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1. 发明申请

US20140120162A1 Bioadhesive Drug Delivery Compositions 审中-公开
标题翻译：生物粘附药物输送组合物
公开(公告)号：US20140120162A1
公开(公告)日：2014-05-01
申请号：US14124040
申请日：2012-06-06
申请人： Edith Mathiowitz , Solomon S. Steiner , Bryan E. Laulicht , Sasha Bakhru
发明人： Edith Mathiowitz , Solomon S. Steiner , Bryan E. Laulicht , Sasha Bakhru
IPC分类号： A61K47/34 , A61K47/32
CPC分类号： A61K47/34 , A61K9/4858 , A61K47/32
摘要： Compositions containing one or more active agents, one or more bioadhesives elements, and one or more charge masking agents are described herein. In some embodiments, the one or more active agents are biomolecules or macromolecules, such as polysaccharides, proteins, peptides, or nucleic acids, which are charged at physiological pH. The one or more charge masking agents are selected based on the nature of the charge on the active agent. The compositions may also contain one or more controlled release materials, such as extended or sustained release materials or delayed release materials, in order to modify release of the active agent.
摘要翻译：本文描述了包含一种或多种活性剂，一种或多种生物粘合剂元件和一种或多种电荷掩蔽剂的组合物。在一些实施方案中，一种或多种活性剂是在生理pH下加入的生物分子或大分子，例如多糖，蛋白质，肽或核酸。基于活性剂上的电荷的性质来选择一种或多种电荷掩蔽剂。为了改变活性剂的释放，组合物还可以含有一种或多种受控释放材料，例如延长或持续释放材料或延迟释放材料。

2. 发明申请

US20140178479A1 Concentrated Felbamate Formulations for Parenteral Administration 审中-公开
标题翻译：用于肠胃外给药的浓缩费尔布糖苷制剂
公开(公告)号：US20140178479A1
公开(公告)日：2014-06-26
申请号：US14238138
申请日：2012-04-09
申请人： Sasha H. Bakhru , Bryan E. Laulicht , Edith Mathiowitz , Solomon S. Steiner
发明人： Sasha H. Bakhru , Bryan E. Laulicht , Edith Mathiowitz , Solomon S. Steiner
IPC分类号： A61K9/00 , A61K31/27 , A61K31/55
CPC分类号： A61K31/27 , A61K9/0019 , A61K9/08 , A61K9/10 , A61K9/145 , A61K31/55 , A61K47/10 , A61K47/20
摘要： Formulations of a neuroprotective agent for parenteral administration are described herein. The formulation is in the form of a concentrated (supersaturated) solution or a concentrated suspension of microparticles. The suspension medium or the solution solvent carrier may also contain dissolved neuroprotective agent. For the supersaturated solutions, the agent is dissolved at high concentrations of at least about 1% by weight, 5% by weight, 10% by weight, 15% by weight, or 20% by weight in a solvent suitable for parenteral administration. For the concentrated suspension, the microparticles have an effective particle size from about 100 nm to about 5 microns, preferably from about 50 nm to about 3 microns, more preferably from about 10 nm to about 2 microns. The formulations described herein can be used to treat a variety of neurological diseases/disorders and/or neurological injury or trauma.
摘要翻译：本文描述了用于肠胃外给药的神经保护剂的制剂。制剂是浓缩（过饱和）溶液或微粒浓缩悬浮液的形式。悬浮介质或溶剂溶剂载体也可以含有溶解的神经保护剂。对于过饱和溶液，在适于肠胃外给药的溶剂中，该试剂以至少约1重量％，5重量％，10重量％，15重量％或20重量％的高浓度溶解。对于浓缩悬浮液，微粒具有约100nm至约5微米，优选约50nm至约3微米，更优选约10nm至约2微米的有效粒度。本文描述的制剂可用于治疗各种神经疾病/障碍和/或神经损伤或创伤。

