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Delivery of Respimat Soft Mist Inhaler from a Valved Holding Chamber
RatIonale•TheSoftMistInhaler(SMI)platformisusedtodeliverinhaledmedicationstotreatdifferentdiseaseconditionsandpatientpopulations.ValvedHoldingChambers(VHCs)arealsousedtotreatthesamepatientpopulations
•questionshavearisenregardingtheapplicabilityoftheSMI+VHCparticularlyinpediatricandgeriatricpatients
•ThislaboratoryinvestigationwasundertakentoassistpractitionerswithinformationregardingpotentialdrugdeliveryfromtheSMI+VHC
MateRIalS anD MetHoDS•Evaluatedwith:
Excellence By Design
V. Kushnarev, M. Nagel, C. Doyle, J. Suggett1TrudellMedicalInternational,London,Canada.
MD-801A-0717.*trade-marksandregisteredtrade-marksofTrudellMedicalInternational.†trade-marksandregisteredtrade-marksofBoehringerIngelheim.Copyright©TrudellMedicalInternational2017.
ERS International Congress Milan, Italy
September 9 – 13, 2017
•MeasurementsofFineParticleMass(FPM,0.54-3.99µmaerodynamicdiameter)weremadebymeansofachilledNextGenerationPharmaceuticalImpactorequippedwithUSPinletoperatedat30L/min
•AssayforactiveingredientsrecoveredfromcomponentsoftheapparatuswasundertakenbyHPLC
NextGenerationPharmaceuticalImpactor
FPMrecoveredfromstages3,4&5
ReSUltS
ConClUSIonS•ThedifferencesinFPMbetweentheSMIandSMI+VHCwerewithinthetypicalmagnitudeofmethodvariabilityandlikelytobeclinicallyinsignificant
•HealthcareproviderscanhaveassurancethattheuseoftheSMIwithAeroChamber Plus*Flow-Vu*AVHCshoulddeliverasimilarFPMofmedicationcomparedtotheSMIalone
Fine Particle Mass (0.54-3.99 µm)
SMI tYPe Respimat SMI alone (µg)
AeroChamber Plus* Flow-Vu* aVHC
(µg)
Spiriva†Respimat†SMI(Tiotropium) 1.8±0.1 1.4±0.1
Inspiolto†Respimat†SMI(Tiotropium/Olodaterol) 2.0±0.1/2.0±0.1 1.7±0.3/1.4±0.2
Combivent†Respimat†SMI(Ipratropiumbromide/Salbutamol) 11.4±0.9/61.7±2.5 11.7±0.8/54.8±5.0
AeroChamber Plus* Flow-Vu* Antistatic Valved Holding Chambers (AVHC)Trudell Medical International, London, Canada
Respimat† Soft Mist Inhaler Formulations
Combivent† Inspiolto† Spiriva†
Vacuumsource
30L/min
1 2 3 4 5 6 7 MOC
SMI Alone(simulated perfect technique)
SMI with AeroChamber Plus* Flow-Vu* AVHC
0.0
1.0
2.0
3.0
4.0
Fine
Par
ticle
Mas
s (µ
g)
Tiotropium
0.0
1.0
2.0
3.0
4.0
Fine
Par
ticle
Mas
s (µ
g)
Tiotropium Olodaterol
SMI Alone(simulated perfect technique)
SMI with AeroChamber Plus* Flow-Vu* AVHC
SMI Alone(simulated perfect technique)
SMI with AeroChamber Plus* Flow-Vu* AVHC
Fine
Par
ticle
Mas
s (µ
g)
0
20
40
60
80
100Ipratropium Bromide Salbutamol
Spiriva† Respimat† SMI
Inspiolto† Respimat† SMI
Combivent† Respimat† SMI
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