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1. 发明申请

WO2014074795A1 HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE 审中-公开
标题翻译：用于脉冲使用的高剂量LEVODOPA胶囊
公开(公告)号：WO2014074795A1
公开(公告)日：2014-05-15
申请号：PCT/US2013/069102
申请日：2013-11-08
申请人： CIVITAS THERAPEUTICS, INC.
发明人： KEE, Kevin, D. , PENACHIO, Ernest, D. , KAMERKAR, Abhijit , LIPP, Michael, M. , BATYCKY, Richard, P.
IPC分类号： A61K9/12 , A61K31/137 , A61P25/16
CPC分类号： A61K9/4833 , A61J3/074 , A61K9/0073 , A61K9/0075 , A61K9/145 , A61K9/4816 , A61K9/4858 , A61K31/198 , B65B1/16 , B65B1/26 , B65B1/36 , B65B63/028
摘要： The present invention provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L. The invention further provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L wherein the capsule's shell comprises hydroxypropylmethylcellulose (HPMC) and titanium dioxide.
摘要翻译：本发明提供了含有可吸入粉末组合物的胶囊，其中所述组合物包含约75重量％或更多的左旋多巴，二棕榈酰磷脂酰胆碱（DPPC）和以小于约100g / L的工作密度为特征的盐。本发明还提供一种含有可吸入粉末组合物的胶囊，其中组合物包含约75重量％或更多的左旋多巴，二棕榈酰磷脂酰胆碱（DPPC）和特征为小于约100g / L的工作密度的盐，其中胶囊的壳包含羟丙基甲基纤维素（HPMC）和二氧化钛。

2. 发明申请

WO2015163840A1 RAPID RELIEF OF MOTOR FLUCTUATIONS IN PARKINSON'S DISEASE 审中-公开
标题翻译：帕金森病中电机波动的快速消除
公开(公告)号：WO2015163840A1
公开(公告)日：2015-10-29
申请号：PCT/US2014/034778
申请日：2014-04-21
申请人： CIVITAS THERAPEUTICS, INC.
发明人： BATYCKY, Richard, P. , FREED, Martin , LIPP, Michael, M.
IPC分类号： A61K9/14 , A61K9/48 , A61K31/198
CPC分类号： A61K31/198 , A61K9/0075
摘要： The present invention provides methods for treating OFF episodes in a Parkinson's Disease patient comprising administering levodopa to the pulmonary system of a patient wherein after administration, the patient's Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 score is improved by, for example, at least about 5 points as compared to placebo control and/or as compared to the patient's UDPRS Part 3 score prior to administration. The invention also provides methods of reducing mean daily OFF time in a Parkinson's patient.
摘要翻译：本发明提供了用于治疗帕金森氏病患者的关闭发作的方法，其包括向患者的肺系统施用左旋多巴，其中在给药后，通过例如至少提高患者的统一帕金森病评分量表（UPDRS）第3部分评分与安慰剂对照相比，和/或与给药前的患者的UDPRS第3部分评分相比，约为5分。本发明还提供了减少帕金森病患者平均每日休息时间的方法。

3. 发明申请

WO2014066206A1 REDUCING INTER-PATIENT VARIABILITY OF LEVODOPA PLASMA CONCENTRATIONS 审中-公开
标题翻译：降低LEVODOPA等离子体浓度的患者间变异性
公开(公告)号：WO2014066206A1
公开(公告)日：2014-05-01
申请号：PCT/US2013/065834
申请日：2013-10-21
申请人： CIVITAS THERAPEUTICS , INC.
发明人： BATYCKY, Richard, P. , FREED, Martin
IPC分类号： A61K9/00 , A61K9/12 , A61K9/14
CPC分类号： A61K31/198 , A61K9/0075 , A61K9/143 , A61K9/145 , A61K31/165 , A61K45/06 , A61K47/02 , A61K47/24 , A61K2300/00
摘要： The present invention provides methods of reducing the inter-patient variability of levodopa plasma concentrations in a population of Parkinson's disease patients. The methods of the invention comprise pulmonary administration of levodopa at therapeutically effective concentrations such that the inter-patient variability of levodopa plasma concentrations at time periods ranging from about 10 minutes post inhalation to about 60 minutes or more post inhalation have less than a 50% coefficient variation. The methods of the invention are particularly useful for treatment of motor fluctuations which arise as a side effect of L-Dopa therapy.
摘要翻译：本发明提供减少帕金森病患者中左旋多巴血浆浓度的患者间变异性的方法。本发明的方法包括以治疗有效浓度肺部施用左旋多巴，使得吸入后约10分钟至吸入后约60分钟或更长时间的左旋多巴血浆浓度的患者间变异性具有小于50％的系数变异。本发明的方法对于治疗作为L-多巴治疗的副作用而引起的运动波动特别有用。

