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    • 91. 发明公开
    • Solid dosage form comprising solid dispersion and method for producing the same
    • 固体剂型,其包含固体分散体,以及制造其的方法
    • EP1886672A2
    • 2008-02-13
    • EP07015395.2
    • 2007-08-06
    • Shin-Etsu Chemical Co., Ltd.
    • Kusaki, FumieHoshino, TakafumiMaruyama, NaosukeNishiyama, YuichiFukui, IkuoUmezawa, Hiroshi
    • A61K9/20A61K47/38A61K31/44
    • A61K9/2054A61K31/44
    • Provided are a solid dosage form comprising a solid dispersion that allows a drug in the preparation to be rapidly dissolved without compromising the solubility of the solid dispersion, and a method for producing the same. More specifically, provided is a solid dosage form comprising a solid dispersion, the dispersion comprising: a poorly soluble drug, a water-soluble polymer and a disintegrant, wherein the disintegrant is low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 µ m and a specific surface area measured by BET method of at least 1.0 m 2 /g. Moreover, provided is a method for producing a solid dosage form comprising a solid dispersion, the method comprising steps of: spraying a water-soluble polymer solution in which a poorly soluble drug has been dispersed or dissolved, on a powder of low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 µm and a specific surface area measured by BET method of at least 1.0 m 2 /g and serving as a disintegrant and granulating the resultant; and drying.
    • 本发明提供一种固体剂型,其包含做了固体分散体允许在制备药物而不损害固体分散体中的溶解度迅速溶解,和用于生产其的方法。 更具体地,提供了一种固体剂型,其包含固体分散体,所述分散体包括:难溶性药物,水溶性聚合物和崩解剂,worin所述崩解剂是具有在10平均颗粒尺寸为100μ低substituiertem羟丙基纤维素 m和至少1.0米2 /克的BET法测定的比表面积。 更完了,提供的是用于制备固体剂型,其包含固体分散体的方法,该方法包括以下步骤:喷雾在其中溶解性差的药物已被分散或溶解于其中的水溶性聚合物溶液,在低substituiertem羟丙基的粉末 具有在10至100微米的平均粒径和比表面积通过至少为1.0米2 /克和作为崩解剂和造粒得到的BET法测定; 和干燥。