improved pharmacokinetics

Abstract

The present invention relates to the field of antimicrobial agents. In particular, the present invention relates to the use of aerosolized fluoroquinolones formulated with divalent or trivalent cations and having improved pulmonary availability for the treatment and management of bacterial infections of the lung and upper respiratory tract.

1 .- 10 . (canceled) 
     
     
         11 . A method of treating a chronic pulmonary infection due to  Pseudomonas aeruginosa  in a subject with cystic fibrosis in need thereof, the method comprising administering to the lungs of the subject with cystic fibrosis about 240 mg of an aerosol of a solution comprising about 100 mg/ml of levofloxacin and about 200 mM of magnesium chloride; wherein the solution has a pH from about 5 to about 7 and an osmolality from about 350 mOsmol/kg to about 400 mOsmol/kg, to treat the chronic pulmonary infection due to  Pseudomonas aeruginosa.    
     
     
         12 . A method of treating a  Pseudomonas aeruginosa  pulmonary infection in a subject in need thereof, the method comprising administering to the lungs of the subject an aerosol of a solution comprising from about 90 mg/ml to about 110 mg/ml of levofloxacin and from about 190 mM to about 210 mM of a magnesium cation to treat the  Pseudomonas aeruginosa  pulmonary infection. 
     
     
         13 . The method of  claim 12 , wherein the subject has cystic fibrosis. 
     
     
         14 . The method of  claim 12 , wherein the solution comprises about 100 mg/ml of levofloxacin and about 200 mM of the magnesium cation; wherein the solution has a pH from about 5 to about 7 and an osmolality from about 300 mOsmol/kg to about 500 mOsmol/kg; and wherein from about 200 mg to about 280 mg of levofloxacin is administered to the subject. 
     
     
         15 . The method of  claim 14  wherein from about 230 mg to about 250 mg of levofloxacin is administered to the subject. 
     
     
         16 . The method of  claim 14  wherein the solution has a pH from about 6.0 to about 6.5 and an osmolality from about 350 mOsmol/kg to about 400 mOsmol/kg. 
     
     
         17 . The method of  claim 14 , wherein the magnesium cation is in the form of magnesium chloride.