Lockout mechanism for aerosol drug delivery devices

• US 20020000225A1
• Filed: 05/09/2001
• Published: 01/03/2002
• Est. Priority Date: 06/02/2000
• Status: Abandoned Application

• Current Assignee: Novartis Pharma AG (Novartis Ag)
• Original Assignee: Novartis Pharma AG (Novartis Ag)
• Inventors: Weers, Jeff, Tarara, Thomas, Nantel, Normand, Schuler, Carlos
• Application Number:
  US09/852,408
• Publication Number:
  US 20020000225A1
• Time in Patent Office: Days
• US Class Current: 128/200.14
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• 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 15/0096 Hindering inhalation before activation of the dispenser
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes

Abstract

A hand-held, portable, aerosol drug delivery system comprises a disposable container containing a drug formulation. The system also includes an aerosol generator for aerosolizing the drug formulation, and a prevention device. The prevention device prevents access to the drug formulation when in an inactive state and permits access to the drug formulation when in an activated state.

Claims

1. A hand-held, portable, aerosol drug delivery system, comprising:

a disposable container containing a drug formulation;

an aerosol generator for aerosolizing the drug formulation;

a prevention device which prevents access to the drug formulation when in an inactive state and which permits access to the drug formulation when in an activated state.

2. A system as in claim 1, wherein the prevention device comprises an electronic lockout device having a lockout element that is positioned in a dose preventing position when in the inactive state, and is movable to a dosing permitting position when electric current is supplied to place the lockout device in the activated state.

3. A system as in claim 2, wherein the lockout device further comprises circuitry for supplying electrical current to move the lockout element to the dose permitting position when the lockout device is in the activated state.

4. A system as in claim 2, wherein the lockout device further comprises a controller having an associated memory for storing a dosing condition, and wherein the controller is configured to send a signal to place the lockout device in the activated state only after the dosing condition has been satisfied.

5. A system as in claim 2, wherein the container comprises a canister, and wherein the aerosol generator comprises a metering valve and an actuator operably coupled to the canister.

6. A system as in claim 5, further comprising a housing, wherein the canister is reciprocally held within at least a portion of the housing between a home position and a dosing position where the actuator is engaged to open the metering valve and to permit the escape of a metered amount of the drug formulation from the canister.

7. A system as in claim 6, wherein the lockout element is positioned to prevent engagement of the actuator when in the dose preventing position to thereby prevent opening of the metering valve.

8. A system as in claim 7, wherein the lockout element has a distal end that is engageable with the canister to prevent substantial displacement of the canister into the housing when the lockout element is in the dose preventing position.

9. A system as in claim 8, wherein upon placement of the preventing device into the activated state, the distal end of the lockout element is retracted to permit displacement of the canister into the housing and to permit engagement of the actuator to open the metering valve.

10. A system as in claim 7, wherein the canister is movable within the housing when the preventing device is in the inactive state, and further comprising a stop that is reciprocally disposed within the housing below the actuator, and wherein the lockout element has a distal end that is engageable with the stop when in the activated state to prevent movement of the stop within the housing such that displacement of the canister engages the actuator with the stop to permit dispensing of the metered drug formulation when the preventing device is in the activated state.

11. A system as in claim 1, further comprising a high pressure gas source to assist in aerosolizing the drug formulation when the preventing device is in the activated state.

12. A system as in claim 1, further comprising a dose counter disposed to count the number of doses of the drug formulation dispensed from the container.

13. A system as in claim 12, wherein the container is reciprocatably disposed within a housing, and wherein the dose counter comprises a dose counting circuit positioned to sense when the container has been reciprocated within the housing.

14. A system as in claim 13, wherein the dose counter further comprises a display for indicating if the container contains an amount of drug formulation.

15. A system as in claim 5, further comprising a nozzle operable coupled to the canister, and wherein the housing further includes a mouthpiece disposed to receive the drug formulation from the nozzle.

