Methods for the inhalation administration of antibiotics

Abstract

A patient suffering from an endobronchial infection is treated by administering to the patient for inhalation a dose of less than about 4.0ml 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.

1 . A method of the treatment of a patient in need of such treatment comprising administering to the patient for inhalation a nebulized unit dose of 4.0 ml or less of an aqueous solution comprising from about 60 to about 200 mg/ml of an antibiotic for a duration of nebulization less than about 10 minutes, using an inhalation device having a rate of aerosol output of not less than about 4 μl/sec.  
     
     
         2 . A method of  claim 1  wherein the unit dose comprises less than about 3.75 ml of the aqueous solution.  
     
     
         3 . A method of  claim 1  wherein the unit dose comprises 3.5 ml or less of the aqueous solution.  
     
     
         4 . A method of  claim 1  wherein the aqueous solution comprises from about 80 to about 180 mg/ml of the antibiotic.  
     
     
         5 . A method of  claim 1  wherein the aqueous solution comprises from about 90 to about 150 mg/ml of the antibiotic.  
     
     
         6 - 17 . (Canceled)  
     
     
         18 . A method of  claim 1  wherein the inhalation device has a rate of aerosol output of not less than about 5 μl/sec.  
     
     
         19 . A method of  claim 1  wherein the inhalation device has a rate of aerosol output of not less than about 8 μl/sec.  
     
     
         20 . A method of  claim 1  wherein the inhalation device has an emitted dose efficiency of at least about 68 percent.  
     
     
         21 . A method of  claim 1  wherein the inhalation device has an emitted dose efficiency of at least about 75 percent.  
     
     
         22 . A method of  claim 1  wherein the inhalation device has an emitted dose efficiency of at least about 80 percent.  
     
     
         23 . A method of  claim 1  wherein the inhalation device has an emitted dose efficiency of at least about 85 percent.  
     
     
         24 . A method of  claim 1  wherein the duration of nebulization is less than about 8 minutes.  
     
     
         25 . A method of  claim 1  wherein the duration of nebulization is less than about 6 minutes.  
     
     
         26 . A method of  claim 1  wherein the inhalation device is breath actuated.  
     
     
         27 . A method of  claim 1  wherein the antibiotic is an antipseudomonal antibiotic.  
     
     
         28 . A method of  claim 27  wherein the antibiotic is an aminoglycoside antibiotic.  
     
     
         29 . A method of the treatment of a patient in need of such treatment comprising administering to the patient for inhalation a nebulized unit dose of 3.5 ml or less of an aqueous solution comprising from about 90 to about 150 mg/ml of an antipseudomonal antibiotic for a duration of nebulization less than about 6 minutes, using an inhalation device having a rate of aerosol output of not less than about 4 μl/sec.