-3 Omega-3 phospholipid-based formulation of fenofibrate and preparation method thereof

摘要

The present invention relates to crystalline solid dispersion formulations containing omega-3 phospholipid with improved solubility and bioavailability of the poorly soluble drug, and to a method for producing the same.The crystalline solid dispersion preparation according to the present invention can be prepared by preparing a drug into a nanocrystal form through an anti-solvent precipitation method and combining an immediate lyophilization process to inhibit the size of a drug particle from becoming larger or aggregation, . In addition, when omega-3 phospholipid having an amphipathic characteristic is added to sucrose which can act as a low-temperature protecting material during freeze-drying, the drug particles can be uniformly dispersed and the particle size can be kept small, thereby increasing the solubility of the phenobibrate drug Thereby improving the bioavailability. In addition, omega-3 phospholipids can provide cytoprotective effects, reduced blood lipid levels, and additional effects of antioxidants contained in krill oil. Therefore, the omega-3 phospholipid crystalline solid dispersion preparation of the present invention can be used as a preparation for enhancing the solubility and bioavailability of the phenobibrate drug, and can be applied to various insoluble drugs.;