Increased Dissolution Rate and Solubility of Fenofibric Acid-Mannitol Solid Dispersion Prepared by the Hot Melt Method

Fenofibrate acid is a new drug for the treatment of hyperlipidemia with low solubility. The very low solubility of the active pharmaceutical ingredient in water results in low bioavailability of the active pharmaceutical ingredient. Solid dispersion technology is a technique that can be used to increase solubility. In this study, the preparation of fenofibrate acid mannitol solid dispersion was carried out using the melting method. The objective of this study is to evaluate the ability of the solid dispersion system of fenofibrate acid and mannitol to enhance dissolution rate. Three formulations were prepared: F1 (fenofibrate acid to mannitol ratio 1:1), F2 (1:3), and F3 (1:5). The solid dispersion system was characterized using FTIR, DSC, X-ray diffraction, and SEM. The physical mixture and solid dispersion were characterized for dissolution. The results showed that the solid dispersion of fenofibric acid was crystalline with a decrease in the physical properties of the melting point. There was no chemical interaction between fenofibric acid and mannitol, and the crystal morphology of the solid dispersion of fenofibric acid was different from that of the original compound. The dissolution rate increased with increasing mannitol concentrations. F3 showed the highest dissolution rate among all formulas. The dissolution rate of solid dispersion F3 was 91.53% after one hour, while that of pure fenofibric acid was 53.20%. Statistical analysis showed a significant difference (P<0.05) in dissolution efficiency among all formulas.