Characterization of PARI’s new VORTEX® facemasks for babies and children
Andrea Winzen1, Luisa Roßmann1, Yvonne Burmeister2, Paula Riedel2 & Karin Steinführer3
1PARItec GmbH, Lochhamer Schlag 21, 82166 Gräfelfing, Germany
2PARI GmbH, Moosstr. 3, 82319 Starnberg, Germany
3PARI Pharma GmbH, Lochhamer Schlag 21, 82166 Gräfelfing, Germany
Summary
Two new facemasks were developed for PARI’s valved holding chamber VORTEX® to effectively improve aerosol therapy for babies and young children. The mask design was selected to satisfy established requirements for successful inhalation treatment. A detailed analysis of the target group facial anatomy was performed via 3D face scans as basis for geometric and material design choices for the two masks. From the face geometries, basic features were derived and transferred into the contour of the mask. A soft and flexible sealing lip was implemented to allow a tight seal of the mask on children’s faces and simultaneously increase comfort during therapy. Dead space volume, transparency, and weight were additionally considered. To evaluate the compliance of the new VORTEX® masks to the defined requirements, measurement of dead space volume and sealing were performed. It showed that the dead space volume was significantly reduced under clinically relevant application forces. Additionally, the leakage rate of the two new masks proved to be very low, (i.e., approximately 2.5% in the entire range of application forces (4 N to 16 N)) indicating a potentially robust drug delivery, even at varying pressures induced by parents on children’s faces. This might be beneficial in terms of adherence. For similar reasons, transparency was implemented into the design to allow parents optical access to the children’s mouth and nose. The novel VORTEX® masks presented in this study were shown to fulfil major requirements for the effective treatment of babies and children.