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1.发明申请Multiparticulate Pharmaceutical form Comprising Pellets with a Substance Having a Modular Effect in Relation to Active Ingredient Release 审中-公开包含颗粒与具有与活性成分释放有关的模块效应的物质的多颗粒药物形式公开(公告)号：US20080220080A1
公开(公告)日：2008-09-11
申请号：US11816372
申请日：2006-03-03
IPC分类号： A61K9/14 , A61K31/135
CPC分类号： A61K9/209 , A61K9/2886 , A61K9/5026 , A61K9/5078
摘要： The invention relates to a multiparticulate pharmaceutical form, comprising pellets with a multilayer structure for controlled active ingredient release, comprising a) a core layer comprising a substance having a modulating effect, b) an inner controlling layer which influences the delivery of the substance having a modulating effect, consisting of pharmaceutically usable polymers, waxes, resins and/or proteins, c) an active ingredient layer comprising an active pharmaceutical ingredient and, where appropriate, a substance having a modulating effect, d) an outer controlling layer comprising at least 60% by weight of one or a mixture of a plurality of (meth)acrylate copolymers where the layers may additionally and in a manner known per se comprise pharmaceutically usual excipients, where the outer controlling layer d) has a thickness from 20 to less than 55 μm and contains 0.1 to 10% by weight of glycerol monostearate, where the multiparticulate pharmaceutical form contains 20 to 60% by weight of the pellets, which are compressed in mixture with 80 to 40% by weight of an outer phase which consists from 50 to 100% by weight of a cellulose or a derivate of cellulose and optionally 0 to 50% by weight of further pharmaceutical excipients.
摘要翻译： 本发明涉及一种多颗粒药物形式，其包含具有用于受控活性成分释放的多层结构的颗粒，其包含a）包含具有调节作用的物质的芯层，b）影响具有 调节作用，由药学上可用的聚合物，蜡，树脂和/或蛋白质组成，c）活性成分层，其包含活性药物成分和适当时具有调节作用的物质，d）外部控制层，其包含至少60 重量％的一种或多种（甲基）丙烯酸酯共聚物的混合物，其中层可以另外地以本身已知的方式包含药学上通常的赋形剂，其中外部控制层d）的厚度为20至小于55 并含有0.1至10重量％的单硬脂酸甘油酯，其中多颗粒药物形式含有20至60％的b 的颗粒重量，其与80至40重量％的外相以80至40重量％的混合物压缩，所述外相由50至100重量％的纤维素或纤维素衍生物和任选的0至50重量％的进一步的药物 赋形剂。
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2.发明申请公开(公告)号：US20080152719A1
公开(公告)日：2008-06-26
申请号：US11815677
申请日：2006-03-03
IPC分类号： A61K9/16
CPC分类号： A61K9/5078 , A61K9/2081 , A61K9/5015 , A61K9/5026
摘要： The invention relates to a multiparticulate pharmaceutical form, comprising pellets with a multilayer structure for controlled active ingredient release, comprising a) optionally a neutral core (nonpareilles), b) an inner controlling layer comprising a substance having a modulating effect, which is embedded in a matrix which influences the delivery of the modulatory substance and which comprises pharmaceutically usable polymers, waxes, resins and/or proteins, and where appropriate an active ingredient, c) an active ingredient layer comprising an active pharmaceutical ingredient and, where appropriate, a substance having a modulating effect, d) an outer controlling layer comprising at least 60% by weight of one or a mixture of a plurality of (meth) acrylate copolymers where the outer controlling layer has a thickness from 20 to less than 55 μm and contains 0,1 to 10% by weight of glycerol monostearate, where the multiparticulate pharmaceutical form contains 20 to 60% by weight of the pellets, which are compressed in mixture with 80 to 40% by weight of an outer phase which consists from 50 to 100% by weight of a cellulose or a derivate of cellulose and optionally 0 to 50% by weight of further pharmaceutical excipients.
