Nebulizer and container

Patent metadata

Field	Value
Publication number	US-12036355-B2
Application number	US-201917051382-A
Country	US
Kind code	B2
Filing date	May 3, 2019
Priority date	May 4, 2018
Publication date	Jul 16, 2024
Grant date	Jul 16, 2024

Abstract

A system includes a nebulizer for nebulizing a fluid from a container and such a container containing a fluid and are proposed. The fluid is a non-newtonian fluid, in form of a suspension or emulsion or a liposomal fluid or a gel. The nebulizer includes a fluid pump for withdrawing the fluid in doses from the container and pressurizing the respective doses for nebulization through nozzle channels having a hydraulic diameter in the range of 3 to 20 microns at an operational pressure of 5 to 250 MPa.

First claim

The invention claimed is:

1. A system, comprising:
a nebulizer ( 1 ) for nebulizing a fluid ( 2 ) and a container ( 3 ) containing multiple doses of the fluid ( 2 ), wherein the nebulizer ( 1 ) comprises:
a fluid pump ( 5 ) for withdrawing a dose of the fluid ( 2 ) from the container ( 3 ) and pressurizing the respective dose for nebulization with operational pressure of one of: (i) 5 to 250 MPa, and (ii) 10 to 50 MPa, and
a microstructured component forming a nozzle ( 12 ) with nozzle channels ( 12 d ) having a hydraulic diameter in the range of one of: (i) 3 to 20 microns, (ii) 4 to 12 microns, and (iii) 5 to 8 microns,
wherein at room temperature the fluid ( 2 ) has a viscosity at rest of more than one of: (i) 1.7*10 −3 Pascal seconds (1.7 centipoise), and (ii) more than 0.1 Pascal seconds (10 centipoise), and the fluid ( 2 ) has a shear-thinning behavior.

2. The system according to claim 1 , wherein the fluid ( 2 ), which is a structured fluid, comprises a carrier liquid which at room temperature has a viscosity of up to 1.6*10 −3 Pascal seconds (1.6 centipoise), wherein the carrier liquid is water or ethanol or a mixture of water and ethanol.

3. The system according to claim 1 , wherein the fluid ( 2 ) is a suspension of nanoparticles.

4. The system according to claim 3 , wherein the nanoparticles comprising an active ingredient, a beta adrenergic agonists, or a glucocorticosteroid.

5. The system according to claim 3 , wherein the nanoparticles have a concentration of at least one of: up to 10%, up to 7%, and more than 1% in the fluid ( 2 ).

6. The system according to claim 1 , wherein the fluid ( 2 ) is at least one of: an emulsion, and an “oil-in-water” emulsion.

7. The system according to claim 1 , wherein the fluid ( 2 ) is a liposomal fluid.

8. The system according to claim 7 , wherein the fluid ( 2 ) comprises liposomes or lipid droplets or lipid particles wherein the liposomes or lipid droplets or lipid particles comprise a dissolved or embedded active ingredient.

9. The system according to claim 7 , wherein the liposomal fluid comprises at least one of: a physiological lipid, a phospholipid, lecithine, or a mixture of lecithine and cholesterol.

10. The system according to claim 1 , wherein the fluid ( 2 ) comprises at least one of: less than 17% glycerin, less than 10% glycerin, less than 1% glycerin, or no glycerin.

11. The system according to claim 1 , wherein the fluid ( 2 ) at least one of: is a gel, comprises a gelling agent, contains 8.5% or less of a gelling agent, and contains less than 2% of a gelling agent.

12. The system according to claim 1 , wherein the container ( 3 ) comprises a variable or collapsible or compressible volume ( 4 ) containing the fluid ( 2 ).

13. The system according to claim 12 , wherein the container ( 3 ) comprises a collapsible bag as a collapsible volume ( 4 ) containing the fluid ( 2 ).

14. The system according to claim 12 , wherein the container ( 3 ) comprises a rigid casing ( 20 ) and a fluid piston ( 28 ) moveable therein forming a space for directly receiving the fluid ( 2 ) or the variable or compressible volume ( 4 ) containing the fluid ( 2 ).