16. A system as in claim 15, wherein the mouthpiece has a first end and a second end, and wherein the nozzle is positionable within an opening adjacent the first end of the mouthpiece to permit the aerosolized drug formulation to be delivered to a patient upon inhalation through the second end of the mouthpiece.

36. A system as in claim 1, wherein the drug formulation comprises nicotine.

17. A method for administering a drug formulation, the method comprising:

providing a container having an amount of a drug formulation;

preventing the transfer of the drug formulation from the container with an electronic lockout device when the lockout device is in an inactive state; and

supplying electrical current to the lockout device to place the lockout device in an active state, thereby permitting the transfer of the drug formulation from the container.

18. A method as in claim 17, wherein the electronic lockout device comprises a lockout element that is positioned in a dose preventing position when in the inactive state, and further comprising moving the lockout element to a dosing permitting position when electric current is supplied to place the lockout device in the activated state.

19. A method as in claim 18, wherein the container comprises a canister having a metering valve and an actuator, wherein the canister is reciprocatably held within a housing between a home position and a dosing position, and further comprising depressing the canister into the housing to the dosing position to engage the actuator and to release a metered amount of the drug formulation when the lockout device is in the active state.

20. A method as in claim 19, further comprising preventing engagement of the actuator when the lockout element is in the dose preventing position.

21. A method as in claim 20, further comprising engaging the canister with the lockout element to prevent movement of the canister to the dispensing position when the lockout element is in the dose preventing position.

22. A method as in claim 21, further comprising disengaging the lockout element from the canister to permit movement of the canister to the dispensing position upon supply of the electrical current.

23. A method as in claim 20, further comprising engaging the lockout element with a stop that is positioned below the actuator upon supply of the electrical current, and further comprising depressing the canister into the housing to engage the actuator with the stop.

24. A method as in claim 18, further comprising stopping the supply of the electric current to the lockout device after the drug formulation has been transferred from the container.

25. A method as in claim 24, further comprising supplying electric current to the lockout device to permit another dosing only after a certain dosing conditions have been satisfied.

26. A method as in claim 25, further comprising counting the number doses transferred from the container.

27. A method as in claim 26, further comprising displaying whether the container contains an amount of drug formulation based on the number of counts.

28. A hand-held, portable, aerosol drug delivery system, comprising:

a housing having a mouthpiece;

a canister that is movable within the housing when manually depressed into the housing, the canister having a metering valve that is operable to release a metered amount of a drug formulation from the canister; and

a control system to control opening of the valve such that the valve is only opened when a force is manually applied to depress the canister into the housing and when a dosing condition has been satisfied.

29. A system as in claim 28, wherein the control system comprises a controller and a locking mechanism, wherein the controller is configured to send a signal to the locking mechanism to permit opening of the valve once the dosing condition has been satisfied.

30. A system as in claim 29, wherein the dosing condition is the passage of a certain amount of time between dosings, and further comprising an electronic clock coupled to the controller to measure the passage of time between dosings.

31. A system as in claim 28, wherein the locking mechanism is normally in a dose preventing position and is movable to a dosing position when electrical current is supplied to the locking mechanism to permit opening of the valve when the canister is depressed.

32. A system as in claim 28, wherein the locking mechanism includes a locking element that engages the canister to prevent depression of the canister into the housing when in the dose preventing position.

33. A system as in claim 28, wherein the canister includes an actuator, and wherein the locking mechanism includes a locking element that engages a stop that in turn engages the actuator when in the dose permitting position and when the canister is depressed into the housing.

34. A method for administering a nicotine formulation for smoking cessation therapy, the method comprising:

providing an amount of a nicotine formulation;

preventing the aerosolization of the nicotine formulation with a lockout device when the lockout device is in an inactive state;

supplying electric current to the lockout device to place the lockout device in an active state; and

aerosolizing the nicotine formulation.

35. A method as in claim 34, further comprising controlling when electric current may be supplied to the lockout device based on a specified dosing schedule.