摘要翻译： 本发明涉及多颗粒药物形式，其包含具有用于受控活性成分释放的多层结构的颗粒，其包含a）任选的中性核心（非矫正剂），b）包含调节作用的物质的内部控制层，其嵌入 影响调节物质递送的基质，其包含药学上可用的聚合物，蜡，树脂和/或蛋白质，以及适当的活性成分，c）包含活性药物成分和适当的物质的活性成分层 具有调节作用，d）包含至少60重量％的多个（甲基）丙烯酸酯共聚物中的一种或多种（甲基）丙烯酸酯共聚物的混合物的外部控制层，其中外部控制层具有20至小于55μm的厚度并且包含0 ，1至10重量％的甘油单硬脂酸酯，其中多颗粒药物形式包含20至60重量％的p 它们与80至40重量％的外相一起被压制，所述外相由50-100重量％的纤维素或纤维素衍生物和任选的0至50重量％的其它药用赋形剂组成。
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公开(公告)号：US09700520B2
公开(公告)日：2017-07-11
申请号：US12678406
申请日：2007-09-25
IPC分类号： A61K9/50
CPC分类号： A61K9/5078 , A61K9/501 , A61K9/5026
摘要： The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising a core, comprising at least one pharmaceutical active ingredient, which is an opioid, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer, and ii) 5-60% by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, characterized in that the coating layer further contains 110 to 250% by weight, calculated on dry weight of the polymer mixture, of a non-porous inert lubricant and the coating layer is present in an amount of at least 60% by weight calculated on the weight of core.
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4.发明授权PH-dependent controlled release pharmaceutical composition for non-opioids with resistance against the influence of ethanol 有权对依赖乙醇影响的非阿片样物质的PH依赖性控释药物组合物公开(公告)号：US09555006B2
公开(公告)日：2017-01-31
申请号：US12678429
申请日：2007-09-25
IPC分类号： A61K9/50
CPC分类号： A61K9/5078 , A61K9/501 , A61K9/5026
摘要： The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising at least one pharmaceutical active ingredient, with the exception of opioids, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer or copolymer, and ii) 5-60% by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0. characterized in that the coating layer further contains 110 to 250% by weight, calculated on dry weight of the polymer mixture, of a non-porous inert lubricant and the is present in an amount of at least 60% by weight calculated on the weight of core.
摘要翻译： 本发明涉及pH依赖性控释药物组合物，其包含除阿片样物质以外的至少一种药物活性成分，其中核心至少涂覆一层涂层，以控制药物组合物的释放，其中涂层 至少一种不溶于水的基本上中性的乙烯基聚合物或共聚物，和ii）5-60重量％，基于干燥的聚合物混合物，i）40-95重量％，基于聚合物混合物的干重， 聚合物混合物的至少一种阴离子聚合物或共聚物的重量，其不溶于低于pH 4.0的缓冲介质并且可溶于至少在7.0至8.0的范围内。 其特征在于，所述涂层还包含110-250重量％，以聚合物混合物的干重计算的非多孔惰性润滑剂，并且其含量以至少60重量％的量存在，以重量计 核心。
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5.发明申请PH-DEPENDENT CONTROLLED RELEASE PHARMACEUTICAL COMPOSITION FOR NON-OPIOIDS WITH RESISTANCE AGAINST THE INFLUENCE OF ETHANOL 有权对依赖于乙醇的影响的非依赖性药物的PH依赖性控制释放药物组合物公开(公告)号：US20100221324A1
公开(公告)日：2010-09-02
申请号：US12678429
申请日：2007-09-25
IPC分类号： A61K9/14 , A61K9/00 , A61K31/138 , A61K9/22 , A61K9/58
CPC分类号： A61K9/5078 , A61K9/501 , A61K9/5026
摘要： The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising at least one pharmaceutical active ingredient, with the exception of opioids, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer or copolymer, and ii) 5-60% by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0. characterized in that the coating layer further contains 110 to 250% by weight, calculated on dry weight of the polymer mixture, of a non-porous inert lubricant and the is present in an amount of at least 60% by weight calculated on the weight of core.
