CA2464660A1 - Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma - Google Patents
Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma Download PDFInfo
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- CA2464660A1 CA2464660A1 CA002464660A CA2464660A CA2464660A1 CA 2464660 A1 CA2464660 A1 CA 2464660A1 CA 002464660 A CA002464660 A CA 002464660A CA 2464660 A CA2464660 A CA 2464660A CA 2464660 A1 CA2464660 A1 CA 2464660A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
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.
Claims (63)
1. 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 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.
2. The pediatric inhalation solution of claim 1, wherein the inhalation solution is sterile.
3. The pediatric inhalation solution of claim 1, wherein the inhalation solution is free of antimicrobial preservative.
4. The pediatric inhalation solution of claim 3, wherein the antimicrobial preservative is benzalkonium chloride.
5. The pediatric inhalation solution of claim 1, wherein the pH of the inhalation solution ranges from about 3.0 to about 4Ø
6. The pediatric inhalation solution of claim 1, wherein the pH of the inhalation solution is about 3.5.
7. The pediatric inhalation solution of claim 1, wherein the albuterol is in the form of an acid addition salt thereof.
8. The pediatric inhalation solution of claim 7, wherein the acid addition salt of albuterol is albuterol sulfate.
9. The pediatric inhalation solution of claim 1, wherein the albuterol is in the form of a racemic mixture.
10. The pediatric inhalation solution of claim 1, wherein the amount of albuterol in the inhalation solution ranges from about 0.63 mg to about 1.25 mg.
11. The pediatric inhalation solution of claim 1, wherein the amount of albuterol in the solution is about 0.63 mg or about 1.25 mg.
12. The pediatric inhalation solution of claim 1, wherein the inhalation solution is suitable for nebulization in a nebulizer.
13. The pediatric inhalation solution of claim 12, wherein said nebulizer is selected from the group consisting of a jet nebulizer, ultrasonic nebulizer or breath actuated nebulizer.
14. 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 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.
15. A method of inducing bronchodilation or providing relief of bronchospasm in a child suffering from asthma, said method comprising the step:
(a) administering to said child the pediatric inhalation solution of claim 1.
(a) administering to said child the pediatric inhalation solution of claim 1.
16. The method of claim 15, wherein the pediatric inhalation solution is sterile when administered to the child.
17. The method of claim 15, wherein the pediatric inhalation solution is free of antimicrobial preservative.
18. The pediatric inhalation solution of claim 15, wherein the albuterol is in the form of an acid addition salt thereof.
19. The pediatric solution of claim 18, wherein the acid addition salt of albuterol is albuterol sulfate.
20. The pediatric inhalation solution of claim 15, wherein the albuterol is in the form of a racemic mixture.
21. The pediatric inhalation solution of claim 15, wherein the amount of albuterol in the inhalation solution ranges from about 0.63 mg to about 1.25 mg.
22. The pediatric inhalation solution of claim 15, wherein the amount of albuterol in the inhalation solution is about 0.63 mg or about 1.25 mg.
23. The method of claim 15, wherein the pediatric inhalation solution is administered to the child by nebulization.
24. A method of inducing bronchodilation or providing relief of bronchospasm in a child suffering from asthma, said method comprising the step:
(a) administering to the child the pediatric inhalation solution of claim 14 by nebulization.
(a) administering to the child the pediatric inhalation solution of claim 14 by nebulization.
25. 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.
(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.
26. A method of inducing bronchodilation or providing relief of bronchospasm in a child suffering from asthma, said method comprising the steps of:
(a) providing instructions for administering to the child the pediatric inhalation solution of claim 1.
(a) providing instructions for administering to the child the pediatric inhalation solution of claim 1.
27. 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.
(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.
28. The kit according to claim 27, wherein the inhalation solution is sterile.
29. The kit according to claim 27, wherein the inhalation solution is free of antimicrobial preservative.
30. The kit according to claim 27, wherein the amount of albuterol in the inhalation solution ranges from about 0.63 mg to about 1.25 mg.
