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Hypromellose acetate succinate for heat-melt extrusion carrier, composition for heat-melt extrusion, and method for producing heat-melt extrusion molding

机译:用于热熔挤出载体的乙酸羟丙甲纤维素琥珀酸酯,用于热熔挤出的组合物和用于生产热熔挤出成型物的方法

摘要

Provided are a hot-melt extrudate excellent in uniform miscibility with a drug; and a method for producing a hot-melt extrudate capable of smoothly feeding a powder in hot-melt extrusion. More specifically, provided are hypromellose acetate succinate (HPMCAS) for use as a hot-melt extrusion carrier having a volume average particle size (D 50 ) of from 70 to 300 µm as measured by dry laser diffraction and a loose bulk density of from 0.25 to 0.40 g/cm 3 ; and a hot-melt extrusion composition comprising the HPMCAS and a drug. Also provided is a method for producing a hot-melt extrudate comprising the steps of: hot-melting the hot-melt extrusion composition at a hot-melt temperature equal to or higher than a melting temperature of the HPMCAS, or at a hot-melt temperature equal to or higher than a temperature at which both of the HPMCAS and the drug become me and extruding the hot-melted composition.
机译:提供与药物均匀混溶性优异的热熔挤出物;以及能够在热熔挤出中平稳地供给粉末的热熔挤出物的制造方法。更具体地,提供了用作热熔挤出载体的乙酸羟丙甲纤维素琥珀酸酯(HPMCAS),其通过干激光衍射测得的体积平均粒径(D 50)为70至300μm,并且松散堆积密度为0.25。至0.40 g / cm 3;包含HPMCAS和药物的热熔挤出组合物。还提供了一种生产热熔挤出物的方法,该方法包括以下步骤:在等于或高于HPMCAS的熔融温度的热熔温度下或在热熔温度下热熔该热熔挤出组合物。等于或高于HPMCAS和药物融化的温度;并挤出热熔组合物。

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