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

A method of making a prepackaged, stable, premeasured, premixed aqueous nebulizer solution for reducing medication error and enhancing therapeutic compliance of an individual suffering from chronic obstructive pulmonary disease;

• said method comprising the steps:
• (a) adding water into a container at a temperature of between about 2° C. and about 50° C.;
• (b) adding at least a therapeutically effective amount of albuterol and ipratropium bromide to the container until dissolved;
• (c) adding water to adjust the final volume to a desired amount, thus forming a solution;
• (d) wherein the final concentration of the albuterol and ipratropium bromide in the solution ranges from about 0.06 wt. % to about 0.1 wt. % albuterol and about 0.03 wt. % to about 0.1 wt. % ipratropium;
• (e) adding sufficient acid to the solution so that the pH of the solution is from about 3.0 to about 4.0;
• (f) adding sufficient osmotic adjusting agent to the solution so that the isotonicity of the solution is about 280 mOsm/kg to about 320 mOsm/kg;
• (g) passing the solution through a form-fill-seal (FFS) machine;
• (h) passing the solution through a filling nozzle into one or more preformed low density polyethylene dispensing vials;
• (i) filling each of the one or more dispensing vials with about 0.1 ml to about 3 ml of the solution such that each container contains a sterile, unit dose of albuterol and ipratropium bromide, said dose ranging from about 2.00 mg to about 3.00 mg albuterol and 0.1 mg to 1.0 mg ipratropium;
• (j) sealing each of the one or more dispensing containers containing the solution;
• and
• (k) wherein the stability of the solution is such that the shelf-life of the solution in the one or more dispensing vials is more than 12 months.

A method of making a premixed, premeasured inhalation solution for treating bronchospasm in patients suffering from chronic obstructive pulmonary disease;

• said method comprising the steps:
• (a) placing a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide in a vehicle, wherein the concentration of albuterol in the vehicle ranges from about 0.60 mg to about 5.0 mg and the concentration of the ipratropium bromide in the carrier ranges from 0.01 mg to 1.00 mg;
• and
• (b) adding hydrochloric acid to adjust the pH of the inhalation solution to a level ranging from about 3.0 to about 4.0.
• (c) adding an osmotic agent to adjust the isotonicity of the inhalation solution;
• wherein the osmotic adjusting agent is selected from the group consisting of sodium chloride, potassium chloride, zinc chloride, calcium chloride and mixtures thereof.
• (d) sterilizing the inhalation solution by passing it through a filter or by steam sterilization;
• and
• (e) providing the inhalation solution in a single container, wherein the inhalation solution in the single container comprises about 2.5 mg albuterol and 0.5 ipratropium bromide.