Performance of different nebulizers in clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC).


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2024
Historique:
received: 16 03 2023
accepted: 23 02 2024
medline: 2 5 2024
pubmed: 2 5 2024
entrez: 2 5 2024
Statut: epublish

Résumé

Technical ex-vivo comparison of commercial nebulizer nozzles used for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC). The performance of four different commercial nebulizer nozzles (Nebulizer; HurriChemTM; MCR-4 TOPOL®; QuattroJet) was analysed concerning: i) technical design and principle of operation, ii) operational pressure as function of the liquid flow rate, iii) droplet size distribution via laser diffraction spectrometry, iv) spray cone angle, spray cone form as well as horizontal drug deposition by image-metric analyses and v) chemical resistance via exposing to a cytostatic solution and chemical composition by means of spark optical emission spectral analysis. The Nebulizer shows quasi an identical technical design and thus also a similar performance (e.g., mass median droplet size of 29 μm) as the original PIPAC nozzles (MIP/ CapnoPen). All other nozzles show more or less a performance deviation to the original PIPAC nozzles. The HurriChemTM has a similar design and principle of operation as the Nebulizer, but provides a finer aerosol (22 μm). The principle of operation of MCR-4 TOPOL® and QuattroJet differ significantly from that of the original PIPAC nozzle technology. The MCR-4 TOPOL® offers a hollow spray cone with significantly larger droplets (50 μm) than the original PIPAC nozzles. The QuattroJet generates an aerosol (22 μm) similar to that of the HurriChemTM but with improved spatial drug distribution. The availability of new PIPAC nozzles is encouraging but can also have a negative impact if their performance and efficacy is unknown. It is recommended that PIPAC nozzles that deviate from the current standard should be subject to bioequivalence testing and implementation in accordance with the IDEAL-D framework prior to routine clinical use.

Identifiants

pubmed: 38696384
doi: 10.1371/journal.pone.0300241
pii: PONE-D-23-07734
doi:

Substances chimiques

Aerosols 0
Antineoplastic Agents 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0300241

Informations de copyright

Copyright: © 2024 Göhler et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

Auteurs

Daniel Göhler (D)

Topas GmbH, Dresden, Germany.
Research Group Mechanical Process Engineering, Institute of Process Engineering and Environmental Technology, Technische Universität Dresden, Dresden, Germany.

Mehdi Ouaissi (M)

EA4245 Transplantation, Immunology, Inflammation, Université de Tours, Tours, France.
Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, University Hospital of Tours, Tours, France.

Urs Giger-Pabst (U)

EA4245 Transplantation, Immunology, Inflammation, Université de Tours, Tours, France.
Fliedner Fachhochschule, University of Applied Sciences Düsseldorf, Düsseldorf, Germany.

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Classifications MeSH