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1. 发明申请

US20060204576A1 Multilayer dosage forms, which contain active substances and which comprise a neutral core, and an inner and outer coating consisting of methacrylate copolymers and methacrylate monomers 审中-公开
标题翻译：包含活性物质并且包含中性核心的多层剂型，以及由甲基丙烯酸酯共聚物和甲基丙烯酸酯单体组成的内外涂层
公开(公告)号：US20060204576A1
公开(公告)日：2006-09-14
申请号：US10532831
申请日：2003-09-04
申请人： Hans-Ulrich Petereit , Markus Rudolph , Jennifer Dressman , Thomas Beckert
发明人： Hans-Ulrich Petereit , Markus Rudolph , Jennifer Dressman , Thomas Beckert
IPC分类号： A61K9/24
CPC分类号： A61K31/58 , A61K9/1635 , A61K9/209 , A61K9/2846 , A61K9/5026 , A61K9/5078
摘要： The invention relates to a multilayer dosage form comprised of: a) a neutral core; b) an inner coating consisting of a methacrylate copolymer; c) an outer coating consisting of a copolymer of which 40 to 95% by weight is composed of radically polymerized C1 to C4 alkyl esters of acrylic acid or of methacrylic acid and of which 5 to 60% by weight is composed of (meth)acrylate monomers having an anionic group in the alkyl radical. The invention is characterized in that the inner coating is essentially comprised of a methacrylate copolymer, of which at least up to 90% by weight consists of (meth)acrylate monomers with neutral radicals, which, in accordance with DIN 53 787, has a minimum film formation temperature of no higher than 30° C., and which contains the pharmaceutical active substance in bound form.
摘要翻译：本发明涉及一种多层剂型，其包括：a）中性核; b）由甲基丙烯酸酯共聚物组成的内涂层; c）由共聚物组成的外涂层，其中40至95重量％由丙烯酸或甲基丙烯酸的C 4-14烷基酯的自由基聚合的C 1〜并且其中5至60重量％由在烷基中具有阴离子基团的（甲基）丙烯酸酯单体组成。本发明的特征在于，内涂层基本上由甲基丙烯酸酯共聚物组成，其中至少高达90重量％由具有中性自由基的（甲基）丙烯酸酯单体组成，其根据DIN 53787具有最小值成膜温度不高于30℃，含有结合形式的药物活性物质。

2. 发明申请

US20050053660A1 Multi-particulate form of medicament, comprising at least two differently coated forms of pellet 有权
标题翻译：多颗粒形式的药物，包含至少两种不同的包衣形式的丸剂
公开(公告)号：US20050053660A1
公开(公告)日：2005-03-10
申请号：US10949323
申请日：2004-09-27
申请人： Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
发明人： Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
IPC分类号： A61K9/16 , A61K9/20 , A61K9/26 , A61K9/50 , A61K9/54 , A61K9/58 , A61K9/62 , A61K31/573 , A61K31/58 , A61K31/606 , A61K31/635 , A61K47/32 , A61K47/36 , A61K47/38 , A61P1/00
CPC分类号： A61K31/58 , A61K9/2081 , A61K9/5026 , A61K9/5073 , A61K9/5084 , A61K31/573 , A61K31/606 , A61K31/635
摘要： The invention relates to a multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine, comprising at least two forms of pellets A and B which comprise an active pharmaceutical ingredient in the core and have different polymer coatings which determine the release of the active ingredient at different pH values, characterized in that pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and pellet form B is provided with a polymer coating which, in the USP release test, releases less than 20% of the active ingredient at pH 6.8 in 6 hours and releases more than 50% of the active ingredient at pH 7.2 in 6 hours. The invention additionally relates to a process for producing the multiparticulate drug form and to the use of pellet forms A and B for producing the drug form.
摘要翻译：本发明涉及适于在小肠和大肠中均匀释放活性药物成分的多颗粒药物形式，其包含至少两种形式的颗粒A和B，其包含芯中的活性药物成分并具有不同的聚合物确定在不同pH值下释放活性成分的涂层，其特征在于，颗粒形式A具有能够连续释放活性成分的内部聚合物涂层，并且具有快速溶解在约pH 5.5以上的外部肠溶衣，以及颗粒形式B具有聚合物涂层，其在USP释放试验中在6小时内在pH 6.8下释放少于20％的活性成分，并在6小时内在pH 7.2下释放超过50％的活性成分。本发明还涉及生产多颗粒药物形式的方法以及用于制备药物形式的颗粒形式A和B的用途。

