AEROSOLIZED FLUOROQUINOLONES AND USES THEREOF
Disclosed herein are formulations of fluoroquinolones suitable for aerosolization and use of such formulations for aerosol administration of fluoroquinolone antimicrobials for the treatment of pulmonary bacterial infections. In particular, inhaled levofloxacin specifically formulated and delivered for bacterial infections of the lungs is described. Methods include inhalation protocols and manufacturing procedures for production and use of the compositions described.
1 - 22 . (canceled)
23 . A method of treating a bacterial lung infection caused by one or more of the following bacteria: Pseudomonas aeruginosa, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium intracellulare , and Mycobacterium leprae , comprising administering a pharmaceutical aerosol for nasal, sinunasal or pulmonary administration comprising a dispersed liquid phase and a continuous gas phase, wherein the dispersed liquid phase:
(a) consists essentially of aqueous droplets comprising levofloxacin, and at least one excipient comprising a multivalent metal ion;
(b) has a mass median diameter from about 1 to about 5 sm; and
(c) has a droplet size distribution exhibiting a geometrical standard deviation less than or equal to about 3.0 sm.
24 . The method of claim 23 , wherein at least about 20 mg of levofloxacin is administered to the lung.
25 . The method of claim 24 , wherein at least about 100 mg of levofloxacin is administered to the lung.
26 . The method of claim 25 , wherein at least about 125 mg of levofloxacin is administered to the lung.
27 . The method of claim 26 , wherein at least about 150 mg of levofloxacin is administered to the lung.
28 . The method of claim 23 , wherein the aerosol is administered to the lung in less than about 10 minutes.
29 . The method of claim 28 , wherein the aerosol is administered to the lung in less than about 5 minutes.
30 . The method of claim 29 , wherein the aerosol is administered to the lung in less than about 3 minutes.
31 . The method of claim 30 , wherein the aerosol is administered to the lung in less than about 2 minutes.
32 . The method of claim 23 , comprising administering the aerosol once daily.
33 . The method of claim 23 , comprising administering the aerosol twice daily.