PMID- 23780781
OWN - NLM
STAT- MEDLINE
DCOM- 20140408
LR  - 20211021
IS  - 1530-9932 (Electronic)
IS  - 1530-9932 (Linking)
VI  - 14
IP  - 3
DP  - 2013 Sep
TI  - Evaluation of an abbreviated impactor for fine particle fraction (FPF) 
      determination of metered dose inhalers (MDI).
PG  - 1004-11
LID - 10.1208/s12249-013-9984-7 [doi]
AB  - Abbreviated impactors have been developed recently to allow more rapid evaluation 
      of inhalation products as alternates to the eight-stage Andersen Cascade Impactor 
      (ACI) which has been widely used in the pharmaceutical industry for assessing 
      aerodynamic particle size distribution. In this paper, a two-stage abbreviated 
      impactor, Westech Fine Particle Dose Impactor (WFPD), was used to characterize 
      the aerodynamic particle size of metered dose inhaler (MDI) products, and the 
      results were compared with those obtained using the standard eight-stage ACI. 
      Seven commercial MDI products, with different propellants 
      (chlorofluorocarbon/hydrofluoroalkane) and formulation types 
      (suspension/solution, dry/normal/wet), were tested in this study by both WFPD and 
      ACI. Substantially equivalent measures of fine particle fraction were obtained 
      for most of the tested MDI products, but larger coarse particle fraction and 
      extra-fine particle fraction values were measured from WFPD relative to those 
      measured using the ACI. Use of the WFPD also produced more wall loss than the 
      ACI. Therefore, it is recommended that the system suitability be evaluated on a 
      product-by-product basis to establish substantial equivalency before implementing 
      an abbreviated impactor measurement methodology for routine use in inhaler 
      product characterization.
FAU - Guo, Changning
AU  - Guo C
AD  - Division of Pharmaceutical Analysis, US Food and Drug Administration, 1114 Market 
      Street, St. Louis, Missouri 63101, USA. changning.guo@fda.hhs.gov
FAU - Ngo, Diem
AU  - Ngo D
FAU - Ahadi, Shafiq
AU  - Ahadi S
FAU - Doub, William H
AU  - Doub WH
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
DEP - 20130619
PL  - United States
TA  - AAPS PharmSciTech
JT  - AAPS PharmSciTech
JID - 100960111
SB  - IM
MH  - Administration, Inhalation
MH  - *Equipment Design
MH  - *Metered Dose Inhalers
MH  - Particle Size
PMC - PMC3755172
EDAT- 2013/06/20 06:00
MHDA- 2014/04/09 06:00
PMCR- 2014/06/19
CRDT- 2013/06/20 06:00
PHST- 2013/02/26 00:00 [received]
PHST- 2013/05/15 00:00 [accepted]
PHST- 2013/06/20 06:00 [entrez]
PHST- 2013/06/20 06:00 [pubmed]
PHST- 2014/04/09 06:00 [medline]
PHST- 2014/06/19 00:00 [pmc-release]
AID - 9984 [pii]
AID - 10.1208/s12249-013-9984-7 [doi]
PST - ppublish
SO  - AAPS PharmSciTech. 2013 Sep;14(3):1004-11. doi: 10.1208/s12249-013-9984-7. Epub 
      2013 Jun 19.