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    • 7. 发明申请
    • Composition for Hot-Melt Extrusion and Method for Producing Hot-Melt Extrusion Product Using Same
    • 用于热熔体挤出的组合物和使用它的热熔体挤出产物的生产方法
    • US20140357681A1
    • 2014-12-04
    • US14294258
    • 2014-06-03
    • Shin-Etsu Chemical Co., Ltd.
    • Shogo WarashinaFumie KusakiKazuki KikuchiSakae ObaraNaosuke Maruyama
    • A61K31/4422
    • A61K47/38A61K9/146A61K31/4422A61K31/496C08B11/193C08B11/20C08B13/00C08J3/201C08J2301/32C08L1/32
    • Provided are a composition for hot-melt extrusion which can be hot-melt extruded at a temperature lower than a conventional temperature and therefore free of heat-induced deactivation of a drug; and a method for producing a hot-melt extrusion product which is simpler than a spray-drying method. More specifically, provided is a composition for hot-melt extrusion including a drug and hypromellose acetate succinate (HPMCAS) having a hydroxypropoxy molar substitution of 0.40 or more. Also provided is a method for producing a hot-melt extrusion product including a step of hot-melt extruding a composition for hot-melt extrusion including a drug and hypromellose acetate succinate having a hydroxypropoxy molar substitution of 0.40 or more at a hot-melt temperature of melting temperature of the hypromellose acetate succinate or higher, or at a hot-melt temperature equal to or higher than a temperature at which both the hypromellose acetate succinate and the drug become melted.
    • 提供一种用于热熔挤出的组合物,其可以在比常规温度低的温度下进行热熔挤出,因此不导致药物的热诱导失活; 以及比喷雾干燥法简单的热熔挤出制品的制造方法。 更具体地,提供了包含药物和乙氧基甲基纤维素乙酸琥珀酸酯(HPMCAS)的组合物,其具有0.40或更高的羟丙氧基摩尔取代度。 本发明还提供一种热熔挤出产品的制造方法,其特征在于,包括将热熔融挤出用组合物热熔融挤出的步骤,所述组合物包括药物和醋酸羟丙甲纤维素琥珀酸酯,所述组合物的羟丙氧基摩尔取代度为0.40以上, 或者在等于或高于乙酸琥珀酸羟丙甲纤维素和药物熔化的温度的热熔融温度下进行。