Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease

Abstract

The present invention relates to a dual bronchodilator inhalation solution, system, kit and method for relieving bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD). In one alternative embodiment, the solution of the present invention is a prepackaged, sterile, premixed, premeasured single unit dose of albuterol and ipratropium bromide for patients suffering from COPD. The present solution may be free of antimicrobial preservatives, such as benzalkonium chloride. In another alternative embodiment, the solution of the present invention comprises about 2.50 mg albuterol and about 0.50 mg ipratropium bromide in a 0.5 ml volume.

1 . A system for inducing bronchodilation or providing relief of bronchospasm in an individual suffering from chronic obstructive pulmonary disease, said system comprising:
 (a) one or more single dispensing containers; and   (b) an aqueous inhalation solution comprising a therapeutically effective amount of albuterol and a therapeutically effective amount of about 0.001 mg to about 1.0 mg of ipratropium bromide;   wherein the aqueous inhalation solution is prefilled in each of the one or more dispensing containers as a premixed, premeasured, single unit dose of about 0.1 ml to about 0.5 ml, the aqueous inhalation solution administered to the individual from a nebulizer chamber such that the mist is removed from the nebulizer chamber in less than 12 minutes when said aqueous inhalation solution is introduced into a high performance nebulizer.   
     
     
         2 . The system of  claim 1 , wherein each of the one or more containers is prefilled with about 0.5 ml of the inhalation solution. 
     
     
         3 . The system of  claim 1 , wherein said amount of albuterol ranges from about 2.0 mg to about 3.0 mg. 
     
     
         4 . The system of  claim 1 , wherein the albuterol is albuterol base, and said amount of albuterol base is about 2.5 mg and the amount of ipratropium is about 0.5 mg. 
     
     
         5 . The system of  claim 1 , wherein the inhalation solution in each of the one or more containers is sterile. 
     
     
         6 . The system of  claim 1 , wherein the inhalation solution in each of the one or more containers is free of benzalkonium chloride. 
     
     
         7 . The system of  claim 1 , wherein the system further comprises a label which indicates that the inhalation solution can be used to relieve bronchospasm associated with chronic obstructive pulmonary disease. 
     
     
         8 . The system of  claim 7 , wherein said label comprises instructions for using the solution to relieve said bronchospasm. 
     
     
         9 . The system of  claim 7 , wherein said label comprises prescribing information comprising efficacy, dosage, administration, contraindication and adverse reaction information pertaining to the inhalation solution in the container. 
     
     
         10 . The system of  claim 1 , wherein the mist is removed from the nebulizer chamber in less than 10 minutes when said formulation is introduced into a high performance nebulizer. 
     
     
         11 . The system of  claim 1 , wherein the mist is removed from the nebulizer chamber in less than 8 minutes when said formulation is introduced into a high performance nebulizer. 
     
     
         12 . The system of  claim 1 , wherein the mist is removed from the nebulizer chamber in less than 6 minutes when said formulation is introduced into a high performance nebulizer. 
     
     
         13 . The system of  claim 1 , wherein the mist is removed from the nebulizer chamber in less than 4 minutes when said formulation is introduced into a high performance nebulizer. 
     
     
         14 . A system for inducing bronchodilation or providing relief of bronchospasm in an individual suffering from chronic obstructive pulmonary disease, said system comprising:
 (a) one or more single dispensing containers; and   (b) an aqueous inhalation solution comprising a therapeutically effective amount of albuterol and a therapeutically effective amount of about 0.001 mg to about 1.0 mg of ipratropium bromide;   wherein the aqueous inhalation solution is prefilled in each of the one or more dispensing containers as a premixed, premeasured, single unit dose of about 0.1 ml to about 0.5 ml, the aqueous inhalation solution administered to the individual from the one or more dispensing containers.