Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof

Abstract

A system for treating or providing prophylaxus against a pulmonary infection is disclosed comprising: a) a pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition, and b) an inhalation delivery device. A method for providing prophylaxis against a pulmonary infection in a patient and a method of reducing the loss of antiinfective encapsulated in a lipid-based composition upon nebulization comprising administering an aerosolized pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition is also disclosed.

1 . A method of treatment, comprising: aerosolizing a liquid composition to create aerosolized particles; inhaling the aerosolized particles into a patient's lungs; wherein the liquid composition comprises free, unencapsulated ciprofloxacin in an aqueous solution at an effective concentration with a pharmaceutically acceptable salt or buffering agent; and a liposome-encapsulated ciprofloxacin wherein the liposomes of the liposome-encapsulated ciprofloxacin are comprised of cholesterol and a phospholipid. 
     
     
         2 . The method of  claim 1 , wherein the phospholipid is a phosphatidylcholine. 
     
     
         3 . The method of  claim 2 , wherein the phosphatidylcholine is hydrogenated soy phosphatidyl-choline. 
     
     
         4 . The method of  claim 1 , wherein the aerosolized particles are sized for positioning the particles within the pulmonary membrane. 
     
     
         5 . The method of  claim 1 , wherein the ratio by weight of the free unencapsulated ciprofloxacin to the liposome-encapsulated ciprofloxacin is between about 1:100 and about 100:1. 
     
     
         6 . The method of  claim 1 , wherein the patient is suffering from a pulmonary infection. 
     
     
         7 . The method of  claim 5 , wherein the pulmonary infection is due to  P. aeruginosa.    
     
     
         8 . The method of  claim 1 , wherein the liposomes have a mean diameter of about 0.01 microns to about 3 microns. 
     
     
         9 . The method of  claim 1 , wherein the patient is a cystic fibrosis patient. 
     
     
         10 . The method of  claim 7 , wherein the patient is a cystic fibrosis patient. 
     
     
         11 . The method of  claim 1 , wherein the liposomes further comprise an additional component selected from the group consisting of synthetic, semi-synthetic or naturally occurring lipids, phospholipids, tocopherols, sterols, fatty acids and glycoproteins. 
     
     
         12 . The method of  claim 1 , wherein the patient is a bronchiectasis patient. 
     
     
         13 . The method of  claim 3 , wherein the patient is a bronchiectasis patient.