Romanian Society of Pharmaceutical Sciences
 

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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

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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.