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1. 发明申请

US20100227795A1 INSULIN FORMULATIONS FOR RAPID UPTAKE 有权
标题翻译：胰岛素制剂用于快速摄取
公开(公告)号：US20100227795A1
公开(公告)日：2010-09-09
申请号：US12397219
申请日：2009-03-03
申请人： Solomon S. Steiner , Roderike Pohl , Ming Li , Robert Hauser
发明人： Solomon S. Steiner , Roderike Pohl , Ming Li , Robert Hauser
IPC分类号： A61K38/28 , A61P3/10
CPC分类号： A61K9/0019 , A61K38/00 , A61K38/28 , A61K47/12 , A61K47/183 , C07K14/62
摘要： Injectable insulin formulations with improved stability and rapid onset of action are described herein. The formulations may be for subcutaneous, intradermal or intramuscular administration. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a clear liquid, neutral pH, in a multi-use sterile vial. In an alternative embodiment, the insulin is provided as a powder in a sterile vial. This is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water, a zinc chelator such as EDTA and a dissolution agent such as citric acid shortly before or at the time of administration. In another embodiment, the insulin is stored as a frozen mixture, ready for use upon thawing.
摘要翻译：本文描述了具有改善的稳定性和快速起效的可注射的胰岛素制剂。制剂可用于皮下，皮内或肌内给药。在优选的实施方案中，通过皮下注射施用制剂。制剂含有与螯合剂和溶解剂以及任选的其它赋形剂组合的胰岛素。在优选的实施方案中，制剂含有人胰岛素，锌螯合剂如EDTA和溶解剂如柠檬酸或柠檬酸钠。当通过皮下注射给药时，这些制剂被快速地吸收到血流中。在优选的实施方案中，胰岛素以多用途无菌小瓶中的透明液体中性pH提供。在替代实施方案中，胰岛素以无菌小瓶中的粉末形式提供。将其与包含药学上可接受的载体如水，锌螯合剂如EDTA的稀释剂和不久之前或给药时的溶解剂如柠檬酸混合。在另一个实施方案中，将胰岛素作为冷冻混合物储存，准备在解冻时使用。

2. 发明申请

US20090137455A1 RAPID ACTING AND LONG ACTING INSULIN COMBINATION FORMULATIONS 有权
标题翻译：快速行动和长期行动胰岛素组合制剂
公开(公告)号：US20090137455A1
公开(公告)日：2009-05-28
申请号：US12324717
申请日：2008-11-26
申请人： Solomon S. Steiner , Roderike Pohl
发明人： Solomon S. Steiner , Roderike Pohl
IPC分类号： A61K38/28 , A61P3/00
CPC分类号： A61K31/185 , A61K9/0014 , A61K31/19 , A61K31/385 , A61K38/28 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/183 , A61K47/26 , A61K2300/00
摘要： An injectable formulation containing a combination of a rapid acting insulin and a long acting insulin has been developed wherein the pH of the rapid acting insulin is adjusted so that the long acting insulin, e.g. insulin 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 up to 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. Alternatively, through adjustment of the ratio of rapid acting insulin to long acting insulin, the long acting insulin may be shortened to a 12 hour formulation. This rapid and long acting blend is re-administered to the patient at dinner time, providing a safe and effective basal insulin level until morning. As a result, a patient using intensive insulin therapy should only inject three, rather than four, times a day.
摘要翻译：已经开发了含有快速作用的胰岛素和长效胰岛素的组合的可注射制剂，其中调节快速作用的胰岛素的pH，使得长效胰岛素例如。甘精胰岛素，当它们混合在一起时，保持可溶。在优选的实施方案中，该可注射的基础推注胰岛素在早餐之前施用，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达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。或者，通过调整速效胰岛素与长效胰岛素的比例，长效胰岛素可缩短至12小时制剂。这种快速和长效的混合物在晚餐时间重新施用于患者，提供安全有效的基础胰岛素水平直到早晨。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。

