APPLICATION OF THE QUALITY BY DESIGN CONCEPT IN THE
DEVELOPMENT OF QUERCETIN-LOADED POLYMERIC
NANOPARTICLES
LUCIA RUXANDRA TEFAS 1, LUCIA MARIA RUS 2*, MARCELA ACHIM 1, LAURIAN VLASE 1, IOAN TOMUȚĂ 1
1“Iuliu Hațieganu” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Technology
and Biopharmaceutics, 41 Victor Babeș Street, 400012, Cluj-Napoca, Romania
2“Iuliu Hațieganu” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Drug Analysis, 6 Louis
Pasteur Street, 400349, Cluj-Napoca, Romania
*corresponding author: lucia.rus@umfcluj.ro
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Abstract:
The present study aimed at developing quercetin-loaded nanoparticles (QC-NP) by applying a quality by design (Qbd)
approach. A risk analysis was performed to identify formulation and process parameters likely to impact the critical quality
attributes (CQAs) of QC-NP. 6 variables, namely the polymer (PLGA), stabilizer (PVA) and QC concentrations, the stirring
speed and the volumes of acetone and aqueous phase, were considered sources of variability in QC-NP quality. The variables
were screened by experimental design to determine their effect on the CQAs of QC-NP. QC-NP were characterized for size,
polydispersity, Zeta potential and entrapment efficiency, which were the CQAs. The QC-NP were nanosized, monodisperse
and had negative surface charge. The percentage of entrapped QC ranged from 10.19% to 85.36%. Of the studied variables, 4
exhibited main effects on the CQAs: the PLGA and PVA concentration, the volume of aqueous phase and the stirring speed.
The overall results showed the usefulness of the QbD concept in the QC-NP development process.

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