Inhaled biologics: from nebules to SMIs – Dornase alfa in MRX004
Dylan Antoniak1, Philippe Rogeuda1, Adam Stuart1, Graham Purkins1, Chris Vernall2, Daniel Hallisey2, Samuel O’Connell2 & Michelle Lambert2
1Merxin Ltd, 1 Innovation Drive, King’s Lynn, Norfolk, PE30 5BY, United Kingdom
2Intertek, Saxon Way, Melbourn, SG8 6DN, United Kingdom
Summary
This paper aims to demonstrate that soft mist inhalers (SMIs) are suitable for the delivery of biologics, using dornase alfa nebules (as available in Pulmozyme®) as an example via MRX004 (Merxin Ltd). This testing was performed in collaboration with Intertek and has demonstrated the ability to deliver dornase alfa through a combination of droplet size distribution (DSD) testing via laser diffraction, aerodynamic particle size distribution (APSD) via next generation impactor (NGI), and enzymatic activity via fluorescence tracking. The results show that the MRX004-produced aerosol has a fine particle fraction (FPF) of 59.4%, with a fine particle dose (FPD) of 125.6 µg. There was only a minimal decrease in enzymatic activity from the native nebule solution, with 90% activity retained, demonstrating the ability of MRX004 to successfully deliver dornase alfa, a biologic. MRX004 is a portable, handheld inhaler that may offer a convenient and effective delivery platform for biologics.