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Claims for Patent: 6,702,997

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Claims for Patent: 6,702,997

Title: Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Abstract:The present invention relates to an albuterol inhalation solution, system, kit and method for relieving bronchospasm in children suffering from asthma. In one alternative embodiment, the solution of the present invention is a sterile, premixed, premeasured single unit dose of albuterol for asthmatic patients 2 to 12 years of age. The present solution may be free of anti-microbial preservatives, such as benzalkonium chloride. In another alternative embodiment, the solution of the present invention comprises about 0.63 mg or about 1.25 mg albuterol.
Inventor(s): Chaudry; Imtiaz (Napa, CA), Banerjee; Partha (San Ramon, CA)
Assignee: Dey, L.P. (Napa, CA)
Application Number:10/034,829
Patent Claims: 1. A method for inducing bronchodilation in a child 2-12 years of age with asthma, said method comprising the step of: (a) administering to the child at least one single dispensing container comprising; a sterile, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution comprising an active ingredient, the active ingredient consisting essentially of a unit dose of a therapeutically effective pediatric amount of racemic albuterol sulfate; wherein the dosage of racemic albuterol sulfate is from about 0.21 mg to about 1.90 mg; the inhalation solution is suitable for nebulization in a nebulizer; wherein the inhalation solution in the at least one single container is stable, in that the inhalation solution is therapeutically effective following storage for 12 months.

2. The method of claim 1, further comprising the step of: (a) providing indication, adverse reaction, dosage and administration data pertaining to the inhalation solution in the at least one single container; wherein the indication data informs the patient or prescriber that the inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma.

3. The method of claim 2, wherein the adverse reaction data includes a list of one or more adverse events that may occur after administering the inhalation solution the adverse events comprising ottis media.

4. A method for inducing bronchodilation in a child 2-12 years of age wit asthma, said method comprising the step of: (a) administering to the child at least one single dispensing coritainer comprising; a sterile, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution comprising an active ingredient, the active ingredient consisting essentially of a unit dose of a therapeutically effective pediatric amount of racemic albuterol sulfate; wherein the dosage of racemic albuterol sulfate is selected from the group of ranges consisting essentially of about 0.5 mg to about 0.6 mg; about 0.7 mg to about 0.8 mg; about 0.9 mg to about 1.0 mg; about 1.21 mg to about 1.40 mg; about 1.41 mg to about 1.60 mg; about 1.61 mg to about 1.80 mg; the inhalation solution in the at least one single container is suitable for nebulization in a nebulizer; wherein the inhalation solution is stable in that the inhalation solution is therapeutically effective following storage for 12 months; (b) providing data comprising adverse reaction, dosage and administration data pertaining to the inhalation solution in the at least one single container; (c) wherein the indication data providing that the inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma; (d) wherein the adverse reaction data provides that otitis media, asthma exacerbation, might occur after administering the inhalation solution.

5. The method of claim 2, wherein the adverse reaction data includes a list of one or more adverse events that may occur after administering the inhalation solution the adverse events comprising asthma exacerbation.

6. The method of claims 1, 2 or 3 wherein the dosage of racemic albuterol sulfate is about 0.70 mg to about 0.80 mg.

7. The method of claims 1, 2 or 3 wherein the dosage of racemic albuterol sulfate is about 1.41 mg to about 1.60 mg.

8. The method of claims 1, 2 or 3 wherein the dosage of racemic albuterol sulfate is about 0.75 mg.

9. The method of claims 1, 2 or 3 wherein the dosage of racemic albuterol sulfate is about 1.50 mg.
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