4. 发明申请

WO2014074797A1 ULTRA LOW DENSITY PULMONARY POWDERS 审中-公开
标题翻译：超低密度脉冲粉
公开(公告)号：WO2014074797A1
公开(公告)日：2014-05-15
申请号：PCT/US2013/069107
申请日：2013-11-06
申请人： CIVITAS THERAPEUTICS, INC.
发明人： LIPP, Michael, M. , BATYCKY, Richard, P.
IPC分类号： A61K9/16 , A61K39/00 , A61P11/06
CPC分类号： A61K9/4833 , A61J3/074 , A61K9/0073 , A61K9/0075 , A61K9/145 , A61K9/4816 , A61K9/4858 , A61K31/198 , B65B1/16 , B65B1/26 , B65B1/36 , B65B63/028
摘要： The invention provides pharmaceutical compositions for pulmonary delivery comprising particles containing a pharmaceutical agent and having a geometric size of greater than about 5 μm and a tap density of less than about 0.075 g/cm 3 . The invention also provides methods for delivering the pharmaceutical compositions of the invention to the respiratory tract of a patient.
摘要翻译：本发明提供了用于肺部递送的药物组合物，其包含含有药剂并且具有大于约5μm的几何尺寸和小于约0.075g / cm 3的振实密度的颗粒。本发明还提供了将本发明的药物组合物递送到患者的呼吸道的方法。

5. 发明授权

EP1485069B1 METHOD FOR PRODUCING DRY PARTICLES 有权转让
标题翻译：用于生产干颗粒
公开(公告)号：EP1485069B1
公开(公告)日：2014-12-10
申请号：EP03714250.2
申请日：2003-03-19
申请人： Civitas Therapeutics, Inc.
发明人： BATYCKY, Richard, P. , JACKSON, Blair, C. , JOHNSTON, Lloyd, P. , MINTZES, Jeffrey, D. , PENACHIO, Ernest, E. , SUNG, Jean, C. , BLIZZARD, Charles, D. , CHUNG, Marie, Elizabeth
IPC分类号： A61K9/16
CPC分类号： A61K9/0075 , A61K9/1611 , A61K9/1617 , A61K9/1688 , A61K9/1694 , A61K31/137 , A61K38/27 , A61K38/28 , B01D1/18 , B01F3/0803 , B01F5/0619 , B01J2/04 , B01J2/10

6. 发明公开

EP2916826A1 ULTRA LOW DENSITY PULMONARY POWDERS 有权转让
标题翻译：与超低密度肺粉
公开(公告)号：EP2916826A1
公开(公告)日：2015-09-16
申请号：EP13852608.2
申请日：2013-11-08
申请人： Civitas Therapeutics, Inc.
发明人： LIPP, Michael, M. , BATYCKY, Richard, P.
IPC分类号： A61K9/16 , A61K39/00 , A61P11/06
CPC分类号： A61K9/4833 , A61J3/074 , A61K9/0073 , A61K9/0075 , A61K9/145 , A61K9/1611 , A61K9/1617 , A61K9/4808 , A61K9/4816 , A61K9/485 , A61K9/4858 , A61K31/198 , B65B1/16 , B65B1/26 , B65B1/36 , B65B63/028
摘要： The invention relates to a dosator which comprises a tapered elongate cavity; a stationary plunger disposed within the cavity; a removable mesh screen disposed between the stationary plunger and the bottom of the dosator; a dosator chamber defined between the mesh screen and the bottom of the dosator for receiving powder from a powder source and holding the powder until it is expelled into the capsule; at least one vacuum pump operably linked to the dosator and capable of drawing dry powder into the dosator chamber from a powder source, compacting the powder into a slug of powder having a predetermined bulk density; and at least one source of positive pressure operably linked to the dosator and capable of providing positive pressure to expel the powder slug from the dosator and methods of filling capsules.

