Niamh McNea1, Ciaran O Leime1, Mary Joyce1 & Ronan MacLoughlin1
1Aerogen Limited, Galway Business Park, Galway, H91 HE94, Ireland
Summary
Suspension-based formulations present unique challenges for aerosol delivery. For vibrating mesh nebulisers (VMNs), nebulising such formulations are thought to be associated with mesh clogging and increased retained mass [1].
This study evaluated the delivery of the corticosteroid suspension, budesonide (Pulmicort, 1 mg/2 mL), using the Aerogen Solo Vibrating Mesh Nebuliser, with A-VMNTM mesh, in combination with the Aerogen Pro-X controller (Aerogen Limited, Galway, Ireland) across a range of simulated spontaneously breathing patient profiles. Delivery was evaluated through different patient interfaces, including a mouthpiece (MP), facemask (FM), and with concurrent high flow nasal therapy (HFNT), via a nasal cannula (NC).
Results demonstrated that the Aerogen Solo with A-VMN mesh effectively delivered budesonide with tracheal dose percentages across simulated adult (MP = 41.88 ± 0.91%, FM = 13.69 ± 1.32%, NC = 6.39 ± 0.17%), paediatric (FM = 10.17 ± 0.87%, NC = 2.34 ± 0.18%), and neonatal (FM = 1.91 ± 0.17%, NC = 2.26 ± 0.22%) models. Aerosol droplet MMADs (3 – 5 µm) were consistent with previously reported studies [2]. Retained mass remained low across repeated doses at 11.56 ± 1.73% per dose and was further reduced when nebulisation of a 1 mL saline dose was applied between doses (4.97 ± 0.97%). Scanning electron microscopy (SEM) imaging of the mesh aperture plate revealed no structural changes after twenty doses, confirming device robustness.
These findings challenge the idea that VMNs are unsuitable for suspension formulations and support their safe and efficient budesonide delivery in spontaneously breathing patients using different patient interfaces.