摘要翻译： 本发明涉及pH依赖性控释药物组合物，其包含除阿片样物质以外的至少一种药物活性成分，其中核心至少涂覆一层涂层，以控制药物组合物的释放，其中涂层 至少一种不溶于水的基本上中性的乙烯基聚合物或共聚物，和ii）5-60重量％，基于干燥的聚合物混合物，i）40-95重量％，基于聚合物混合物的干重， 聚合物混合物的至少一种阴离子聚合物或共聚物的重量，其不溶于低于pH 4.0的缓冲介质并且可溶于至少在7.0至8.0的范围内。 其特征在于，所述涂层还包含110-250重量％，以聚合物混合物的干重计算的非多孔惰性润滑剂，并且其含量以至少60重量％的量存在，以重量计 核心。
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6.发明申请公开(公告)号：US20100226978A1
公开(公告)日：2010-09-09
申请号：US12678406
申请日：2007-09-25
IPC分类号： A61K9/56 , A61K9/00 , A61K9/46 , A61K9/22 , A61K9/52 , A61K31/55 , A61K31/5377 , A61K31/485 , A61P25/04
CPC分类号： A61K9/5078 , A61K9/501 , A61K9/5026
摘要： The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising a core, comprising at least one pharmaceutical active ingredient, which is an opioid, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer, and ii) 5-60% by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, characterized in that the coating layer further contains 110 to 250% by weight, calculated on dry weight of the polymer mixture, of a non-porous inert lubricant and the coating layer is present in an amount of at least 60% by weight calculated on the weight of core.
摘要翻译： 本发明涉及pH依赖性控释药物组合物，其包含核心，其包含至少一种药物活性成分，其为阿片样物质，其中核心至少涂覆一层涂层，控制药物组合物的释放， 其中所述涂层包含以下混合物：i）基于所述聚合物混合物的干重为40-95重量％的至少一种水不溶性基本中性乙烯基聚合物的混合物，以及ii）5-60重量％，基于 聚合物混合物的干重，至少一种阴离子聚合物或共聚物，其不溶于低于pH 4.0的缓冲介质中并且可溶于至少在pH 7.0至pH 8.0的范围内，其特征在于，所述涂层还包含110至 以聚合物混合物的干重计，250重量％的无孔惰性润滑剂和涂层的含量以核心重量计算为至少60重量％。
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7.发明申请Multilayer pharmaceutical dosage form containing a substance that acts in a modulatory manner with regard to the release of active substances 审中-公开含有在活性物质释放方面以调节方式起作用的物质的多层药物剂型公开(公告)号：US20060269605A1
公开(公告)日：2006-11-30
申请号：US10572963
申请日：2004-09-15
IPC分类号： A61K9/24
CPC分类号： A61K9/5078 , A61K9/5026
摘要： The invention relates to a multilayer pharmaceutical dosage form for the controlled release of active substances, containing: a) a core layer containing a substance that acts in a modulatory manner with regard to the release of active substances, optionally a neutral core and/or an active substance; b) an inner control layer that influences the release of the substance that acts in a modulatory manner and of the optionally contained active substance from the core layer, containing pharmaceutically useable polymers, waxes, resins and/or proteins; c) an active substance layer containing a pharmaceutical active substance and, optionally, a substance that acts in a modulatory manner; d) an outer control layer containing a (meth)acrylate copolymer or a mixture consisting of a number of (meth)acrylate copolymers comprised of 98 to 85 C1-C4 alkyl esters of (meth)acrylic acid and 2 to 15% by weight of methacrylate monomers with a quaternary ammonium group in the alkyl radical and optionally containing pharmaceutically useable polymers that are insoluble in water, whereby the layers can contain, in addition and in a known manner, pharmaceutically conventional adjuvants.
