PMID- 27210737
OWN - NLM
STAT- MEDLINE
DCOM- 20170517
LR  - 20170517
IS  - 1873-3476 (Electronic)
IS  - 0378-5173 (Linking)
VI  - 514
IP  - 2
DP  - 2016 Dec 5
TI  - Exploring the impact of sample flowrate on in vitro measurements of metered dose 
      inhaler performance.
PG  - 420-427
LID - S0378-5173(16)30405-7 [pii]
LID - 10.1016/j.ijpharm.2016.05.025 [doi]
AB  - Pharmacopoeial methods for measurement of the aerodynamic particle size 
      distribution (APSD) of metered dose inhalers (MDIs) by cascade impaction specify 
      a sampling flow rate of 28.3L/min. However, there is little data within the 
      literature to rationalize this figure, or to support its clinical relevance. In 
      addition, the standard United States Pharmacopoeia Induction Port (USP IP) used 
      for testing is known to inaccurately reflect deposition behavior in the upper 
      airway, further compromising the relevance of testing, for product development. 
      This article describes experimental studies of the effect of sampling flow rate 
      on APSD data gathered using an Andersen Cascade Impactor (ACI). Tests were 
      carried out using two different formulations to assess the influence of 
      formulation composition. In addition, comparative testing with an Alberta 
      Idealised Throat, in place of the USP IP, to ensure more realistic representation 
      of the upper airway. The results show how measured APSD and fine particle dose, 
      the dose than on the basis of size would be expected to deposit in the lung, vary 
      as a function of test methodology, providing insight as to how the testing can be 
      modified towards greater clinical relevance.
CI  - Copyright (c) 2016 The Author(s). Published by Elsevier B.V. All rights reserved.
FAU - Lewis, D A
AU  - Lewis DA
AD  - Chiesi Ltd., Bath Rd. Ind. Est., Chippenham, Wiltshire SN14 0AB, UK. Electronic 
      address: d.lewis@chiesi.com.
FAU - O'Shea, H
AU  - O'Shea H
AD  - Chiesi Ltd., Bath Rd. Ind. Est., Chippenham, Wiltshire SN14 0AB, UK.
FAU - Church, T K
AU  - Church TK
AD  - Chiesi Ltd., Bath Rd. Ind. Est., Chippenham, Wiltshire SN14 0AB, UK.
FAU - Brambilla, G
AU  - Brambilla G
AD  - Chiesi Ltd., Bath Rd. Ind. Est., Chippenham, Wiltshire SN14 0AB, UK.
FAU - Traini, D
AU  - Traini D
AD  - Respiratory Technology, Woolcock Institute of Medical Research, The University of 
      Sydney, 2006, Australia; Discipline of Pharmacology, Sydney Medical School, The 
      University of Sydney, 2006, Australia.
FAU - Young, P M
AU  - Young PM
AD  - Respiratory Technology, Woolcock Institute of Medical Research, The University of 
      Sydney, 2006, Australia; Discipline of Pharmacology, Sydney Medical School, The 
      University of Sydney, 2006, Australia.
LA  - eng
PT  - Journal Article
DEP - 20160519
PL  - Netherlands
TA  - Int J Pharm
JT  - International journal of pharmaceutics
JID - 7804127
SB  - IM
MH  - Administration, Inhalation
MH  - Drug Compounding
MH  - *Equipment Design
MH  - Humans
MH  - Metered Dose Inhalers/*standards
MH  - Particle Size
MH  - Rheology/*instrumentation
OTO - NOTNLM
OT  - Aerodynamic particle size distribution
OT  - Alberta idealized throat
OT  - Cascade impactor
OT  - Fine particle dose
OT  - Metered dose inhalers
OT  - Testing conditions
EDAT- 2016/05/24 06:00
MHDA- 2017/05/18 06:00
CRDT- 2016/05/24 06:00
PHST- 2016/03/23 00:00 [received]
PHST- 2016/05/11 00:00 [revised]
PHST- 2016/05/13 00:00 [accepted]
PHST- 2016/05/24 06:00 [pubmed]
PHST- 2017/05/18 06:00 [medline]
PHST- 2016/05/24 06:00 [entrez]
AID - S0378-5173(16)30405-7 [pii]
AID - 10.1016/j.ijpharm.2016.05.025 [doi]
PST - ppublish
SO  - Int J Pharm. 2016 Dec 5;514(2):420-427. doi: 10.1016/j.ijpharm.2016.05.025. Epub 
      2016 May 19.