PREPARATION AND IN VITRO CHARACTERIZATION OF PELLETS
CONTAINING FELODIPINE SOLID DISPERSIONS

RAREȘ IULIU IOVANOV1*, IOAN TOMUȚĂ1, ALEXANDRA BARBU1, LUCIA RUS2, SORIN E. LEUCUȚA1
”Iuliu Haţieganu” University of Medicine and Pharmacy, Faculty of Pharmacy
1Department of Pharmaceutical Technology and Biopharmaceutics, 41 Victor Babes Street, 400023, Cluj-Napoca, Romania
2Department of Drug Analysis, 6 L. Pasteur Street, 400349, Cluj-Napoca, Romania
*corresponding author: riovanov@umfcluj.ro
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Abstract:
The aim of the study was the preparation and characterization of prolonged release pellets loaded with felodipine (FD) solid
dispersions (SD) and coated with different polymeric coatings in order to release the active pharmaceutical ingredient (API)
over a 12 hours period. A central composite experimental design with three factors and three levels was developed in order to
determine the influence of the polyvinylpyrrolidone (PVP)/FD ratio in the SD, the percentage of polymeric coating and the
percent of pore forming polymer in the coating on the kinetics release of FD. The good data fit with the chosen model
indicates that the results dependent on the studied formulation factors. All the studied formulations released the API over a 12
hours period. The DSC analysis showed that in the PVP:FD = 2 SD, the FD is found in an amorphous state. The SEM studies
showed that the pellets were evenly loaded and coated throughout the entire preparation process. The statistical analysis of
the experimental data highlighted that the increase of PVP ratio in the SD and the increase in the percent of pore forming
polymer in the coating increases the release rate of FD and that the increase in the percent of the polymeric coating
determines a reduction in the release rate of the chosen model drug. In this research there were developed and characterized
some prolonged release coated pellets with FD solid dispersions, pellets that released the model drug over a 12 hours period
and the release kinetics of the API fitted best with the Peppas, Higuchi, Baker-Lonsdale and First order mathematical
equations.






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