3. 发明申请

US20140207105A1 Methods for Effectively and Rapidly Desensitizing Allergic Patients 审中-公开
标题翻译：有效和快速脱敏过敏患者的方法
公开(公告)号：US20140207105A1
公开(公告)日：2014-07-24
申请号：US14240706
申请日：2012-08-30
申请人： Bryan E. Laulicht , Sasha H. Bakhru , Solomon S. Steiner , Edith Mathiowitz
发明人： Bryan E. Laulicht , Sasha H. Bakhru , Solomon S. Steiner , Edith Mathiowitz
IPC分类号： A61K39/35 , A61M37/00
CPC分类号： A61K39/35 , A61K31/43 , A61K31/60 , A61K39/36 , A61K2039/54 , A61K2039/55511 , A61K2039/55555 , A61K2039/55583 , A61K2039/577 , A61M37/0015 , A61M2037/0023 , A61M2037/003 , A61M2037/0061
摘要： Methods and compositions for delivering antigens to the lymphatic system in doses that desensitize patients to future exposure to antigens have been developed. Rapid desensitization is achieved by introducing small quantities of antigen into the lymphatic system. In preferred embodiments, the compositions are administered to yield therapeutically effective levels of antigen within the lymph, where macrophages reside in the greatest concentration, by intradermal administration, using for example, microneedles or microparticles, oral administration, using for example, enteric coated capsules or tablets, or autologous transfusion. In some embodiments, the methods and compositions for delivering antigens orally achieve uptake by the Peyer's patches of the small intestines.
摘要翻译：已经开发了用于将患者未来接触抗原脱敏的剂量将抗原递送至淋巴系统的方法和组合物。通过将少量抗原引入淋巴系统来实现快速脱敏。在优选的实施方案中，施用组合物以通过皮内给药，使用例如微针或微粒，口服给药，使用例如肠溶衣胶囊或淋巴细胞，以产生治疗有效水平的淋巴内的抗原，其中巨噬细胞以最大浓度存在片剂或自体输血。在一些实施方案中，用于递送抗原的方法和组合物通过小肠的派尔氏贴片摄取。

4. 发明授权

US08394414B2 Method for drug delivery to the pulmonary system 失效
公开(公告)号：US08394414B2
公开(公告)日：2013-03-12
申请号：US10706243
申请日：2003-11-12
申请人： Solomon S. Steiner , Robert Feldstein , Huiling Lian , Christopher A. Rhodes , Gregory S. Shen
发明人： Solomon S. Steiner , Robert Feldstein , Huiling Lian , Christopher A. Rhodes , Gregory S. Shen
IPC分类号： A61K9/16
CPC分类号： A61K9/5146 , A61K9/0073 , A61K9/0075 , A61K9/1617
摘要： Drug delivery to the pulmonary system has been achieved by encapsulation of the drug to be delivered in microparticles having a size range between 0.5 and ten microns, preferably in the range of two to five microns, formed of a material releasing drug at a pH of greater than 6.4. In a preferred embodiment, the drug delivery system is based on the formation of diketopiperazine microparticles which are stable at a pH of 6.4 or less and unstable at pH of greater than 6.4, or which are stable at both acidic and basic pH, but which are unstable at pH between about 6.4 and 8. Other types of materials can also be used, including biodegradable natural and synthetic polymers, such as proteins, polymers of mixed amino acids (proteinoids), alginate, and poly(hydroxy acids). In another embodiment, the microparticles have been modified to effect targeting to specific cell types and to effect release only after reaching the targeted cells.

