The abbreviated impactor measurement (AIM) concept: part II--Influence of evaporation of a volatile component-evaluation with a "droplet-producing" pressurized metered dose inhaler (pMDI)-based formulation containing ethanol as cosolvent.
The abbreviated impactor measurement (AIM) concept is a potential solution to the labor-intensive full-resolution cascade impactor (CI) methodology for inhaler aerosol aerodynamic particle size measurement. In this validation study, the effect of increasing the internal dead volume on determined mass fractions relating to aerodynamic particle size was explored with two abbreviated impactors both based on the Andersen nonviable cascade impactor (ACI) operating principle (Copley fast screening Andersen impactor [C-FSA] and Trudell fast screening Andersen impactor [T-FSA]). A pressurized metered dose inhaler-delivered aerosol producing liquid ethanol droplets after propellant evaporation was chosen to characterize these systems. Measures of extrafine, fine, and coarse particle mass fractions from the abbreviated systems were compared with corresponding data obtained by a full-resolution ACI. The use of liquid ethanol-sensitive filter paper provided insight by rendering locations visible where partly evaporated droplets were still present when the "droplet-producing" aerosol was sampled. Extrafine particle fractions based on impactor-sized mass were near equivalent in the range 48.6% to 54%, comparing either abbreviated system with the benchmark ACI-measured data. The fine particle fraction of the impactor-sized mass determined by the T-FSA (94.4 +/- 1.7%) was greater than using the C-FSA (90.5 +/- 1.4%) and almost identical with the ACI-measured value (95.3 +/- 0.4%). The improved agreement between T-FSA and ACI is likely the result of increasing the dead space between the entry to the induction port and the uppermost impaction stage, compared with that for the C-FSA. This dead space is needed to provide comparable conditions for ethanol evaporation in the uppermost parts of these impactors.
Mitchell
J P
JP
Trudell Medical International, 725 Third Street, London, Ontario, Canada. jmitchell@trudellmed.com
Nagel
M W
MW
Avvakoumova
V
V
MacKay
H
H
Ali
R
R
D000280:Administration, Inhalation; D000336:Aerosols; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000737:chemistry*; D001507:Beclomethasone / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004867:Equipment Design; D000431:Ethanol / Q000737:chemistry*; D008422:Materials Testing / Q000295:instrumentation*; D036501:Metered Dose Inhalers; D010316:Particle Size; D011312:Pressure; D015203:Reproducibility of Results; D012997:Solvents / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000295:instrumentation*; D014835:Volatilization
D000336:Aerosols; D018927:Anti-Asthmatic Agents; D012997:Solvents; D000431:Ethanol; D001507:Beclomethasone