Aerosol inhalation device

Patent metadata

Field	Value
Publication number	US-10737044-B2
Application number	US-201615276291-A
Country	US
Kind code	B2
Filing date	Sep 26, 2016
Priority date	Aug 29, 2012
Publication date	Aug 11, 2020
Grant date	Aug 11, 2020

Abstract

Actuators for an aerosol inhalation device containing a housing adapted to receive an aerosol canister containing a pressurized medicament formulation, a mouthpiece portion through which the user inhales, a nozzle block and an orifice and a tubular element extending in the mouthpiece portion from the orifice aperture in a longitudinal axis substantially aligned with a longitudinal axis of the mouthpiece portion provide a significant reduction in the non-respirable, coarse fraction of the emitted aerosol medicament via inertial impaction and retention in the actuator than in the oro-pharynx, with consequent less associated side effects and oral candidiasis in the patient. In addition the presence of the tubular element has minimal, negligible impact on the fine particle dose and on the particle size distribution (PSD) of the delivered particles having aerodynamic diameter lower than 9 μm.

First claim

The invention claimed is:

1. An actuator for an oral aerosol inhalation device, comprising:
a housing adapted to receive an aerosol canister containing a pressurized medicament formulation, provided with a metering valve having a hollow valve stem with a longitudinal axis;
a mouthpiece portion terminating in a mouthpiece opening through which a user inhales;
a nozzle block defining a valve stem receptacle, an expansion chamber or sump, and an orifice, with an orifice aperture, to propel an aerosol formulation toward said mouthpiece opening; and
a tubular element extending in the mouthpiece portion from the orifice aperture along a longitudinal axis aligned with a longitudinal axis of the mouthpiece portion and coinciding with a longitudinal axis of the orifice,
wherein the longitudinal axis of the orifice in the nozzle block, aligned with the longitudinal axis of the mouthpiece portion, is arranged at an angle greater than or equal to 90° to a direction of the longitudinal axis of the hollow valve stem, and
wherein the tubular element has an internal diameter in the range from 5 to 7 mm and a length in the range from 8 to 12 mm.

2. An actuator according to 1, wherein the tubular element is configured such that one of its terminal openings is close fit to an external surface of the nozzle block, around the orifice aperture, so as to be in a continuous flow path with the orifice and to enclose the orifice aperture within a recess.

3. An actuator according to claim 1 , wherein the tubular element is secured to an external surface of the nozzle block, around the orifice aperture to be in a continuous flow path with the orifice.

4. An actuator according to claim 1 , wherein the tubular element is on a lateral part of a shaped hollow cylindrical object tightly fitted to an outside of the nozzle block, covering its lateral surfaces such that the tubular element is in a continuous flow path with the orifice.

5. An actuator according to claim 1 , wherein the tubular element, the nozzle block, the housing adapted to receive the aerosol canister, and the mouthpiece portion form a single piece moulded actuator.

6. An actuator according to claim 1 , wherein at least one of the nozzle block, the tubular element, and a shaped hollow cylindrical object tightly fitted to an outside of the nozzle block, covering its lateral surfaces such that the tubular element is in a continuous flow path with the orifice, are formed of a same or different materials selected from metal materials selected from aluminium, aluminium alloy or stainless steel; plastic polymeric materials, selected from thermoplastic resins and UV curable, including different grades polypropylene or polyethylene; fluorinated polymers; an acrylate a polycarbonate; a polyamide; or a polyester.

7. An actuator according to claim 6 , wherein the plastic polymeric material is coated with antistatic agents using a moulding or a coating process.

8. An oral inhaler comprising:
a canister having a metering valve and containing a pressurised medicament formulation; and
the actuator according to claim 1 .

9. An oral metered-dose inhaler comprising:
a canister having a metering valve and containing a pressurised medicament formulation; and
the actuator according to claim 1 .

10. An actuator according to claim 1 , wherein a longitudinal axis of the orifice in the nozzle block, aligned with the longitudinal axis of the mouthpiece portion, is located at an angle in the range front greater than 90° to 120° to the direction of the longitudinal axis of the hollow valve stem.

