PMID- 22752252
OWN - NLM
STAT- MEDLINE
DCOM- 20130610
LR  - 20211021
IS  - 1573-904X (Electronic)
IS  - 0724-8741 (Linking)
VI  - 29
IP  - 11
DP  - 2012 Nov
TI  - Measurement of drug in small particles from aqueous nasal sprays by Andersen 
      Cascade Impactor.
PG  - 3122-30
LID - 10.1007/s11095-012-0804-7 [doi]
AB  - PURPOSE: To determine if cascade impactor (CI) measurement of drug in small 
      particles from aqueous nasal sprays, described in FDA's 2003 draft Nasal 
      Bioavailability/Bioequivalence Guidance, can be optimized to reduce measurement 
      variability. To examine the influence of flow rate configurations and number of 
      impactor stages on CI deposition and explore the importance of inlet volume. 
      METHODS: A total of eight assemblies and manual vs. automatic actuation were 
      tested for deposition on the sum of all stages of the CI, and for Group 2 total 
      drug mass per the Guidance. Mean deposition and variance about the mean were 
      determined for each assembly. RESULTS: The path length for a spherical 1 l inlet 
      was too short to allow adequate aerosol formation. Data variance was reduced by a 
      factor of two or more by using an automatic actuator relative to manual 
      actuation. Impactor assembly modification did not improve variance over the 
      standard assembly. CONCLUSIONS: Use of a spherical inlet (>/= 2 l volume) and 
      automatic actuation are recommended for comparative measurements of drug in small 
      particles arising from aqueous nasal sprays. The standard (8-stage) 28.3 lpm CI 
      flow rate configuration is recommended when using the Andersen Cascade Impactor 
      (ACI), as no other assembly showed a distinct advantage.
FAU - Doub, William H
AU  - Doub WH
AD  - Division of Pharmaceutical Analysis, Food and Drug Administration CDER, OPS, St. 
      Louis, Missouri, USA. william.doub@fda.hhs.gov
FAU - Adams, Wallace P
AU  - Adams WP
FAU - Wokovich, Anna M
AU  - Wokovich AM
FAU - Black, John C
AU  - Black JC
FAU - Shen, Meiyu
AU  - Shen M
FAU - Buhse, Lucinda F
AU  - Buhse LF
LA  - eng
PT  - Journal Article
DEP - 20120703
PL  - United States
TA  - Pharm Res
JT  - Pharmaceutical research
JID - 8406521
RN  - 0 (Aerosols)
RN  - 0 (Nasal Sprays)
RN  - 0 (Pharmaceutical Solutions)
RN  - 0 (Respiratory System Agents)
SB  - IM
MH  - Administration, Inhalation
MH  - Aerosols/administration & dosage/*chemistry
MH  - Biological Availability
MH  - Chemistry, Pharmaceutical/*instrumentation
MH  - Equipment Design/*instrumentation
MH  - *Metered Dose Inhalers
MH  - *Nasal Sprays
MH  - Particle Size
MH  - Pharmaceutical Solutions/administration & dosage/*chemistry
MH  - Respiratory System Agents/administration & dosage/chemistry
EDAT- 2012/07/04 06:00
MHDA- 2013/06/12 06:00
CRDT- 2012/07/04 06:00
PHST- 2012/01/27 00:00 [received]
PHST- 2012/06/08 00:00 [accepted]
PHST- 2012/07/04 06:00 [entrez]
PHST- 2012/07/04 06:00 [pubmed]
PHST- 2013/06/12 06:00 [medline]
AID - 10.1007/s11095-012-0804-7 [doi]
PST - ppublish
SO  - Pharm Res. 2012 Nov;29(11):3122-30. doi: 10.1007/s11095-012-0804-7. Epub 2012 Jul 
      3.