3. 发明授权

US07438929B2 Multi-particulate form of medicament, comprising at least two differently coated forms of pellet 有权
标题翻译：多颗粒形式的药物，包含至少两种不同的包衣形式的丸剂
公开(公告)号：US07438929B2
公开(公告)日：2008-10-21
申请号：US10949323
申请日：2004-09-27
申请人： Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
发明人： Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
IPC分类号： A61K9/52 , A61K9/14
CPC分类号： A61K31/58 , A61K9/2081 , A61K9/5026 , A61K9/5073 , A61K9/5084 , A61K31/573 , A61K31/606 , A61K31/635
摘要： The invention relates to a multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine, comprising at least two forms of pellets A and B which comprise an active pharmaceutical ingredient in the core and have different polymer coatings which determine the release of the active ingredient at different pH values, characterized in that pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and pellet form B is provided with a polymer coating which, in the USP release test, releases less than 20% of the active ingredient at pH 6.8 in 6 hours and releases more than 50% of the active ingredient at pH 7.2 in 6 hours. The invention additionally relates to a process for producing the multiparticulate drug form and to the use of pellet forms A and B for producing the drug form.
摘要翻译：本发明涉及适于在小肠和大肠中均匀释放活性药物成分的多颗粒药物形式，其包含至少两种形式的颗粒A和B，其包含芯中的活性药物成分并具有不同的聚合物确定在不同pH值下释放活性成分的涂层，其特征在于，颗粒形式A具有能够连续释放活性成分的内部聚合物涂层，并且具有快速溶解在约pH 5.5以上的外部肠溶衣，以及颗粒形式B具有聚合物涂层，其在USP释放试验中在6小时内在pH 6.8下释放少于20％的活性成分，并在6小时内在pH 7.2下释放超过50％的活性成分。本发明还涉及生产多颗粒药物形式的方法以及用于制备药物形式的颗粒形式A和B的用途。

4. 发明授权

US06897205B2 Multi-particulate form of medicament, comprising at least two differently coated forms of pellet 有权
公开(公告)号：US06897205B2
公开(公告)日：2005-05-24
申请号：US10239209
申请日：2001-03-09
申请人： Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
发明人： Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
IPC分类号： A61K9/16 , A61K9/20 , A61K9/26 , A61K9/50 , A61K9/54 , A61K9/58 , A61K9/62 , A61K31/573 , A61K31/58 , A61K31/606 , A61K31/635 , A61K47/32 , A61K47/36 , A61K47/38 , A61P1/00 , A61K31/60 , A61K31/54 , A61K31/56 , A61K38/00
CPC分类号： A61K31/58 , A61K9/2081 , A61K9/5026 , A61K9/5073 , A61K9/5084 , A61K31/573 , A61K31/606 , A61K31/635
摘要： The invention relates to a multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine, comprising at least two forms of pellets A and B which comprise an active pharmaceutical ingredient in the core and have different polymer coatings which determine the release of the active ingredient at different pH values, characterized in that pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and pellet form B is provided with a polymer coating which, in the USP release test, releases less than 20% of the active ingredient at pH 6.8 in 6 hours and releases more than 50% of the active ingredient at pH 7.2 in 6 hours. The invention additionally relates to a process for producing the multiparticulate drug form and to the use of pellet forms A and B for producing the drug form.

5. 发明申请

US20050089571A1 Pharmaceutical formulation for the active ingredient budesonide 审中-公开
标题翻译：活性成分布地奈德的药物制剂
公开(公告)号：US20050089571A1
公开(公告)日：2005-04-28
申请号：US10501236
申请日：2003-03-06
申请人： Thomas Beckert , Jennifer Dressman , Markus Rudolph
发明人： Thomas Beckert , Jennifer Dressman , Markus Rudolph
IPC分类号： A61K9/16 , A61K9/20 , A61K9/50 , A61K31/58 , A61K31/635 , A61K47/32 , A61K47/38 , A61K47/42 , A61P1/00 , A61P1/04 , A61K9/24
CPC分类号： A61K9/5078 , A61K9/5026 , A61K9/5084 , A61K31/58
摘要： The invention relates to a pharmaceutical formulation containing essentially a) an inner layer which can optionally be applied to a core, with the active substance budesonide, bound with a binding agent; b) a middle layer with a polymer covering agent which is soluble in intestinal juice or retardant; and c) an outer envelope or outer layer which is resistant to stomach juice, said layers being able to contain in a manner known per se other pharmaceutically usual adjutants. The inventive formulation is characterised in that the binding agent is a polymer or a copolymer with acid groups and the formulation of the inner layer without the middle and outer layer releases the bound active ingredient in a release test according to USP XXIII monography dissolution with apparatus 2 (addle) at a rotational speed of 100/min in a phosphate buffer pH 7.5 after 30 min to a value of more than 80%.
摘要翻译：本发明涉及一种药物制剂，其基本上包含：a）内层，其可以任选地施加到核心与活性物质布地奈德，与结合剂结合; b）具有可溶于肠液或阻燃剂的聚合物覆盖剂的中间层; 和c）耐胃液的外包层或外层，所述层能够以本身已知的其它药学上可接受的辅助剂的方式包含。本发明的制剂的特征在于粘合剂是具有酸基团的聚合物或共聚物，并且根据USP XXIII monography <711>溶解的释放试验中，没有中间层和外层的内层制剂释放结合的活性成分在30分钟后的pH7.5的磷酸盐缓冲液中以100 /分钟的转速装入装置2（addle）至大于80％的值。

