Dissolution enhancement and physicochemical characterization of fenofibric acid in surface solid dispersion with croscarmellose sodium

Abstract

The dissolution enhancement of the water-insoluble drug fenofibric acid (FA) was conducted by the surface solid dispersion (SSD) technique with croscarmellose sodium (CS) as a carrier. The SSD formulations of FA were prepared by the solvent evaporation method in three different drug-to-carrier weight ratios, evaluated for the dissolutions, and compared to the physical mixtures (PMs). The optimum SSD formulation and its corresponding PM were characterized by Scanning Electron Microscopy (SEM), Powder X-ray Diffraction (PXRD), Differential Thermal Analysis (DTA), and Fourier Transform Infrared Spectroscopy (FTIR) and were compressed into tablets to evaluate the dissolution after compression. The best dissolution was obtained from the SSD 1:1. The recrystallization of FA in the SSD preparation could change the crystal habit of FA and deposited it on the surface of CS. İn addition, there was no chemical interaction observable between both FA and CS in the SSD formulation. No chemical interaction between FA and CS in the SSD. However, a slight reduction was noticed in the crystallinity of FA if compared to that of the pure drug. This study showed that the SSD formulation had the best dissolution compared to the PM, the conventional direct compression, and the reference formulation of FA in its commercial tablets. The SSD preparation with CS could enhance the dissolution of FA from its tablet dosage form.