Establishing a multi-vial design space for the freeze-drying process by means of mathematical modeling of the primary drying stage.
freeze-drying
lyophilization
mathematical model
processing
quality by design
simulation
sucrose
thermodynamic
Journal
Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R
Informations de publication
Date de publication:
09 Feb 2024
09 Feb 2024
Historique:
received:
21
11
2023
revised:
05
02
2024
accepted:
05
02
2024
medline:
12
2
2024
pubmed:
12
2
2024
entrez:
11
2
2024
Statut:
aheadofprint
Résumé
Primary drying is the most critical stage of the freeze-drying process. This work aimed to establish a design space for this process by means of mathematical modeling of the primary drying stage, capable of addressing the thermal characteristics of distinct vial suppliers. Modeling of primary drying was implemented on Microsoft Excel using steady-state heat and mass transfer equations at two extreme conditions as assessed by risk analysis, to predict product temperature and primary-drying time. The heat transfer coefficients (K
Identifiants
pubmed: 38342340
pii: S0022-3549(24)00049-2
doi: 10.1016/j.xphs.2024.02.007
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024. Published by Elsevier Inc.
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.