PREPARATION AND IN VITRO EVALUATION OF FELODIPINELOADED
POLY(ε-CAPROLACTONE) MICROSPHERES: QUALITY BY DESIGN APPROACH
MARCELA ACHIM 1, LUCIA RUXANDRA TEFAS 1*, RAREȘ IOVANOV 1, ANDREEA LOREDANA VONICA-GLIGOR 1,2, LUCIAN BARBU-TUDORAN 3, IOAN TOMUȚĂ 1
1“Iuliu Hațieganu” University of Medicine and Pharmacy Cluj-Napoca, Faculty of Pharmacy, Department of Pharmaceutical
Technology and Biopharmacy, 41 V. Babeş Street, 400012 Cluj-Napoca, Romania
2“Lucian Blaga” University, 2A L. Blaga Street, 550169 Sibiu, Romania
3“Babeș-Bolyai” University, Faculty of Biology & Geology, Electron Microscopy Center, 5-7 Clinicilor Street, 400006 Cluj-
Napoca, Romania
*corresponding author: tefas.lucia@umfcluj.ro
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Abstract:
Felodipine was encapsulated into poly(ε-caprolactone) microspheres by the emulsion solvent evaporation method by
employing the Quality by Design (QbD) strategy. Based on a risk analysis, the influence of 4 critical process parameters
(type of stirrer, stirring rate, shape of mixing vessel, aqueous phase volume) on the critical quality attributes of the
microspheres (size, polydispersity, entrapment efficiency (EE)), was evaluated by a full factorial experimental design. The
microspheres’ morphology and felodipine in vitro release were also studied. The particles’ size ranged between 39.8 and
302.5 μm, and the polydispersity index varied from 0.279 to 0.517. Felodipine EE was above 93.59%. Scanning electron
microscopy (SEM) analysis revealed spherical particles, with imperfections and micropores on the surface. The microspheres
exhibited an extended release of felodipine over a period of 12 hours. In conclusion, the QbD approach helped understand the
process parameters and their impact on the quality profile in the development of felodipine-loaded microspheres.

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