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1.发明授权Hypromellose acetate succinate for use as hot-melt extrusion carrier, hot-melt extrusion composition, and method for producing hot-melt extrudate 有权羟丙甲纤维素乙酸琥珀酸酯用作热熔挤出的载体，热熔融挤出组合物和方法用于产生Heißschmelzextrudats
公开(公告)号：EP2837391B1
公开(公告)日：2017-05-10
申请号：EP14178879.4
申请日：2014-07-29
IPC分类号： A61K9/14 , A61K31/4422 , A61K47/38 , A61K9/20
CPC分类号： A61K31/4422 , A61K9/146 , A61K9/20 , A61K47/38 , Y10T428/2982
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 melt; and extruding the hot-melted composition.
摘要翻译： 提供具有优异的混溶性均匀与药物热熔挤出; 和用于生产热熔挤出能够顺利供给在热熔挤出的粉末的方法。 更具体地，提供的是羟丙甲纤维素乙酸琥珀酸酯（HPMCAS）用作从70至300微米，通过干式激光衍射和从12时25分的松散堆积密度测量具有体积平均粒径（D 50）热熔挤出载体 到0.40克/厘米3; 和热熔挤出组合物，包含的HPMCAS和药物。 这样提供了一种用于生产热熔挤出包括以下步骤的方法：热熔融在热熔温度的热熔挤出组合物等于或高于HPMCAS的熔融温度，或在热熔 温度比在其中两个HPMCAS和药物成为熔体的温度等于或更高; 和挤压热熔融组合物。
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2.发明公开HYPROMELLOSE ACETATE SUCCINATE AND METHOD FOR PRODUCING HYPROMELLOSE ACETATE SUCCINATE 审中-公开醋酸胞外酯琥珀酸酯和生产醋酸胞内酯琥珀酸酯的方法
公开(公告)号：EP3290444A1
公开(公告)日：2018-03-07
申请号：EP17187808.5
申请日：2017-08-24
IPC分类号： C08B13/00
摘要： Provided is a method for producing HPMCAS capable of reducing the average particle size of HPMCAS particles to an intended range without a pulverization step. Specifically provided is a method for producing hypromellose acetate succinate, comprising an esterification step of reacting hypromellose with an esterification agent in the presence of a catalyst to obtain a reaction solution containing crude hypromellose acetate succinate, a precipitation step of mixing the reaction solution with water to precipitate the crude hypromellose acetate succinate, thereby obtaining a hypromellose acetate succinate suspension, a liquid removal step of removing a liquid from the hypromellose acetate succinate suspension with a centrifugal decanter to obtain liquid-removed hypromellose acetate succinate, and a drying step of drying the liquid-removed hypromellose acetate succinate.
摘要翻译： 本发明提供一种HPMCAS的制造方法，其能够在不进行粉碎工序的情况下将HPMCAS粒子的平均粒径缩小至目标范围。 具体而言，提供一种乙酸琥珀酸羟丙甲纤维素酯的制造方法，其包括使羟丙甲纤维素与酯化剂在催化剂存在下反应的酯化工序，得到含有醋酸琥珀酸羟丙甲纤维素酯的反应溶液，将反应溶液与水混合 从而得到琥珀酸羟丙甲纤维素琥珀酸酯，从而得到琥珀酸羟丙甲纤维素琥珀酸酯悬浮液;用离心滗析器从乙酸羟丙甲纤维素琥珀酸酯悬浮液中除去液体以获得液体除去的乙酸琥珀酸羟丙甲纤维素酯的液体除去步骤;以及干燥步骤， 去除醋酸羟丙甲纤维素琥珀酸酯。
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3.发明授权Composition for hot-melt extrusion and method for producing hot-melt extrusion product using same 有权用于热熔挤出的组合物和使用该组合物生产热熔挤出产品的方法
公开(公告)号：EP2810660B1
公开(公告)日：2017-07-26
申请号：EP14170863.6
申请日：2014-06-03
CPC分类号： A61K47/38 , A61K9/146 , A61K31/4422 , A61K31/496 , C08B11/193 , C08B11/20 , C08B13/00 , C08J3/201 , C08J2301/32 , C08L1/32
摘要： 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 comprising 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 comprising a step of hot-melt extruding a composition for hot-melt extrusion comprising 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.
摘要翻译： 本发明提供一种热熔挤出用组合物，其可以在低于常规温度的温度下热熔挤出并且因此不会引起热诱导的药物失活; 以及比喷雾干燥法简单的热熔挤出物的制造方法。 更具体而言，提供一种用于热熔挤出的组合物，其包含药物和羟丙氧基摩尔取代度为0.40或更高的乙酸羟丙甲纤维素琥珀酸酯（HPMCAS）。 还提供一种用于生产热熔挤出产品的方法，其包括热熔挤出组合物的步骤，所述热熔挤出组合物包含在热熔温度下具有羟基丙氧基摩尔取代度为0.40或更高的药物和乙酸羟丙甲纤维素琥珀酸酯 乙酸羟丙甲纤维素琥珀酸酯的熔化温度或更高，或者在等于或高于乙酸羟丙甲纤维素琥珀酸酯和药物熔化的温度的热熔温度下进行。
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4.发明公开Hypromellose acetate succinate for use as hot-melt extrusion carrier, hot-melt extrusion composition, and method for producing hot-melt extrudate 有权羟丙甲纤维素乙酸琥珀酸酯用作热熔挤出的载体，热熔融挤出组合物和方法用于产生Heißschmelzextrudats
公开(公告)号：EP2837391A1
公开(公告)日：2015-02-18
申请号：EP14178879.4
申请日：2014-07-29
CPC分类号： A61K31/4422 , A61K9/146 , A61K9/20 , A61K47/38 , Y10T428/2982
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 melt; and extruding the hot-melted composition.
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5.发明公开Composition for hot-melt extrusion and method for producing hot-melt extrusion product using same 有权组合物熔融挤出，以及用于由此制备熔融挤出产品的方法
公开(公告)号：EP2810660A1
公开(公告)日：2014-12-10
申请号：EP14170863.6
申请日：2014-06-03
CPC分类号： A61K47/38 , A61K9/146 , A61K31/4422 , A61K31/496 , C08B11/193 , C08B11/20 , C08B13/00 , C08J3/201 , C08J2301/32 , C08L1/32
摘要： 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 comprising 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 comprising a step of hot-melt extruding a composition for hot-melt extrusion comprising 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.
摘要翻译： 提供的是用于热熔挤出哪个可以是热熔在比常规温度低，因此游离药物的热诱导失活的温度下挤出的组合物; 和用于生产热熔挤出产品中的所有比喷雾干燥方法更简单的方法。 更具体地，提供了一种用于热熔融挤出含有药物和羟丙基甲基纤维素乙酸琥珀酸酯（HPMCAS），其具有的羟基丙氧基○时40或更大的摩尔取代度的组合物。 这样提供了一种用于生产热熔挤出产品，其包括热熔挤出用于热熔融挤出，其包括具有热熔融温度的0:40或更高的羟基丙氧基摩尔取代的药物和羟丙基甲基纤维素乙酸琥珀酸酯的组合物的步骤的方法 羟丙甲纤维素乙酸酯琥珀酸酯或更高的熔融温度的，或在热熔温度比在其中两个羟丙甲纤维素醋酸琥珀酸酯和药物成为熔融的温度等于或更高。
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