Valved Holding Chambers Can Have Different Medication Delivery

Valved Holding Chambers Can Have Different Medication Delivery Performance as a Function
of Delay Interval Following Actuation of the Pressurized Metered Dose Inhaler
Jason Suggett , Mark Nagel , Cathy Doyle , Heather Schneider and Jolyon Mitchell
1
1
1
1
1
Trudell Medical International, London, Canada. 2 Jolyon Mitchell Inhaler Consulting Services Inc.
Rationale
Results
• Valved Holding Chambers (VHCs) are prescribed
for patients who cannot coordinate inhalation with
actuation of a pressurized Metered Dose Inhaler
(pMDI) containing the drug product
Fine Particle Mass <4.7µm (FPM<4.7µm) for
†
Seretide FP at two delay intervals for each VHC
• Delay intervals of 5 and 10 seconds were tested
to account for poor coordination and situations
where multiple breaths are required to evacuate the
chamber
• this study explored the in vitro performance of
three different anti-static VHCs, simulating 5 s and
10 s delays
MATERIALS AND METHODS
Fine Particle Mass <4.7µm (FPM<4.7µm) for
†
Seretide SX at two delay intervals for each VHC
VHC Type
AeroChamber Plus* Flow-Vu*
OptiChamber† Diamond† Anti-Static Valved Holding Chamber
Vortex† Anti-Static Valved Holding Chamber
OptiChamber† Diamond†
Vortex†
• Each VHC was tested out-of-package
• The VHC on test was connected to an Andersen
Cascade Impactor operated at 28.3 L/min
• A proprietary apparatus enabled the required delay
interval to be simulated
• Recovered FP and SX were assayed using HPLCUV/fluorescence spectrophotometry by internally
validated methods
• 5 actuations of Seretide† 250µg fluticasone
propionate (FP)/25µg salmeterol xinafoate (SX)
(GSK)
• Delivered via three different antistatic VHCs (n=5 devices/group)
• AeroChamber Plus* Flow-Vu* Anti-Static
VHC (Trudell Medical International)
Delay (s)
FPM<4.7 µm
(µg/actuation)
5
10
5
10
5
10
88.2 ± 5.6
78.3 ± 6.7
63.8 ± 7.8
48.6 ± 9.3
67.4 ± 9.7
47.8 ± 8.1
Mean ± SD
VHC Type
5
10
5
10
5
10
8.6 ± 0.6
7.3 ± 0.5
6.2 ± 0.9
4.7 ± 0.8
7.0 ± 1.0
4.7 ± 0.8
OptiChamber† Diamond†
Vortex†
100
• FPM<4.7μm was significantly greater using the
AeroChamber Plus* Flow-Vu* VHC compared
†
†
†
to the OptiChamber Diamond and Vortex VHCs
for both components at both time delays (1-way
ANOVA, p ≤ 0.002)
• Differences in performance of anti-static VHCs
was observed, which points toward other factors
such as chamber shape and capacity as well as
inhalation valve design affecting medication delivery
• The clinical impact of potential under-dosing with
poorly coordinated patients should be considered
when selecting a VHC
10.0
85
70
55
40
Delay (s)
FPM<4.7 µm
(µg/actuation)
AeroChamber Plus* Flow-Vu*
FPM<4.7 µm (µg/actuation)
• Anti-static VHCs help maximize aerosol suspension
time
Conclusions
Mean ± SD
FPM<4.7 µm (µg/actuation)
• Performance of these add-on devices as a function
of delayed inhalation is therefore critical for dose
assurance
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber
2
5 second Delay
10 second Delay
AeroChamber Plus* Flow-Vu*
OptiChamber† Diamond†
Vortex†
8.5
7.0
5.5
4.0
5 second Delay
10 second Delay
AeroChamber Plus* Flow-Vu*
OptiChamber† Diamond†
Vortex†
• OptiChamber Diamond VHC (Philips Respironics)
†
†
• Vortex VHC (PARI Respiratory Equipment)
†
ERS International Congress
September 6 – 10, 2014
Munich, Germany
MD-458A-0614. * trade-marks and registered trade-marks of Trudell Medical International. † trade-marks and registered trade-marks of respective companies. Copyright © Trudell Medical International 2014.
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