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US 2003/0140920 A1Published application
Albuterol inhalation soultion, system, kit and method for relieving symptoms of pediatric asthma
AssigneeDey, L.P.
InventorsImtiaz Chaudry, Partha Banerjee
Life of this patent
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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.
Claims63
A pediatric inhalation solution comprising:
- a premixed, premeasured aqueous formulation comprising a single unit dose of a therapeutically effective pediatric amount of albuterol for inducing bronchodilation or providing relief of bronchospasm in children suffering from asthma, wherein the amount of albuterol in the inhalation solution ranges from about 0.08 mg to about 1.90 mg;
- the solution being provided in a single container.
A pediatric inhalation solution comprising:
- a sterile, premixed, premeasured aqueous formulation free of benzalkonium chloride comprising a single unit dose of a therapeutically effective pediatric amount of albuterol for inducing bronchodilation or providing relief of bronchospasm in children suffering from asthma, wherein the amount of albuterol in the solution ranges from about 0.63 mg to about 1.25 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 child suffering from asthma, 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 child's mouth or face;
- (c) passing the inhalation solution in a mist form from the nebulizer chamber through the mouthpiece or facemask to the child while the child breathes into the mouthpiece or facemask;
- and
- (d) the child breathing into the mouthpiece or facemask until at least substantially all the mist is removed from the nebulizer chamber.
2 more elements
A kit for relieving bronchospasm in a child suffering from asthma, 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 pediatric amount of albuterol;
- wherein the amount of albuterol in the solution ranges from about 0.08 mg to about 1.90 mg;
- the solution being suitable for nebulization in a nebulizer.
1 more element
A kit for treating bronchospasm in a child suffering from asthma, said kit comprising:
- (a) one or more containers;
- said one or more containers each comprising a sterile, premixed, premeasured aqueous inhalation solution free of benzalkonium chloride for use in a nebulizer;
- said inhalation solution comprising a single unit dose of a therapeutically effective pediatric amount of albuterol, wherein said pediatric amount ranges from about 0.63 mg to about 1.25 mg;
- (b) a label which indicates that the inhalation solution can be used to relieve bronchospasm in children suffering from asthma;
- and
- (c) instructions for using the inhalation solution to relieve said bronchospasm.
3 more elements
A prepackaged therapeutic system for relieving bronchospasm in children suffering from asthma, 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 pediatric amount of albuterol;
- wherein said pediatric amount of albuterol ranges from 0.08 mg to about 1.90 mg;
- the solution being suitable for nebulization in a nebulizer.
1 more element
A prepackaged therapeutic system for relieving bronchospasm in children suffering from asthma, 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 antimicrobial preservative for nebulization in a nebulizer;
- the inhalation solution comprising a single unit dose of a therapeutically effective pediatric amount of albuterol, wherein the pediatric amount of albuterol ranges from about 0.63 mg to about 1.25 mg;
- (b) a label indicating that the inhalation solution can be used to relieve bronchospasm in children;
- and
- (c) instructions for using the inhalation solution to relieve bronchospasm in children.
3 more elements
A method of making a premixed, premeasured inhalation solution for relieving bronchospasm in children suffering from asthma;
- said method comprising the steps:
- (a) placing a unit dose of a therapeutically effective pediatric amount of albuterol in a pharmaceutically acceptable vehicle, wherein the amount of albuterol in the vehicle ranges from about 0.08 mg to about 1.90 mg;
- (b) providing the inhalation solution in a single container.
A method of making a premixed, premeasured inhalation solution for relieving bronchospasm in a child suffering from asthma;
- said method comprising the steps:
- (a) placing a unit dose of a therapeutically effective pediatric amount of albuterol in a pharmaceutically acceptable vehicle, wherein the amount of albuterol in the vehicle ranges from about 0.002 weight percent to about 0.075 weight percent;
- (b) providing the inhalation solution in a single container.
A device for use in the relieving bronchospasm in a child suffering from asthma, the device having indicia;
- the indicia providing instructions for utilizing a premixed, premeasured inhalation solution comprising a single unit dose of a therapeutically effective pediatric amount of albuterol to relieve said bronchospasm;
- wherein said pediatric amount of albuterol ranges from about 0.63 mg to about 1.25 mg albuterol;
- said solution being suitable for nebulization in a nebulizer.
