Assembly

• US 20050121023A1
• Filed: 11/22/2002
• Published: 06/09/2005
• Est. Priority Date: 11/23/2001
• Status: Active Grant

• Current Assignee: Innovata Biomed Limited (Vectura Group Ltd.)
• Original Assignee: Innovata Biomed Limited (Vectura Group Ltd.)
• Inventors: Braithwaite, Philip
• Granted Patent: US 7,464,704 B2
• Time in Patent Office: Days
• US Class Current: 128/200.140
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 16/127 by Venturi effect, i.e. entrainment mixers
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8218 Gas operated
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

There is described a medicament delivery assembly which comprises mouthpiece provided with an air amplifier and a primer source, wherein the mouthpiece and the air amplifier are each is connected to the primer source via an actuatable valve; the air amplifier is also provided with a medicament extraction tube such that when the actuatable valve is opened then the primer source is activated and causes air to flow to the air amplifier. There is also described a method of administering a medicament which comprises the use of such a medicament delivery assembly.

Claims

1. A medicament delivery assembly which comprises a mouthpiece provided with an air amplifier and a primer source, wherein the mouthpiece and the air amplifier are each connected to the primer source via an actuatable valve;

the air amplifier is also provided with a medicament extraction tube such that when the actuatable valve is opened then the primer source is activated and causes air to flow to the air amplifier.

2. A medicament delivery assembly according to claim 1 characterised in that when the primer source is activated air also flows to the mouthpiece.

3. A medicament delivery assembly according to claim 1 characterised in that the mouthpiece and the air amplifier are separately connected to the actuatable valve.

4. A medicament delivery assembly according to claim 3 characterised in that a medicament reservoir is provided and actuation of the valve causes medicament to be extracted into the medicament extraction tube.

5. A medicament delivery assembly according to claim 3 characterised in that a conduit connecting the air amplifier to the actuatable valve includes a branch adapted to direct flushing gas to the medicament reservoir.

6. A medicament delivery assembly according to claim 5 characterised in that the medicament extraction tube is linked to the air amplifier such that non-laminar flow of the medicament is created.

8. A medicament delivery assembly according to claim 1 characterised in that the extraction tube is connected to a medicament chamber which is an annular chamber adapted to provide non-laminar flow of the medicament.

9. A medicament delivery assembly according to claim 8 characterised in that assembly comprises an annular medicament chamber and an axial gas jet.

10. A medicament delivery assembly according to claim 9 characterised in that the medicament chamber is substantially circumferential to the body of the amplifying system and the gas jet is axial to the body.

11. A medicament delivery assembly according to claim 4 characterised in that the reservoir comprises a plurality of individual dosage units.

12. A medicament delivery assembly according to claim 1 characterised in that the air amplifier comprises an assembly, such as is described in co-pending application No. PCT/GB02/02251.

13. A medicament delivery assembly according to claim 4 characterised in that the air amplifier comprises means for creating an entrained air flow through the medicament reservoir and/or metering member comprises and air inlet, preferentially adjacent to the medicament reservoir and/or metering member, and means for creating a pressure differential sufficient to draw entrained air through the inlet.

14. A medicament delivery assembly according to claim 1 characterised in that the primer source comprises a volatile propellant delivered from a pressurized canister.

15. A medicament delivery assembly according to claim 14 characterised in that the volatile propellant is a compressed gas propellant.

16. A medicament delivery assembly according to claim 14 characterised in that the propellant filled canister may be connected to an expansion reservoir.

17. A medicament delivery assembly according to claim 1 characterised in that the actuatable valve is a diaphragm valve.

18. A medicament delivery assembly according to claim 1 characterised in that the assembly comprises an inhaler.

19. A medicament delivery assembly according to claim 9 characterised in that the valve is a breath actuated valve.

20. A medicament delivery assembly according to claim 1 characterised in that the assembly incorporates a pulse valve.

22. A medicament delivery assembly according to claim 1 characterised in that the medicament is a powder.

23. An inhaler according to claim 15 characterised in that the inhaler is a dry powder inhaler.

24. A medicament delivery assembly according to claim 18 characterised in that the inhaler is a metered dose inhaler (MDI).

25. A medicament delivery assembly according to claim 1 characterised in that the inhaler is a nebulizer.

26. A medicament delivery assembly according to either of claims 20 or 21 characterised in that the cycle of the pulse valve is from 10 to 100 cycles/second.

27. A medicament delivery assembly according to claim 23 characterised in that the inhaler is a CLICKHALER (described in European Patent application No. 0 539 469).

28. A medicament delivery assembly according to claim 1 characterised in that the inhaler is a TECHNOHALER (described in European Patent Application No. 0 626 689).

29. A medicament delivery assembly according to claim 1 characterised in that the medicament selected from to β

₂-agonists, e.g. fenoterol, formoterol, pirbuterol, reproterol, rimiterol, salbutamol, salmeterol and terbutaline;

non-selected beta-stimulants such as isoprenaline;

xanthine bronchodilators, e.g. theophylline, aminophylline and choline theophyllinate;

anticholinergics e.g. ipratropium bromide;

mast cell stabilisers, e.g. sodium cromoglycate and ketotifen;

bronchial anti-inflammatory agents, e.g. nedocromil sodium; and

steroids, e.g. beclomethasone dipropionate, fluticasone, budesonide, ciclesonide and flunisolide; and

combinations thereof.

30. A medicament delivery assembly according to claim 1 characterised in that two or more medicaments to be administered.

31. A medicament delivery assembly according to claim 1 characterised in that the medicaments are selected from systemically active materials, such as, proteinaceous compounds and/or macromolecules, for example, hormones and mediators, such as insulin, human growth hormone, leuprolide and alpha interferon;

growth factors, anticoagulants, immunomodulators, cytokines and nucleic acids.

32. A method of administering a medicament which comprises the use of a medicament delivery assembly according to claim 1.

33. A method according to claim 32 characterised in that the method comprises administering the medicament with an inhaler, wherein the inhaler incorporates a pulse valve.

34. A method of administering a medicament which comprises the use of an inhaler according to claim 18.

35. A method of treatment of a patient with a respiratory disorder which comprises the administration of a medicament using a delivery assembly according to claim 1.

36. A method according to claim 35 characterised in that the method comprises administration of a medicament by inhalation.

37. A method of treatment of a patient with a systemic disorder which comprises the administration of a medicament using a delivery assembly according to claim 1.

38. A method of treating insulin dependent diabetes which comprises administration of an effective amount of insulin using an assembly according to claim 1.

7. A medicament delivery assembly according to claim 7 characterised in that the entrainment air flow is sufficient to cause deagglomeration and/or entrainment and then subsequent aerosolisation of the medicament.

21. A medicament inhaler which incorporates a pulse valve.

39. A medicament delivery assembly or an inhaler substantially as described with reference to the accompanying drawings.