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In vitro aerodynamic characterization of the dose emitted during nebulization of tobramycin high strength solution by novel and jet nebulizer delivery systems
Mashat, M. Clark, Brian J. Assi, Khaled H. Chrystyn, Henry
Mashat, M.
Clark, Brian J.
Assi, Khaled H.
Chrystyn, Henry
Publication Date
2016-04
End of Embargo
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Ā© 2016 Elsevier. Reproduced in accordance with the publisher's selfarchiving
policy. This manuscript version is made available under the CC-BY-NC-ND 4.0 license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Peer-Reviewed
Yes
Open Access status
openAccess
Accepted for publication
2015-12-26
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Department
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Abstract
Background: Chronic infections with Pseudomonas aeruginosa are a leading cause of morbidity in patients
with cystic fibrosis (CF). The aim of tobramycin inhalation therapy in CF patients with chronic pulmonary
infection is to deliver high amounts of drug directly to the site of infection. TOBIĀ® is a tobramycin
nebulizer solution (300 mg/5 ml) approved by FDA for maintenance therapy for patient with CF. The 20%
tobramycin sulfate solution was reported as the optimal and maximal concentration.
Methods: Nebulization of high strength tobramycin solution (20% tobramycin sulfate) (HSTS) has been
assessed in this study by using different selected high performance nebulizer delivery systems: two
different designs of jet nebulizers, and three new nebulizers based on vibrating mesh technology. The
aerosol particle size distribution and output characteristics were measured for in vitro performance
assessment of the nebulizer systems. The methodology was adapted from the current European standard,
EN 13544-1:2001E.
Results: The particle size distribution characteristic measurements showed that all tested nebulizers may
be suitable for inhalation of HSTS. The mean (SD) of highest percentage of fine particles (<5 mm) was
77.64 (2.3) % for SidestreamĀ®, at flow rate 16 L/min. The highest respirable inhaled mass was for Pari LC
PlusĀ® combined with PariBoyNĀ® compressor, with mean (SD) 90.85 (8.6) mg. The mean (SD) of highest
drug wastage percentage was 63.9 (3.9) % for SidestreamĀ® jet nebulizer combined with compressed air
cylinder at flow rate 16 L/min, while the lowest was 2.3 (0.26) % for NE-U22 OmronĀ® (high frequency).
Conclusions: The HSTS can be nebulized by all tested nebulisers but the high frequency NE-U22 OmronĀ®
and Aeroneb GoĀ® are more efficient. When the HSTS compared to TOBIĀ®, the respirable inhaled dose was
increased to more than 73%.
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Pre-print
Citation
Mashat M, Clark BJ, Assi KH et al (2016) In vitro aerodynamic characterization of the dose emitted during nebulization of tobramycin high strength solution by novel and jet nebulizer delivery systems. Pulmonary Pharmacology and Therapeutics. 37: 37-42.
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Article