The impact of possible improper use on the performance in vitro of NEXThaler in comparison with Ellipta inhaler.


Journal

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
ISSN: 1879-0720
Titre abrégé: Eur J Pharm Sci
Pays: Netherlands
ID NLM: 9317982

Informations de publication

Date de publication:
01 Apr 2023
Historique:
received: 02 09 2022
revised: 11 01 2023
accepted: 12 01 2023
pubmed: 17 1 2023
medline: 3 3 2023
entrez: 16 1 2023
Statut: ppublish

Résumé

The correct use of dry powder inhalers by the patients is essential to ensure effective treatment and management of the disease. The purpose of the work was to assess the consequence of inhaler misuse in terms of emitted dose and aerodynamic parameters. One reservoir multidose device (Foster-NEXThaler®) and one pre-dosed device (Relvar-Ellipta®), both sharing the "open, inhale and close" procedure, were the subject of the study. NEXThaler activated at different degrees of inclination showed a consistent dose delivery for both the drugs included in the formulation (beclometasone dipropionate/formoterol fumarate). Contrary, Ellipta showed a decrease of the emitted dose for both fluticasone furoate (FluF) and vilanterol trifenatate (VT) when the device was operated facing downward (-14% at 45° and -22% at 90°). Similarly, the delivered dose of NEXThaler was unaffected by an accidental fall, while Ellipta released FluF and VT doses 50% lower than control values. The presence of the dose protector in NEXThaler offers the advantage of retaining the powder if the inhaler is subjected to incorrect manipulations. Both products proved to be reliable in double activation. Finally, simulation exhalation conditions impaired, although not significantly, the aerodynamic profile of the two products.

Identifiants

pubmed: 36646153
pii: S0928-0987(23)00016-7
doi: 10.1016/j.ejps.2023.106385
pii:
doi:

Substances chimiques

Formoterol Fumarate W34SHF8J2K
Beclomethasone KGZ1SLC28Z
vilanterol 028LZY775B
Bronchodilator Agents 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

106385

Informations de copyright

Copyright © 2023. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest L Cavalieri and A Piraino are employees of Chiesi Farmaceutici SpA. F Buttini received several research grants from Chiesi Farmaceutici on project focusing on inhalation products in the last 5 years. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Auteurs

Giada Varacca (G)

Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy.

Davide D'Angelo (D)

Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy.

Stefania Glieca (S)

Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy.

Luca Cavalieri (L)

Medical Affairs Chiesi Italy S.p.A., Via Giacomo Chiesi 1, Parma 43122, Italy.

Alessio Piraino (A)

Medical Affairs Chiesi Italy S.p.A., Via Giacomo Chiesi 1, Parma 43122, Italy.

Eride Quarta (E)

Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy.

Fabio Sonvico (F)

Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy; Interdepartmental Center for Innovation in Health Products, Biopharmanet_TEC, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy.

Francesca Buttini (F)

Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy; Interdepartmental Center for Innovation in Health Products, Biopharmanet_TEC, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy. Electronic address: francesca.buttini@unipr.it.

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Classifications MeSH