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1. 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。

2. 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.

3. 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。

4. 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。

5. 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。

6. 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。

7. 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。

8. 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。

9. 发明申请

US20080039365A1 Rapid Acting and Long Acting Insulin Combination Formulations 有权
标题翻译：快速作用和长效胰岛素组合配方
公开(公告)号：US20080039365A1
公开(公告)日：2008-02-14
申请号：US11695562
申请日：2007-04-02
申请人： Solomon S. Steiner , Roderike Pohl
发明人： Solomon S. Steiner , Roderike Pohl
IPC分类号： A61K38/28 , A61K31/385 , A61K31/185 , A61K31/19 , A61K36/02
CPC分类号： A61K38/28 , A61K31/185 , A61K31/19 , A61K31/385 , A61K2300/00
摘要： A combined rapid acting-long acting insulin formulation has been developed wherein the pH of the rapid acting insulin is decreased so that the long acting glargine remains soluble when they are mixed together. In the preferred embodiment, this injectable basal bolus insulin is administered before breakfast, provides adequate bolus insulin levels to cover the meal, does not produce hypoglycemia after the meal and provides adequate basal insulin for 24 hours. Lunch and dinner can be covered by two bolus injections of a fast acting, or a rapid acting or a very rapid acting insulin. As a result, a patient using intensive insulin therapy should only inject three, rather than four, times a day. Experiments have been performed to demonstrate the importance of the addition of specific acids to hexameric insulin to enhance speed and amount of absorption and preserve bioactivity following dissociation into the monomeric form by addition of a chelator such as EDTA. As shown by the examples, the preferred acids are aspartic, glutamic and citric acid. These are added in addition to a chelator, preferably ethylenediaminetetraacetic acid (EDTA). The results show that the citric acid formulation was more effective at dropping the blood glucose rapidly than the identical rapid acting formulation prepared with HCl in swine. Charge masking by the polyacid appears to be responsible for rapid insulin absorption. EDTA was not effective when used with adipic acid, oxalic acid or HCl at hastening the absorption of insulin. These results confirm the results seen in clinical subjects and patients with diabetes treated with the rapid acting insulin in combination with citric acid and EDTA.
摘要翻译：已经开发了组合的快速作用长效胰岛素制剂，其中快速作用的胰岛素的pH降低，使得长效甘精胰醇混合在一起时仍然是可溶的。在优选的实施方案中，这种可注射的基础推注胰岛素在早餐前施用，提供足够的推注胰岛素水平以覆盖膳食，在餐后不产生低血糖并提供足够的基础胰岛素24小时。午餐和晚餐可以通过快速作用或快速作用或非常快速作用的胰岛素的两次快速注射来覆盖。因此，使用强化胰岛素治疗的患者每天只能注射三次，而不是四次。已经进行了实验以证明向六聚胰岛素中加入特定酸的重要性，以通过加入螯合剂如EDTA解离成单体形式来提高速度和吸收量并保持生物活性。如实施例所示，优选的酸是天冬氨酸，谷氨酸和柠檬酸。除了螯合剂，优选乙二胺四乙酸（EDTA）之外还加入它们。结果表明，柠檬酸配方比在猪中用HCl制备的相同的快速作用制剂快速降低血糖。多酸的电荷掩蔽似乎是快速胰岛素吸收的原因。当与己二酸，草酸或HCl一起使用以加速胰岛素的吸收时，EDTA无效。这些结果证实了临床受试者和用快速作用胰岛素与柠檬酸和EDTA组合治疗的糖尿病患者的结果。

10. 发明授权

US07305986B1 Unit dose capsules for use in a dry powder inhaler 有权
标题翻译：用于干粉吸入器的单位剂量胶囊
公开(公告)号：US07305986B1
公开(公告)日：2007-12-11
申请号：US09621092
申请日：2000-07-21
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 are capsules to contain a drug for use in an inhaler. The capsules may be two-part capsules where each half has apertures which may correspond to apertures in the other half. The first half fits snugly within the second half and the two halves may be rotated around their longitudinal axes with respect to each other to produce unlocked and locked positions. In the unlocked position, at least one aperture in the first half aligns with at least one aperture in the second half, which permits introduction of a medicament. In the locked position, at least two apertures in the first half align with at least two apertures in the second half, allowing air to pass through the capsule, releasing the medicament contained therein. Each capsule may have a unique key on each half that only fits with a particular inhaler or identifies the medicament contained therein.
摘要翻译：描述了容纳用于吸入器的药物的胶囊。胶囊可以是两部分胶囊，其中每一半具有可对应于另一半中的孔的孔。前半部分紧密地配合在第二半部分内，并且两个半部可以相对于彼此绕其纵向轴线旋转以产生解锁和锁定位置。在解锁位置，前半部中的至少一个孔与第二半中的至少一个孔对准，这允许引入药物。在锁定位置，第一半部中的至少两个孔与第二半部中的至少两个孔对准，允许空气通过胶囊，释放其中所含的药物。每个胶囊可以在每一半上具有仅与特定吸入器匹配的识别钥匙，或识别其中包含的药物。

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