Abstract
RATIONALE: This laboratory study used a model taken from a 7-month infant with soft tissue face modeling and an anatomically correct oro and nasopharynx to explore medication delivery differences achieved via three different VHCs with facemasks.
METHODS: The following VHCs were evaluated (n=5/group): AeroChamber Plus* Flow-Vu* Anti-Static VHC with infant mask (AC-Plus FV); OptiChamber® Diamond® (OPT); InspiraChamber® with InspiraMask® (INS). The facemask of the VHC-on-test was applied to the face of the model with a clinically appropriate force of 0.9 kg, and the mask positioned to optimize seal to the face as much as possible. A breathing simulator (tidal volume=50 mL; 30 breaths/min; duty cycle=25%) was connected, via a filter, to the distal airway to capture aerosol, representing medication potentially available for lung delivery. Fluticasone propionate 50 μg/actuation pMDI was delivered to the VHC and 6 breaths were taken. Drug was recovered from the filter (EMcarina) and assayed using HPLC.
RESULTS: EMcarinaand VHC retention (mean ± SD), normalized to a percentage of label claim dose/actuation, are summarized below.
AC-Plus FV | OPT | INS | |
Within VHC | 52.8 +/- 5.8 | 65.3 +/- 2.4 | 79.0 +/- 5.6 |
EM (carina) | 4.6 +/- 1.5 | 3.5 +/- 0.6 | 0.5 +/- 0.3 |
CONCLUSIONS: EMcarinawas highest for the AC-Plus VHC, which was significantly greater than for the INS VHC (t-test, p < 0.0001). The results correlated well with previously reported data that indicated differences in face to facemask leakage for the same VHCs / Facemasks, and therefore highlights the importance of a good facemask to face seal in order to be able to effectively deliver drug to the infant's lungs.
- Copyright ©the authors 2016