A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/14 (2006.01) A61K 9/10 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 47/26 (2006.01) A61K 47/40 (2006.01)
Patent
CA 2580529
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.
L'invention concerne une composition contenant de fines particules d'un médicament modérément soluble, qui est stable et non influencée par les conditions d'environnement de stockage; et un procédé de fabrication de la composition. La composition contenant de fines particules comprend de fines particules d'un médicament modérément soluble, un tensioactif et un oligosaccharide cyclique, et est caractérisée en ce que les fines particules ont un diamètre particulaire moyen de 50 à 1.000 nm. Le procédé, permettant de fabriquer la composition contenant de fines particules, comprend : (I) une phase de mélange où un médicament modérément soluble, un tensioactif et un solvant médiocre sont mélangés pour obtenir un mélange liquide ; (II) une phase de pulvérisation dans laquelle le mélange liquide est pulvérisé avec un dispersant humide pour obtenir une dispersion de fines particules ; (III) une phase d'addition dans laquelle on ajoute un oligosaccharide cyclique à la dispersion de fines particules ; et (IV) une phase de séchage dans laquelle la dispersion de fines particules contenant l'oligosaccharide cyclique est séchée.
Bereskin & Parr Llp/s.e.n.c.r.l.,s.r.l.
Eisai R. & D. Management Co. Ltd.
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