Methods and systems for operating an aerosol generator

• US 20050217666A1
• Filed: 03/24/2005
• Published: 10/06/2005
• Est. Priority Date: 05/05/2000
• Status: Active Grant

• Current Assignee: Novartis Ag
• Original Assignee: Aerogen, Inc. (Nektar Therapeutics)
• Inventors: Dunne, Paul, Power, John, Ivri, Ehud, Smith, Niall, Fink, James B., Moran, Declan, O'Sullivan, Gavan, Gibbons, Keith
• Granted Patent: US 7,971,588 B2
• Time in Patent Office: Days
• US Class Current: 128/200.140
• CPC Class Codes: A61K 31/7036 having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 33/02 Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis

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. Additionally, an aerosolized medicament for the treatment of a pulmonary disease, where the medicament includes amikacin mixed with an aqueous solution having an adjusted pH from about 5.5 to about 6.3. The pH is adjusted by adding hydrochloric acid and sodium hydroxide to the aqueous solution.

Claims

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

delivering a dose of aerosolized medicament intermittently to a ventilator circuit coupled to the respiratory system of the patient.

2. The method of claim 1, wherein the intermittent delivery of the aerosolized medicament includes starting and stopping the delivery in each inhalation phase of a respiratory cycle of the patient.

3. The method of claim 1, wherein the intermittent delivery of the aerosolized medicament includes starting the delivery in each inhalation phase of a respiratory cycle of the patient, and stopping delivery in each exhalation phase of the respiratory cycle.

4. The method of claim 1, the intermittent delivery of the aerosolized medicament includes starting the delivery in each exhalation phase of a respiratory cycle of the patient.

5. The method of claim 1, wherein the ventilator circuit is in an off-ventilator configuration.

6. The method of claim 1, wherein the pulmonary disease is selected from the group consisting of ventilator-associated pneumonia, hospital-acquired pneumonia, cystic fibrosis, mycobacterial infection, bronchitis, staph infection, fungal infections, viral infections, protozal infections, and acute exacerbation of Chronic Obstructive Pulmonary Disease.

7. The method of claim 1, wherein the medicament comprises an antibiotic.

8. The method of claim 1, wherein the medicament is selected from the group consisting of an anti-oxidant, bronchodialator, corticosteroid, leukotriene, protease inhibitor, and surfactant.

9. The method of claim 8, wherein the antibiotic is selected from the group consisting of aminoglycosides, β

-lactams, and quinolines.

10. The method of claim 9, wherein the aminoglycoside comprises amikacin.

11. A method of treating a patient with a pulmonary disease, the method comprising administering to the patient, through a ventilator circuit, a nebulized aerosol comprising from about 100 μ

g to about 500 mg of a medicament, wherein at least 40% of the nebulized aerosol is delivered to the patient.

12. The method of claim 11, wherein at least 70% of the nebulized aerosol is delivered to the patient.

13. The method of claim 11, wherein the medicament is administered once or twice daily for at least three days.

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

taking the patient off a ventilator; and

administering to the patient, a nebulized aerosol comprising from about 100 μ

g to about 500 mg of a medicament.

15. The method of claim 14, wherein at least 70% of the nebulized aerosol is inhaled by the patient.

16. A method of treating a pulmonary disease, the method comprising administering to a patient a medicament comprising 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.

17. The method of claim 16, wherein the medicament is administered for a period of about 1 hour.

18. The method of claim 16, wherein the medicament is administered to the patient once or twice per day.

19. The method of claim 18, wherein the treatment lasts for 3 days or more.

20. The method of claim 16, wherein the medicament is administered in a dose of about 400 mg of the amikacin.

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

administrating an aerosolized medicament to the patient; and

administrating, intravenously, a second medicament to the patient that also treats the pulmonary disease.

22. The method of claim 21, wherein the aerosolized medicament and the second medicament share an active ingredient.

23. The method of claim 22, wherein the active ingredient is an antibiotic.

24. The method of claim 23, wherein the antibiotic comprises amikacin.

25. An aerosolized medicament for the treatment of a pulmonary disease, the medicament comprising amikacin mixed with an aqueous solution having an adjusted pH from about 5.5 to about 6.3, wherein the pH is adjusted by adding hydrochloric acid and sodium hydroxide to the aqueous solution.

26. The medicament of claim 25, wherein the amikacin comprises amikacin sulfate.

27. The medicament of claim 25, wherein the medicament has a concentration of about 125 mg/ml.

28. The medicament of claim 25, where the medicament further comprises a surfactant.