Drug delivery apparatus

• US 20030205229A1
• Filed: 11/14/2002
• Published: 11/06/2003
• Est. Priority Date: 02/11/2000
• Status: Active Grant

• Current Assignee: Respironics Respiratory Drug Delivery (UK) Ltd. (Koninklijke Philips N.V.)
• Original Assignee: Respironics Respiratory Drug Delivery (UK) Ltd. (Koninklijke Philips N.V.)
• Inventors: Denyer, John Stanley Harold, Crockford, David Roe
• Granted Patent: US 8,464,706 B2
• Time in Patent Office: Days
• US Class Current: 128/204.23
• CPC Class Codes: A61K 38/12 Cyclic peptides , e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C A61K38/043 - A61K38/046 take precedence
• 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 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 : Antiasthmatics
• CPC Class Codes: A61P 11/12 : Mucolytics
• CPC Class Codes: A61P 31/04 : Antibacterial agents

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. 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.

2. An apparatus according to claim 1, configured to deliver the full amount of the desired dose in at least 90% of treatments.

3. An apparatus according to claim 1 or 2, wherein the dose calculator includes a formulation input through which the formulation of the drug being delivered is entered for use in the calculations made by the dose calculator.

4. An apparatus according to any one of the preceding claims, further comprising a data log for recordal of information relating to each treatment, including the dose which was delivered.

5. An apparatus according to any one of the preceding claims, wherein the controller includes a pulse length generator which determines the duration of each pulse on the basis of the monitored breathing pattern of the patient.

6. An apparatus according to claim 5, wherein the pulse length generator includes a breathing pattern analyser which analyses the breathing pattern of a patient in order to determine the time at which a patient begins to inhale an end volume, the end volume being the volume of the upper airways of the a patient which, at the end of the inhalation, contains the end volume of air which does not reach the lungs.

7. An apparatus according to claim 6, wherein the pulse length generator generates a pulse having a length which stops delivery of drug-laden air into the end volume.

8. An apparatus according to claim 6 or 7, wherein the breathing pattern analyser includes a tidal volume measuring device for measuring the tidal volume of a patient, a timer for measuring the duration of inhalation of the patient, and an estimate storage device for storing an estimate of the volume of the patient'"'"'s upper airways, and an end volume estimator which determines the time at which the patient begins to inhale the end volume on the basis of the measured tidal volume, the measured duration of inspiration, and the stored estimate of the volume of the patient'"'"'s upper airways.

9. An apparatus according to claim 8, wherein the analyser further includes an averaging device whereby the time at which the patient begins to inhale the end volume is determined on the basis of an average of the values collected by the analyser over more than one breath.

10. An apparatus according to any one of the preceding claims, wherein the sensor is a pressure sensor.

11. An apparatus according to any one of the preceding claims, wherein the feedback indicator is a vibrator which causes the apparatus to vibrate in order to indicate that the patient is inhaling effectively.

12. An apparatus according to any one of the preceding claims 1 to 11, wherein the drug delivery device is a spacer including a receptacle defining a holding chamber in which the air within the holding chamber is loaded with the drug prior to treatment.

13. An apparatus according to any one of claims 1 to 11, wherein the drug delivery device is an atomiser which atomises the drug during inhalation into a stream of air leading to the patient.

14. An apparatus according to claim 13, wherein the drug delivery device is a mesh-type atomiser.

15. An apparatus according to claim 13, wherein the drug delivery device is a pneumatic atomiser in which atomisation of the drug is caused by pressurised air.

16. In a drug delivery apparatus according to any one of claims 1 to 15, the use of a drug formulation in which about 19 mg tobramycin is dissolved in a solvent.

17. The use of the drug formulation according to claim 16, wherein the solvent is about 0.3 ml in volume.

18. The use of the drug formulation according to claim 16 or 17, 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 use of the drug formulation of any one of claims 16 or 18, wherein the concentration of tobramycin is about 60 mg/ml.

20. In a drug delivery apparatus according to any one of claims 1 to 15, the use of a drug formulation including about 187,000 U colistin.

21. The use of a drug formulation of claim 20, in which 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 use of the drug formulation of claim 20 or 21, 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. In a drug delivery apparatus according to any one of claims 1 to 15, the use of a drug formulation including about 0.156 mg DNase in a solvent.

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

25. The use of a drug formulation according to claim 23 or 24, 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. In a drug delivery apparatus according to any one of claims 1 to 15, the use of the drug formulation including about 12.5 mg AIAT in solvent.

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

28. The use of a drug formulation according to claim 26 or 27, wherein the drug formulation further includes an additional amount of between 0.1 ml and 0.8 ml of solvent.

29. In a drug delivery apparatus according to any one of claims 1 to 15, the use of a drug formulation including about 25 μ

g of Budesonide in a solvent.

30. The use of a drug formulation according to claim 29, wherein the volume of the solvent is about 0.05 ml.

31. The use of a drug delivery apparatus according to any one of claims 1 to 15, the use of a drug formulation including about 12 μ

g of fluticasone.

32. A drug product comprising a drug formulation according to any one of claims 16 to 25, and a multi-part package within which the formulation components are mixed prior to delivery.