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Aerosolization Performance of Jet Nebulizers and Biopharmaceutical Aspects

1
Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, 43124 Parma, Italy
2
Apotheke, University Medical Center, Johannes Gutenberg University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany
3
Interdepartmental Center for Innovation in Health Products, BIOPHARMANET TEC, University of Parma, Parco Area delle Scienze 27/A, 43124 Parma, Italy
4
Department of Life Sciences and Biotechnology, University of Ferrara, Via Fossato di Mortara 17/19, 44121 Ferrara, Italy
*
Author to whom correspondence should be addressed.
Current address: College of Pharmacy, R&D Pharmaceutical and Cosmetic Laboratory, Rua Augusto Corrêa 1, Guamá, 66075-110, Belém, PA, Brazil.
Pharmaceutics 2019, 11(8), 406; https://doi.org/10.3390/pharmaceutics11080406
Received: 1 July 2019 / Revised: 5 August 2019 / Accepted: 8 August 2019 / Published: 11 August 2019
(This article belongs to the Special Issue Advances in Pulmonary Drug Delivery)
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PDF [4300 KB, uploaded 11 August 2019]
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Abstract

In this work, 13 jet nebulizers, some of which in different configurations, were investigated in order to identify the biopharmaceutical constraints related to the quality attributes of the medicinal products, which affect their safety, efficiency, compliance, and effectiveness. The aerosolization parameters, including the aerosol output, aerosol output rate, mass median aerodynamic diameter, and fine particle fraction, were determined according to the European Standard EN 13544-1, using sodium fluoride as a reference formulation. A comparison between the aerosol output nebulization time and the fine particle fraction displayed a correlation between the aerosol quality and the nebulization rate. Indeed, the quality of the nebulization significantly increased when the rate of aerosol emission was reduced. Moreover, the performance of the nebulizers was analyzed in terms of respirable delivered dose and respirable dose delivery rate, which characterize nebulization as the rate and amount of respirable product that could be deposited into the lungs. Depending on which of these two latter parameters was used, the nebulizers showed different performances. The differences, in terms of the rate and amount of delivered aerosol, could provide relevant information for the appropriate choice of nebulizer as a function of drug product, therapy, and patient characteristics. View Full-Text
Keywords: nebulizers; aerosol output rate; aerosol output; mass median aerodynamic diameter; fine particle fraction; respirable dose delivery rate; respirable delivered dose nebulizers; aerosol output rate; aerosol output; mass median aerodynamic diameter; fine particle fraction; respirable dose delivery rate; respirable delivered dose
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Adorni, G.; Seifert, G.; Buttini, F.; Colombo, G.; Stecanella, L.A.; Krämer, I.; Rossi, A. Aerosolization Performance of Jet Nebulizers and Biopharmaceutical Aspects. Pharmaceutics 2019, 11, 406.

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