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Engineering of budesonide-loaded lipid-polymer hybrid nanoparticles using a quality-by-design approach
- Source :
- International Journal of Pharmaceutics. 548:740-746
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
Abstract
- Chronic obstructive pulmonary disease (COPD) is a complex disease, characterized by persistent airflow limitation and chronic inflammation. The purpose of this study was to design lipid-polymer hybrid nanoparticles (LPNs) loaded with the corticosteroid, budesonide, which could potentially be combined with small interfering RNA (siRNA) for COPD management. Here, we prepared LPNs based on the biodegradable polymer poly(dl-lactic-co-glycolic acid) (PLGA) and the cationic lipid dioleyltrimethylammonium propane (DOTAP) using a double emulsion solvent evaporation method. A quality-by-design (QbD) approach was adopted to define the optimal formulation parameters. The quality target product profile (QTPP) of the LPNs was identified based on risk assessment. Two critical formulation parameters (CFPs) were identified, including the theoretical budesonide loading and the theoretical DOTAP loading. The CFPs were linked to critical quality attributes (CQAs), which included the intensity-based hydrodynamic particle diameter (z-average), the polydispersity index (PDI), the zeta-potential, the budesonide encapsulation efficiency, the actual budesonide loading and the DOTAP encapsulation efficiency. A response surface methodology (RSM) was applied for the experimental design to evaluate the influence of the CFPs on the CQAs, and to identify the optimal operation space (OOS). All nanoparticle dispersions displayed monodisperse size distributions (PDI
- Subjects :
- Quality Control
Budesonide
Materials science
Polymers
Dispersity
Anti-Inflammatory Agents
Pharmaceutical Science
Nanoparticle
Nanotechnology
02 engineering and technology
010402 general chemistry
01 natural sciences
Fatty Acids, Monounsaturated
chemistry.chemical_compound
medicine
Response surface methodology
chemistry.chemical_classification
Polymer
Chemical Engineering
021001 nanoscience & nanotechnology
Lipids
Biodegradable polymer
0104 chemical sciences
Quaternary Ammonium Compounds
PLGA
chemistry
Chemical engineering
Nanoparticles
0210 nano-technology
Critical quality attributes
medicine.drug
Subjects
Details
- ISSN :
- 03785173
- Volume :
- 548
- Database :
- OpenAIRE
- Journal :
- International Journal of Pharmaceutics
- Accession number :
- edsair.doi.dedup.....205a300a5696226e7df57a0c8c194caa