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11. 发明授权

US09555006B2 PH-dependent controlled release pharmaceutical composition for non-opioids with resistance against the influence of ethanol 有权
标题翻译：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
申请人： Hans-Ulrich Petereit , Hema Ravishankar , Ashwini Samel
发明人： Hans-Ulrich Petereit , Hema Ravishankar , Ashwini Samel
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。

12. 发明申请

US20100255092A1 COATED PHARMACEUTICAL OR NUTRACEUTICAL PREPARATION WITH ACCELERATED CONTROLLED ACTIVE SUBSTANCE RELEASE 审中-公开
标题翻译：加速控制的活性物质释放的包装药物或营养制剂
公开(公告)号：US20100255092A1
公开(公告)日：2010-10-07
申请号：US12742263
申请日：2008-02-01
申请人： Hema Ravishankar , Hans-Ulrich Petereit , Shradda Bodinge
发明人： Hema Ravishankar , Hans-Ulrich Petereit , Shradda Bodinge
IPC分类号： A61K9/32 , A61K9/00 , A61K31/522 , A61P43/00
CPC分类号： A61K9/5026 , A61K9/5078
摘要： The present invention relates to pharmaceutical or nutraceutical preparations comprising a) a core containing a pharmaceutically or nutraceutically active substance; and b) a controlling layer surrounding the core comprising i) 55 to 92% by weight based on the total weight of (meth)acrylic copolymers present in the layer of one or a mixture of a plurality of (meth)acrylate copolymers composed of 80 to 98% by weight based on the weight of the (meth)acrylic copolymer of structural units derived from Ci to C4 alkyl esters of (meth)acrylic acid and 2 to 20% by weight based on the weight of the (meth)acrylic copolymer of structural units derived from (meth)acrylate monomers with a quaternary ammonium group in the alkyl radical; and ii) 8 to 45% by weight based on the total weight of (meth)acrylic copolymers present in the layer of one or a mixture of a plurality of (meth)acrylate copolymers composed of more than 5 to 59% by weight based on the weight of the copolymer of structural units derived from acrylic acid or methacrylic acid, and to tablets and capsules containing same.
摘要翻译：本发明涉及药物或营养制剂，其包含a）含有药学或营养物质活性物质的核心; 和b）围绕芯的控制层，其包含i）55至92重量％，基于存在于由80重量份组成的多个（甲基）丙烯酸酯共聚物的一种或多种混合物的层中的（甲基）丙烯酸共聚物的总重量至（甲基）丙烯酸共聚物的重量比为基于（甲基）丙烯酸的C 1〜C 4烷基酯的结构单元的（甲基）丙烯酸共聚物的重量为98重量％，基于（甲基）丙烯酸共聚物的重量为2〜20重量％衍生自烷基中具有季铵基团的（甲基）丙烯酸酯单体的结构单元; 和ii）8至45重量％，基于存在于由多于5至59重量％组成的多个（甲基）丙烯酸酯共聚物的一种或多种（甲基）丙烯酸酯共聚物的层中的（甲基）丙烯酸共聚物）的总重量，基于衍生自丙烯酸或甲基丙烯酸的结构单元的共聚物的重量，以及含有它们的片剂和胶囊的重量。

13. 发明申请

US20080044470A1 PHARMACEUTICAL COMPOSITION WITH CONTROLLED ACITVE INGREDIENT RELEASE FOR ACTIVE INGREDIENTS WITH GOOD SOLUBILITY IN WATER 有权
标题翻译：具有控制性成分的药物组合物，用于在水中具有良好溶解性的活性成分
公开(公告)号：US20080044470A1
公开(公告)日：2008-02-21
申请号：US11695848
申请日：2007-04-03
申请人： Hans-Ulrich Petereit , Hema Ravishankar , Shraddh Bodinge
发明人： Hans-Ulrich Petereit , Hema Ravishankar , Shraddh Bodinge
IPC分类号： A61K47/08 , A61K47/12 , A61K9/28 , A61K9/48
CPC分类号： A61K9/5078 , A61K9/5026
摘要： A pharmaceutical preparation comprising: a) a core with an active ingredient and with an organic acid and/or the salt of an organic acid; and b) a coating which envelops the core and which comprises a polymer content of (meth)acrylate copolymers which have not more than 15% by weight of cationic or anionic groups, and which comprises at least 60% by weight of a (meth)acrylate copolymer which is composed of free-radically polymerized units of 93 to 98% by weight C1- to C4-alkyl esters of acrylic or of methacrylic acid and 7 to 2% by weight (meth)acrylate monomers having a quaternary ammonium group in the alkyl radical, wherein the active ingredient has a solubility in water of at least 10 g/l at 20° C. and the coating comprises silicon dioxide particles having an average particle size in the range from 1 to 50 μm.
摘要翻译：一种药物制剂，其包含：a）具有活性成分和有机酸和/或有机酸盐的核心; 和b）包封芯的涂层，其包含具有不超过15重量％的阳离子或阴离子基团的（甲基）丙烯酸酯共聚物的聚合物含量，并且其包含至少60重量％的（甲基）丙烯酸酯共聚物，丙烯酸酯共聚物，其由93至98重量％的C 1〜C 4 - 丙烯酸或甲基丙烯酸的C 4 - 烷基酯的自由基聚合单元和7至 2重量％的在烷基中具有季铵基团的（甲基）丙烯酸酯单体，其中活性成分在20℃下在水中的溶解度至少为10g / l，并且涂层包含具有平均值的二氧化硅颗粒粒径在1〜50μm的范围内。