7. 发明授权

EP1455755B1 IMPROVED PARTICULATE COMPOSITIONS FOR PULMONARY DELIVERY 有权转让
标题翻译：用于肺部递送的改进的颗粒组合物
公开(公告)号：EP1455755B1
公开(公告)日：2013-04-17
申请号：EP02789792.5
申请日：2002-11-20
申请人： Civitas Therapeutics, Inc.
发明人： BATYCKY, Richard, P. , EDWARDS, David, A. , LIPP, Michael M.
IPC分类号： A61K9/50 , A61K9/00
CPC分类号： A61K9/0075 , A61K9/1694

8. 发明授权

EP1531794B1 INHALABLE EPINEPHRINE 有权转让
标题翻译： EPINEPHRIN ZUR吸入
公开(公告)号：EP1531794B1
公开(公告)日：2017-05-10
申请号：EP03742233.4
申请日：2003-06-26
申请人： Civitas Therapeutics, Inc.
发明人： BATYCKY, Richard, P. , CAPONETTI, Giovanni , CHILDS, Mariko , EHRICH, Elliot , FU, Karen , HRKACH, Jeffrey, S. , LI, Wen-I , LIPP, Michael, M. , PAN, Mei-Ling , SUMMA, Jason
IPC分类号： A61K9/12
CPC分类号： A61K31/137 , A61K9/0073 , A61K9/0075 , A61K9/1617 , A61K31/135 , A61M15/0091 , A61M2202/06

9. 发明公开

EP2916821A1 HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE 有权
标题翻译： HOCHDOSIERTE LEVODOPAKAPSELN ZUR PULMONALEN VERWENDUNG
公开(公告)号：EP2916821A1
公开(公告)日：2015-09-16
申请号：EP13852876.5
申请日：2013-11-08
申请人： Civitas Therapeutics, Inc.
发明人： KEE, Kevin, D. , PENACHIO, Ernest, D. , KAMERKAR, Abhijit , LIPP, Michael, M. , BATYCKY, Richard, P.
IPC分类号： A61K9/12 , A61K31/137 , A61P25/16
摘要： The invention relates to a dosator which comprises a tapered elongate cavity; a stationary plunger disposed within the cavity; a removable mesh screen disposed between the stationary plunger and the bottom of the dosator; a dosator chamber defined between the mesh screen and the bottom of the dosator for receiving powder from a powder source and holding the powder until it is expelled into the capsule; at least one vacuum pump operably linked to the dosator and capable of drawing dry powder into the dosator chamber from a powder source, compacting the powder into a slug of powder having a predetermined bulk density; and at least one source of positive pressure operably linked to the dosator and capable of providing positive pressure to expel the powder slug from the dosator and methods of filling capsules.
摘要翻译：本发明涉及一种定量器，其包括锥形细长腔; 设置在所述空腔内的固定柱塞; 设置在固定柱塞和定量器的底部之间的可移除的网状筛; 限定在筛网和定剂器底部之间的剂量器室，用于从粉末源接收粉末并保持粉末直到其被排出到胶囊中; 至少一个真空泵，其可操作地连接到所述定量器并且能够将粉末从粉末源吸入所述定量器室中，将所述粉末压实成具有预定堆积密度的粉末块; 以及至少一个正压源，可操作地连接到定量给药器并且能够提供正压力以从剂量器排出粉末塞子和填充胶囊的方法。

10. 发明公开

EP2908804A1 REDUCING INTER-PATIENT VARIABILITY OF LEVODOPA PLASMA CONCENTRATIONS 审中-实审转让
标题翻译：还原变异左旋多巴血浆浓度患者之间
公开(公告)号：EP2908804A1
公开(公告)日：2015-08-26
申请号：EP13849720.1
申请日：2013-10-21
申请人： Civitas Therapeutics, Inc.
发明人： BATYCKY, Richard, P. , FREED, Martin
IPC分类号： A61K9/00 , A61K9/12 , A61K9/14
CPC分类号： A61K31/198 , A61K9/0075 , A61K9/143 , A61K9/145 , A61K31/165 , A61K45/06 , A61K47/02 , A61K47/24 , A61K2300/00
摘要： The present invention provides methods of reducing the inter-patient variability of levodopa plasma concentrations in a population of Parkinson's disease patients. The methods of the invention comprise pulmonary administration of levodopa at therapeutically effective concentrations such that the inter-patient variability of levodopa plasma concentrations at time periods ranging from about 10 minutes post inhalation to about 60 minutes or more post inhalation have less than a 50% coefficient variation. The methods of the invention are particularly useful for treatment of motor fluctuations which arise as a side effect of L-Dopa therapy.

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