15. The system according to claim 12 , wherein the system comprises a pressurizing mechanism to pressurize the fluid ( 2 ) in the container ( 3 ) or a mechanism to apply pressure to the variable or collapsible or compressible volume ( 4 ) containing the fluid ( 2 ), wherein the mechanism to pressurize or the mechanism to apply pressure pressurizes the fluid ( 2 ) (in addition to the ambient pressure) with at least one of: a pressure of 5000 to 3*10 5 Pascal (0.05 to 3 bars), a pressure of 5000 to 3*10 5 Pascal (0.05 to 3 bars), a pressure of 20000 to 10 5 Pascal or 10 5 to 2*10 5 Pascal (0.2-1 bar or 1-2 bars), during the withdrawal of fluid ( 2 ) from the container ( 3 ).

16. The system according to of claim 15 , wherein the mechanism to apply pressure to the variable or collapsible or compressible volume ( 4 ) is configured to apply the pressure at least one of: in the direction of a fluid outlet of the container ( 3 ) and/or in the direction of at least one of: a fluid entrance, and a conveying tube ( 9 ), into the nebulizer ( 1 ) during withdrawal of the fluid ( 2 ).

17. The system according to claim 15 , wherein the mechanism to pressurize or the mechanism to apply pressure is formed by or comprises an air pump ( 30 ) associated to the container ( 3 ) for pressurizing the fluid ( 2 ) in the container ( 3 ) to help withdrawing the fluid ( 2 ) in doses from the container ( 3 ).

18. The system according to claim 17 , wherein during use of the nebulizer ( 1 ), the air pump ( 30 ) and the fluid pump ( 5 ) pressurize alternately, in particular the air pump ( 30 ) pressurizes air when tensioning or loading the nebulizer ( 1 ) and the fluid pump ( 5 ) pressurizes a dose of fluid ( 2 ) when dispensing or nebulizing the dose of fluid ( 2 ).

19. The system according to claim 17 , wherein at least one of: the air pump ( 30 ) is actuated by a relative movement of the container ( 3 ) within a housing ( 1 b ) of the nebulizer ( 1 ), and the container ( 3 ) is moveable stroke-like in the nebulizer ( 1 ) when withdrawing a dose of fluid ( 2 ) and/or when pressurizing or dispensing a dose of the fluid ( 2 ).

20. The system according to claim 17 , wherein the air pump ( 30 ) comprises or forms a piston/cylinder arrangement for pumping air to help withdrawing the fluid ( 2 ) in doses from the container ( 3 ).

21. The system according to claim 17 , wherein at least one of: the container ( 3 ) drives or forms a pump piston ( 31 ) of the air pump ( 30 ), the container ( 3 ) cooperates with or is moveable in a detachable housing part ( 18 ), an associated cylinder ( 32 ), or insert ( 33 ).

22. The system according to claim 17 , wherein the nebulizer ( 1 ) or air pump ( 30 ) comprises an inlet valve ( 44 ) preventing any underpressure in the air pump ( 30 ) or its pump chamber ( 39 ).

23. The system according to claim 1 , wherein the nebulizer ( 1 ) operates purely mechanically.

24. The system according to claim 1 , wherein the nebulizer ( 1 ) is a hand-held device and/or a portable device.

25. The system according to claim 1 , wherein the nebulizer ( 1 ) is an inhaler.

26. The system according to claim 1 , wherein the nebulizer ( 1 ) is a device for ophthalmological application of the fluid ( 2 ).

27. The system according to claim 1 , wherein the fluid ( 2 ) is fabricated/produced from at least two components and wherein the container ( 3 ) comprises at least two chambers/inner volumes each containing one of the at least two components, wherein the fluid ( 2 ) is fabricated/produced by combining/mixing the two components within the container ( 3 ).

28. The system according to claim 27 , wherein the at least two components are stored within the at least two chambers and/or inner volumes in the container ( 3 ), each chamber and/or inner volume containing one of the at least two components, and the at least two chambers and/or inner volumes being initially fluidically separate, and
wherein the at least two chambers and/or inner volumes are fluidically connectable, so that at least one of the components is at least partly transferred into the other and/or into one of the other chambers, so that the at least two components are mixed and/or combined for fabricating and/or producing and/

Assignees

• Boehringer Ingelheim Int

Inventors

• Dunne Stephen Terence
• Huesch Dana
• Langguth Peter Rolf Werner

Classifications

• B05B9/0822

  a discharge device being fixed to the container · CPC title

• B05B11/1091

  being first hold in a loaded state by locking means or the like, then released (B05B11/1092 takes precedence) · CPC title

• A61M15/0035

  Piercing means · CPC title

• B05B11/028

  Pistons separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container · CPC title

• B05B11/026

  Membranes separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container · CPC title