31. The kit according to claim 27, wherein the amount of albuterol in the inhalation solution is about 0.63 mg or about 1.25 mg.
32. The kit according to claim 27, further comprising a label which indicates that the inhalation solution can be used to relieve bronchospasm in children suffering from asthma.
33. The kit according to claim 27, further comprising instructions for using the inhalation solution to relieve bronchospasm in children.
34. The kit of claim 27, wherein the one or more containers are packaged in the same pouch or box.
35. The kit of claim 34, wherein said containers comprise semi-permeable plastic and are packaged in an aluminum foil pouch.
36. 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.
(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.
37. 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.
(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.
38. The prepackaged therapeutic system of claim 37, wherein said pediatric amount of albuterol ranges from about 0.63 mg to about 1.25 mg.
39. The prepackaged therapeutic system of claim 37, wherein said pediatric amount of albuterol is about 0.63 mg or about 1.25 mg.
40. The prepackaged therapeutic system of claim 37, wherein the inhalation solution in each of the one or more containers is sterile.
41. The prepackaged therapeutic system of claim 37, wherein the inhalation solution in each of the one or more containers is free of antimicrobial preservative.
42. The prepackaged therapeutic system of claim 37, wherein said packaging material further comprises a label which indicates that the inhalation solution can be used to relieve bronchospasm in children.
43. The prepackaged therapeutic system of claim 37, wherein said packaging material comprises instructions for using the solution to relieve bronchospasm in children.
44. 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.
(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.
45. 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) 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.
46. The method of claim 45, further comprising the step of adding sulfuric acid to adjust the pH of the inhalation solution to a level ranging from about 3.0 to about 4Ø
47. The method of claim 45, further comprising the step of 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.
48. The method according to claim 45, further comprising the step:
(a) sterilizing the inhalation solution by passing it through a filter or by steam sterilization.
(a) sterilizing the inhalation solution by passing it through a filter or by steam sterilization.
49. The process of claim 45, further comprising the step of adding sulfuric acid to adjust the pH of the inhalation solution to a level ranging from about 3.0 to about 4Ø
50. 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) 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.
51. 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.
52. 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.
(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.
53. The prepackaged therapeutic system of claim 52, wherein the racemic albuterol is in the form of an acid addition salt.
54. The prepackaged therapeutic system of claim 53, wherein the acid addition salt is albuterol sulfate.
55. The prepackaged therapeutic system of claim 52, 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.
56. The prepackaged inhalation solution of claim 52, wherein the adverse reaction data includes a list of one or more preprinted adverse events that may occur after administering the inhalation solution in each of the one or more containers, the adverse events comprising asthma exacerbation, allergic reaction, gastroenteritis, flu syndrome, lymphadenopathy, urticaria, migraine, chest pain, bronchitis or nausea.
57. 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.
(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.
58. A method for inducing bronchodilation in a child suffering from asthma, said method comprising the step of:
(b) providing the child or prescribes 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 atbuterol 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.
(b) providing the child or prescribes 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 atbuterol 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.
59. The method of claim 58, wherein the racemic albuterol is in the form of an acid addition salt.
60. The method of claim 59, wherein the acid addition salt of the racemic albuterol is albuterol sulfate.
61. The method of claim 58, wherein the dosage and administration data informs the patient or prescriber that the dosage for children 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.
62. The method of claim 58, wherein the adverse reaction data includes a list of one or more preprinted adverse events that may occur after administering the inhalation solution in each of the one or more containers, the adverse events comprising asthma exacerbation, allergic reaction, gastroenteritis, flu syndrome, lymphadenopathy, urticaria, migraine, chest pain, bronchitis or nausea.
63. 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.
(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.
