Heat flux sensor to create a design space for freeze-drying development.

Freeze Drying / methods Hot Temperature Spectrum Analysis / methods Technology, Pharmaceutical / methods
Design space Freeze-drying Gravimetric technique Heat flux sensor PAT QbD

Journal

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
ISSN: 1873-3441
Titre abrégé: Eur J Pharm Biopharm
Pays: Netherlands
ID NLM: 9109778

Informations de publication

Date de publication:
Aug 2020
Historique:
received: 09 03 2020
revised: 11 05 2020
accepted: 27 05 2020
pubmed: 5 6 2020
medline: 10 2 2021
entrez: 5 6 2020
Statut: ppublish

Résumé

Freeze-drying methodology requires an in-depth understanding and characterization for optimal processing of biopharmaceuticals. Particularly the primary drying phase, the longest and most expensive stage of the process, is of interest for optimization. The currently used process analytical technology (PAT) tools give highly valuable insights but come with limitations. Our study describes, for the first time, the application of a heat flux sensor (HFS) to build a primary drying design space and predict the process evolution. First, the heat transfer coefficient (K

Identifiants

DOI: 10.1016/j.ejpb.2020.05.028 PMID: 32497769
pubmed: 32497769
pii: S0939-6411(20)30155-7
doi: 10.1016/j.ejpb.2020.05.028
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

84-94

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Marco Carfagna (M)

Coriolis Pharma Research GmbH, D-82152 Planegg, Germany; Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig Maximilian University, D-81377 Munich, Germany.

Monica Rosa (M)

Coriolis Pharma Research GmbH, D-82152 Planegg, Germany.

Matthias Lucke (M)

Coriolis Pharma Research GmbH, D-82152 Planegg, Germany.

Andrea Hawe (A)

Coriolis Pharma Research GmbH, D-82152 Planegg, Germany. Electronic address: andrea.hawe@coriolis-pharma.com.

Wolfgang Frieß (W)

Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig Maximilian University, D-81377 Munich, Germany.

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Classifications MeSH

questionsmedicales.fr › Techniques d'investigation › Conservation biologique › Cryoconservation › Lyophilisation › Heat flux sensor to create a design space for...
questionsmedicales.fr › Environnement et santé publique › Environnement › Concepts météorologiques › Atmosphère › Temps (météorologie) › Température › Température élevée › Heat flux sensor to create a design space for...
questionsmedicales.fr › Techniques d'investigation › Techniques de chimie analytique › Analyse spectrale › Heat flux sensor to create a design space for...
questionsmedicales.fr › Technologie, industrie et agriculture › Technologie › Technologie pharmaceutique › Heat flux sensor to create a design space for...