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11. 发明授权

US06942868B2 Aerodynamically light particles for pulmonary drug delivery 失效
标题翻译：用于肺部药物递送的空气动力学轻微颗粒
公开(公告)号：US06942868B2
公开(公告)日：2005-09-13
申请号：US10441948
申请日：2003-05-20
申请人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Abdellaziz Ben-Jebria , Robert S. Langer
发明人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Abdellaziz Ben-Jebria , Robert S. Langer
IPC分类号： A61K9/12 , A61K9/00 , A61K9/14 , A61K9/16 , A61K9/72 , A61K31/137 , A61K47/32 , A61K49/00 , A61L15/00
CPC分类号： A61K9/0075 , A61K9/1647 , A61K31/137
摘要： Improved aerodynamically light particles for drug delivery to the pulmonary system, and methods for their synthesis and administration are provided. In a preferred embodiment, the aerodynamically light particles are made of biodegradable material and have a tap density of less than 0.4 g/cm3 and a mass mean diameter between 5 μm and 30 μm. The particles may be formed of biodegradable materials such as biodegradable polymers. For example, the particles may be formed of a functionalized polyester graft copolymer consisting of a linear α-hydroxy-acid polyester backbone having at least one amino acid group incorporated therein and at least one poly(amino acid) side chain extending from an amino acid group in the polyester backbone. In one embodiment, aerodynamically light particles having a large mean diameter, for example greater than 5 μm, can be used for enhanced delivery of a therapeutic agent to the alveolar region of the lung. The aerodynamically light particles incorporating a therapeutic agent may be effectively aerosolized for administration to the respiratory tract to permit systemic or local delivery of wide variety of therapeutic agents.
摘要翻译：提供用于向肺系统输送药物的空气动力学轻微颗粒，以及用于其合成和给药的方法。在优选的实施方案中，空气动力学轻微颗粒由可生物降解的材料制成，并且具有小于0.4g / cm 3的振实密度和5μm和30μm之间的质量平均直径。颗粒可以由可生物降解的材料如可生物降解的聚合物形成。例如，颗粒可以由官能化的聚酯接枝共聚物形成，所述聚酯接枝共聚物由具有至少一个氨基酸基团的直链α-羟基酸聚酯主链和至少一个从氨基酸延伸的聚（氨基酸）侧链组成集团在聚酯骨干。在一个实施方案中，具有大平均直径（例如大于5μm）的空气动力学轻微颗粒可用于增强治疗剂递送至肺的肺泡区域。掺入治疗剂的空气动力学轻微颗粒可以被有效地雾化，用于给予呼吸道以允许全身或局部递送多种治疗剂。

12. 发明授权

US06740310B2 Porous particles comprising excipients for deep lung delivery 有权
公开(公告)号：US06740310B2
公开(公告)日：2004-05-25
申请号：US10209654
申请日：2002-07-30
申请人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Robert S. Langer , Abdellaziz Ben-Jebria
发明人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Robert S. Langer , Abdellaziz Ben-Jebria
IPC分类号： A61K912
CPC分类号： A61K9/0075 , A61K9/1647 , A61K31/137 , Y10S514/826 , Y10S514/851
摘要： Improved porous particles for drug delivery to the pulmonary system, and methods for their synthesis and administration are provided. In a preferred embodiment, the porous particles are made of a biodegradable material and have a mass density less than 0.4 g/cm3/. The particles may be formed of biodegradable materials such as biodegradable polymers. For example, the particles may be formed of a functionalized polyester graft copolymer consisting of a linear a-hydroxy-acid polyester backbone having at least one amino acid group incorporated therein and at least one poly(amino acid) side chain extending from an amino acid group in the polyester backbone. In one embodiment, porous particles having a relatively large mean diameter, for example greater than 5 &mgr;m, can be used for enhanced delivery of a therapeutic agent to the alveolar region of the lung. The porous particles incorporating a therapeutic agent may be effectively aerosolized for administration to the respiratory tract to permit systemic or local delivery of wide variety of therapeutic agents.