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US34820301P | 2001-10-26 | 2001-10-26 | |
| US60/348,203 | 2001-10-26 | ||
| US10/034,829 | 2001-12-27 | ||
| US10/034,829 US6702997B2 (en) | 2001-10-26 | 2001-12-27 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| AU32975/02A AU3297502A (en) | 2001-10-26 | 2002-04-05 | An albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| AU32975/02 | 2002-04-05 | ||
| JP2002-145456 | 2002-04-11 | ||
| JP2002145456A JP2003212764A (en) | 2001-10-26 | 2002-04-11 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| PCT/US2002/033352 WO2003037317A1 (en) | 2001-10-26 | 2002-10-18 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2464660A1 true CA2464660A1 (en) | 2003-05-08 |
| CA2464660C CA2464660C (en) | 2011-12-20 |
Family
ID=27422969
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2464660A Expired - Fee Related CA2464660C (en) | 2001-10-26 | 2002-10-18 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP1441709A1 (en) |
| JP (1) | JP2006513129A (en) |
| CA (1) | CA2464660C (en) |
| MX (1) | MXPA04003928A (en) |
| NZ (1) | NZ550304A (en) |
| WO (1) | WO2003037317A1 (en) |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62292719A (en) * | 1986-06-12 | 1987-12-19 | Kaken Pharmaceut Co Ltd | Clear water-soluble drug for external use and production thereof |
| GB8825892D0 (en) * | 1988-11-04 | 1988-12-07 | Fisons Plc | Pharmaceutical composition |
| DE69324161T2 (en) * | 1992-12-09 | 1999-10-28 | Boehringer Ingelheim Pharma | STABILIZED MEDICAL AEROSOL SOLUTIONS |
| CA2182568A1 (en) * | 1994-02-10 | 1995-08-17 | Makoto Takeuchi | Novel carbamate derivative and medicinal composition containing the same |
| ES2163032T3 (en) * | 1995-07-11 | 2002-01-16 | Merck & Co Inc | TRIAZOLILMETIL-INDOL ETHYLAMINE BISULFATE SALT. |
| DE19653969A1 (en) * | 1996-12-20 | 1998-06-25 | Boehringer Ingelheim Kg | New aqueous pharmaceutical preparation for the production of propellant-free aerosols |
| US6126919A (en) * | 1997-02-07 | 2000-10-03 | 3M Innovative Properties Company | Biocompatible compounds for pharmaceutical drug delivery systems |
| AU9674398A (en) * | 1997-10-09 | 1999-05-03 | Schering Corporation | Mometasone furoate suspensions for nebulization |
| AU2001256168A1 (en) * | 2000-03-01 | 2001-09-12 | Glaxo Group Limited | Metered dose inhaler |
| US6451289B2 (en) * | 2000-03-24 | 2002-09-17 | Sepracor Inc. | Albuterol formulations |
-
2002
- 2002-10-18 CA CA2464660A patent/CA2464660C/en not_active Expired - Fee Related
- 2002-10-18 WO PCT/US2002/033352 patent/WO2003037317A1/en active Application Filing
- 2002-10-18 EP EP02784157A patent/EP1441709A1/en not_active Ceased
- 2002-10-18 JP JP2003539661A patent/JP2006513129A/en active Pending
- 2002-10-18 NZ NZ550304A patent/NZ550304A/en not_active IP Right Cessation
- 2002-10-18 MX MXPA04003928A patent/MXPA04003928A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| WO2003037317A1 (en) | 2003-05-08 |
| NZ550304A (en) | 2008-05-30 |
| CA2464660C (en) | 2011-12-20 |
| MXPA04003928A (en) | 2005-03-31 |
| EP1441709A1 (en) | 2004-08-04 |
| JP2006513129A (en) | 2006-04-20 |
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| Engel | PROBLEMS ASSOCIATED WITH THE USE OF DRUGS ADMINISTERED BY INTERMITTENT POSITIVE PRESSURE VENTILATION∗ |
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| Date | Code | Title | Description |
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| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20201019 |