11. An actuator according to claim 1 , wherein the longitudinal axis of the orifice in the nozzle block, aligned with the longitudinal axis of the mouthpiece portion, is located at an angle in the range from greater than 90° to 110° to the direction of the longitudinal axis of the hollow valve stem.

12. An actuator according to claim 1 , wherein a ratio of length to internal diameter of the tubular element is from 1.4 to 1.8, the ratio being set to remove an amount of non-respirable particles or droplets from a cloud of the aerosol formulation before the cloud of the aerosol formulation is dispensed through the mouthpiece opening.

13. An actuator according to claim 1 , wherein a length of the tubular element is less than half a length of the mouthpiece portion.

14. An actuator according to claim 1 , wherein the tubular element includes a hollow cylinder that extends along the longitudinal axis aligned with the longitudinal axis of the mouthpiece portion and coinciding with the longitudinal axis of the orifice.

15. A kit of parts comprising:
an aerosol canister containing a pressurised medicament formulation;
an actuator for an oral pMDI inhaler; and
a shaped hollow cylindrical component tightly fitted to an outside of a nozzle block of the actuator for the oral pMDI inhaler, covering lateral surfaces of the nozzle block, and comprising, in a lateral side, a tubular element arranged in a continuous flow path with an orifice, with an orifice aperture, of the nozzle block such that when the shaped hollow cylindrical object is tightly fitted to the outside of the nozzle block, said tubular element extends in a mouthpiece portion of the oral pMDI inhaler from the orifice aperture along a longitudinal axis aligned with a longitudinal axis of the mouthpiece portion and coinciding with a longitudinal axis of the orifice,
wherein the longitudinal axis of the orifice, aligned with the longitudinal axis of the mouthpiece portion, is at an angle greater than or equal to 90° to a direction of a longitudinal axis of a hollow valve stem of a canister seated in the nozzle block, and
wherein a ratio of length to internal diameter of the tubular element is from 1.4 to 1.8, the ratio being set to remove an amount of non-respirable particles or droplets from a cloud of an aerosol formulation before the cloud of the aerosol formulation is dispensed through the mouthpiece opening.

16. An actuator for an oral aerosol inhalation device, comprising:
a housing adapted to receive an aerosol canister containing a pressurized medicament formulation, provided with a metering valve having a hollow valve stem with a longitudinal axis;
a mouthpiece portion terminating in a mouthpiece opening through which a user inhales;
a nozzle block defining a valve stem receptacle, an expansion chamber or sump, and an orifice, with an orifice aperture, to propel an aerosol formulation toward said mouthpiece opening; and
a tubular element extending in the mouthpiece portion from the orifice aperture along a longitudinal axis aligned with a longitudinal axis of the mouthpiece portion and coinciding with a longitudinal axis of the orifice,
wherein the longitudinal axis of the orifice in the nozzle block, aligned with the longitudinal axis of the mouthpiece portion, is arranged at an angle greater than or equal to 90° to a direction of the longitudinal axis of the hollow valve stem, and
wherein a ratio of length to internal diameter of the tubular element is from 1.4 to 1.8, the ratio being set to remove an amount of non-respirable particles or droplets from a cloud of the aerosol formulation before the cloud of the aerosol formulation is dispensed through the mouthpiece opening.

17. An actuator according to claim 16 , wherein the tubular element is on a lateral part of a shaped hollow cylindrical object tightly fitted to an outside of the nozzle block, covering its lateral surfaces such that the tubular element is in a continuous flow path with the orifice.

18. An actuator according to claim

Assignees

• Chiesi Farm Spa

Inventors

• Brambilla Gaetano
• Johnson Robert
• Lewis David Andrew

Classifications

• A61M2205/0233

  Conductive materials, e.g. antistatic coatings for spark prevention · CPC title

• A61M2205/0238

  the material being a coating or protective layer · CPC title

• A61M2209/06

  Packaging for specific medical equipment · CPC title

• A61M11/02 Primary

  operated by air {or other gas} pressure applied to the liquid {or other product} to be sprayed or atomised {(sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C)} · CPC title

• A61M15/0065

  Inhalators with dosage or measuring devices (A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52) · CPC title