Methods and unit dose formulations for the inhalation administration of aminoglycoside antibiotics

Abstract

A patient suffering from an endobronchial infection is treated by administering to the patient for inhalation a dose of less than about 4.0 ml of a nebulized aerosol formulation comprising from about 60 to about 200 mg/ml of an aminoglycoside antibiotic, such as tobramycin, in a physiologically acceptable carrier in a time period of less than about 10 minutes. Unit dose devices for storage and delivery of the aminoglycoside antibiotic formulations are also provided.

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:  
     
         1 . A method of the treatment of a patient in need of such treatment comprising administering to the patient a dose of 4.0 ml or less of a nebulized aerosol formulation comprising from about 60 to about 200 mg/ml of an aminoglycoside antibiotic in less than 10 minutes.  
     
     
         2 . A method of  claim 1  wherein the dose comprises less than about 3.75 ml of the nebulized aerosol formulation.  
     
     
         3 . A method of  claim 1  wherein the dose comprises 3.5 ml or less of the nebulized aerosol formulation.  
     
     
         4 . A method of  claim 1  wherein the aerosol formulation comprises from about 80 to about 180 mg/ml of the aminoglycoside antibiotic.  
     
     
         5 . A method of  claim 1  wherein the aerosol formulation comprises from about 90 to about 150 mg/ml of the aminoglycoside antibiotic.  
     
     
         6 . The method of  claim 1  wherein the aminoglycoside antibiotic is selected from the group consisting of gentamycin, amikacin, kanamycin, streptomycin, neomycin, netilmicin and tobramycin.  
     
     
         7 . A method of  claim 6  wherein the aminoglycoside antibiotic is tobramycin.  
     
     
         8 . A method of  claim 7  wherein the dose comprises 3.5 ml or less of a nebulized aerosol formulation comprising from about 80 to about 180 mg/ml of tobramycin.  
     
     
         9 . A unit dose device, comprising a container containing less than about 4.0 ml of an aminoglycoside antibiotic formulation comprising from about 60 to about 200 mg/ml of an aminoglycoside antibiotic in a physiologically acceptable carrier.  
     
     
         10 . A unit dose device of  claim 9  which contains less than about 3.75 ml of the aminoglycoside antibiotic formulation.  
     
     
         11 . A unit dose device of  claim 9  which contains 3.5 ml or less of the aminoglycoside antibiotic formulation.  
     
     
         12 . A unit dose device of  claim 9  wherein the aminoglycoside antibiotic formulation comprises from about 80 to about 180 mg/ml of the aminoglycoside antibiotic.  
     
     
         13 . A unit dose formulation of  claim 9  wherein the aminoglycoside antibiotic formulation comprises from about 90 to about 150 mg/ml of the aminoglycoside antibiotic.  
     
     
         14 . A unit dose formulation of  claim 9  wherein the aminoglycoside antibiotic is selected from the group consisting of gentamycin, amikacin, kanamycin, streptomycin, neomycin, netilmicin and tobramycin.  
     
     
         15 . A unit dose formulation of  claim 14  wherein the aminoglycoside antibiotic is tobramycin.  
     
     
         16 . A unit dose device of  claim 9  which contains less than about 4.0 ml of aminoglycoside antibiotic formulation comprising from about 80 to about 180 mg/ml of tobramycin.  
     
     
         17 . A system for delivering an aminoglycoside antibiotic formulation to a patient in need of such treatment, comprising a unit dose device comprising a container containing less than about 4.0 ml of an aminoglycoside antibiotic formulation comprising from about 60 to about 200 mg/ml of an aminoglycoside antibiotic in a physiologically acceptable carrier, and means for delivering the aminoglycoside antibiotic formulation from the unit dose device for inhalation by the patient in aerosolized form in less that 10 about minutes.