abstract |
A composition containing fine particles of a sparingly soluble drug, which is stable and is not influenced by storage environment conditions; and a process for producing the composition. The fine-particle-containing composition comprises fine particles of a sparingly soluble drug, a surfactant, and a cyclic oligosaccharide, and is characterized in that the fine particles have an average particle diameter of 50-1,000 nm. The process, which is for producing the composition containing fine particles, comprises: (I) a mixing step in which a sparingly soluble drug, a surfactant, and a poor solvent are mixed to obtain a liquid mixture; (II) a pulverization step in which the liquid mixture is pulverized with a wet disperser to obtain a dispersion of fine particles; (III) an addition step in which a cyclic oligosaccharide is added to the fine-particle dispersion; and (IV) a drying step in which the fine-particle dispersion containing the cyclic oligosaccharide is dried. |