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dc.contributor.authorMashat, M.*
dc.contributor.authorClark, Brian J.*
dc.contributor.authorAssi, Khaled H.*
dc.contributor.authorChrystyn, Henry*
dc.date.accessioned2017-06-05T16:15:56Z
dc.date.available2017-06-05T16:15:56Z
dc.date.issued2017-06
dc.identifier.citationMashat M, Clark BJ, Assi KH and Chrystyn H (2017) Assessment of recent nebulizer delivery systems using urinary pharmacokinetics method and aerodynamic characteristics of TOBI® nebulized dose following inhalation. Journal of Drug Delivery Science and Technology. 39: 428–434.
dc.identifier.urihttp://hdl.handle.net/10454/12122
dc.descriptionYes
dc.description.abstractBackground Chronic infections with Pseudomonas aeruginosa are a leading cause of morbidity in patients with cystic fibrosis (CF). Tobramycin nebulizer solution (TNS) is indicated for maintenance therapy in CF patients. TOBI® is a tobramycin nebulizer solution (TNS) approved by FDA for maintenance therapy for patient with CF. Adherence to recommended therapy in CF has always been a challenge and new generation nebulizers are increasingly used “off label” to reduce the time required for inhalation, potentially improving patient compliance. Objectives To assess the performance of selected recent nebulizer delivery systems for determination the optimum combinations to deliver TOBI®. Using the relative lung bioavailability of TOBI® to the lungs in healthy volunteers, following inhalation from selected nebulizer delivery systems, using a urinary pharmacokinetics method. In vitro aerodynamic characteristics of the nebulized dose were also determined. Methods Serial urine samples were collected from 12 healthy volunteers up to 24 h post-inhalation of TOBI® inhaled solution following delivery by Pari LC Plus®, Sidestream®, NE-U22-E Omron® and Aeroneb® Go nebulizers. In vitro aerodynamic characteristics of the nebulized dose were also determined according to the CEN (Committee European de Normalization) method. Results The mean (SD) relative lung bioavailability from Pari LC Plus®, Sidestream®, Omron®, and Aeroneb® Go nebulizers was 4.9 (0.5), 3.9 (0.5), 7.1 (1.3), and 7.7 (0.7) %, respectively. The mean (SD) mass median aerodynamic diameter (MMAD) of the drug particles from the same systems was 2 (0.2), 2 (0.2), 1.2 (0.03) and 2.0 (0.1) μm, and the corresponding fine particle doses (FPD) were 2.2 (0.23), 1.5 (0.2), 3.44 (0.3) and 2.8 (0.3) mg. Conclusion The data obtained from in-vitro and in-vivo studies reflect poor relative lung bioavailability of tobramycin following jet nebulization.
dc.language.isoen
dc.rights© 2017 Elsevier. Reproduced in accordance with the publisher's self-archiving policy. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.
dc.subjectLung bioavailability
dc.subjectUrinary pharmacokinetics
dc.subjectCEN (Committee European de Normalization) method
dc.subjectTobramycin
dc.subjectInhalation
dc.subjectNebulizer
dc.titleAssessment of recent nebulizer delivery systems using urinary pharmacokinetics method and aerodynamic characteristics of TOBI® nebulized dose following inhalation
dc.status.refereedYes
dc.date.Accepted03/04/2017
dc.date.application17/04/2017
dc.typeArticle
dc.type.versionAccepted manuscript
dc.identifier.doihttps://doi.org/10.1016/j.jddst.2017.04.007
dc.rights.licenseCC-BY-NC-ND
refterms.dateFOA2018-07-27T01:25:58Z
dc.openaccess.statusopenAccess


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