6. 发明申请

US20060159757A1 Pharmaceutical composition for controlled release of beta-lactam antibiotics in combination with beta-lactamase inhibitors 审中-公开
标题翻译： β-内酰胺抗生素与β-内酰胺酶抑制剂联合控制释放的药物组合物
公开(公告)号：US20060159757A1
公开(公告)日：2006-07-20
申请号：US11303516
申请日：2005-12-16
申请人： Keith Payne , Christian Kiera , Jennifer Dressman
发明人： Keith Payne , Christian Kiera , Jennifer Dressman
IPC分类号： A61K31/43 , A61K31/545 , A61K9/26 , A61K31/407
CPC分类号： A61K31/424 , A61K9/5026 , A61K9/5084 , A61K31/43
摘要： The invention relates to a pharmaceutical composition containing a β-lactam antibiotic and/or a pharmaceutically tolerable salt thereof in the form of coated pellets that may optionally contain a β-lactamase inhibitor and/or a pharmaceutically tolerable salt thereof, some or all pellets comprising coatings that dissolve at different pH values depending on the composition of said coatings. This pharmaceutical composition allows the blood plasma level of the β-lactam antibiotic and/or a pharmaceutically tolerable salt thereof to remain above 2 μg/ml for at least 12 hours within a period of 24 hours if administered twice a day.
摘要翻译：本发明涉及含有β-内酰胺抗生素和/或其药学上可耐受的盐的药物组合物，其为包衣颗粒的形式，其可以任选地含有β-内酰胺酶抑制剂和/或其药学上可耐受的盐，一些或全部颗粒包含根据所述涂层的组成，溶解在不同pH值下的涂层。该药物组合物允许β-内酰胺抗生素和/或其药学上可耐受的盐的血浆水平在24小时内保持在2ug / ml以上至少12小时，如果每天施用两次。

7. 发明申请

US20090011007A1 Pharmaceutical Compositions Containing Mixtures of Polymers and Active Agents Poorly Soluble in Water 审中-公开
标题翻译：含有聚合物和活性剂混合物的药物组合物难溶于水
公开(公告)号：US20090011007A1
公开(公告)日：2009-01-08
申请号：US12159538
申请日：2007-01-17
申请人： Christian Meier , Kathrin Nollenberger , Andreas Gryczke , Hans-Ulrich Petereit , Jennifer Dressman
发明人： Christian Meier , Kathrin Nollenberger , Andreas Gryczke , Hans-Ulrich Petereit , Jennifer Dressman
IPC分类号： A61K9/48 , A61K47/00 , A61K47/38 , A61K31/4418 , A61K9/14 , A61K9/20
CPC分类号： A61K9/2027 , A61K9/1635 , A61K9/1652 , A61K9/2054 , A61K9/2077 , A61K9/5084
摘要： The invention relates to a pharmaceutical composition comprising a mixture of at least one cationic, water-soluble (meth)acrylate copolymer, at least one water-insoluble polymer and at least one active ingredient having a solubility in demineralized water of 3.3 g/l or less, characterized in that the water-insoluble polymer and the active ingredient are present in a ratio of at most 3.5 to 1 parts by weight, and the pharmaceutical composition has the property of releasing the active ingredient present in a medium buffered to pH 1.2 in dissolved form in a concentration which, after 2 hours at pH 1.2, corresponds to at least sixteen times the solubility value of the active ingredient alone at pH 1.2.
摘要翻译：本发明涉及药物组合物，其包含至少一种阳离子，水溶性（甲基）丙烯酸酯共聚物，至少一种水不溶性聚合物和在软化水中溶解度为3.3g / l的至少一种活性成分的混合物或其特征在于，水不溶性聚合物和活性成分以至多3.5至1重量份的比例存在，并且药物组合物具有释放缓冲至pH 1.2的培养基中存在的活性成分的性质溶解形式的浓度，其在pH2.2下2小时后对应于在pH1.2下单独的活性成分的溶解度值的至少十六倍。

