VACCINE NEBULISERS

20130032140

13/650535

October 12, 2012

The invention provides a method of selecting a nebuliser device to be used to deliver a vaccine comprising selecting a nebuliser capable of producing a plurality of vaccine particles having the following particle droplet size distribution: (i) Dv10: 2.0+/−0.2 μm (ii) Dv50: 5.0+/−0.5 μm (iii) Dv90: 10.0+/−1.0 μm (iv) a mean mass aerodynamic diameter (MMAD) of 4.5 to 8.0 μm This allows the selection of, for example, commercially available nebulisers, previously used for drug delivery, for vaccine delivery. This considerably reduces the work required to identify suitable nebulisers. Nebulisers identified by the methods of the invention are also claimed.

World Health Organization (Geneva, CH)

1. A method for selecting a nebuliser device for delivery of a vaccine, the method comprising the step of: using a particle size analyzer to identify a nebuliser device capable of delivering a plurality of vaccine particles having a particle droplet size distribution of: (i) Dv10: 2.0+/−0.2 μm (ii) Dv50: 5.0+/−0.5 μm (iii) Dv90: 10.0+/−1.0 μm (iv) a mean mass aerodynamic diameter (MMAD) of 4.5 to 8.0 μm.

2. The method of claim 1, wherein the step of identifying a nebuliser device further requires that the mean mass aerodynamic diameter (MMAD) be 6.5 μm with a Geometric Standard Deviation (GSD) of 1.7.

3. The method of claim 1, wherein the step of identifying a nebuliser device further requires that the identified nebuliser device allows a potency retention of at least about 75% for a reconstituted vaccine delivered by the nebuliser device to a patient after 40 doses have been delivered.

4. The method of claim 3, wherein the step of identifying a nebuliser device requires that the reconstituted vaccine comprises an Edmonston-Zagreb vaccine.

5. The method of claim 1, wherein the step of identifying a nebuliser device further requires that the nebuliser device comprise a receptacle for receiving two or more doses of vaccine.

6. The method of claim 1, wherein the step of identifying a nebuliser device further requires that the nebuliser device be able to produce a substantially consistent dose delivery for each delivery of the virus.

7. The method of claim 1, wherein the step of identifying a nebuliser device further requires that the identified nebuliser device be capable of delivering vaccine particles, wherein at least about 95% of the particles are greater than about 0.5 μm in diameter (MMAD).

8. The method of claim 3, wherein the potency retention is achieved without cooling the reconstituted vaccine.

9. The method of claim 1, wherein the method further comprises: screening the nebuliser device for the ability to provide an immunizing dose of vaccine to an infant or child within 20 to 40 seconds.

10. The method of claim 4, wherein the method further comprises the step of requiring a receptacle for receiving the two or more doses of vaccine, whereby the receptacle is detachable, and whereby the receptacle provides an environment suitable to prevent contamination of the vaccine within the receptacle.

11. The method of claim 10, whereby the receptacle containing the vaccine provides the environment suitable to prevent contamination of the vaccine between vaccinations.

12. The method of claim 1, further comprising the step of requiring the nebuliser device to comprise a piezoelectric nebulising element.

13. The method of claim 1, further comprising the step of requiring the nebuliser device to comprise an air delivery element.

14. The method of claim 13, wherein the air delivery element comprises an air intake filter operable to filter airborne microorganisms.

15. The method of claim 1, further comprising the step of requiring the nebuliser device to comprise a facial interface, adapted to substantially fit the contours of a patient's face when in use.

16. The method of claim 15, further comprising the step of requiring a nebuliser element in fluid connection with the facial interface, a mouthpiece, or nasal prongs via a spacer.

17. The method of claim 16, further comprising the step of requiring the nebuliser device to comprise one or more air hoses between the facial interface, the mouthpiece, or the nasal prongs and the nebuliser element.

18. The method of claim 17, further comprising the step of requiring one or more of a receptacle, the nebuliser element, the facial interface, the mouthpiece, the nasal prongs, an air intake filter, or the air hose to be disposable.

19. The method of claim 18, wherein the nebuliser device further comprises a one-way valve between a patient utilizing the nebuliser device, and one or more of a nebuliser element, and an air delivery means when used.

20. The method of claim 19, wherein the nebuliser device further comprises a needle-free vaccine loading device.

21. A method for selecting a nebuliser device for delivery of a vaccine, the method comprising the step of using a particle size analyzer to select a nebuliser device comprising: a piezoelectric nebulising element operable to nebulize a vaccine such that vaccine particles display the following particle droplet size distribution: (i) Dv10: 2.0+/−0.2 μm (ii) Dv50: 5.0+/−0.5 μm (iii) Dv90: 10.0+/−1.0 μm (iv) a mean mass aerodynamic diameter (MMAD) of about 4.5 to about 8.0 μm; and at least one element selected from the group consisting of: (a) an air intake filter capable of filtering airborne microorganisms; (b) a facial interface adapted to fit substantially to the contours of the face of a patient; (c) one or more connections for receiving a supply of vaccine, wherein the connections are selected from the group consisting of a mouthpiece, a nasal prong, and an air hose; and (d) a receptacle for receiving a two or more doses of vaccine; wherein the nebulising element and the at least one element are operably connected to one another.

22. The method of claim 21, whereby the nebuliser device comprise at least two different elements selected from the group identified in claim 21.

23. The method of claim 21, whereby the nebuliser device comprise at least three different elements selected from the group identified in claim 21.

24. A method for selecting a nebuliser device for delivery of a vaccine, the method comprising the step of using a particle size analyzer to select a nebuliser device comprising: (a) a piezoelectric nebulising element operable to nebulize a vaccine such that vaccine particles display the following particle droplet size distribution: (i) Dv10: 2.0+/−0.2 μm (ii) Dv50: 5.0+/−0.5 μm (iii) Dv90: 10.0+/−1.0 μm (iv) a mean mass aerodynamic diameter (MMAD) of about 4.5 to about 8.0 μm (b) an air intake filter capable of filtering airborne microorganisms; (c) a facial interface adapted to fit substantially to the contours of the face of a patient; (d) one or more connections for receiving a supply of vaccine, wherein the connections are selected from the group consisting of a mouthpiece, a nasal prong, and an air hose; and (e) a receptacle for receiving a two or more doses of vaccine; wherein the nebulising element, the air intake filter, the facial interface, the one or more connection for receiving a supply of vaccine, and the receptacle are operably connected to one another.

25. The method of claim 24, whereby the nebuliser device further comprises a rechargeable battery.

26. The method of claim 25, whereby the nebuliser device further comprises a needle-free vaccine loading device.

27. A method of administering a vaccine comprising providing the vaccine as an aerosol via a nebuliser device selected by the method defined in claim 21.

28. A vaccine kit comprising: a nebuliser device selected according to the method identified in claim 21, and a vaccine.

29. A kit according to claim 28, further comprising: a lockable, watertight carrying case.

12820/023

01; 61

edspap.20130032140