14. 发明授权

US09011907B2 Coated pharmaceutical or nutraceutical preparation with enhanced pulsed active substance release 有权
标题翻译：具有增强脉冲活性物质释放的涂层药物或营养制剂
公开(公告)号：US09011907B2
公开(公告)日：2015-04-21
申请号：US12742945
申请日：2008-02-01
申请人： Hema Ravishankar , Shradda Bodinge , Hans-Ulrich Petereit
发明人： Hema Ravishankar , Shradda Bodinge , Hans-Ulrich Petereit
IPC分类号： A61K9/64 , A61K9/20 , A61K9/50
CPC分类号： A61K9/5078 , A61K9/2081
摘要： The present invention relates to a pharmaceutical or nutraceutical preparation comprising a) a core containing a pharmaceutically or nutraceutically active substance and a substance that acts in a modulatory manner with regard of the release of pharmaceutically or nutraceutically active substances; and b) a controlling layer surrounding the core comprising i) 55 to 92% by weight based on the total weight of (meth)acrylic copolymers present in the layer of one or a mixture of a plurality of (meth)acrylate copolymers composed of 80 to 98% by weight based on the weight of the (meth)acrylic copolymer of structural units derived from C1 to C4 alkyl esters of (meth)acrylic acid and 2 to 20% by weight based on the weight of the (meth)acrylic copolymer of structural units derived from (meth)acrylate monomers with a quaternary ammonium group in the alkyl radical; and ii) 8 to 45% by weight based on the total weight of (meth)acrylic copolymers present in the layer of one or a mixture of a plurality of (meth)acrylate copolymers composed of more than 5 to 59% by weight based on the weight of the copolymer of structural units derived from acrylic acid or methacrylic acid and to tablets or capsules comprising same.
摘要翻译：本发明涉及一种药物或营养制剂，其包含a）含有药学上或营养活性物质的核心和在释放药学或营养活性物质方面以调节方式起作用的物质; 和b）围绕芯的控制层，其包含i）55至92重量％，基于存在于由80重量份组成的多个（甲基）丙烯酸酯共聚物的一种或多种混合物的层中的（甲基）丙烯酸共聚物的总重量至（甲基）丙烯酸共聚物的重量比为基于（甲基）丙烯酸的C1至C4烷基酯的结构单元的（甲基）丙烯酸共聚物的重量计为98重量％，以及（甲基）丙烯酸共聚物的重量为2至20重量％衍生自烷基中具有季铵基团的（甲基）丙烯酸酯单体的结构单元; 和ii）8至45重量％，基于存在于由多于5至59重量％组成的多个（甲基）丙烯酸酯共聚物的一种或多种的（甲基）丙烯酸酯共聚物的层中的（甲基）丙烯酸共聚物的总重量）衍生自丙烯酸或甲基丙烯酸的结构单元的共聚物与包含其的片剂或胶囊的重量。

15. 发明申请

US20100226978A1 PH-DEPENDENT CONTROLLED RELEASE PHARMACEUTICAL OPIOID COMPOSITION WITH RESISTANCE AGAINST THE INFLUENCE OF ETHANOL 有权
标题翻译： PH依赖性控释药物抗药性组合物对乙醇的影响
公开(公告)号：US20100226978A1
公开(公告)日：2010-09-09
申请号：US12678406
申请日：2007-09-25
申请人： Hans-Ulrich Petereit , Hema Ravishankar , Ashwini Samel
发明人： Hans-Ulrich Petereit , Hema Ravishankar , Ashwini Samel
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％。

16. 发明申请

US20080220080A1 Multiparticulate Pharmaceutical form Comprising Pellets with a Substance Having a Modular Effect in Relation to Active Ingredient Release 审中-公开
标题翻译：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
申请人： Hans-Ulrich Petereit , Rosario Lizio , Hema Ravishankar , Ashwini Samel
发明人： Hans-Ulrich Petereit , Rosario Lizio , Hema Ravishankar , Ashwini Samel
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。

17. 发明申请

US20060269605A1 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
标题翻译：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
申请人： Rosario Lizio , Hans-Ulrich Petereit , Manfred Assmus , Hema Ravishankar
发明人： Rosario Lizio , Hans-Ulrich Petereit , Manfred Assmus , Hema Ravishankar
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。

