Performance variability of commercial jet nebuliser systems measured with European standard and its clinical implication

Fischer R¹, Jain A K², Jukic F² & Ledermüller R¹

¹PARI GmbH, Moosstraße 3, Starnberg, 82319, Germany

² PARI Pharma GmbH, Lochhamer Schlag 21, Gräfelfing, 82166, Germany

Summary

There are many inhalers on the market with considerably different performances. The aim of this in vitro study was to evaluate the aerosol delivery efficiency of 15 commercially available jet nebuliser systems and to discuss the clinical implications of the differences in their performance. For the determination of aerosol parameters like Mass Median Aerodynamic Diameter (MMAD), Respirable Fraction (RF), Aerosol Output (AO) and Aerosol Output Rate (AOR), the new version of the European standard DIN EN ISO 27427:2020 was used, which allows an objective comparison of the parameters that manufactures are required to comply with. Respirable Dose (RD = RF x AO) and Respirable Drug Delivery Rate (RDDR = RF x AOR) representing the rate of the drug mass which can be theoretically deposited intrabronchially per time unit. The PARI BOY Junior and the PARI COMPACT2 have the highest RD and RDDR, surpassing the Aponorm Compact plus and the BRM-085II in terms of RDDR by a factor of about 3 each. RDDR (calculated from aerosol parameters measured according to the European standard [12]) differs significantly between commercially available jet nebuliser systems. Therefore, it is important that physicians consider RDDR to ensure that patients receive clinically effective doses. RDDR is an objective, quality parameter for the efficiency of a nebuliser. To achieve the best possible therapeutic effect and avoid insufficient drug dosage a jet nebuliser system with a high RDDR should be selected. Taking this into account, nebuliser therapy offers a reliable treatment option especially for young children and the elderly due to its ease of application.

Key Message

Drug delivery efficiency measured according to the new version of DIN EN ISO 27427:2020 [12] differs significantly between commercially available jet nebuliser systems. Therefore, it is important that physicians consider a nebuliser system with high RDDR to ensure that patients receive clinically effective doses to achieve the best possible therapeutic effect.