Step-By-Step Standardization of the Bottom-Up Semi-Automated Nanocrystallization of Pharmaceuticals: A Quality By Design and Design of Experiments Joint Approach
Jazyk angličtina Země Německo Médium print-electronic
Typ dokumentu časopisecké články, práce podpořená grantem
Grantová podpora
Education, Audiovisual and Culture Executive Agency
Erasmus Mundus Joint Master Degree
Nanomedicine for Drug Delivery
International Affairs and Foreign Cooperation Office
OAICE-13-2022
University of Costa Rica
317758 IEA-2021
France/Czech Republic International Emerging Actions program
CNRS-22-01
France/Czech Republic International Emerging Actions program
PubMed
38299478
DOI
10.1002/smll.202306054
Knihovny.cz E-zdroje
- Klíčová slova
- design space, nanocrystals, orthogonal characterization, response surface methodology, solvent–antisolvent precipitation,
- MeSH
- automatizace MeSH
- krystalizace MeSH
- kurkumin chemie MeSH
- léčivé přípravky chemie MeSH
- nanočástice * chemie MeSH
- velikost částic MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- kurkumin MeSH
- léčivé přípravky MeSH
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-1, 25 °C). Formal and informal risk assessment tools allow identifying the critical factors. A fractional factorial 24-1 screening design evaluates their impact on the average size and polydispersity of nanocrystals. The optimization of significant factors is done by a Central Composite Design. This response surface methodology supports the rational design of the nanocrystals, identifying and exploring the design space. The proposed joint approach leads to a reproducible, robust, and stable nanocrystalline preparation of 316 nm with a PdI of 0.217 in compliance with the quality profile. An orthogonal approach for particle size and polydispersity characterization allows discarding the formation of aggregates. Overall, the synergy between advanced data analysis and semi-automated standardized nanocrystallization of drugs is highlighted.
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