www.pharm.monash.edu.au/mips

8 December 2011 DDL 22, Edinburgh, Scotland

Choosing the Right Device The case for Nebulisers Philippe Rogueda

The Case for Nebulisers

•  Mature Technology – Oldest form of inhalation therapy? – Device is separate from medication

•  Well established with user community – Mostly CF and clinical settings

•  Varied, cheap and convenient? - Many combinations, new technologies, not easily replaced by alternatives

Example: the De Vilbiss Range

Traveller Portable PulmoNeb LT PulmoNeb PulmoAide Compact

PulmoAide PulmoMate Heavy Duty Compressor

Choosing a Nebuliser

Technology and Performance

Reading Through the Lines

Alternative Technologies

Criteria List

Setting your Criteria

•  Properties of the API, dosage, regimen •  Target use and patient group •  Required functionality •  Intended operating conditions •  Handling and ergonomics

What?

•  Appearance and visual language •  Basic safety •  Accessories and connections to other devices •  Target costs, production costs and forecast •  Target countries

Where?

Clinical and C

omm

ercial Needs

•  Mode of supply •  Lifetime, disposal, cleaning and servicing •  Quality and regulatory •  Intellectual property •  Suppliers and external contracts

How?

20 nebulisers – 24 compressors – 13 combinations – EU & USA From Clinic to Market

Jet Nebulisers

| Presentation Title | Presenter Name | Date | Subject | Business Use Only

6

Manufacturer Nebuliser Compressor

PARI EU: JunioBOY, BOY SX, LC Sprint Junior, LC Sprint Baby, LC Sprint Star, LL – USA: LC Plus, LC Sprint, LC star, LC disposable

EU: JunioBOY S, TurboBOY S, BOY SX, Mobile S - USA: Vios adult Vios Paediatric Trek S Portable

De Vilbiss VixOne Disposable VixOne Reusable

PulmoNeb LT Traveler Portable PulmoNeb Polumo-aide Compact PulmoMate Pulmo-Aire Heavy Duty Compressor

Invacare Stratos Pro (USA and EU models) Stratos Compact (USA) Stratos Portable (USA)

Envoy Jr XP Compressor (USA) Envoy Compressor (USA)

MOBILAIR Compressor (USA) §  Other suppliers include Covidien (raindrop),

Omron Comp range, Evo and Salter Labs

Manufacturer Nebuliser Compressor

DTF/Aerodrug Atomisor range: NSL2 NL9, NL9F, NL9M

Box Box+ Synchrone Vanity AL

Truddel Medical Aeroeclipse III

Philips Sidestream Sidestream Plus Ventstream MicroPlus

InspirationElite MicroElite MiniElite OptionHome

Clement Clarke Medix Actineb Medix AC2000

Medix World traveller Medix Econoneb Medix Turboneb 2

Medix Micro Neb III

Intersurgical MicroCirrus Cirrus Cirrus 2 Hot Top Plus

Jet Nebulisers LC / Boy – PARI

Junior BOY S

LC Sprint Junior

Turbo BOY S

LC Sprint

+ + BOY SX

+

LC Sprint or BOY SX

Mobile S Trek S Portable (USA)

+

LC Sprint

Vios Pediatric (USA) Vios Adult (USA)

Mesh Nebulisers

Manufacturer Model PARI eFlow Rapid Philips (Respironics) iNeb Covidien (Nellcor) Easyneb Clement Clarke Medix Microneb

(same as MicroAir U22 technology from Omron) Omron MicroAir U22

UltraAir Aerogen Aeroneb Go range

§  Omron technology: forms the core of the MicroAir and UltraAir devices, as well as the Medix Microneb of Clement Clark.

§  Easyneb (Covidien, Nellcor, Puritan Bennett) is an ultrasonic nebuliser for ventilators.

Mesh Nebulisers

Performance of the vibrating membrane aerosol generation device: aeroneb micropump nebulizer. G Zhang, A David, T S Wiedmann. J. Aerosol Med. 20(4), 408-416 (2007)

Mesh: 1000’s tapered holes, 4-80 µm. F~128 kHz. Holes act as micro-pumps.

Performance Variations

VMD (um)

Dv50 (um)

Res Vol (ml)

Output

Treatment time Delivery rate

Mesh

4.8 ± 0.2 (5%)

0.3 ± 0.1 (32%)

0.40 ± 0.07 (18%) mg/min

Jet 4.1 ± 0.6 (14%)

1.19 ± 0.13 (11%)

1.19 ± 0.2 (17%) mg

5.64 ± 1.09 (19%) min

0.22 ± 0.05 (23%) mg/min

Mesh 5.24 ± 0.75 (14%)

0.34 ± 0.03 (8%) ml

49 ± 10 (21%) sec

0.43 ± 0.09 (21%) ml/min

•  Performance variation is greater than for DPIs or pMDIs •  Variations include: droplet size, residual volumes, delivered dose,

delivery rate, battery life, aging of mesh, blocking of mesh

Reading Through the Lines: Data Review

-Make sure the data has not been generated at an “optimal” flow rate -Check that the residual volumes include all volumes left behind (residual vs. rain drop)

-A warm compressor performs better than a cold one, but a patient will always start with a cold compressor

-Check how the chambers are cleaned. Residual detergent between runs can improve performance. Can the cleaning be performed according to the CF society recommendations?

-Check that performance has been tested with known breathing patterns, preferably with cooling of the impactor and %RH control.

-Check the performance of the motors and battery life on portable instruments -Know the difference between nasal and mouth breathing, cf paediatric applications

-Is your chosen nebuliser available on all markets?

Alternatives to Current Technologies

•  BI •  Aqueous solution mechanically propelled

New technologies update the concept of nebulisation, open new markets, improve performance.

Respimat

Dry Powder

Supraer

•  Microdose Therapeutics •  Based on piezo electric crystal technology

•  Kaer Biotherapeutics •  For Biomolecules, aerosolisation of pure

molecules

Dry Powder Nebuliser

Alternatives to Current Technologies

•  BI •  Aqueous solution mechanically propelled

New technologies update the concept of nebulisation, open new markets, improve performance.

Respimat

Dry Powder

Supraer

•  Microdose Therapeutics •  Based on piezo electric crystal technology

•  Kaer Biotherapeutics •  For Biomolecules, aerosolisation of pure

molecules

Nebulisers: The best Platform for

Telehealth?

And Finally