Step-By-Step Standardization of the Bottom-Up Semi-Automated Nanocrystallization of Pharmaceuticals: A Quality By Design and Design of Experiments Joint Approach.
design space
nanocrystals
orthogonal characterization
response surface methodology
solvent-antisolvent precipitation
Journal
Small (Weinheim an der Bergstrasse, Germany)
ISSN: 1613-6829
Titre abrégé: Small
Pays: Germany
ID NLM: 101235338
Informations de publication
Date de publication:
01 Feb 2024
01 Feb 2024
Historique:
revised:
10
10
2023
received:
18
07
2023
medline:
1
2
2024
pubmed:
1
2
2024
entrez:
1
2
2024
Statut:
aheadofprint
Résumé
Nanosized drug crystals have been reported with enhanced apparent solubility, bioavailability, and therapeutic efficacy compared to microcrystal materials, which are not suitable for parenteral administration. However, nanocrystal design and development by bottom-up approaches are challenging, especially considering the non-standardized process parameters in the injection step. This work aims to present a systematic step-by-step approach through Quality-by-Design (QbD) and Design of Experiments (DoE) for synthesizing drug nanocrystals by a semi-automated nanoprecipitation method. Curcumin is used as a drug model due to its well-known poor water solubility (0.6 µg mL
Identifiants
pubmed: 38299478
doi: 10.1002/smll.202306054
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e2306054Subventions
Organisme : Education, Audiovisual and Culture Executive Agency
Organisme : Erasmus Mundus Joint Master Degree
Organisme : Nanomedicine for Drug Delivery
Organisme : International Affairs and Foreign Cooperation Office
Organisme : University of Costa Rica
ID : OAICE-13-2022
Organisme : France/Czech Republic International Emerging Actions program
ID : 317758 IEA-2021
Organisme : France/Czech Republic International Emerging Actions program
ID : CNRS-22-01
Informations de copyright
© 2024 The Authors. Small published by Wiley-VCH GmbH.
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