Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease
AssigneeDey, L.P.
InventorsImtiaz Chaudry, Partha Banerjee
Life of this patent
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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.
Claims79
An inhalation solution comprising:
- a premixed, premeasured aqueous formulation comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide for inducing bronchodilation or providing relief of bronchospasm in patients suffering from chronic obstructive pulmonary disease, wherein the amount of albuterol in the inhalation solution ranges from about 0.60 mg to about 5.0 mg and the amount of ipratropium bromide ranges from about 0.01 mg to about 1.0 mg;
- the solution being provided in a single container.
An inhalation solution comprising:
- a sterile, premixed, premeasured aqueous formulation free of benzalkonium chloride comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide for inducing bronchodilation or providing relief of bronchospasm in patients suffering from chronic obstructive pulmonary disease, wherein the amount of albuterol in the solution is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg, the solution being provided in a single container and wherein the inhalation solution is suitable for nebulization in a nebulizer.
A method of inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the steps:
- (a) placing the inhalation solution into a chamber of a nebulizer, said nebulizer having a mouthpiece or facemask associated with the chamber of the nebulizer;
- (b) positioning the mouthpiece or facemask in close proximity to the patient's mouth or face;
- (c) passing the inhalation solution in a mist form from the nebulizer chamber through the mouthpiece or facemask to the patient while the patient breathes into the mouthpiece or facemask;
- and
- (d) the patient breathing into the mouthpiece or facemask until at least substantially all the mist is removed from the nebulizer chamber.
A kit for treating bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said kit comprising:
- (a) one or more containers;
- said one or more containers each comprising a premixed, premeasured aqueous inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide;
- wherein the amount of albuterol in the solution ranges from about 0.60 mg to about 5.00 mg and the amount of ipratropium bromide in the solution ranges from about 0.01 mg to about 1.00 mg;
- the solution being suitable for nebulization in a nebulizer.
A kit for treating bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said kit comprising:
- (a) one or more containers;
- said one or more containers each comprising a sterile, benzalkonium-free, premixed, premeasured aqueous inhalation solution for use in a nebulizer;
- said inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein said amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg;
- (b) a label which indicates that the inhalation solution can be used to relieve bronchospasm in patients suffering from chronic obstructive pulmonary disease;
- and
- (c) instructions for using the solution to relieve said bronchospasm.
A prepackaged therapeutic system for treating bronchospasm in patients suffering from chronic obstructive pulmonary disease, said prepackaged therapeutic system comprising packaging material, wherein said packaging material comprises:
- (a) one or more containers;
- said one or more containers each comprising a premixed, premeasured aqueous inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide;
- wherein said amount of albuterol ranges from 0.60 mg to about 5.0 mg and said amount of ipratropium bromide ranges from about 0.01 mg to about 1.0 mg;
- the solution being suitable for nebulization in a nebulizer.
A prepackaged therapeutic system for treating bronchospasm in patients suffering from chronic obstructive pulmonary disease, said prepackaged therapeutic system comprising packaging material, wherein said packaging material comprises:
- (a) one or more containers;
- the one more containers each comprising a sterile, premixed, premeasured aqueous inhalation solution free of benzalkonium chloride for nebulization in a nebulizer;
- the inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein the amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg;
- (b) a label indicating that the inhalation solution can be used to relieve said bronchospasm;
- and
- (c) instructions for using the inhalation solution to relieve said bronchospasm.
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) providing the inhalation solution in a single container.
A device for use in relieving bronchospasm in a patient suffering from chronic obstructive pulmonary disease, the device having indicia;
- the indicia providing instructions for utilizing a premixed, premeasured inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide to treat said bronchospasm;
- wherein said amount of albuterol ranges from about 2.00 mg to about 3.00 mg albuterol and the amount of ipratropium bromide ranges from 0.20 mg to 0.60 mg;
- said solution being suitable for nebulization in a nebulizer.
A method of making a prepackaged, stable, premeasured, premixed aqueous nebulizer solution for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease;
- said method comprising the steps:
- a) mixing water, EDTA, hydrochloric acid, an osmotic adjusting agent, albuterol sulfate and ipratropium bromide into a stainless steel tank at a temperature between 18° C. and 25° C. to form a nebulizer solution;
- i) the final concentration of the albuterol and ipratropium bromide in the nebulizer solution ranges from about 0.06 wt. % to about 0.1 wt. % albuterol and about 0.03 wt. % to about 0.1 wt. % ipratropium;
- ii) sufficient hydrochloric acid is added to the nebulizer solution so that the pH of said solution is about 3.0 to about 4.0;
- iii) sufficient osmotic adjusting agent is added to the nebulizer solution so that the isotonicity of said solution is about 280 to about 320 mOsm/kg;
- and
- b) passing the nebulizer solution through at least one sterilizing filter;
- c) sterile filling the nebulizer solution into one or more low density polyethylene dispensing containers, each container being filled with about 3 ml of the sterile, premixed, premeasured aqueous nebulizer solution comprising a unit dose of therapeutically effective amount of albuterol and ipratropium bromide, wherein the dosage of albuterol ranges from about 2.00 mg to about 3.00 mg and the dosage of ipratropium bromide ranges from about 0.1 mg to about 1.0 mg;
- d) sterile sealing each of the one or more dispensing containers containing the nebulizer solution;
- and
- wherein the stability of the nebulizer solution in the one or more dispensing containers is such that the shelf-life of said solution is more than 12 months;
- wherein the nebulizer solution is free of benzalkonium chloride.
A method of making a prepackaged, stable, premeasured, premixed aqueous nebulizer solution for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease;
- said method comprising the steps:
- a) adding purified water into a stainless steel tank at a temperature of between 18° C. to 25° C.;
- said tank having a bottom drain and a tri-blender for mixing;
- b) while mixing, adding EDTA, hydrochloric acid and at least a therapeutically effective amount of albuterol sulfate and ipratropium bromide to the tank until dissolved;
- c) adding purified water to adjust the final volume to a desired amount, thus forming the nebulizer solution;
- i) the final concentration of the albuterol and ipratropium bromide in the nebulizer solution ranges from about 0.06 wt. % to about 0.1 wt. % albuterol and about 0.03 wt. % to about 0.1 wt. % ipratropium;
- ii) sufficient hydrochloric acid is added to the nebulizer solution so that the pH of said solution to about 3.0 to about 4.0;
- iii) sufficient osmotic adjusting agent is added to the nebulizer solution so that isotonicity of said solution is about 280 to about 320 mOsm/kg
- b) passing the nebulizer solution through a sanitary delivery line directly into a form-fill-seal (FFS) machine;
- c) passing the nebulizer solution through a first 0.2 micron sterilizing cartridge filter, then passing the nebulizer solution into a reservoir tank;
- and then passing the nebulizer solution through a second 0.2 micron sterilizing cartridge filter;
- d) said second cartridge filter being connected to at least one filling nozzle positioned within a sterile air shower compartment;
- the nebulizer solution is passed through the filling nozzle into one or more preformed low density polyethylene dispensing containers;
- e) filling each of the one or more dispensing containers with about 3 ml of the nebulizer 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 to 1.0 mg ipratropium;
- f) sterile sealing each of the one or more dispensing containers containing the nebulizer solution;
- and
- g) wherein the stability of the nebulizer solution is such that the shelf-life of said solution in one or more dispensing containers is more than 12 months;
- wherein the nebulizer solution is free of benzalkonium chloride.
Dependencies are inferred from the claim text.