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31. 发明授权

US07713929B2 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：US07713929B2
公开(公告)日：2010-05-11
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 , A61K38/16 , A61K31/185 , C07K14/62
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 in which 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.
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，使得长效甘精氨酸在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。

32. 发明申请

US20090192075A1 Amylin Formulations 审中-公开
标题翻译：胰岛淀粉样多肽制剂
公开(公告)号：US20090192075A1
公开(公告)日：2009-07-30
申请号：US12410754
申请日：2009-03-25
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模拟组合物的组合，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。

33. 发明授权

US07464706B2 Unit dose cartridge and dry powder inhaler 有权
标题翻译：单位剂量筒和干粉吸入器
公开(公告)号：US07464706B2
公开(公告)日：2008-12-16
申请号：US10655153
申请日：2003-09-04
申请人： Solomon S. Steiner , Trent A. Poole , Per B. Fog , Roderike Pohl , Michael Crick , Robert Feldstein
发明人： Solomon S. Steiner , Trent A. Poole , Per B. Fog , Roderike Pohl , Michael Crick , Robert Feldstein
IPC分类号： A61M11/00
CPC分类号： A61M15/0015 , A61M15/002 , A61M15/0023 , A61M15/0025 , A61M15/0028 , A61M15/0086 , A61M16/0495 , A61M16/0825 , A61M2202/064 , A61M2205/43
摘要： A dry powder inhaler having improved aerodynamic properties for diluting, dispersing, and metering drug particles for increasing the efficiency of pulmonary drug delivery to a patient is described. The inhaler comprises, in general, a housing having an air intake, an air flow-control/check-valve, a mixing section and a mouthpiece. A cartridge loaded with a single dose of medicament can be installed in the mixing section.
摘要翻译：描述了具有改善的空气动力学特性以用于稀释，分散和计量药物颗粒以提高肺部药物递送给患者的效率的干粉吸入器。吸入器通常包括具有进气口的壳体，空气流量控制/止回阀，混合部分和吹嘴。装有单剂量药物的药筒可以安装在混合部分中。

34. 发明授权

US06652885B2 Purification and stabilization of peptide and protein pharmaceutical agents 有权
公开(公告)号：US06652885B2
公开(公告)日：2003-11-25
申请号：US10224761
申请日：2002-08-20
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： A61K914
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, i.e. undesirable components, from the peptide or protein. In a preferred embodiment, a peptide, such as insulin, containing one or more impurities, e.g., zinc ions, is entrapped in diketopiperazine to form a precipitate of peptide/diketopiperazine/impurity, which is then washed with a solvent for the impurity to be removed, which is a nonsolvent for the diketopiperazine and a nonsolvent for the peptide. 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 a preferred embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. The charge on the insulin molecule is masked by hydrogen bonding it to the diketopiperazine, thereby enabling the insulin to pass through the target membrane. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.

35. 发明授权

US06428771B1 Method for drug delivery to the pulmonary system 失效
标题翻译：向肺系统输送药物的方法
公开(公告)号：US06428771B1
公开(公告)日：2002-08-06
申请号：US08441378
申请日：1995-05-15
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： A61K912
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.
摘要翻译：药物递送到肺部系统已经通过将待递送的药物封装在尺寸范围在0.5至10微米之间的微粒中，优选在2至5微米的范围内，通过在pH较大的材料释放药物形成超过6.4。在优选的实施方案中，药物递送系统基于在pH6.4或更低的pH下稳定的二酮哌嗪微粒的形成，并且在pH大于6.4时不稳定，或者在酸性和碱性pH两者下都是稳定的还可以使用其他类型的材料，包括可生物降解的天然和合成聚合物，如蛋白质，混合氨基酸（蛋白质类），藻酸盐和聚（羟基酸）的聚合物。在另一个实施方案中，微粒已经被修饰以实现靶向特定细胞类型，并且仅在达到靶细胞后才能实现释放。

36. 发明授权

US6071497A Microparticles for lung delivery comprising diketopiperazine 失效
公开(公告)号：US6071497A
公开(公告)日：2000-06-06
申请号：US847352
申请日：1997-04-24
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： A61K9/00 , A61K9/12 , A61K9/14 , A61K9/16 , A61K9/50 , A61K9/51 , A61K9/72 , A61K31/727 , A61K38/28 , A61K48/00
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.

