QbD BASED CONTROL STRATEGY OF LORATADINE
NANOSUSPENSIONS AND DRY NANOPARTICLES STABILIZED BY
SOLUPLUS®
AREEN ALSHWEIAT, RITA AMBRUS *, GÁBOR KATONA, ILDIKÓ CSÓKA
Faculty of Pharmacy, Interdisciplinary Excellence Centre, Institute of Pharmaceutical Technology and Regulatory Affairs,
University of Szeged, Szeged, Hungary
*corresponding author: arita@pharm.u-szeged.hu
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Abstract:
The preparation of nanosuspensions has been introduced as a well-defined method to enhance the solubility and dissolution
of poorly water-soluble drugs. The aim of this study was to evaluate the feasibility of using Soluplus® as a stabilizer for
loratadine nanosuspensions. The concept of Quality by design (QbD) was followed particularly to link the critical material
parameters (CMPs) and the critical process parameters (CPPs) with the required critical quality attributes (CQAs) and risk
assessment (RA) to select the optimized critical material and process parameters. The ultrasonic-assisted precipitation
method was selected to prepare the nanosuspensions with different concentrations of Soluplus®. Particle size, polydispersity
index (PDI), solubility and dissolution were set as the main CQAs. Soluplus® successfully produced loratadine nanosuspensions
with particle size ranging between 168.3 - 245.35 nm and PDI in the range of 0.12 and 0.25. The freeze dried
sample with 0.6% Soluplus® (DLNS3) showed an amorphous status of loratadine with particle size and PDI in the range of
220 ± 6.23 and 0.21 ± 0.02, respectively. Contact angles, surface free energy, and polarity measurements showed an
enhancement of the hydrophilic properties of DLNS3. DLNS3 displayed 121-fold saturation solubility and released
approximately 57% of loratadine within 15 min. The effects of CMPs and CPPs on the CQA were expected by the QbD approach.

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