13. 发明授权

US06503480B1 Aerodynamically light particles for pulmonary drug delivery 有权
标题翻译：用于肺部药物递送的空气动力学轻微颗粒
公开(公告)号：US06503480B1
公开(公告)日：2003-01-07
申请号：US09194068
申请日：1999-04-08
申请人： David A. Edwards , Giovannia Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Abdell Aziz Ben-Jebria , Robert S. Langer
发明人： David A. Edwards , Giovannia Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Abdell Aziz Ben-Jebria , Robert S. Langer
IPC分类号： A61K912
CPC分类号： A61K9/0075 , A61K9/1647 , A61K31/56 , A61K31/568 , A61K38/28
摘要： Improved aerodynamically light particles for delivery to the pulmonary system, and methods for their preparation and administration are provided. In a preferred embodiment, the aerodynamically light particles are made of a biodegradable material and have a tap density less than 0.4 g/cm3 and a mass mean diameter between 5 &mgr;m and 30 &mgr;m. The particles may be formed of biodegradable mat as biodegradable polymers. For example, the particles may be formed of a functionalized polyester graft copolymer consisting of a linear &agr;-hydroxy-acid polyester backbone having at least one amino acid group incorporated therein and at least one poly(amino acid) side chain extending from an amino acid group in the polyester backbone. In one embodiment, aerodynamically light particles having a large mean diameter, for example greater than 5 &mgr;m, can be used for enhanced delivery of a therapeutic or diagnostic agent to the alveolar region of the lung. The aerodynamically light particles optionally can incorporate a therapeutic or diagnostic agent, and may be effectively aerosolized for administration to the respiratory tract to permit systemic or local delivery of wide variety of incrorporated agents.
摘要翻译：提供用于递送至肺系统的改善的空气动力学轻微颗粒，以及其制备和给药方法。在优选的实施方案中，空气动力学轻微颗粒由可生物降解的材料制成，并且振实密度小于0.4g / cm 3，质量平均直径在5μm和30μm之间。颗粒可以由可生物降解的垫形成为可生物降解的聚合物。例如，颗粒可以由官能化聚酯接枝共聚物形成，该聚酯接枝共聚物由具有至少一个氨基酸基团的直链α-羟基酸聚酯主链和至少一个从氨基酸延伸的聚（氨基酸）侧链组成集团在聚酯骨干。在一个实施方案中，具有大平均直径（例如大于5μm）的空气动力学轻的颗粒可用于增强治疗或诊断剂递送至肺的肺泡区域。空气动力学轻微颗粒任选地可以掺入治疗剂或诊断剂，并且可以有效地雾化以用于向呼吸道施用以允许全身或局部递送各种各样的掺入剂。

14. 发明授权

US06254854B1 Porous particles for deep lung delivery 有权
公开(公告)号：US06254854B1
公开(公告)日：2001-07-03
申请号：US09569153
申请日：2000-05-11
申请人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Robert S. Langer , Abdellaziz Ben-Jebria
发明人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Robert S. Langer , Abdellaziz Ben-Jebria
IPC分类号： A61K912
CPC分类号： A61K9/0075 , A61K9/1647 , A61K31/137 , Y10S514/826 , Y10S514/851
摘要： Improved porous particles for drug delivery to the pulmonary system, and methods for their synthesis and administration are provided. In a preferred embodiment, the porous particles are made of a biodegradable material and have a mass density less than 0.4 g/cm3/. The particles may be formed of biodegradable materials such as biodegradable polymers. For example, the particles may be formed of a functionalized polyester graft copolymer consisting of a linear &agr;-hydroxy-acid polyester backbone having at least one amino acid group incorporated therein and at least one poly(amino acid) side chain extending from an amino acid group in the polyester backbone. In one embodiment, porous particles having a relatively large mean diameter, for example greater than 5 &mgr;m, can be used for enhanced delivery of a therapeutic agent to the alveolar region of the lung. The porous particles incorporating a therapeutic agent may be effectively aerosolized for administration to the respiratory tract to permit systemic or local delivery of wide variety of therapeutic agents.

