Delivery of Respimat Soft Mist Inhaler from a Valved Holding …€¦ · AeroChamber Plus* Flow-Vu*...
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Delivery of Respimat Soft Mist Inhaler from a Valved Holding Chamber RATIONALE • The Soft Mist Inhaler (SMI) platform is used to deliver inhaled medications to treat different disease conditions and patient populations. Valved Holding Chambers (VHCs) are also used to treat the same patient populations • Questions have arisen regarding the applicability of the SMI+VHC particularly in pediatric and geriatric patients • This laboratory investigation was undertaken to assist practitioners with information regarding potential drug delivery from the SMI+VHC MATERIALS AND METHODS • Evaluated with: Excellence By Design V. Kushnarev, M. Nagel, C. Doyle, J. Suggett 1 Trudell Medical International, London, Canada. MD-801A-0717. * trade-marks and registered trade-marks of Trudell Medical International. † trade-marks and registered trade-marks of Boehringer Ingelheim. Copyright © Trudell Medical International 2017. ERS International Congress Milan, Italy September 9 – 13, 2017 • Measurements of Fine Particle Mass (FPM, 0.54-3.99 µm aerodynamic diameter) were made by means of a chilled Next Generation Pharmaceutical Impactor equipped with USP inlet operated at 30 L/min • Assay for active ingredients recovered from components of the apparatus was undertaken by HPLC Next Generation Pharmaceutical Impactor FPM recovered from stages 3, 4 & 5 RESULTS CONCLUSIONS • The differences in FPM between the SMI and SMI+ VHC were within the typical magnitude of method variability and likely to be clinically insignificant • Healthcare providers can have assurance that the use of the SMI with AeroChamber Plus* Flow-Vu* AVHC should deliver a similar FPM of medication compared to the SMI alone 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 (Ipratropium bromide/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 † Vacuum source 30 L/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 Particle Mass (μg) Tiotropium 0.0 1.0 2.0 3.0 4.0 Fine Particle Mass (μg) 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 Particle Mass (μg) 0 20 40 60 80 100 Ipratropium Bromide Salbutamol Spiriva † Respimat † SMI Inspiolto † Respimat † SMI Combivent † Respimat † SMI
Transcript of Delivery of Respimat Soft Mist Inhaler from a Valved Holding …€¦ · AeroChamber Plus* Flow-Vu*...
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
