Effective disease management of chronic respiratory conditions is crucial, especially during times with high incidences of common viral respiratory infections. Using valved holding chambers (VHCs) combined with pressurized metered dose inhalers (pMDIs) is recommended to overcome application issues when treating respiratory diseases in children. With the aim to further improve pediatric inhalation therapy, we developed two new face masks for our VHC.

A strong aerosol performance of VHCs and a close seal of VHC masks are key factors for the efficient treatment of children using pMDIs. This study investigated the performance of our VHC (VORTEX^®) with two newly developed facemasks. The new baby and child masks were tested with budesonide (BUD, Budiair^®, Chiesi) and salbutamol (SAL, Sutanol^®, GSK) pMDIs. Next generation impactor tests were conducted with an automated shake-and-fire unit. Sample analysis was carried out via HPLC methods (n=12). To analyse the ability of the new masks to seal tightly to the face, leakage tests at different contact forces were performed.

The VORTEX^® with the new baby mask (BM) and child mask (CM) shows an enhanced fine particle dose (FPD, <5µm) compared to pMDI alone for SAL (pMDI=24.1%, BM=37.8%, CM=37.8%) and BUD (pMDI=10.9%, BM=23.8%, CM=25.6%). Throat deposition was significantly reduced for both masks and substances (?0.5%). Leakage tests show leakage of ?5% at F=16N for both masks. Similar results were found at F=4N indicating an excellent seal for a wide range of contact forces. Good sealing at small contact forces has the potential to improve inhalation therapy for babies and children. Further aerosol performance tests are planned.