A prepackaged therapeutic system for inducing bronchodilation in a child suffering from asthma, the prepackaged therapeutic system comprising:
- (e) one or more dispensing containers;
- the one or more containers each prefilled with about 3 ml of a sterile, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution comprising a unit dose of a therapeutically effective pediatric amount of racemic albuterol;
- wherein the dosage of racemic albuterol is about 0.63 or about 1.25 mg;
- the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer;
- wherein the inhalation solution in each of the one or more containers has a long shelf life;
- (f) indicia comprising indication, adverse reaction, dosage and administration data pertaining to the inhalation solution in each of the one or more containers;
- (g) wherein the indication data comprises data that the inhalation solution in each of the one or more containers is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma;
- and
- (h) wherein the adverse reaction data comprises data indicating that otitis media and skin-appendage infection might occur after administering the inhalation solution in the one or more containers.
6 more elements
A prepackaged therapeutic system for inducing bronchodilation in a child suffering from asthma, the prepackaged therapeutic system comprising:
- (f) one or more dispensing containers;
- the one or more containers each prefilled with about 3 ml of a sterile, stable, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution consisting essentially of a unit dose of a therapeutically effective pediatric amount of racemic albuterol;
- wherein the dosage of racemic albuterol is about 0.63 or about 1.25 mg;
- wherein the racemic albuterol is in the form of an acid addition salt;
- wherein the acid addition salt is albuterol sulfate;
- the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer;
- wherein the inhalation solution in each of the one or more containers has a long shelf life;
- (g) indicia comprising indication, adverse reaction, and dosage and administration data pertaining to the inhalation solution in each of the one or more containers;
- (h) wherein the indication data comprises data that the inhalation solution in each of the one or more containers is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma;
- (i) wherein the adverse reaction data comprises a list of preprinted adverse events that may occur after administering the inhalation solution in each of the one or more containers;
- the adverse events comprising otitis media, skin-appendage infection, asthma exacerbation, allergic reaction, gastroenteritis, flu syndrome, lymphadenopathy, urticaria, migraine, chest pain, bronchitis or nausea;
- and
- (j) wherein the dosage and administration data comprises data that the dosage for patients 2 to 12 years of age is 0.63 mg or 1.25 mg of albuterol administered 3 to 4 times daily by nebulization over 5 to 15 minutes.
10 more elements
A method for inducing bronchodilation in a child suffering from asthma, said method comprising the step of:
- (b) providing the child or prescriber a prepackaged therapeutic system comprising:
- one or more dispensing containers;
- the one or more containers each prefilled with about 3 ml of a sterile, stable, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution comprising a unit dose of a therapeutically effective pediatric amount of racemic albuterol;
- wherein the dosage of racemic albuterol is about 0.63 or about 1.25 mg;
- the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer;
- wherein the inhalation solution in each of the one or more containers has a long shelf life;
- (e) providing the child or prescriber of the prepackaged therapeutic system indication, adverse reaction, dosage and administration data pertaining to the inhalation solution in each of the one or more containers;
- (f) wherein the indication data informs the patient or prescriber that the inhalation solution in each of the one or more containers is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma;
- and
- (g) wherein the adverse reaction data informs the patient or prescriber that otitis media and skin-appendage infection might occur after administering the inhalation solution in the one or more containers.
7 more elements
A method for inducing bronchodilation in a child suffering from asthma, said method comprising the step of:
- (b) providing the child or prescriber a prepackaged therapeutic system comprising:
- one or more dispensing containers;
- the one or more containers each prefilled with about 3 ml of a sterile, stable, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution consisting essentially of a unit dose of a therapeutically effective pediatric amount of racemic albuterol;
- wherein the dosage of racemic albuterol is about 0.63 or about 1.25 mg;
- wherein the racemic albuterol is in the form of an acid addition salt;
- wherein the acid addition salt is albuterol sulfate;
- the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer;
- wherein the inhalation solution in each of the one or more containers has a long shelf life;
- (f) providing the child or prescriber of the prepackaged therapeutic system indication, adverse reaction, dosage and administration data pertaining to the inhalation solution in each of the one or more containers;
- (g) wherein the indication data informs the patient or prescriber that the inhalation solution in each of the one or more containers is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma;
- (h) wherein the adverse reaction data informs the patient or prescriber that otitis media, skin-appendage infection, asthma exacerbation, allergic reaction, gastroenteritis, flu syndrome, lymphadenopathy, urticaria, migraine, chest pain, bronchitis or nausea might occur after administering the inhalation solution in the one or more containers;
- and
- (i) wherein the dosage and administration data comprises data that informs the patient or prescriber that the dosage for patients 2 to 12 years of age is 0.63 mg or 1.25 mg of albuterol administered 3 to 4 times daily by nebulization over 5 to 15 minutes.
10 more elements
Dependencies are inferred from the claim text.