Micro Freeze-Dryer and Infrared-Based PAT: Novel Tools for Primary Drying Design Space Determination of Freeze-Drying Processes.
Design space
freeze-drying process design/optimization
heat and mass transfer
mechanistic approach
model parameters
primary drying
Journal
Pharmaceutical research
ISSN: 1573-904X
Titre abrégé: Pharm Res
Pays: United States
ID NLM: 8406521
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
received:
17
11
2020
accepted:
23
02
2021
pubmed:
10
3
2021
medline:
9
11
2021
entrez:
9
3
2021
Statut:
ppublish
Résumé
Present (i) an infrared (IR)-based Process Analytical Technology (PAT) installed in a lab-scale freeze-dryer and (ii) a micro freeze-dryer (MicroFD®) as effective tools for freeze-drying design space calculation of the primary drying stage. The case studies investigated are the freeze-drying of a crystalline (5% mannitol) and of an amorphous (5% sucrose) solution processed in 6R vials. The heat (K The IR-based method allows a non-gravimetric estimation of the K The proposed tools can be effectively used for design space calculation in substitution of other well-spread methods. Their advantages are mainly the less laborious K
Identifiants
pubmed: 33686561
doi: 10.1007/s11095-021-03023-x
pii: 10.1007/s11095-021-03023-x
pmc: PMC8057969
doi:
Substances chimiques
Mannitol
3OWL53L36A
Sucrose
57-50-1
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
707-719Références
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