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1. 发明授权

US07943178B2 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：US07943178B2
公开(公告)日：2011-05-17
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： A61K9/14 , A61K9/19 , A61K9/00 , A61K38/00 , A61K38/02 , A61K38/16
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。

2. 发明申请

US20130143801A1 METHODS AND COMPOSITIONS FOR DELIVERING PEPTIDES 有权
公开(公告)号：US20130143801A1
公开(公告)日：2013-06-06
申请号：US13754698
申请日：2013-01-30
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： A61K9/00
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.

3. 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.

4. 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。

5. 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。

6. 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。

7. 发明授权

US06444226B1 Purification and stabilization of peptide and protein pharmaceutical agents 有权
标题翻译：肽和蛋白质药剂的纯化和稳定
公开(公告)号：US06444226B1
公开(公告)日：2002-09-03
申请号：US09606468
申请日：2000-06-29
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.
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（即不合需要的组分）来纯化肽和蛋白质的方法。在优选的实施方案中，将包含一种或多种杂质（例如锌离子）的肽例如包被在二酮哌嗪中以形成肽/二酮哌嗪/杂质的沉淀物，然后用溶剂洗涤以使杂质为去除，这是二酮哌嗪的非溶剂和肽的非溶剂。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。在优选的实施方案中，胰岛素经由包含富马酰二酮哌嗪和胰岛素的微粒的肺部递送以其生物活性形式施用。胰岛素分子上的电荷被氢键键合到二酮哌嗪上，从而使胰岛素能够通过靶膜。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

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。

9. 发明授权

US07648960B2 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles 有权
标题翻译：用于递送与二酮哌嗪微粒络合的单体或二聚体胰岛素的方法
公开(公告)号：US07648960B2
公开(公告)日：2010-01-19
申请号：US10719734
申请日：2003-11-21
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 , A61K38/00 , A61K9/00 , 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 of 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生物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。

10. 发明授权

US09140651B2 Determining percent solids in suspension using raman spectroscopy 有权
标题翻译：使用拉曼光谱法测定悬浮液中的固体百分数
公开(公告)号：US09140651B2
公开(公告)日：2015-09-22
申请号：US13696650
申请日：2011-05-04
申请人： Jason J. Antunovich , Arthur T. Hamfeldt , Rodney J. Woods , Sam C. Shum
发明人： Jason J. Antunovich , Arthur T. Hamfeldt , Rodney J. Woods , Sam C. Shum
IPC分类号： G01J3/44 , G01N21/65
CPC分类号： G01N21/65 , G01G9/00 , G01N15/06 , G01N2201/06113 , G01N2201/121 , G01N2201/127
摘要： Methods and apparatus are provided for determining weight percent of solids in a suspension using Raman spectroscopy. The methods can be utilized to acquire Raman spectral data from the suspension and to determine weight percent of solids in a process being carried out, for example, in a vessel, without the need to remove samples for analysis. The weight percent of the solids can be determined with a desired accuracy in a relatively short time, typically 10 minutes or less. The acquired Raman spectral data may be processed by chemometric software using, for example, a Partial Least Squares algorithm and data pretreatment to provide a predicted value of weight percent solids. In some embodiments, the invention is used to determine the weight percent of microparticles of a diketopiperazine in an aqueous solution.
摘要翻译：提供了使用拉曼光谱测定悬浮液中固体重量百分比的方法和装置。这些方法可用于从悬浮液中获得拉曼光谱数据，并确定例如在容器中进行的方法中固体的重量百分比，而不需要除去样品进行分析。固体的重量百分比可以在相对较短的时间（通常为10分钟或更短）内以期望的精度确定。获得的拉曼光谱数据可以通过化学计量学软件使用例如部分最小二乘算法和数据预处理来提供重量百分比固体的预测值。在一些实施方案中，本发明用于测定水溶液中二酮哌嗪微粒的重量百分比。

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