5. 发明授权

US08389470B2 Methods and compositions for delivering peptides 有权
标题翻译：用于递送肽的方法和组合物
公开(公告)号：US08389470B2
公开(公告)日：2013-03-05
申请号：US12985197
申请日：2011-01-05
申请人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
发明人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
IPC分类号： A61K9/14 , A61K38/28
CPC分类号： A61K47/22 , A61K9/0019 , A61K9/0073 , A61K9/0075 , A61K9/14 , A61K9/145 , A61K9/1617 , A61K9/1676 , A61K38/28 , A61K47/6949 , B82Y5/00 , C07D241/08 , C07K1/30 , C07K1/32 , C07K14/605 , C07K14/62 , Y10S514/866
摘要： Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.
摘要翻译：提供了通过将肽或蛋白质掺入二酮哌嗪或竞争性络合剂来促进从肽或蛋白质中去除一种或多种杂质来纯化肽和蛋白质的方法。提供制剂和方法用于改善活性剂在生物膜上的转运，导致例如血药剂浓度的快速增加。制剂包括由（i）可以带电或中性的活性剂形成的微粒，和（ii）掩蔽试剂的电荷和/或与靶生物膜形成氢键的运输增强剂，以便于运输。在一个实施方案中，胰岛素经由包含富马酰二酮基哌嗪和胰岛素的微粒的肺部递送以其生物活性形式施用。这种递送胰岛素的方法导致血浆胰岛素浓度的快速增加，其与由静脉内递送产生的增加相当。

6. 发明申请

US20110105391A1 Methods and Compositions for Delivering Peptides 有权
标题翻译：递送肽的方法和组合
公开(公告)号：US20110105391A1
公开(公告)日：2011-05-05
申请号：US12985197
申请日：2011-01-05
申请人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
发明人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
IPC分类号： A61K38/28 , A61P3/10
CPC分类号： A61K47/22 , A61K9/0019 , A61K9/0073 , A61K9/0075 , A61K9/14 , A61K9/145 , A61K9/1617 , A61K9/1676 , A61K38/28 , A61K47/6949 , B82Y5/00 , C07D241/08 , C07K1/30 , C07K1/32 , C07K14/605 , C07K14/62 , Y10S514/866
摘要： Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.
摘要翻译：提供了通过将肽或蛋白质掺入二酮哌嗪或竞争性络合剂来促进从肽或蛋白质中去除一种或多种杂质来纯化肽和蛋白质的方法。提供制剂和方法用于改善活性剂在生物膜上的转运，导致例如血药剂浓度的快速增加。制剂包括由（i）可以带电或中性的活性剂形成的微粒，和（ii）掩蔽试剂的电荷和/或与靶生物膜形成氢键的运输增强剂，以便于运输。在一个实施方案中，胰岛素经由包含富马酰二酮基哌嗪和胰岛素的微粒的肺部递送以其生物活性形式施用。这种递送胰岛素的方法导致血浆胰岛素浓度的快速增加，其与由静脉内递送产生的增加相当。

7. 发明申请

US20100086609A1 Methods and Compositions for Delivering Peptides 有权
标题翻译：递送肽的方法和组合
公开(公告)号：US20100086609A1
公开(公告)日：2010-04-08
申请号：US12635380
申请日：2009-12-10
申请人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
发明人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
IPC分类号： A61K38/28 , A61K38/26 , A61K31/496 , A61K31/495 , A61K9/14
CPC分类号： A61K47/22 , A61K9/0019 , A61K9/0073 , A61K9/0075 , A61K9/14 , A61K9/145 , A61K9/1617 , A61K9/1676 , A61K38/28 , A61K47/6949 , B82Y5/00 , C07D241/08 , C07K1/30 , C07K1/32 , C07K14/605 , C07K14/62 , Y10S514/866
摘要： Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.
摘要翻译：提供了通过将肽或蛋白质掺入二酮哌嗪或竞争性络合剂来促进从肽或蛋白质中去除一种或多种杂质来纯化肽和蛋白质的方法。提供制剂和方法用于改善活性剂在生物膜上的转运，导致例如血药剂浓度的快速增加。制剂包括由（i）可以带电或中性的活性剂形成的微粒，和（ii）掩蔽试剂的电荷和/或与靶生物膜形成氢键的运输增强剂，以便于运输。在一个实施方案中，胰岛素经由包含富马酰二酮基哌嗪和胰岛素的微粒的肺部递送以其生物活性形式施用。这种递送胰岛素的方法导致血浆胰岛素浓度的快速增加，其与由静脉内递送产生的增加相当。