3. 发明申请

US20120087985A1 SMALL PEPTIDE SEQUENCES FOR STABILIZING BIOMOLECULES 审中-公开
标题翻译：用于稳定生物分子的小肽序列
公开(公告)号：US20120087985A1
公开(公告)日：2012-04-12
申请号：US13253410
申请日：2011-10-05
申请人： Solomon S. Steiner
发明人： Solomon S. Steiner
IPC分类号： A61K9/50 , B01J13/04 , A61K38/26 , A61P3/10 , A61K38/02 , A61K38/28
CPC分类号： A61K38/26 , A61K9/0019 , A61K9/10 , A61K9/1617
摘要： Disclosed herein are a class of small molecules, referred to as Small Peptide Sequences (SPS), that can stabilize biomolecules, particles containing the SPS and biomolecules, and compositions and methods of making the particles. The SPS are composed solely of amino acids common to humans and too small to trigger an immunological response (typically less than seven amino acids in total) and which will self assemble into particles sufficiently small to stay in liquid suspension at a first pH, typically a non-physiological pH, but which dissociate, releasing the biomolecule entrapped therein into solution, at a second pH, typically a physiological pH. The particles contain a SPS and a biomolecule, wherein the biomolecule is entrapped with the particle, immobilized on the surface of the particle, or combinations thereof. The particle releases the biomolecule upon contact with physiological fluids.
摘要翻译：本文公开了一类称为小肽序列（SPS）的小分子，其可以稳定生物分子，含有SPS和生物分子的颗粒，以及制备颗粒的组合物和方法。 SPS仅由人类常见的氨基酸组成，太小而不能触发免疫应答（通常总共小于7个氨基酸），并且其将自我组装成足够小的颗粒，以在第一pH下停留在液体悬浮液中，通常为非生理pH，但其解离，在第二个pH（通常为生理pH）下将包埋在其中的生物分子释放到溶液中。颗粒含有SPS和生物分子，其中生物分子被捕获，固定在颗粒的表面上，或其组合。颗粒在与生理液体接触时释放生物分子。

4. 发明申请

US20080085298A1 Rapid Mucosal Gel or Film Insulin Compositions 审中-公开
标题翻译：快速粘膜凝胶或薄膜胰岛素组合物
公开(公告)号：US20080085298A1
公开(公告)日：2008-04-10
申请号：US11869724
申请日：2007-10-09
申请人： Roderike Pohl , Solomon Steiner
发明人： Roderike Pohl , Solomon Steiner
IPC分类号： A61K38/28 , A61K9/70 , A61P3/00
CPC分类号： A61K9/0056 , A61K9/006 , A61K9/06 , A61K9/107 , A61K38/28 , A61K47/12 , A61K47/183 , A61K2300/00
摘要： Gel, powder, suspension, emulsions or film formulations for systemic delivery of insulin with improved stability and rapid onset of action are described herein. The formulations are preferably absorbed to a mucosal surface, most preferably via buccal or sublingual administration, although rectal, vaginal, nasal or ocular administration is possible. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid. Following administration, these formulations are rapidly absorbed into the blood stream. The formulation is preferably a polymeric gel, powder or film which adheres to the mucosal surface, thereby enhancing uptake of the incorporated drug. In the preferred embodiment, this formulation is administered sublingually, most preferably before a meal or after a meal.
摘要翻译：本文描述了具有改善的稳定性和快速起效的胰岛素全身递送的凝胶，粉末，悬浮液，乳剂或膜制剂。制剂优选被吸收到粘膜表面，最优选通过颊或舌下施用，尽管可以进行直肠，阴道，鼻或眼睛给药。制剂含有与螯合剂和溶解剂以及任选的其它赋形剂组合的胰岛素。在优选的实施方案中，制剂含有人胰岛素，锌螯合剂如EDTA和溶解剂如柠檬酸。给药后，这些制剂被快速吸收到血液中。制剂优选是粘附到粘膜表面的聚合物凝胶，粉末或膜，从而增强所掺入的药物的摄取。在优选的实施方案中，该制剂是舌下给药，最优选在饭前或饭后服用的。

