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1. 发明申请

US20090117180A1 STABLE DIGESTIVE ENZYME COMPOSITIONS 审中-公开
标题翻译：稳定的食品组合物
公开(公告)号：US20090117180A1
公开(公告)日：2009-05-07
申请号：US12163530
申请日：2008-06-27
申请人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
发明人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
IPC分类号： A61K9/50 , A61K38/46 , A61K38/48 , A61K9/48 , A61K9/14 , A61K9/28
CPC分类号： A61K9/4808 , A61K9/2813 , A61K9/2866 , A61K9/501 , A61K9/5047 , A61K38/465 , C12Y301/01003
摘要： Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 9% or less or 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 25%, about 20%, about 15% or about 10% after six months of accelerated stability testing and the titer level of a viral contaminant present in the pancreatin is at least about 1000 times less than the titer level of the viral contaminant present in a preparation from which the pancreatin is obtained.
摘要翻译：包含至少一种消化酶（例如，胰脂肪酶）的本发明组合物可用于治疗或预防与消化酶缺陷相关的病症。本发明的组合物可以包含多个包被的颗粒，每个涂覆的颗粒由涂覆有包含至少一种肠溶聚合物和4-10％的至少一种碱化剂的肠溶衣的核心组成，或者含有约9％或更少或3％或更少的水活度为约0.6或更小，或在加速稳定六个月后表现出不超过约25％，约20％，约15％或约10％的活性损失存在于胰酶中的病毒污染物的测试和滴度水平比存在于获得胰酶的制剂中的病毒污染物的滴度水平低至少约1000倍。

2. 发明申请

US20110123633A1 STABLE DIGESTIVE ENZYME COMPOSITIONS 有权
公开(公告)号：US20110123633A1
公开(公告)日：2011-05-26
申请号：US13019844
申请日：2011-02-02
申请人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
发明人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
IPC分类号： A61K9/14 , A61K38/43 , A61K38/54 , A61P1/04 , A61P1/14
CPC分类号： A61K9/4808 , A61K9/1617 , A61K9/1652 , A61K9/2813 , A61K9/2866 , A61K9/4866 , A61K9/501 , A61K9/5015 , A61K9/5047 , A61K9/5073 , A61K38/465 , A61K38/47 , A61K38/4826 , C12Y301/01003
摘要： Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.

3. 发明申请

US20110123605A1 STABLE DIGESTIVE ENZYME COMPOSITIONS 有权
标题翻译：稳定的食品组合物
公开(公告)号：US20110123605A1
公开(公告)日：2011-05-26
申请号：US13019860
申请日：2011-02-02
申请人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
发明人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
IPC分类号： A61K38/54 , A61K9/50 , A61K9/48 , A61P1/00 , A61P1/14
CPC分类号： A61K9/4808 , A61K9/1617 , A61K9/1652 , A61K9/2813 , A61K9/2866 , A61K9/4866 , A61K9/501 , A61K9/5015 , A61K9/5047 , A61K9/5073 , A61K38/465 , A61K38/47 , A61K38/4826 , C12Y301/01003
摘要： Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.
摘要翻译：包含至少一种消化酶（例如，胰脂肪酶）的本发明组合物可用于治疗或预防与消化酶缺陷相关的病症。本发明的组合物可以包含多个包被的颗粒，每个涂覆的颗粒由涂覆有包含至少一种肠溶聚合物和4-10％的至少一种碱化剂的肠溶衣的核心组成，或者含有约3％或更少的水分活度为约0.6或更小，或在加速稳定性测试6个月后表现出不超过约15％的活性损失。

4. 发明申请

US20110123634A1 STABLE DIGESTIVE ENZYME COMPOSITIONS 有权
公开(公告)号：US20110123634A1
公开(公告)日：2011-05-26
申请号：US13019856
申请日：2011-02-02
申请人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
发明人： Giovanni ORTENZI , Marco Marconi , Luigi Mapelli
IPC分类号： A61K38/54 , A61K9/14 , A61K38/43 , A61P1/14
CPC分类号： A61K9/4808 , A61K9/1617 , A61K9/1652 , A61K9/2813 , A61K9/2866 , A61K9/4866 , A61K9/501 , A61K9/5015 , A61K9/5047 , A61K9/5073 , A61K38/465 , A61K38/47 , A61K38/4826 , C12Y301/01003
摘要： Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.

5. 发明申请

US20120201875A1 STABLE LOW DIGESTIVE ENZYME CONTENT FORMULATION 审中-公开
标题翻译：稳定的低消毒酶含量配方
公开(公告)号：US20120201875A1
公开(公告)日：2012-08-09
申请号：US13251926
申请日：2011-10-03
申请人： Giovanni ORTENZI , Giuseppe De Franza , Danilo Clementi , Christian Stollberg , Luigi Boltri
发明人： Giovanni ORTENZI , Giuseppe De Franza , Danilo Clementi , Christian Stollberg , Luigi Boltri
IPC分类号： A61K9/48 , A61K38/43 , B65D81/26 , A61K38/46 , A61P3/00 , A61K9/16 , A61K38/54
CPC分类号： A61K9/2054 , A61K9/2072 , A61K9/2866 , A61K9/4808 , A61K38/465
摘要： The present invention is directed to a pharmaceutical composition or dosage form having a stable, low (diluted) digestive enzyme content comprising at least one digestive enzyme and at least one carrier, or a dosage form thereof. The invention is also directed to a process of preparation of the composition or the dosage form. In addition the invention is directed to the treatment and prevention of disorders or conditions associated with a digestive enzyme deficiency in a patient in need thereof, comprising administering to said patient a pharmaceutically acceptable amount of the composition having a stable low digestive enzyme content or dosage form thereof.
摘要翻译：本发明涉及具有包含至少一种消化酶和至少一种载体或其剂型的稳定，低（稀释）的消化酶含量的药物组合物或剂型。本发明还涉及组合物或剂型的制备方法。此外，本发明涉及治疗和预防与有需要的患者的消化酶缺乏有关的病症或病症，包括向所述患者施用药学上可接受量的具有稳定的低消化酶含量或剂型的组合物其中。

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