Drug delivery apparatus

• US 20050087189A1
• Filed: 11/19/2004
• Published: 04/28/2005
• Est. Priority Date: 02/11/2000
• Status: Active Grant

• Current Assignee: Profile Drug Delivery Limited
• Original Assignee: Profile Drug Delivery Limited
• Inventors: Denyer, John Stanley Harold, Crockford, David Roe
• Granted Patent: US 8,820,316 B2
• Time in Patent Office: Days
• US Class Current: 128/203.150
• CPC Class Codes: A61M 11/002 by flow deviation causing inertial separation of transported particles
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0088 with variable volume
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws

Abstract

A drug delivery apparatus comprising: a drug delivery device for selectively delivering drug-laden air or air not laden with the drug; a sensor for monitoring the breathing pattern of a patient; a controller arranged to control the drug delivery device to deliver drug-laden air in pulses which begin when the patient is monitored by the sensor to begin inhalation, the pulses having a duration which is adjusted by the controller on the basis of the monitored breathing pattern of the patient; a feedback indicator which indicates to a patient whether the monitored breathing pattern is effective for inhaling drug-laden air or not a dose calculator which calculates the dose delivered to the patient; and an indicator which indicates to the patient when a desired dose has been delivered, whereby the apparatus is configured to deliver the full amount of the desired dose in at least 80% of treatments.

Claims

1-15. -15. (canceled)

16. A drug delivery apparatus comprising:

a drug delivery device for selectively delivering drug-laden air or air not laden with the drug;

a sensor for monitoring the breathing pattern of a patient a controller arranged to control the drug delivery device to deliver drug-laden air in pulses which begin when the patient is monitored by the sensor to begin inhalation, the pulses having a duration which is adjusted by the controller on the basis of the monitored breathing pattern of the patient;

a feedback indicator which indicates to a patient whether the monitored breathing pattern is effective for inhaling drug-laden air or not a dose calculator which calculates the dose delivered to the patient;

an indicator which indicates to the patient when a desired dose has been delivered, whereby the apparatus is configured to deliver the full amount of the desired dose in at least 80% of treatments; and

a drug formulation in which about 19 mg tobramycin is dissolved in a solvent.

17. The drug delivery apparatus according to claim 16, wherein the solvent is about 0.3 ml in volume.

18. The drug delivery apparatus according to claim 16, wherein the drug formulation further comprises an additional amount of between about 6 and 50 mg tobramycin in about 0.1 to 0.8 ml solution which fills the dead volume of the delivery apparatus and which is residual once all of the drug which can be delivered has been delivered.

19. The drug delivery apparatus according to claim 16, wherein the concentration of tobramycin is about 60 mg/ml.

32. The drug delivery apparatus according to claim 16, wherein the apparatus further includes a multi-part package within which the formulation components are mixed prior to delivery.

20. A drug delivery apparatus comprising:

a drug delivery device for selectively delivering drug-laden air or air not laden with the drug;

a sensor for monitoring the breathing pattern of a patient a controller arranged to control the drug delivery device to deliver drug-laden air in pulses which begin when the patient is monitored by the sensor to begin inhalation, the pulses having a duration which is adjusted by the controller on the basis of the monitored breathing pattern of the patient;

a feedback indicator which indicates to a patient whether the monitored breathing pattern is effective for inhaling drug-laden air or not a dose calculator which calculates the dose delivered to the patient;

an indicator which indicates to the patient when a desired dose has been delivered whereby the apparatus is configured to deliver the full amount of the desired dose in at least 80% of treatments; and

a drug formulation including about 187,000 U colistin.

21. The drug delivery apparatus according to claim 20, wherein the colistin is in a concentration of about 1 million units/2 ml in one of the following solutions:

a) 2 ml 0.9% NaCl b) a 2 ml solvent including 0.75 ml 0.9% NaCl and 1.275 ml water c) a solution of 2.5 mg salbutamol in 2.5 ml 0.9% NaCl d) a solution of 2.5 mg salbutamol in 0.75% 0.9% NaCl and 1.275 ml water e) a solution of 2.5 mg DNase in 2.5 ml 0.9% NaCl, or f) a solution of 2.5 mg DNase and 2.5 mg sulbutamol in 2.5 ml 0.9% NaCl.