5. 发明申请

US20070191757A1 Method and Device for Sublingual Drug Delivery Using Iontophoresis 审中-公开
标题翻译：使用离子电渗法进行舌下给药的方法和装置
公开(公告)号：US20070191757A1
公开(公告)日：2007-08-16
申请号：US11675430
申请日：2007-02-15
申请人： Solomon Steiner , Robert Feldstein , Roderike Pohl , David Rhodes , Erik Steiner
发明人： Solomon Steiner , Robert Feldstein , Roderike Pohl , David Rhodes , Erik Steiner
IPC分类号： A61N1/30
CPC分类号： A61N1/306 , A61M2210/0625 , A61M2210/0643
摘要： Methods, devices and kits for sublingual drug delivery using iontophoresis are described herein. An active agent can be administered sublingually by placing a solid oral dosage form containing the active agent in the sublingual region of a patient and applying iontophoresis for a suitable period of time. Preferably up to 4 mA of current are applied to the sublingual region. Different time ranges can be used to administer iontophoresis; preferably iontophoresis is administered for up to 2 minutes at a time. Any suitable device for administering iontophoresis to the sublingual region may be used. The preferred device is a hand-held device that contains a handle, two electrodes, one of which is located on the handle and the other of which is attached to the end of the handle, and a connection to a power source. Optionally, the device contains a timer, which can be used turn off the current at a preset time. The device can be used to administer an active agent by iontophoresis to the sublingual region of a patient, by attaching the second electrode of the device to a solid oral dosage form containing the active agent to be administered. A kit contains the device for administering iontophoresis and one or more solid oral dosage forms, preferably in the form of one or more tabs or wafers. The tabs or wafers may be completely dissolvable or edible, or may contain a non-edible and non-dissolvable component. In a preferred embodiment, the solid oral dosage form contains insulin or an analog thereof and one or more excipients, preferably EDTA and citric acid.
摘要翻译：本文描述了使用离子电渗法进行舌下药物递送的方法，装置和试剂盒。可以通过将含有活性剂的固体口服剂型置于患者的舌下区域中并施用离子电渗疗法适当的时间段来向舌下施用活性剂。优选地，最多将4mA的电流施加到舌下区域。不同的时间范围可用于管理离子电渗疗法; 优选每次一次给予离子电渗疗法达2分钟。可以使用用于向舌下区域施用离子电渗疗法的任何合适的装置。优选的装置是手持装置，其包括手柄，两个电极，其中一个电极位于手柄上，另一个电极连接到手柄的端部，并且连接到电源。可选地，设备包含定时器，其可以在预设时间关闭电流。该装置可用于通过将装置的第二电极连接到含有待施用的活性剂的固体口服剂型，通过离子电渗法向患者的舌下区域施用活性剂。试剂盒包含用于施用离子电渗疗法的装置和一种或多种固体口服剂型，优选以一个或多个片或晶片的形式。标签或晶片可以是完全可溶的或可食用的，或者可以包含不可食用和不可溶的组分。在优选的实施方案中，固体口服剂型含有胰岛素或其类似物和一种或多种赋形剂，优选EDTA和柠檬酸。

6. 发明申请

US20050155601A1 Sublingual drug delivery device 失效
标题翻译：舌下给药装置
公开(公告)号：US20050155601A1
公开(公告)日：2005-07-21
申请号：US11037737
申请日：2005-01-18
申请人： Solomon Steiner , Craig Brown , Roderike Pohl , Trent Poole , Erik Steiner
发明人： Solomon Steiner , Craig Brown , Roderike Pohl , Trent Poole , Erik Steiner
IPC分类号： A61K9/14 , A61L9/04 , A61M11/00 , A61M15/00
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气雾化以使其在口腔中，更具体地在口腔舌下区域中形成细小涂层的药物递送装置。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. 发明授权

US08933023B2 Rapid acting injectable insulin compositions 有权
标题翻译：快速作用的可注射胰岛素组合物
公开(公告)号：US08933023B2
公开(公告)日：2015-01-13
申请号：US14156307
申请日：2014-01-15
申请人： Biodel Inc.
发明人： Roderike Pohl , Solomon S. Steiner
IPC分类号： A61K38/28 , A61K47/18 , A61K9/00 , A61K47/12
CPC分类号： A61K47/183 , A61K9/0056 , A61K38/28 , A61K47/12 , A61K2300/00
摘要： Injectable insulin formulations with improved stability and rapid onset of action are described herein. The formulations may be for subcutaneous, intradermal or intramuscular administration. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a dry powder in a sterile vial. This is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water, a zinc chelator such as EDTA and a dissolution agent such as citric acid shortly before or at the time of administration. In another embodiment, the insulin is stored as a frozen mixture, ready for use upon thawing.
摘要翻译：本文描述了具有改善的稳定性和快速起效的可注射的胰岛素制剂。制剂可用于皮下，皮内或肌内给药。在优选的实施方案中，通过皮下注射施用制剂。制剂含有与螯合剂和溶解剂以及任选的其它赋形剂组合的胰岛素。在优选的实施方案中，制剂含有人胰岛素，锌螯合剂如EDTA和溶解剂如柠檬酸。当通过皮下注射给药时，这些制剂被快速地吸收到血流中。在优选的实施方案中，胰岛素以无菌小瓶中的干粉提供。将其与包含药学上可接受的载体如水，锌螯合剂如EDTA的稀释剂和不久之前或给药时的溶解剂如柠檬酸混合。在另一个实施方案中，将胰岛素作为冷冻混合物储存，准备在解冻时使用。

