Myriam Eckes and Brenda Hervieu, Lina Fontaine & Thierry Porée
OptimHal-ProtecSom, 24 rue du Train Renard, 50700 Valognes, France.
Summary
The aim of this study was to evaluate in vitro aerosol delivery from a pressurized metered dose inhaler (pMDI) and inhalation chamber without inspiratory valve for neonatal patients compared with classic valved holding chambers (VHCs). The effect of mask holding duration to the model face on drug delivery was also investigated and measurements were performed with different numbers of breathing cycles after each pMDI dose release. Emitted drug mass was measured using a breathing simulator and aerodynamic particle size distribution (APSD) was determined with an in Vitro in Vivo Correlation (IVIVC) model from data collected with a cascade impactor at a constant flow of 15L/min. For both sets of measurements, the tidal breathing pattern of a neonatal patient was recreated by a breathing simulator. Inhalation chambers with facemasks were applied on an infant face model with a 0.8 kg force. Salbutamol sulfate, fluticasone propionate and beclomethasone dipropionate, were administered in separate experiments through the inhalation chambers. The aerosol dose delivered with the inhalation chamber without inspiratory valve was observed to be about 50% higher than the aerosol dose delivered with the classic valved holding chamber. The delivered drug dose increased with the number of breathing cycles after each pMDI dose release up to 14 cycles, corresponding to 16.2 seconds mask holding duration. Using an inhalation chamber without inspiratory valve increased the delivered drug dose and the facemask holding duration after each pMDI actuation has an impact on drug delivery.
Key Message
Removing the inspiratory valve of an inhalation chamber increases both in vitro delivered drug with a pMDI and fine particle dose (< 5 µm aerodynamic diameter) deposited to a filter distal to a neonatal model.