15. 发明授权

US07556798B2 Highly efficient delivery of a large therapeutic mass aerosol 有权
公开(公告)号：US07556798B2
公开(公告)日：2009-07-07
申请号：US09878146
申请日：2001-06-08
申请人： David A. Edwards , Richard P. Batycky , Lloyd Johnston
发明人： David A. Edwards , Richard P. Batycky , Lloyd Johnston
IPC分类号： A61K9/12 , A61K9/14
CPC分类号： A61K9/14 , A61K9/0075 , A61K9/1617 , A61K31/198
摘要： A method for delivering an agent to the pulmonary system, in a single, breath-activated step or a single breath, comprises administering from a receptacle enclosing a mass of particles, to a subject's respiratory tract, particles which have a tap density of less than 0.4 g/cm3 and deliver at least about 50% of the mass of particles. The particles are capable of carrying agents. The agent is (1) part of the spray-drying pre-mixture and thereby incorporated into the particles, (2) added to separately-prepared particles so that the agent is in chemical association with the particles or (3) blended so that the agent is mixed with, and co-delivered with the particles.Respirable compositions comprising carrier particles having a tap density of less than 0.4 g/cm3 and a composition comprising an agent are also disclosed. Methods of delivering these respirable compositions are also included.

16. 发明授权

US07384649B2 Particulate compositions for pulmonary delivery 有权
标题翻译：用于肺部输送的颗粒组合物
公开(公告)号：US07384649B2
公开(公告)日：2008-06-10
申请号：US11633750
申请日：2006-12-05
申请人： Richard P. Batycky , David A. Edwards , Michael M. Lipp
发明人： Richard P. Batycky , David A. Edwards , Michael M. Lipp
IPC分类号： A61K9/50
CPC分类号： A61K9/0075 , A61K9/1694
摘要： This invention concerns an improved particulate composition for delivering a drug to the pulmonary system. Applicants disclose a method of identifying an optimal form of aerodynamically light particles which are highly dispersible. The particles of the instant invention are made by creating hollow, spherical drug particles (i.e., progenitor particles) that collapse in the process of particle formation, leading to wrinkled, thin-walled drug particles of very low envelope density. Additionally, Applicants have found that such particles are especially optimal for inhaled aerosols when the surface area parameter (σ) is greater than 2, optimally greater than 3.
摘要翻译：本发明涉及用于将药物递送至肺部系统的改进的颗粒组合物。申请人公开了一种识别高分散性的空气动力学轻微颗粒的最佳形式的方法。本发明的颗粒通过在颗粒形成过程中产生塌陷的中空的球形药物颗粒（即祖细胞颗粒）制成，导致具有非常低的包膜密度的褶皱，薄壁的药物颗粒。此外，申请人已经发现，当表面积参数（σ）大于2，最佳大于3时，这些颗粒对于吸入的气溶胶是特别优选的。

17. 发明授权

US06956021B1 Stable spray-dried protein formulations 有权
标题翻译：稳定的喷雾干燥蛋白制剂
公开(公告)号：US06956021B1
公开(公告)日：2005-10-18
申请号：US09383054
申请日：1999-08-25
申请人： David A. Edwards , Jeffrey S. Hrkach
发明人： David A. Edwards , Jeffrey S. Hrkach
IPC分类号： A61K9/00 , A61K9/14 , A61K9/16 , A61K38/00 , A61K38/27 , A61K47/00
CPC分类号： A61K9/0075 , A61K9/1617 , Y10S514/951 , Y10S514/97 , Y10S514/975
摘要： Spray-dried particles having improved protein stability are produced by spray-drying a mixture including a protein, a phospholipid and an organic-aqueous co-solvent. Spray-dried particles which include at least 1 weight % phospholipid, having a tap density of less than 0.4 g/cm3 can be prepared. The particles can be delivered to the pulmonary system of a patient.
摘要翻译：具有改善的蛋白质稳定性的喷雾干燥颗粒通过喷雾干燥包括蛋白质，磷脂和有机 - 水性共溶剂的混合物而产生。包含至少1重量％磷脂的喷雾干燥颗粒，其振实密度小于0.4g / cm 3，可以制备。颗粒可以输送到患者的肺部系统。

