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    • 38. 发明公开
    • Solid dosage form of enteric solid dispersion and method for producing the same
    • Feste Arzneiform einerdarmlöslichenDispersion und Verfahren zur Herstellung derselben
    • EP1886673A2
    • 2008-02-13
    • EP07015396.0
    • 2007-08-06
    • Shin-Etsu Chemical Co., Ltd.
    • Kusaki, FumieHoshino, TakafumiMaruyama, NaosukeNishiyama, YuichiFukui, IkuoUmezawa, Hiroshi
    • A61K9/20A61K47/38A61K31/44
    • A61K9/1652A61K9/1623A61K9/2018A61K9/2054A61K9/2059A61K31/44
    • Provided are a solid dosage form comprising an enteric 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 an enteric solid dispersion comprising a poorly soluble drug, an enteric polymer and a disintegrant, wherein the disintegrant is 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. Moreover, provided is a method for producing a solid dosage form comprising an enteric solid dispersion, the method comprising steps of: spraying an enteric 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 µ m 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.
    • 本发明提供了一种固体剂型,其包含肠溶固体分散体,其允许制剂中的药物快速溶解而不损害固体分散体的溶解性,及其制备方法。 更具体地,提供了包含包含难溶性药物,肠溶性聚合物和崩解剂的肠溶性固体分散体的固体剂型,其中所述崩解剂是平均粒径为10〜100μm的低取代羟丙基纤维素,比表面积 通过BET法测量为至少1.0m 2 / g。 此外,提供了一种生产包含肠溶固体分散体的固体剂型的方法,所述方法包括以下步骤:将难溶性药物已经分散或溶解的肠溶性聚合物溶液喷雾到具有 平均粒径为10〜100μm,BET法测定的比表面积为1.0m 2 / g以上,作为崩解剂; 并造成结果; 并干燥。