Solubility Enhancement Solid Dispersion Fenofibric Acid HPMC and Their Physicochemical Characterization
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Abstract
Fenofibric acid is a water-soluble antihyperlipidemia drug, and the solubility of fenofibric acid is 162.5 µg/mL.1 Solid dispersion systems are aimed to improve the solubility of poorly soluble active pharmaceutical ingredients. This study aimed to formulate and characterization fenofibric acid-hydroxypropyl methylcellulose (HPMC) solid dispersion. The solid dispersion of fenofibric acid was prepared using the solvent evaporation method. The ratios of fenofibric acid and HPMC were F1 (1:1), F2 (1:3) and F3 (1:5). The formulated products were subjected to various physicochemical characterisation using X-ray diffractograms, DSC thermograms, SEM and FTIR, including particle size distribution and solubility test. The physicochemical characterisation showed the specific characteristics of the solid dispersions. X-ray diffractograms, DSC thermograms and SEM photographs indicated that fenofibric acid was amorphous and trapped in the HPMC matrix. FTIR test results show no new functional groups indicating no chemical interaction between the active pharmaceutical ingredients and the matrix. SEM results show that the solid dispersion system was morphologically different from pure fenofibric acid and the physical mixture. The solubility of fenofibrate acid was 42.33 µg/mL while the solubility of solid dispersion F3 ratio 1:3 was 113.25 µg/mL. The solubility of fenofibrate acid solid dispersion with HPMC 1:3 ratio is 2.68 times greater than that of pure fenofibrate acid.
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