18. 发明授权

US09237760B2 Coated pharmaceutical or nutraceutical preparation with enhanced active substance release in the colon 有权
标题翻译：在结肠中具有增强的活性物质释放的涂覆的药物或营养制剂
公开(公告)号：US09237760B2
公开(公告)日：2016-01-19
申请号：US12742842
申请日：2008-02-01
申请人： Hema Ravishankar , Shraddha Bodinge , Hans-Ulrich Petereit
发明人： Hema Ravishankar , Shraddha Bodinge , Hans-Ulrich Petereit
IPC分类号： A61K9/00 , A61K9/28 , A61K9/48 , A23L1/00 , A23L1/22 , A61K9/50
CPC分类号： A23P10/30 , A23L27/72 , A61K9/5078
摘要： The present invention relates to a pharmaceutical or nutraceutical preparation comprising a) a core containing a pharmaceutically or nutraceutically active substance; and b) an inner controlling layer surrounding the core comprising i) one or a mixture of a plurality of (meth)acrylate copolymers bearing a cationic group or a group that can be converted to a cationic group; and ii) one or a mixture of a plurality of polymers or copolymers bearing an anionic group or group that can be converted to an anionic group; and c) an outer controlling layer comprising one or a mixture of a plurality of polymers or copolymers bearing an anionic group or group that can be converted to an anionic group and to tablets or capsules comprising same.
摘要翻译：本发明涉及药物或营养制剂，其包含a）含有药学或营养活性物质的核心; 和b）围绕所述芯的内部控制层，包括i）一个或多个带有阳离子基团的甲基丙烯酸酯共聚物或可转化为阳离子基团的基团的混合物; 和ii）可以转化成阴离子基团的多个带有阴离子基团或基团的聚合物或共聚物的一种或多种混合物; 和c）包含一个或多个带有阴离子基团的聚合物或共聚物的混合物或可以转化成阴离子基团的外部控制层和包含其的片剂或胶囊的外部控制层。

19. 发明授权

US08465769B2 Pharmaceutical composition with controlled active ingredient release for active ingredients with good solubility in water 有权
标题翻译：具有控制活性成分释放活性成分，具有良好溶解性的药物组合物
公开(公告)号：US08465769B2
公开(公告)日：2013-06-18
申请号：US11695848
申请日：2007-04-03
申请人： Hans-Ulrich Petereit , Hema Ravishankar , Shradda Bodinge
发明人： Hans-Ulrich Petereit , Hema Ravishankar , Shradda Bodinge
IPC分类号： A61K9/48
CPC分类号： A61K9/5078 , A61K9/5026
摘要： A pharmaceutical preparation comprising: a) a core with an active ingredient and with an organic acid and/or the salt of an organic acid; and b) a coating which envelops the core and which comprises a polymer content of (meth)acrylate copolymers which have not more than 15% by weight of cationic or anionic groups, and which comprises at least 60% by weight of a (meth)acrylate copolymer which is composed of free-radically polymerized units of 93 to 98% by weight C1- to C4-alkyl esters of acrylic or of methacrylic acid and 7 to 2% by weight (meth)acrylate monomers having a quaternary ammonium group in the alkyl radical, wherein the active ingredient has a solubility in water of at least 10 g/l at 20° C. and the coating comprises silicon dioxide particles having an average particle size in the range from 1 to 50 μm.
摘要翻译：一种药物制剂，其包含：a）具有活性成分和有机酸和/或有机酸盐的核心; 和b）包封芯的涂层，其包含具有不超过15重量％的阳离子或阴离子基团的（甲基）丙烯酸酯共聚物的聚合物含量，并且其包含至少60重量％的（甲基）丙烯酸酯共聚物，丙烯酸酯共聚物，其由93至98重量％的丙烯酸或甲基丙烯酸的C 1〜C 4 - 烷基酯和7〜2重量％的具有季铵基的（甲基）丙烯酸酯单体的自由基聚合单元组成，烷基，其中所述活性成分在20℃下在水中的溶解度为至少10g / l，并且所述涂层包含平均粒度在1至50μm之间的二氧化硅颗粒。

20. 发明授权

US08343542B2 Method for producing an immediately decomposing oral form of administration which releases active ingredients 有权
公开(公告)号：US08343542B2
公开(公告)日：2013-01-01
申请号：US10542283
申请日：2003-11-21
申请人： Hans-Ulrich Petereit , Christian Meier , Andreas Gryczke
发明人： Hans-Ulrich Petereit , Christian Meier , Andreas Gryczke
IPC分类号： A61K9/20 , B27N3/00
CPC分类号： A61J3/10 , A61K9/0056 , A61K9/146 , A61K9/1647 , A61K9/2054 , A61K31/192
摘要： The invention relates to a method for producing an oral form of administration which decomposes immediately and releases active ingredients in the mouth. According to said method, (a) an anionic pharmaceutical active ingredient is intensively mixed with (b) a copolymer consisting of radically polymerized C1-C4 esters of the acrylic acid or methacrylic acid and other (meth)acrylate monomers containing functional tertiary amino groups, and (c) between 5 and 50 wt. %, in relation to (b), of a C12-C22 carboxylic acid in the melted mass; the mixture is solidified and ground to form a powder containing active ingredients having an average particle size of 200 μm or less; and the powder is encapsulated in a water-soluble matrix consisting of pharmaceutically standard adjuvants, on the condition that no more than 3 wt. %, in relation to the copolymer, of emulsifiers with an HLB value of at least 14 must be contained therein. The invention also relates to the powder containing active ingredients and the uses of the same.

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