Optimised formulation of tobramycin for aerosolization

Abstract

The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.

1 . A method for treating a lung infection, said method comprising administering an effective amount of an aerosol formulation to a subject in need thereof, said aerosol formulation comprising:
 75 mg/ml of tobramycin dissolved in an aqueous solution containing 0.45% w/v of sodium chloride;   wherein the pH is between 4.5 and 5.5 and the osmolarity ranges between 250 and 450 mOsm/l, and   said formulation is free of preservatives and anti-oxidants.   
     
     
         2 . The method according to  claim 1 , wherein said lung infection is due to Gram positive bacteria. 
     
     
         3 . The method according to  claim 1 , wherein said lung infection is due to Gram negative bacteria. 
     
     
         4 . The method according to  claim 1 , wherein said subject is suffering from cystic fibrosis. 
     
     
         5 . The method according to  claim 1 , wherein said subject is suffering from bronchiectasis. 
     
     
         6 . The method according to  claim 1 , wherein said subject is suffering from bronchiectasis and infected with  Pseudomonas aeruginosa.    
     
     
         7 . The method according to  claim 1 , wherein said subject is suffering from a chronic pneumopathy. 
     
     
         8 . The method according to  claim 1 , wherein said subject is suffering from bronchial asthma. 
     
     
         9 . The method according to  claim 1 , wherein the pH of said aerosol formulation is 5.2 and the osmolarity thereof is between 280 and 350 mOsm/l. 
     
     
         10 . The method according to  claim 1 , wherein said osmolarity of said aerosol formulation is from 280 to 350 mOsm/l.