18. 发明授权

US06447752B2 Amorphous porous particles for deep lung delivery 有权
标题翻译：用于深肺输送的无定形多孔颗粒
公开(公告)号：US06447752B2
公开(公告)日：2002-09-10
申请号：US09888781
申请日：2001-06-25
申请人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Robert S. Langer , Abdellaziz Ben-Jebria
发明人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Robert S. Langer , Abdellaziz Ben-Jebria
IPC分类号： A61K912
CPC分类号： A61K9/0075 , A61K9/1647 , A61K31/137 , Y10S514/826 , Y10S514/851
摘要： Improved porous particles for drug delivery to the pulmonary system, and methods for their synthesis and administration are provided. In a preferred embodiment, the porous particles are made of a biodegradable material and have a mass density less than 0.4 g/cm3/. The particles may be formed of biodegradable materials such as biodegradable polymers. For example, the particles may be formed of a functionalized polyester graft copolymer consisting of a linear &agr;-hydroxy-acid polyester backbone having at least one amino acid group incorporated therein and at least one poly(amino acid) side chain extending from an amino acid group in the polyester backbone. In one embodiment, porous particles having a relatively large mean diameter, for example greater than 5 &mgr;m, can be used for enhanced delivery of a therapeutic agent to the alveolar region of the lung. The porous particles incorporating a therapeutic agent may be effectively aerosolized for administration to the respiratory tract to permit systemic or local delivery of wide variety of therapeutic agents.
摘要翻译：提供用于向肺系统递送药物的改进的多孔颗粒，以及用于其合成和给药的方法。在优选的实施方案中，多孔颗粒由可生物降解的材料制成，其质量密度小于0.4g / cm 3 /。颗粒可以由可生物降解的材料如可生物降解的聚合物形成。例如，颗粒可以由官能化聚酯接枝共聚物形成，该聚酯接枝共聚物由具有至少一个氨基酸基团的直链α-羟基酸聚酯主链和至少一个从氨基酸延伸的聚（氨基酸）侧链组成集团在聚酯骨干。在一个实施方案中，具有相对大的平均直径，例如大于5um的多孔颗粒可用于增强治疗剂递送至肺的肺泡区域。掺入治疗剂的多孔颗粒可以有效地雾化，用于给予呼吸道以允许全身或局部递送多种治疗剂。

