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Claims for Patent: 6,632,842

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Claims for Patent: 6,632,842

Title: 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.
Inventor(s): Chaudry; Imtiaz (Napa, CA), Banerjee; Partha (San Ramon, CA)
Assignee: Dey, L.P. (Napa, CA)
Application Number:10/162,460
Patent Claims: 1. A method of reducing medication error and enhancing therapeutic compliance of an individual suffering from chronic obstructive pulmonary disease, said method comprising the steps of: (a) administering to the individual at least one single dispensing container wherein the container is prefilled with about 3 ml of a sterile, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution comprising a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the amount of albuterol is about 2.5 mg and the amount of ipratropium bromide is about 0.5 mg; the inhalation solution in the container is suitable for nebulization in a nebulizer; the inhalation solution in the container is stable, in that the inhalation solution is therapeutically effective following storage for 12 months at 25.degree. C.; and (b) providing prescribing information; said prescribing information comprising dosage, administration, contraindication and adverse reaction information pertaining to the inhalation solution in the container; (c) wherein the contraindication information comprises information indicating that the inhalation solution in the container is contraindicated for humans with hypersensitivity to atropine and derivatives thereof; and (d) wherein the adverse reaction information comprises information indicating that lung disease, bronchitis, diarrhea, and pharyngitis may occur after administrating the inhalation solution in the container.

2. The method of claim 1, wherein the prescribing information comprises information indicating that immediate hypersensitivity reactions to the inhalation solution in container may occur after administration of the inhalation solution, said hypersensitivity reaction including urticaria, angioedema, rash, pruritis, oropharyngeal cdema, bronchospasm, and anaphylaxis; wherein the adverse reaction information comprises information indicating that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, pneumonia dyspepsia, urinary tract infection, wheezing, exacerbation of chronic obstructive pulmonary, disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat and constipation may occur after administrating the inhalation solution in the container.

3. A method of reducing medication error and enhancing therapeutic compliance of an individual suffering from chronic obstructive pulmonary disease, said method comprising the steps of: (a) administering to the individual at least one single dispensing container wherein the container is prefilled with about 3 ml of a sterile, premixed, premeasured aqueous inhalation solution free of benzalkonium chloride; the inhalation solution comprising water, edetate disodium, sodium chloride, and an acid to adjust the pH of the inhalation solution between about 3 and 4, and a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein the amount of albuterol is about 2.50 mg/3 ml and the amount of ipratropium bromide is about 0.5 mg/3 ml; the inhalation solution in the container is suitable for nebulization in a nebulizer; the inhalation solution in the container is stable, in that the inhalation solution is therapeutically effective following storage for 12 months at 25.degree. C.; (b) providing prescribing information; said prescribing information comprising efficacy, dosage and administration, contraindication and adverse reaction information pertaining to the inhalation solution in the container; (c) wherein the dosage and administration information indicates that the recommended dose of the inhalation solution is one container prefilled with 3 ml of the inhalation solution administered 4 times per day by nebulization with up to 2 additional doses allowed per day, if needed; (d) wherein the contraindication information comprises information indicating that the inhalation solution in the container is contraindicated for humans with hypersensitivity to atropine and derivatives thereof; (e) wherein the adverse reaction information comprises information indicating that immediate hypersensitivity reactions to the inhalation solution in the container may occur after administrating the inhalation solution in the container, said hypersensitivity reaction including urticaria, angioedema, rash, pruritis, oropharyngeal edema, bronchospasm, and anaphylaxis; (f) wherein the adverse reaction information comprises information indicating that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the container; and (g) wherein the adverse reaction information comprises information indicating that, after administration of the inhalation solution in the container, one or more adverse reactions may occur; such adverse events comprising chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
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