Inhalers and related methods

Patent metadata

Field	Value
Publication number	US-11793953-B2
Application number	US-202217957079-A
Country	US
Kind code	B2
Filing date	Sep 30, 2022
Priority date	Feb 14, 2017
Publication date	Oct 24, 2023
Grant date	Oct 24, 2023

Abstract

A nasal inhaler for the inhalation of inhalable substances comprise: a canister having an interior reservoir containing pressurised inhalable substances including fluid; a metering valve including a metering chamber and a valve stem defining a communication path between the metering chamber and the interior reservoir, the communication path including an opening configured to permit flow between a transfer space inside the valve stem and the interior reservoir, the interior reservoir being arranged for orientation above the metering chamber whereby gas located within the metering chamber is replaced with liquid from the interior reservoir.

First claim

What is claimed is:

1. A method of preventing gas lock within a medicament inhaler having a metering valve with a metering chamber and a valve stem extending from the metering chamber to an interior reservoir of a canister containing a fluid, the method comprising:
allowing atmospheric gas to enter the metering chamber;
retracting the valve stem relative to the canister to create a communication path between the metering chamber and the interior reservoir for a time period of about 2 minutes to about 24 hours; and
following the time period, altering an orientation of the interior reservoir relative to the metering chamber to cause an amount of fluid sufficient to administer greater than 75% of a labelled claim for a dose to enter the metering chamber and displace the atmospheric gas.

2. The method of claim 1 , wherein the fluid is a liquid medicament.

3. The method of claim 2 , wherein the liquid medicament has a higher density than a density of the atmospheric gas.

4. The method of claim 1 , wherein an amount of atmospheric gas entering the metering chamber is sufficient to create a gas lock within the medicament inhaler.

5. The method of claim 1 , wherein the amount of fluid fills the metering chamber when the orientation of the interior reservoir relative to the metering chamber is altered.

6. The method of claim 1 , wherein the amount of fluid partially fills the metering chamber when the orientation of the interior reservoir relative to the metering chamber is altered.

7. The method of claim 1 , wherein a portion of the displaced atmospheric gas is displaced from the metering chamber to the interior reservoir.

8. The method of claim 1 , wherein altering the orientation of the interior reservoir relative to the metering chamber causes placement of the interior reservoir above the metering chamber.

9. The method of claim 1 further comprising:
administering the amount of fluid sufficient to administer greater than 75% of the labelled claim for the dose.

10. The method of claim 1 , wherein the communication path includes an opening configured to permit flow between a transfer space inside the valve stem and the interior reservoir.

11. The method of claim 10 , wherein the opening includes an axially oriented opening portion oriented to face axially along a longitudinal axis of the valve stem into the interior reservoir.

12. The method of claim 10 , in which the opening is configured to permit flow in a direction with an axial component along the valve stem directly between the transfer space inside the valve stem and the interior reservoir.

13. The method of claim 10 , wherein altering the orientation of the interior reservoir relative to the metering chamber causes the amount of fluid to travel through the opening into the metering chamber.

14. The method of claim 10 , wherein causing the amount of fluid to enter the metering chamber and displace the atmospheric gas includes allowing the amount of fluid to flow under pressure through the opening, along the valve stem to a portion of the communication path communicating with the metering chamber.

15. The method of claim 10 further comprising:
causing atmospheric gas to flow from the metering chamber, in a direction counter to a direction of the mount of fluid, along the communication path into the interior chamber.

16. The method of claim 10 including providing the opening as an elongated opening.

17. The method of claim 10 including providing a second opening to the communication path diametrically opposed to the opening.

18. The method of claim 1 further comprising:
providing the valve stem with an opening having an axially oriented opening portion into the interior reservoir which is oriented facing directly axially along a longitudinal axis of the valve stem into the interior reservoir.

19. The method of claim 1 comprising providing the medicament inhaler as a breath actuated inhaler, and, in response to flow of the atmospheric gas, firing the canister by closing communication between the metering chamber and interior reservoir and opening communication between the metering chamber and atmosphere, the valve stem being held depressed after firing.

20. The method of claim 19 comprising resetting the inhaler to a reset configuration with a reset actuator so as to close communication between the metering chamber and atmosphere and open communication between the metering chamber and the interior reservoir, and by carrying out the altering of the orientation of the interior reservoir above the metering chamber while the inhaler is in the reset configuration.

21. The method of claim 20 comprising providing the reset actuator as dust cap or a mouthpiece cap for the inhaler and in which closing the cap resets the inhaler.

22. The method of claim 1 comprising providing the medicament inhaler as a metered dose inhaler and which includes applying a force to the canister to hold the valve stem depressed; and which includes subsequently releasing the canister to extend the valve stem and carrying out the altering of the orientation of the interior reservoir above the metering chamber.

23. The method of claim 1 , wherein the medicament inhaler is configured to provide an inhalable substance including at least one propellant.

24. The method of claim 23 including providing at least one said propellant as a hydrofluoroalkane.

25. The method of claim 1 including providing at least one propellant with a surface tension at 25° C. of about 6 to 10 mN/m, typically about 7 to 9 mN/m, about 8 mN/m being one example.

26. The method of claim 1 including providing inhalable substances as including an active ingredient in suspension or in solution.

27. The method of claim 1 , wherein the time period is from about 5 minutes to about 24 hours.

28. The method of claim 1 , wherein the time period is from about 30 minutes to about 24 hours.

29. The method of claim 1 , wherein orienting the interior reservoir above the metering chamber causes the valves stem to reposition from the retracted position to an extended position.

30. The method of claim 1 , wherein 75% to about 110% of the labelled claim for the dose is administered.

31. The method of claim 1 , wherein the medicament inhaler includes a mouthpiece and a mouthpiece cap coupled to the mouthpiece, the mouthpiece cap having an open position and closed position, and the mouthpiece cap remaining in the open position from a start of the time period to an end of the time period.

32. The method of claim 1 , including venting the metering chamber to atmosphere for a time period which is one hour, more than one hour, 24 hours or more than 24 hours.

33. A method of treating a respiratory disease or disorder to administer a therapeutically effective amount of one or more active ingredients, the method including carrying out the method of claim 27 .

34. The method of claim 33 , wherein the inhaler is a breath-actuated inhaler and the step of actuating the inhaler comprises inhaling through the inhaler.

35. The method of claim 33 , wherein the respiratory disease or disorder is asthma.

36. The method of claim 33 , wherein the respiratory disease or disorder is COPD.

37. The method of claim 33 , wherei

Assignees

• Norton Waterford Ltd

Inventors

• Buck Daniel
• Prendergast Paul
• Walsh Declan

Classifications

• B65D83/52

  Metering valves; Metering devices · CPC title

• A61M15/0066 Primary

  with means for varying the dose size · CPC title

• A61K9/007

  Pulmonary tract; Aromatherapy · CPC title

• A61K31/439

  the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46) · CPC title

• A61K31/569

  substituted in position 17 alpha, e.g. ethisterone · CPC title