摘要翻译： 本发明涉及用于控制释放活性物质的多层药物剂型，其包含：a）核心层，其含有相对于活性物质的释放以调节方式起作用的物质，任选的中性核和/或 活性物质 b）内部控制层，其影响以调节方式起作用的物质的释放，以及含有药学上可用的聚合物，蜡，树脂和/或蛋白质的核心层中任选地含有的活性物质; c）含有药物活性物质和任选的以调节方式作用的物质的活性物质层; d）包含（甲基）丙烯酸酯共聚物的外部控制层或由多个（甲基）丙烯酸酯共聚物组成的混合物，所述（甲基）丙烯酸酯共聚物包含98至85℃1〜 （甲基）丙烯酸的烷基酯和2至15重量％的在烷基中具有季铵基团的甲基丙烯酸酯单体，并且任选地含有不溶于水的药学上可用的聚合物，其中所述层还可以包含 已知的方式，药学上常规的佐剂。
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公开(公告)号：US08431157B2
公开(公告)日：2013-04-30
申请号：US11815632
申请日：2005-12-15
CPC分类号： C08F220/18 , A61K9/2846 , A61K9/5026
摘要： The invention relates to a partly neutralized anionic (meth)acrylate copolymer consisting of radically polymerized units containing 25-95% by weight (meth)acrylic acid C1 to C4 alkylesters and 5-75% by weight (meth)acrylate monomer with an anionic group, wherein 0.1 to 25% contained anionic groups are neutralized by a base. Said invention is characterized in that said base is embodied in the form of an cationic organic base whose molecular weight is greater than 150. A medical form containing said partly neutralized anionic (meth)acrylate copolymer and the use of said partly neutralized anionic (meth)acrylate copolymer for producing a medical form rapidly releasing an active substance having a determined pH value are also disclosed.
摘要翻译： 本发明涉及一种部分中和的阴离子（甲基）丙烯酸酯共聚物，它由含25-95％（重量）（甲基）丙烯酸C1至C4烷基酯和5-75％（重量）（甲基）丙烯酸阴离子基团单体的自由基聚合单元组成 ，其中0.1〜25％的阴离子基团被碱中和。 所述发明的特征在于所述碱以分子量大于150的阳离子有机碱的形式实施。含有所述部分中和的阴离子（甲基）丙烯酸酯共聚物的医用形式以及所述部分中和的阴离子（甲基）丙烯酸酯共聚物的用途， 丙烯酸酯共聚物，用于制备快速释放具有确定的pH值的活性物质的医用形式。
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9.发明申请公开(公告)号：US20090280183A1
公开(公告)日：2009-11-12
申请号：US11721399
申请日：2005-11-05
IPC分类号： A61K9/10 , A61K31/7088 , A61P1/00 , A61K39/395
CPC分类号： A61K9/5138 , A61K9/1652 , A61K9/1676 , A61K9/1694 , A61K9/5192 , A61K31/7088
摘要： The invention relates to an oral, multiparticulate form of administration, comprising pellets in the size ranging from 50 to 2500 $g(m)m which are substantially constituted of a) an inner matrix layer containing nanoparticles that contain a nucleic acid active ingredient and being embedded in a matrix of a polymer having a mucoadhesive effect, and b) an outer film coating, substantially consisting of an anionic polymer or copolymer that is optionally formulated with pharmaceutically conventional adjuvants, especially emollients.
摘要翻译： 本发明涉及口服，多颗粒形式的施用，其包含尺寸范围为50至2500g（m）m的颗粒，其基本上由以下组成：a）含有含有核酸活性成分的纳米颗粒的内基质层， 嵌入在具有粘膜粘附作用的聚合物的基质中，以及b）外膜包衣，其基本上由阴离子聚合物或共聚物组成，其任选地与药学上常规的佐剂特别是润肤剂配制。
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公开(公告)号：US09597293B2
公开(公告)日：2017-03-21
申请号：US12598138
申请日：2007-05-07
申请人： Fang Liu , Abdul W. Basit , Rosario Lizio , Hans-Ulrich Petereit , Christian Meier , Michael Damm
发明人： Fang Liu , Abdul W. Basit , Rosario Lizio , Hans-Ulrich Petereit , Christian Meier , Michael Damm
CPC分类号： A61K9/5073 , A61K9/5026
摘要： The present invention provides a solid dosage form including an inner coating located between a core containing a pharmaceutically active ingredient and an outer enteric coating; wherein the inner coating includes a partially neutralized anionic polymeric material, and at least a carboxylic acid having 2 to 16 carbon atoms the salts thereof or mixtures of the acid and its salt; wherein the outer coating includes an anionic polymeric material which is less or not at all neutralized than the material of the inner coating.
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