A New Model-Based Approach for the Development of Freeze-Drying Cycles Using a Small-Scale Freeze-Dryer.
Freeze-drying
Mathematical modelling
Micro freeze-dryer
Optimization
Scale-up
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:
08 2023
08 2023
Historique:
received:
12
04
2023
revised:
15
05
2023
accepted:
15
05
2023
medline:
17
7
2023
pubmed:
22
5
2023
entrez:
21
5
2023
Statut:
ppublish
Résumé
This paper presents a model-based approach for the design of the primary drying stage of a freeze-drying process using a small-scale freeze-dryer (MicroFD® by Millrock Technology Inc.). Gravimetric tests, coupled with a model of the heat transfer to the product in the vials that account also for the heat exchange between the edge vials and the central vials, are used to infer the heat transfer coefficient from the shelf to the product in the vial (K
Identifiants
pubmed: 37211317
pii: S0022-3549(23)00194-6
doi: 10.1016/j.xphs.2023.05.007
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2176-2189Informations de copyright
Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Millrock Technology Inc. has supported the study by loaning the MicroFD® used in this study to the research group of the Politecnico di Torino and by helping the researchers to solve practical issues related to the experimental investigation.