8. 发明申请

US20070243247A1 Dosage Form Containing The Active Ingredient Cholylsarcosine 审中-公开
标题翻译：含有活性成分Cholyls肌氨酸的剂型
公开(公告)号：US20070243247A1
公开(公告)日：2007-10-18
申请号：US11569581
申请日：2005-05-12
申请人： Jennifer Dressman , Hans-Jürgen Stein , Thomas Furst , Christiane Bott
发明人： Jennifer Dressman , Hans-Jürgen Stein , Thomas Furst , Christiane Bott
IPC分类号： A61K9/16 , A61K9/20
CPC分类号： A61K9/5026 , A61K31/575
摘要： The invention relates to a dosage form, containing the active ingredient cholylsarcosine, in the form of pellets, which are provided with a polymer coating that is resistant to gastric juices. The invention is characterised in that it discloses pellets comprising an active ingredient, which contain between 50 and 80 wt. % of the active ingredient cholylsarcosine and between 50 and 20 wt. % of one or more conventional pharmaceutical adjuvants as binding agents, whereby at least 90 wt. % of said adjuvants are water-soluble and the size of at least 80 % of the pellets comprising an active ingredient is between 800 and 2,500 $g(m)m. The granulates containing an active ingredient are coated with an anonic, film-forming polymer coating agent, which dissolves in a 0.07M sodium phosphate buffer with a pH value of 5.5 at a dissolution rate of at least 10 mg/min*g and whose dissolution rate in a 0.07M sodium phosphate buffer with a pH value of 6.0 is at least 200 mg/min*g. The polymer coating amounts to between 5 and 15 wt. % of the pellet weight. The invention also relates to a method for producing said dosage form.
摘要翻译：本发明涉及一种剂型，其含有丸粒形式的活性成分胆甾肌苷，其具有耐胃液的聚合物涂层。本发明的特征在于它公开了包含活性成分的丸剂，其含有50至80wt。％的活性成分胆固醇和50至20wt。％的一种或多种常规药物佐剂作为粘合剂，其中至少90wt。所述佐剂的百分比是水溶性的，并且至少80％的包含活性成分的丸粒的尺寸为800-2,500元（m）m。含有活性成分的颗粒用无声成膜聚合物涂层剂涂覆，其溶解速率至少为10mg / min * g，溶解于pH值为5.5的0.07M磷酸钠缓冲液中，其溶解度 pH值为6.0的0.07M磷酸钠缓冲液中的速率为至少200mg / min * g。聚合物涂层为5至15wt。颗粒重量的百分比。本发明还涉及生产所述剂型的方法。

9. 发明申请

US20070178152A1 Carboxyalkylcellulose esters for administration of poorly soluble pharmaceutically active agents 审中-公开
标题翻译：用于给予不良溶性药物活性剂的羧甲基纤维素酯
公开(公告)号：US20070178152A1
公开(公告)日：2007-08-02
申请号：US11592130
申请日：2006-11-03
申请人： Michael Shelton , Jessica Posey-Dowty , Kevin Edgar , Larry Lingerfelt , Sandra Klein , Shane Kirk , Jennifer Dressman
发明人： Michael Shelton , Jessica Posey-Dowty , Kevin Edgar , Larry Lingerfelt , Sandra Klein , Shane Kirk , Jennifer Dressman
IPC分类号： A61K31/717 , A61K9/20
CPC分类号： A61K9/141 , A61K9/10 , A61K31/717 , A61K47/38
摘要： Disclosed herein are pharmaceutical compositions comprising carboxyalkylcellulose esters for delivery of pharmaceutically active substances having low solubility in a medium such as water, an acidic aqueous buffer, a neutral aqueous buffer, or a basic aqueous buffer. Also disclosed are methods for making pharmaceutical compositions and methods of administering the compositions.
摘要翻译：本文公开了包含羧基烷基纤维素酯的药物组合物，用于递送在诸如水，酸性水性缓冲液，中性水性缓冲液或碱性水性缓冲液的介质中具有低溶解度的药学活性物质。还公开了制备药物组合物的方法和施用组合物的方法。

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