8. 发明授权

US07658721B2 Sublingual drug delivery device 失效
标题翻译：舌下给药装置
公开(公告)号：US07658721B2
公开(公告)日：2010-02-09
申请号：US11037737
申请日：2005-01-18
申请人： Solomon S. Steiner , Craig Brown , Roderike Pohl , Trent Poole , Erik Steiner
发明人： Solomon S. Steiner , Craig Brown , Roderike Pohl , Trent Poole , Erik Steiner
IPC分类号： A61M37/00 , A61M15/00 , A61M16/10 , A61M16/00 , A61M11/00
CPC分类号： A61M11/00 , A61M15/0028 , A61M15/0048 , A61M15/0051 , A61M2202/064 , A61M2205/073 , A61M2205/8225
摘要： A drug delivery device that aerosolizes a dry powder formulation so that it forms a fine coating in the oral cavity and, more specifically in the sublingual region of the oral cavity is described herein. In the preferred embodiment, the device contains five main parts: (i) a compressed gas canister, (ii) a dispenser body (also referred to herein as the main housing ), (iii) a means for storing one or more doses of a drug formulation, (iv) a means for releasing a dose of the drug formulation such as a gas canister or spring piston and (v) a mouthpiece. Preferred configurations include circular, tubular, and rectangular. The means for storing the drug formulation may be configured to separately store one or more materials. In one embodiment, the means for storing the active agent is in the form of one or more drug discs, where the drug discs contain a plurality of blister packs, each storing one dose of the drug formulation. In another embodiment, the means for storing the active agent is a dosage cartridge containing a single dose of the drug formulation. In yet another embodiment, the drug formulation is stored on a ribbon containing a plurality of blister packs, each storing one dose of the drug formulation.
摘要翻译：本文描述了使干燥粉末制剂雾化以使其在口腔中形成细小涂层并且更具体地在口腔的舌下区域中的药物递送装置。在优选实施例中，该装置包含五个主要部分：（i）压缩气体罐，（ii）分配器主体（在本文中也称为主壳体），（iii）用于存储一个或多个剂量的药物制剂，（iv）用于释放剂量的药物制剂如气体罐或弹簧活塞的装置，（v）口器。优选的构造包括圆形，管状和矩形。用于储存药物制剂的方法可以被配置成分开存储一种或多种材料。在一个实施方案中，用于储存活性剂的装置是一种或多种药物盘的形式，其中药物盘包含多个泡罩包装，每个存储一剂药物制剂。在另一个实施方案中，用于储存活性剂的装置是含有单剂量药物制剂的剂量筒。在另一个实施方案中，药物制剂储存在含有多个泡罩包装的条带上，每个存在一剂药物制剂。

9. 发明申请

US20080248999A1 AMYLIN FORMULATIONS 审中-公开
标题翻译： AMYLIN配方
公开(公告)号：US20080248999A1
公开(公告)日：2008-10-09
申请号：US12062355
申请日：2008-04-03
申请人： Solomon S. Steiner
发明人： Solomon S. Steiner
IPC分类号： A61K38/28 , A61P3/10
CPC分类号： A61K45/06 , A61K9/0019 , A61K38/28 , A61K47/183 , A61K2300/00
摘要： A combined insulin and amylin and/or GLP-1 mimetic formulation has been developed wherein the pH of the insulin is decreased so that the amylin and/or GLP-1 remains soluble when mixed together with the insulin. In the preferred embodiment, a bolus insulin is administered by injection before breakfast, providing adequate bolus insulin levels to cover the meal, without producing hypoglycemia after the meal. This can be combined with an adequate basal insulin for 24 hours. Lunch and dinner can be covered by two bolus injections of the insulin and amylin and/or GLP-1 mimetic combination. A GLP-1 mimetic may be combined with either rapid acting or basal insulin formulations. As a result, a patient using the combination formulation therapy may only need to inject half as many times per day.
摘要翻译：已经开发了胰岛素和胰岛淀粉样多肽和/或GLP-1模拟组合物，其中胰岛素的pH降低，使得当与胰岛素一起混合时，胰岛淀粉样多肽和/或GLP-1保持可溶。在优选实施方案中，在早餐之前通过注射施用推注胰岛素，提供足够的推注胰岛素水平以覆盖膳食，而不会在饭后产生低血糖。这可以与足够的基础胰岛素组合24小时。午餐和晚餐可以通过两次快速注射胰岛素和胰岛淀粉样多肽和/或GLP-1模拟组合来覆盖。 GLP-1模拟物可以与快速作用或基础胰岛素制剂组合。因此，使用组合制剂治疗的患者可能只需要每天注射一半次。

