PMID- 29024795
OWN - NLM
STAT- MEDLINE
DCOM- 20190114
LR  - 20190114
IS  - 1522-9629 (Electronic)
IS  - 1094-5539 (Linking)
VI  - 48
DP  - 2018 Feb
TI  - Are valved holding chambers (VHCs) interchangeable? An in vitro evaluation of VHC 
      equivalence.
PG  - 179-184
LID - S1094-5539(17)30184-0 [pii]
LID - 10.1016/j.pupt.2017.10.005 [doi]
AB  - INTRODUCTION: The European Medicines Agency (EMA) requires that a specific valved 
      holding chamber (VHC) is designated for use with a given pressurised metered dose 
      inhaler (pMDI). No other regulatory authorities impose similar requirements, 
      implying that VHCs are interchangeable. This in vitro study, employing EMA 
      assessment criteria, assessed the equivalence of four anti-static VHCs (aVHCs) 
      versus the non-conducting VHC most widely referenced in pMDI monographs, the 
      AeroChamber Plus (AC+) VHC. MATERIAL & METHODS: The "reference" AC + VHC was 
      prepared by soaking in detergent solution. The four test aVHCs (AeroChamber Plus 
      Flow-Vu [AC + FV]; Compact Space Chamber Plus [CSC+]; InspiraChamber [IC]; 
      OptiChamber Diamond [OCD]) were tested "out-of-packet". Twenty devices of each 
      type were evaluated. A salbutamol pMDI was actuated into each VHC with a 2-s 
      delay between actuation and Andersen Cascade Impactor (ACI) sampling. Drug 
      deposition in four ACI particle size groups was assessed: Group 1, >5.8-10 mum; 
      Group 2, >3.3-5.8 mum; Group 3, >1.1-3.3 mum; Group 4, </=1.1 mum. Equivalence versus 
      the reference VHC was demonstrated where the 90% confidence interval for the 
      test/reference mass ratio was within 85-118%. RESULTS: The mass retained within 
      the VHC was similar for the AC + VHC and AC + FV aVHC, but was approximately 
      twice as great for the other aVHCs. Salbutamol deposition in all ACI groups with 
      the AC + FV aVHC was equivalent to the reference AC + VHC. By contrast, 
      deposition in ACI groups 1 to 3 with the CSC+, IC and OCD aVHCs was inequivalent 
      to (approximately half that of) the reference VHC. Inter-device variability for 
      each VHC type was greatest for the IC and least for the AC + VHC and AC + FV 
      aVHC. CONCLUSIONS: The performance of VHCs that superficially resemble one 
      another may differ markedly. Thus, as implied by EMA guidelines, VHCs should not 
      automatically be considered to be interchangeable.
CI  - Copyright (c) 2017 Elsevier Ltd. All rights reserved.
FAU - Dissanayake, Sanjeeva
AU  - Dissanayake S
AD  - Certior Consulting, 143 Victoria Road, London NW6 6TE, UK. Electronic address: 
      sanjeeva@certiorconsulting.com.
FAU - Nagel, Mark
AU  - Nagel M
AD  - Trudell Medical International, 725 Third Street, London, Ontario N5V 5G4, Canada. 
      Electronic address: MNagel@trudellmed.com.
FAU - Falaschetti, Emanuela
AU  - Falaschetti E
AD  - Imperial College Clinical Trials Unit, 68 Wood Lane, London W12 7RH, UK. 
      Electronic address: e.falaschetti@imperial.ac.uk.
FAU - Suggett, Jason
AU  - Suggett J
AD  - Trudell Medical International, 725 Third Street, London, Ontario N5V 5G4, Canada. 
      Electronic address: JSuggett@trudellmed.com.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20171010
PL  - England
TA  - Pulm Pharmacol Ther
JT  - Pulmonary pharmacology & therapeutics
JID - 9715279
RN  - 0 (Aerosols)
RN  - 0 (Bronchodilator Agents)
RN  - QF8SVZ843E (Albuterol)
SB  - IM
MH  - Administration, Inhalation
MH  - Aerosols
MH  - Albuterol/*administration & dosage
MH  - Bronchodilator Agents/administration & dosage
MH  - *Drug Delivery Systems
MH  - Equipment Design
MH  - *Inhalation Spacers
MH  - *Metered Dose Inhalers
MH  - Particle Size
OTO - NOTNLM
OT  - Aerochamber
OT  - Equivalence
OT  - Spacer
OT  - Valved holding chamber
EDAT- 2017/10/13 06:00
MHDA- 2019/01/15 06:00
CRDT- 2017/10/13 06:00
PHST- 2017/07/30 00:00 [received]
PHST- 2017/10/06 00:00 [revised]
PHST- 2017/10/08 00:00 [accepted]
PHST- 2017/10/13 06:00 [pubmed]
PHST- 2019/01/15 06:00 [medline]
PHST- 2017/10/13 06:00 [entrez]
AID - S1094-5539(17)30184-0 [pii]
AID - 10.1016/j.pupt.2017.10.005 [doi]
PST - ppublish
SO  - Pulm Pharmacol Ther. 2018 Feb;48:179-184. doi: 10.1016/j.pupt.2017.10.005. Epub 
      2017 Oct 10.