19. 发明授权

US6136295A Aerodynamically light particles for pulmonary drug delivery 有权
标题翻译：用于肺部药物递送的空气动力学轻微颗粒
公开(公告)号：US6136295A
公开(公告)日：2000-10-24
申请号：US211940
申请日：1998-12-15
申请人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Abdell Aziz Ben-Jebria , Robert S. Langer
发明人： David A. Edwards , Giovanni Caponetti , Jeffrey S. Hrkach , Noah Lotan , Justin Hanes , Abdell Aziz Ben-Jebria , Robert S. Langer
IPC分类号： A61K9/12 , A61K9/00 , A61K9/14 , A61K9/16 , A61K9/72 , A61K31/137 , A61K47/32 , A61L9/04 , A61F2/00
CPC分类号： A61K9/0075 , A61K31/137 , A61K9/1647
摘要： Improved aerodynamically light particles for drug delivery to the pulmonary system, and methods for their synthesis and administration are provided. In a preferred embodiment, the aerodynamically light particles are made of a biodegradable material and have a tap density less than 0.4 g/cm.sup.3 and a mass mean diameter between 5 .mu.m and 30 .mu.m. The particles may be formed of biodegradable materials such as biodegradable polymers. For example, the particles may be formed of a functionalized polyester graft copolymer consisting of a linear .alpha.-hydroxy-acid polyester backbone having at least one amino acid group incorporated therein and at least one poly(amino acid) side chain extending from an amino acid group in the polyester backbone. In one embodiment, aerodynamically light particles having a large mean diameter, for example greater than 5 .mu.m, can be used for enhanced delivery of a therapeutic agent to the alveolar region of the lung. The aerodynamically light particles incorporating a therapeutic agent may be effectively aerosolized for administration to the respiratory tract to permit systemic or local delivery of wide variety of therapeutic agents.
摘要翻译：提供用于向肺系统输送药物的空气动力学轻微颗粒，以及用于其合成和给药的方法。在优选的实施方案中，空气动力学轻微颗粒由可生物降解的材料制成，并且具有小于0.4g / cm 3的振实密度和5μm-30μm之间的质量平均直径。颗粒可以由可生物降解的材料如可生物降解的聚合物形成。例如，颗粒可以由官能化的聚酯接枝共聚物形成，该聚酯接枝共聚物由具有至少一个氨基酸基团的直链α-羟基酸聚酯主链和至少一个从氨基酸延伸的聚（氨基酸）侧链组成集团在聚酯骨干。在一个实施方案中，具有大平均直径（例如大于5μm）的空气动力学轻的颗粒可用于增强治疗剂递送至肺的肺泡区域。掺入治疗剂的空气动力学轻微颗粒可以被有效地雾化，用于给予呼吸道以允许全身或局部递送多种治疗剂。

20. 发明申请

US20090068274A1 HIGHLY EFFICIENT DELIVERY OF A LARGE THERAPEUTIC MASS AEROSOL 审中-公开
标题翻译：高效治疗大剂量气溶胶的高效运输
公开(公告)号：US20090068274A1
公开(公告)日：2009-03-12
申请号：US12253449
申请日：2008-10-17
申请人： David A. Edwards , Richard P. Batycky , Lloyd Johnston
发明人： David A. Edwards , Richard P. Batycky , Lloyd Johnston
IPC分类号： A61K9/14 , A61P11/00
CPC分类号： A61K9/14 , A61K9/0075 , A61K9/1617 , A61K31/198
摘要： A method for delivering an agent to the pulmonary system, in a single, breath-activated step or a single breath, comprises administering from a receptacle enclosing a mass of particles, to a subject's respiratory tract, particles which have a tap density of less than 0.4 g/cm3 and deliver at least about 50% of the mass of particles. The particles are capable of carrying agents. The agent is (1) part of the spray-drying pre-mixture and thereby incorporated into the particles, (2) added to separately-prepared particles so that the agent is in chemical association with the particles or (3) blended so that the agent is mixed with, and co-delivered with the particles.Respirable compositions comprising carrier particles having a tap density of less than 0.4 g/cm3 and a composition comprising an agent are also disclosed. Methods of delivering these respirable compositions are also included.
摘要翻译：用于在单个呼吸激活步骤或单次呼吸中将药物递送至肺部系统的方法包括从包围大量颗粒的容器向受试者的呼吸道施用具有小于 0.4克/厘米3，并输送至少约50％的颗粒。颗粒能够携带。试剂是（1）部分喷雾干燥预混合物，由此加入到颗粒中，（2）加入到单独制备的颗粒中，使得试剂与颗粒化学缔合，或（3）混合试剂与颗粒混合并与颗粒共同传送。还公开了包含振实密度小于0.4g / cm 3的载体颗粒和包含试剂的组合物的可吸入组合物。还包括递送这些可呼吸组合物的方法。

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