Methods and systems for operating an aerosol generator

• US 20070267010A1
• Filed: 01/16/2007
• Published: 11/22/2007
• Est. Priority Date: 05/05/2000
• Status: Active Grant

• Current Assignee: Novartis Pharma AG (Novartis Ag)
• Original Assignee: Novartis Pharma AG (Novartis Ag)
• Inventors: Power, John, Ivri, Ehud, Fink, James, Corkery, Kevin
• Granted Patent: US 8,336,545 B2
• Time in Patent Office: Days
• US Class Current: 128/200.230
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 16/08 Bellows; Connecting tubes having means for taking samples G01N1/22; Water traps; Patient circuits
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves

Abstract

A method of treating a patient with a pulmonary disease, where the method includes delivering a dose of aerosolized medicament intermittently to a ventilator circuit coupled to the respiratory system of the patient. Also, a method of treating a patient with a pulmonary disease, where the method includes taking the patient off a ventilator, and administering to the patient, a nebulized aerosol comprising from about 100 μg to about 500 mg of a medicament. Also a method of treating a patient with a pulmonary disease, the method comprising administering an aerosolized first medicament comprising amikacin to the patient and administering, systemically a second medicament comprising an antibiotic to the patient that also treats the pulmonary disease, wherein a resulting amikacin concentration in the lung and/or pulmonary system is therapeutically-effective, and an amount of the systemically administered antibiotics is reduced.

Claims

1. A method of treating a patient with a pulmonary disease, the method comprising:

administering an aerosolized first medicament to the patient; and

administering, a non-aerosolized second medicament to the patient that also treats the pulmonary disease, wherein the first and second medicaments may be the same or different, and wherein the administration of the first medicament provides a therapeutic effect with a reduction in an amount of the second medicament, compared to the amount of the second medicament which would be required in the absence of the first medicament.

2. The method of claim 1 wherein the first medicament comprises amikacin, and the second medicament comprises an antibiotic.

3. The method of claim 2 wherein the first medicament and the second medicament comprise the same active ingredient.

4. The method of claim 3 wherein the second medicament comprises amikacin.

5. The method of claim 1 wherein the reduction in amount of the second medicament is about 50%.

6. The method of claim 1 wherein the reduction in amount of the second medicament comprises a reduction in the number of days the medicament is administered.

7. The method of claim 1, wherein a maximum concentration of aerosolized first medicament in the blood serum is less than about 35 μ

g/mL, or a trough level is less than about 10 μ

g/mL, or both.

8. The method of claim 1, wherein a maximum concentration of aerosolized first medicament in the blood serum is less than about 20 μ

g/mL, or a trough level is less than about 5 μ

g/mL, or both.

9. A method of treating a patient with a pulmonary disease, the method comprising:

administering an aerosolized first medicament comprising amikacin to the patient; and

administering, systemically a second medicament comprising an antibiotic to the patient that also treats the pulmonary disease, wherein a resulting amikacin concentration in the lung and/or pulmonary system is therapeutically-effective, and an amount of the systemically administered antibiotics is reduced.

10. The method of claim 9 wherein the amikacin is dispersed into the deep lung and/or peripheral regions to provide a therapeutically-effective amount thereto.

11. The method of claim 10 wherein the aerosolized amikacin is delivered to the lung with an efficiency of at least about 20%.

12. A method of treating a pulmonary disease, the method comprising administering an aerosolized medicament wherein the medicament concentration in an epithelial lining fluid exceeds a minimum inhibitory concentration for microorganisms usually responsible for Gram-negative pneumonia.

13. The method of claim 12 wherein the medicament comprises an antibiotic.

14. The method of claim 13 wherein the antibiotic comprises amikacin.

15. A method of treating a pulmonary disease, the method comprising administering an aerosolized medicament wherein a medicament deposition to the lung is at least about 20%.

16. The method of claim 15 wherein the medicament deposition to the lung is at least about 40%.

17. The method of claim 16 wherein the medicament deposition to the lung occurs in less than about one hour.

18. The method of claim 15 wherein the administration of medicament is to a patient on a ventilator.

19. The method of claim 15 wherein the administration of medicament is to a free-breathing patient.

20. The method of claim 15 wherein the medicament comprises an antibiotic.

21. The method of claim 20 wherein the antibiotic comprises amikacin.

22. A method of treating a pulmonary disease, the method comprising administering to a patient a medicament consisting essentially of an antibiotic dissolved in an aqueous solution comprising sodium chloride that is adjusted to a pH between 5.5 and 6.3, and administered by nebulization using a vibratable member with apertures, the member configured to produce 70% or more of aerosol particles with mass mean aerodynamic diameters from about 1 μ

m to about 7 μ

m.

23. The method of claim 22, wherein the medicament is administered intermittently.

24. The method of claim 22, wherein the medicament is administered continuously.

25. The method of claim 22, wherein the medicament is administered for a period of less than about one hour.

26. The method of claim 22, wherein the medicament is administered to the patient once or twice per day.

27. The method of claim 26, wherein the treatment lasts for 3 days or more.

28. The method of claim 22, wherein the medicament is administered in a dose of about 400 mg of the amikacin.