37. 发明授权

US5503852A Method for making self-assembling diketopiperazine drug delivery system 失效
标题翻译：自组装二酮哌嗪药物输送系统的方法
公开(公告)号：US5503852A
公开(公告)日：1996-04-02
申请号：US299842
申请日：1994-09-01
申请人： Solomon S. Steiner , Christopher A. Rhodes , Gregory S. Shen , R. Tyler McCabe
发明人： Solomon S. Steiner , Christopher A. Rhodes , Gregory S. Shen , R. Tyler McCabe
IPC分类号： C07D319/12 , A61K9/16 , A61K9/50 , A61K47/22 , C07D241/08
CPC分类号： A61K9/1617
摘要： Drug delivery systems have been developed based on the formation of diketopiperazine (or analogs) microparticles. In the preferred embodiment the microparticle is stable at low pH and disintegrates at physiological pH, and is particularly useful for oral drug delivery. In other embodiments, the microparticles are stable at high pH and disintegrate at neutral or basic pH, or are stable at neutral pH and disintegrate at high or low pH. In the most preferred embodiment the microparticles are formed in the presence of the drug to be delivered, for example, insulin, felbamate, calcitonin or heparin. The diketopiperazine synthetic intermediates are preferably formed by cyclodimerization to form diketopiperazine derivatives at elevated temperatures under dehydrating conditions, functionalized on the side chains, and then precipitated with drug to be incorporated into microparticles.
摘要翻译：已经基于二酮哌嗪（或类似物）微粒的形成开发了药物递送系统。在优选的实施方案中，微粒在低pH下是稳定的并且在生理pH下分解，并且对于口服药物递送特别有用。在其它实施方案中，微粒在高pH下是稳定的，并且在中性或碱性pH下分解，或者在中性pH下是稳定的，并在高或低pH下崩解。在最优选的实施方案中，在待递送的药物例如胰岛素，麦芽糖素，降钙素或肝素的存在下形成微粒。二酮哌嗪合成中间体优选通过环二聚作用形成二酮哌嗪衍生物，在脱水条件下在侧链官能化的高温下形成二酮哌嗪衍生物，然后用药物沉淀以引入微粒。

38. 发明授权

US5352461A Self assembling diketopiperazine drug delivery system 失效
标题翻译：自组装二酮哌嗪药物输送系统
公开(公告)号：US5352461A
公开(公告)日：1994-10-04
申请号：US849186
申请日：1992-03-11
申请人： Robert Feldstein , John Glass , Solomon S. Steiner
发明人： Robert Feldstein , John Glass , Solomon S. Steiner
IPC分类号： C07D319/12 , A61K9/16 , A61K9/50 , A61K47/22 , C07D241/08
CPC分类号： A61K9/1617
摘要： Drug delivery systems have been developed based on the formation of diketopiperazine (or analogs) microparticles. In the preferred embodiment the microparticle is stable at low pH and disintegrates at physiological pH, and is particularly useful for oral drug delivery. In the most preferred embodiment the microparticles are formed in the presence of the drug to be delivered, for example, insulin or heparin. The diketopiperazine synthetic intermediates are preferably formed by cyclodimerization to form diketopiperazine derivatives at elevated conditions under dehydrating conditions, then precipitated with drug to be incorporated into microparticles.
摘要翻译：已经基于二酮哌嗪（或类似物）微粒的形成开发了药物递送系统。在优选的实施方案中，微粒在低pH下是稳定的并且在生理pH下分解，并且对于口服药物递送特别有用。在最优选的实施方案中，微粒在待递送药物存在下形成，例如胰岛素或肝素。二酮哌嗪合成中间体优选通过环状二聚化形成，在脱水条件下在升高的条件下形成二酮哌嗪衍生物，然后用药物沉淀以引入微粒。

39. 发明授权

US09061111B2 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：US09061111B2
公开(公告)日：2015-06-23
申请号：US13408896
申请日：2012-02-29
申请人： Solomon S. Steiner , Robert Feldstein , Per B. Fog , Trent A. Poole
发明人： Solomon S. Steiner , Robert Feldstein , Per B. Fog , Trent A. Poole
IPC分类号： A61M15/00 , A61M13/00 , A61M16/04
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.
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。

40. 发明授权

US09006175B2 Potentiation of glucose elimination 有权
标题翻译：增加葡萄糖消除
公开(公告)号：US09006175B2
公开(公告)日：2015-04-14
申请号：US11329686
申请日：2006-01-10
申请人： Anders Hasager Boss , Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
发明人： Anders Hasager Boss , Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
IPC分类号： A61K38/28 , A61K9/72 , A61P3/08 , A61K9/00 , A61K9/14
CPC分类号： A61K38/28 , A61K9/007 , A61K9/0073 , A61K9/0075 , A61K31/495 , A61K47/545 , Y10S514/866
摘要： Methods related to the treatment of diabetes and improving the efficiency of insulin utilization are provided. The method enables effective control of prandial glucose levels while reducing the risk of postprandial hypoglycemia. In particular, methods of potentiating the activity of endogenous insulin in type 2 diabetics and exogenous long-acting insulin in diabetics requiring basal insulin replacement are provided.
摘要翻译：提供了与治疗糖尿病和提高胰岛素利用效率相关的方法。该方法可有效控制餐前葡萄糖水平，同时降低餐后低血糖风险。特别地，提供了在需要基础胰岛素替代物的糖尿病患者中增强2型糖尿病患者和外源性长效胰岛素内源性胰岛素活性的方法。

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