Methodology for the in vitro evaluation of the delivery efficiency from valved holding chambers with facemasks.
BACKGROUND
In vitro performance studies of valved holding chamber (VHC)-facemask systems are a cost-effective means of circumventing potentially confounding clinical variables. This article reports results of an in vitro investigation into VHC-facemask performance, using three age-specific soft anatomical model (SAM) faces, under clinically relevant conditions.


METHODS
A potentially standardized method was developed to assess VHC-facemask seal leakage, and evaluate the in vitro delivery efficiency of conventional and antistatic VHC-facemask systems. A custom-built test rig and VHC cradles were used to position the VHC-facemask systems against the SAM faces, with a constant, reproducible force. A standardized simulated pediatric breathing pattern (tidal volume = 155 mL; inhalation:exhalation ratio = 40:60; 25 breaths/min) was utilized. Percent facemask seal leakage, percent delivered dose, and the effect of different numbers of simulated breaths (2 to 8) were investigated.


RESULTS
Of the VHC-facemask systems tested, the OptiChamber Diamond VHC with LiteTouch facemask (Diamond) system had the lowest percent seal leakage with each SAM face. Percent seal leakage from the other VHC-facemask systems was similar with SAM0 and SAM2 faces; the AeroChamber Plus Z-Stat VHC with ComfortSeal facemask (AC Z-Stat) system had a substantially greater percent seal leakage with the SAM1 face. Regardless of the number of simulated breaths, the Diamond system delivered the greatest mean percent delivered dose, with the lowest coefficient of variation, with each SAM face. Percent delivered dose did not correlate well with seal leakage, particularly for VHC-facemask systems with high seal leakage. The electrostatic properties of the VHCs appeared to influence drug delivery.


CONCLUSIONS
This study describes a potentially standardized method for the evaluation of VHC-facemask systems. Use of this method enabled a comprehensive investigation into the influence of clinically relevant variables, including age-specific facial anatomy, number of simulated breaths, and seal leakage, on the delivery efficiency of several commercially available VHC-facemask systems.
1 School of Pharmacy, University of Maryland , Baltimore, MD 21201.
Zhen
Z
Xu
Wenchi
W
Hsu
Dirk
D
von Hollen
Ashwin
A
Viswanath
Kurt
K
Nikander
Richard
R
Dalby
D000280:Administration, Inhalation; D000336:Aerosols; D000367:Age Factors; D000420:Albuterol / Q000008:administration & dosage* / Q000737:chemistry; D002675:Child, Preschool; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004867:Equipment Design; D005145:Face / Q000033:anatomy & histology; D006801:Humans; D001239:Inhalation; D008297:Male; D008397:Masks; D036501:Metered Dose Inhalers; D008953:Models, Anatomic; D010316:Particle Size; D011312:Pressure; D056152:Respiratory Rate; D012212:Rheology; D013997:Time Factors
D000336:Aerosols; D000420:Albuterol
aerosol drug therapy; anatomical models; facemasks; in vitro; metered dose inhalers; seal leakage; spacer-inhalers; valved holding chambers