22. The drug delivery apparatus according to claim 20, wherein the drug formulation further comprises an additional amount of between about 0.1 to 0.8 ml of the formulation which fills the dead volume of the delivery apparatus and which is residual once all of the drug which can be delivered has been delivered.

23. A drug delivery apparatus comprising:

a drug delivery device for selectively delivering drug-laden air or air not laden with the drug;

a sensor for monitoring the breathing pattern of a patient a controller arranged to control the drug delivery device to deliver drug-laden air in pulses which begin when the patient is monitored by the sensor to begin inhalation, the pulses having a duration which is adjusted by the controller on the basis of the monitored breathing pattern of the patient;

a feedback indicator which indicates to a patient whether the monitored breathing pattern is effective for inhaling drug-laden air or not a dose calculator which calculates the dose delivered to the patient;

an indicator which indicates to the patient when a desired dose has been delivered, whereby the apparatus is configured to deliver the full amount of the desired dose in at least 80% of treatments; and

a drug formulation including about 0.156 mg DNase in a solvent.

24. The drug delivery apparatus according to claim 23, wherein the solvent has a volume of about 0.156 ml.

25. The drug delivery apparatus according to claim 23, wherein the drug formulation further comprises an additional amount of between about 0.1 to 0.8 ml of the drug formulation which fills the dead volume of the delivery apparatus and which is residual once all of the drug which can be delivered has been delivered.

26. A drug delivery apparatus comprising:

a drug delivery device for selectively delivering drug-laden air or air not laden with the drug;

a sensor for monitoring the breathing pattern of a patient a controller arranged to control the drug delivery device to deliver drug-laden air in pulses which begin when the patient is monitored by the sensor to begin inhalation, the pulses having a duration which is adjusted by the controller on the basis of the monitored breathing pattern of the patient;

a feedback indicator which indicates to a patient whether the monitored breathing pattern is effective for inhaling drug-laden air or not a dose calculator which calculates the dose delivered to the patient;

an indicator which indicates to the patient when a desired dose has been delivered, whereby the apparatus is configured to deliver the full amount of the desired dose in at least 80% of treatments; and

a drug formulation including about 12.5 mg AIAT in solvent.

27. The drug delivery apparatus according to claim claim 26, wherein the solvent has a volume of about 0.25 ml.

28. The drug delivery apparatus according to claim 26, wherein the drug formulation further includes an additional amount of between 0.1 ml and 0.8 ml of solvent.

29. A drug delivery apparatus comprising:

a drug delivery device for selectively delivering drug-laden air or air not laden with the drug;

a sensor for monitoring the breathing pattern of a patient a controller arranged to control the drug delivery device to deliver drug-laden air in pulses which begin when the patient is monitored by the sensor to begin inhalation, the pulses having a duration which is adjusted by the controller on the basis of the monitored breathing pattern of the patient;

a feedback indicator which indicates to a patient whether the monitored breathing pattern is effective for inhaling drug-laden air or not a dose calculator which calculates the dose delivered to the patient;

an indicator which indicates to the patient when a desired dose has been delivered, whereby the apparatus is configured to deliver the full amount of the desired dose in at least 80% of treatments; and

a drug formulation including about 25 μ

g of Budesonide in a solvent.

30. The drug delivery apparatus according to claim claim 29, wherein the volume of the solvent is about 0.05 ml.

31. A drug delivery apparatus comprising:

a drug delivery device for selectively delivering drug-laden air or air not laden with the drug;

a sensor for monitoring the breathing pattern of a patient a controller arranged to control the drug delivery device to deliver drug-laden air in pulses which begin when the patient is monitored by the sensor to begin inhalation, the pulses having a duration which is adjusted by the controller on the basis of the monitored breathing pattern of the patient;

a feedback indicator which indicates to a patient whether the monitored breathing pattern is effective for inhaling drug-laden air or not a dose calculator which calculates the dose delivered to the patient;

an indicator which indicates to the patient when a desired dose has been delivered, whereby the apparatus is configured to deliver the full amount of the desired dose in at least 80% of treatments; and

a drug formulation including about 12 μ

g of fluticasone.