8. 发明授权

US08637458B2 Insulin with a stable basal release profile 有权
标题翻译：胰岛素具有稳定的基础释放特征
公开(公告)号：US08637458B2
公开(公告)日：2014-01-28
申请号：US12778719
申请日：2010-05-12
申请人： Roderike Pohl , Nandini Kashyap , Robert Hauser , Koray Ozhan , Solomon S. Steiner
发明人： Roderike Pohl , Nandini Kashyap , Robert Hauser , Koray Ozhan , Solomon S. Steiner
IPC分类号： A61K38/28 , C07K14/62
CPC分类号： A61K9/0021 , A61K9/0024 , A61K9/19 , A61K38/28 , A61K47/02 , A61K47/183 , A61K47/26
摘要： A basal insulin formulation composed of insulin, preferably insulin glargine, injectable zinc and injectable iron compounds as precipitating and/or stabilizing agents has been developed for subcutaneous, intradermal or intramuscular administration. The formulation is designed to form a precipitate of insulin following injection, creating a slow releasing “basal insulin” over a period of 12 to 24 hours.
摘要翻译：已经开发了用于皮下，皮内或肌肉内施用的由胰岛素，优选甘精胰岛素，可注射锌和可注射铁化合物作为沉淀和/或稳定剂的基础胰岛素制剂。该制剂被设计成在注射后形成胰岛素沉淀，在12至24小时的时间段内产生缓慢释放的“基础胰岛素”。

9. 发明授权

US08084420B2 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：US08084420B2
公开(公告)日：2011-12-27
申请号：US12324717
申请日：2008-11-26
申请人： Solomon S. Steiner , Roderike Pohl
发明人： Solomon S. Steiner , Roderike Pohl
IPC分类号： A61K38/28 , A61K38/16 , A61K31/185 , C07K14/62
CPC分类号： A61K31/185 , A61K9/0014 , A61K31/19 , A61K31/385 , A61K38/28 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/183 , A61K47/26 , A61K2300/00
摘要： An injectable formulation containing a rapid acting insulin and a long acting insulin has been developed. The pH of the rapid acting insulin is adjusted so that the long acting insulin, remains soluble when they are mixed together. Preferably, the formulation is administered before breakfast, provides adequate bolus insulin levels to cover the meal and basal insulin for up to 24 hours, and does not produce hypoglycemia after the meal. Lunch and dinner can be covered by two bolus injections of a fast, rapid, or very rapid acting insulin. Alternatively, by adjusting the ratio of rapid to long acting insulin, the long acting insulin may be shortened to a 12 hour formulation, and re-administered to the patient at dinner time, providing a safe and effective basal insulin level until morning. As a result, a patient using intensive insulin therapy should only inject three times a day.
摘要翻译：已经开发了含有快速作用的胰岛素和长效胰岛素的可注射制剂。调整快速作用胰岛素的pH，使得长效胰岛素在混合在一起时保持溶解。优选地，在早餐之前施用制剂，提供足够的推注胰岛素水平以覆盖膳食和基础胰岛素达24小时，并且在饭后不产生低血糖。午餐和晚餐可以通过快速，快速或非常快速作用的胰岛素的两次快速注射来覆盖。或者，通过调节快速胰岛素与长效胰岛素的比例，长效胰岛素可缩短至12小时制剂，并在晚餐时间再次给予患者，从而提供安全有效的基础胰岛素水平至早晨。因此，使用强化胰岛素治疗的患者每天只能注射三次。

10. 发明申请

US20110237510A1 STABILIZED GLUCAGON SOLUTIONS 有权
公开(公告)号：US20110237510A1
公开(公告)日：2011-09-29
申请号：US12891240
申请日：2010-09-27
申请人： Solomon S. Steiner , Robert Hauser , Ming Li , Robert Feldstein , Roderike Pohl
发明人： Solomon S. Steiner , Robert Hauser , Ming Li , Robert Feldstein , Roderike Pohl
IPC分类号： A61K38/26 , A61P3/08 , B65D85/00
CPC分类号： A61K38/26 , A61K9/0019 , A61K9/1075 , A61K9/19 , A61K47/26
摘要： A formulation composed of a sugar such as glucose and a surfactant such as myristoyl lysophosphocholine (LMPC) has been designed to stabilize both hydrophilic and hydrophobic portions of the glucagon molecule, under prolonged physiological conditions, in a formulation that is sufficiently similar to the pH and osmolarity of plasma so as not to induce or to minimize site irritation. The combination of a simple sugar and an surfactant stabilizes the glucagon molecule in an aqueous solution for seven days at 37° C.

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