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Open AccessArticle

In Vitro Performance of an Investigational Vibrating-Membrane Nebulizer with Surfactant under Simulated, Non-Invasive Neonatal Ventilation Conditions: Influence of Continuous Positive Airway Pressure Interface and Nebulizer Positioning on the Lung Dose

1
Department of Preclinical Pharmacology, R&D, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy
2
Scientific Consultancy, 48640 Bilbao, Spain
3
PARI Pharma GmbH, 82319 Starnberg, Germany
4
Division of Neonatology, Cantonal Hospital Winterthur, 8401 Winterthur, Switzerland
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(3), 257; https://doi.org/10.3390/pharmaceutics12030257
Received: 13 February 2020 / Revised: 6 March 2020 / Accepted: 9 March 2020 / Published: 12 March 2020
(This article belongs to the Special Issue Paediatric Drug Delivery)
Non-invasive delivery of nebulized surfactant has been a long-pursued goal in neonatology. Our aim was to evaluate the performance of an investigational vibrating-membrane nebulizer in a realistic non-invasive neonatal ventilation circuit with different configurations. Surfactant (aerosols were generated with a nebulizer in a set-up composed of a continuous positive airway pressure (CPAP) generator with a humidifier, a cast of the upper airway of a preterm infant (PrINT), and a breath simulator with a neonatal breathing pattern. The lung dose (LD), defined as the amount of surfactant collected in a filter placed at the distal end of the PrINT cast, was determined after placing the nebulizer at different locations of the circuit and using either infant nasal mask or nasal prongs as CPAP interfaces. The LD after delivering a range of nominal surfactant doses (100–600 mg/kg) was also investigated. Surfactant aerosol particle size distribution was determined by laser diffraction. Irrespective of the CPAP interface used, about 14% of the nominal dose (200 mg/kg) reached the LD filter. However, placing the nebulizer between the Y-piece and the CPAP interface significantly increased the LD compared with placing it 7 cm before the Y-piece, in the inspiratory limb. (14% ± 2.8 vs. 2.3% ± 0.8, nominal dose of 200 mg/kg). The customized eFlow Neos showed a constant aerosol generation rate and a mass median diameter of 2.7 μm after delivering high surfactant doses (600 mg/kg). The customized eFlow Neos nebulizer showed a constant performance even after nebulizing high doses of undiluted surfactant. Placing the nebulizer between the Y-piece and the CPAP interface achieves the highest LD under non-invasive ventilation conditions. View Full-Text
Keywords: eFlow nebulizer; nebulized surfactant; aerosol; non-invasive ventilation; PrINT eFlow nebulizer; nebulized surfactant; aerosol; non-invasive ventilation; PrINT
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Bianco, F.; Pasini, E.; Nutini, M.; Murgia, X.; Stoeckl, C.; Schlun, M.; Hetzer, U.; Bonelli, S.; Lombardini, M.; Milesi, I.; Pertile, M.; Minocchieri, S.; Salomone, F.; Bucholski, A. In Vitro Performance of an Investigational Vibrating-Membrane Nebulizer with Surfactant under Simulated, Non-Invasive Neonatal Ventilation Conditions: Influence of Continuous Positive Airway Pressure Interface and Nebulizer Positioning on the Lung Dose. Pharmaceutics 2020, 12, 257.

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