10. 发明申请

US20080127970A1 Unit Dose Capsules and Dry Powder Inhaler 有权
标题翻译：单位剂量胶囊和干粉吸入器
公开(公告)号：US20080127970A1
公开(公告)日：2008-06-05
申请号：US11949707
申请日：2007-12-03
申请人： Solomon S. Steiner , Robert Feldstein , Per B. Fog , Trent Poole
发明人： Solomon S. Steiner , Robert Feldstein , Per B. Fog , Trent Poole
IPC分类号： A61M15/00
CPC分类号： A61M15/003 , A61M13/00 , A61M15/002 , A61M15/0021 , A61M15/0023 , A61M15/0025 , A61M15/0028 , A61M15/0043 , A61M16/0495 , A61M16/0825 , A61M2202/064 , A61M2205/43 , F16L37/252
摘要： Described is a dry powder inhaler comprising an intake section; a mixing section, and a mouthpiece. The mouthpiece is connected by a swivel joint to the mixing section, and may swivel back onto the intake section and be enclosed by a cover. The intake chamber comprises a special piston with a tapered piston rod and spring, and one or more bleed-through orifices to modulate the flow of air through the device. The intake chamber further optionally comprises a feedback module to generate a tone indicating to the user when the proper rate of airflow has been achieved. The mixing section holds a capsule with holes containing a dry powder medicament, and the cover only can open when the mouthpiece is at a certain angle to the intake section. The mixing section further opens and closes the capsule when the intake section is at a certain angle to the mouthpiece. The mixing section is a Venturi chamber configured by protrusions or spirals to impart a cyclonic flow to air passing through the mixing chamber. The mouthpiece includes a tongue depressor, and a protrusion to contact the lips of the user to tell the user that the DPI is in the correct position. An optional storage section, with a cover, holds additional capsules. The cover for the mouthpiece, and the cover for the storage section may both be transparent, magnifying lenses. The capsules may be two-part capsules where each portion has apertures which correspond to apertures in the other half when each half is partially fitted to the other half, and fully fitted to the other half. All the apertures may be closed when the two halves are rotated around their longitudinal axes with respect to each other. Each capsule may have a unique key on each half that only fits with a particular inhaler.
摘要翻译：描述了一种干粉吸入器，其包括进气段; 混合部分和喉舌。接口通过旋转接头连接到混合部分，并且可以旋转回到进气部分并被盖封闭。进气室包括具有锥形活塞杆和弹簧的特殊活塞，以及一个或多个渗流孔口，用于调节通过该装置的空气流。进气室还可选地包括反馈模块，以产生当达到适当的气流速率时向用户指示的音调。混合部分容纳具有含有干粉药物的孔的胶囊，并且仅当吸嘴与进气部分成一定角度时，盖子才能打开。当进气部分与嘴件成一定角度时，混合部分进一步打开和关闭胶囊。混合部分是由突起或螺旋构成的文丘里室，以使气流通过混合室。接口管包括舌形按压器和用于接触用户嘴唇的突起，以告诉用户DPI处于正确的位置。带有盖子的可选存储部分可容纳另外的胶囊。用于接口管的盖和用于存储部的盖可以都是透明的放大镜。胶囊可以是两部分胶囊，其中每个部分具有对应于另一半中的孔的孔，当每个半部分部分地配合到另一半时，并且完全配合到另一半。当两个半部相对于彼此的纵向轴线旋转时，所有的孔可以被关闭。每个胶囊可以在每一半上具有仅与特定吸入器配合的唯一键。

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