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1. 发明申请

US20110281790A1 INSULIN WITH A STABLE BASAL RELEASE PROFILE 有权
标题翻译：胰岛素具有稳定的基本释放特征
公开(公告)号：US20110281790A1
公开(公告)日：2011-11-17
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 , B65D69/00 , A61P3/10
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。该制剂被设计为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”。

2. 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”。

3. 发明申请

US20100069292A1 INSULIN WITH A BASAL RELEASE PROFILE 审中-公开
标题翻译：胰岛素具有基本释放特征
公开(公告)号：US20100069292A1
公开(公告)日：2010-03-18
申请号：US12552855
申请日：2009-09-02
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
CPC分类号： A61K47/02 , A61K9/0019 , A61K38/28 , A61K47/183
摘要： A clear basal insulin formulation composed of insulin (preferably human recombinant insulin), buffering agents, precipitating agents, and/or stabilizing agents 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, which can be varied by compositional changes to tailor the release profile to the needs of the individual diabetic patient
摘要翻译：由胰岛素（优选人重组胰岛素），缓冲剂，沉淀剂和/或用于皮下，皮内或肌内给药的稳定剂组成的清楚的基础胰岛素制剂。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”，这可以通过组合变化而变化，以根据个体糖尿病患者的需要调整释放曲线

4. 发明申请

US20090175840A1 INSULIN FORMULATIONS FOR INSULIN RELEASE AS A FUNCTION OF TISSUE GLUCOSE LEVELS 审中-公开
标题翻译：胰岛素释放作为组织葡萄糖水平的功能的胰岛素制剂
公开(公告)号：US20090175840A1
公开(公告)日：2009-07-09
申请号：US12348839
申请日：2009-01-05
申请人： Nandini Kashyap , Solomon S. Steiner , Roderike Pohl
发明人： Nandini Kashyap , Solomon S. Steiner , Roderike Pohl
IPC分类号： A61K38/44 , A61K38/28 , A61K38/43 , A61P3/10
CPC分类号： A61K9/0019 , A61K38/28 , A61K47/46
摘要： Injectable insulin formulations that are capable of modifying the amount of insulin released based on the patient's tissue glucose levels, methods for making and using these formulations are described herein. The formulation may be administered via subcutaneous, intradermal or intramuscular administration. In one preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin, an oxidizing agent or enzyme and a reducing agent or enzyme, a diluent and optionally one or more thickening agents. If a thickening agent is present in the formulation, the thickening agent increases the viscosity of the formulation following administration. Preferably the formulation contains an insulin, a diluent, glucose oxidase and peroxidase. Following administration to a patient, the insulin is released from the formulations as a function of the patient's tissue glucose level, which in turn maintains the patient's blood glucose level within an optimum range. The formulation is often referred to as a “smart” formulation since it modifies its release rate of insulin according to the patient's needs at a particular time. In a preferred embodiment, the formulation is designed to release insulin into the systemic circulation over time with a basal release profile following injection in a patient. In another embodiment, the formulation is designed to release insulin into the systemic circulation over time with a non-basal release profile following injection in a patient, such as a regular human insulin release profile or a prandial release profile.
摘要翻译：本文描述了能够改变基于患者组织葡萄糖水平释放的胰岛素量的可注射胰岛素制剂，制备和使用这些制剂的方法。制剂可以通过皮下，皮内或肌肉内施用来施用。在一个优选的实施方案中，通过皮下注射施用制剂。制剂含有胰岛素，氧化剂或酶，还原剂或酶，稀释剂和任选的一种或多种增稠剂。如果制剂中存在增稠剂，则增稠剂在给药后增加制剂的粘度。优选地，制剂含有胰岛素，稀释剂，葡萄糖氧化酶和过氧化物酶。在给予患者之后，胰岛素作为患者组织葡萄糖水平的函数从制剂中释放，其又将患者的血糖水平维持在最佳范围内。该制剂通常被称为“智能”制剂，因为其在特定时间根据患者的需要改变其胰岛素的释放速率。在优选的实施方案中，所述制剂被设计为在患者中注射后具有基础释放曲线随时间将胰岛素释放到全身循环中。在另一个实施方案中，所述制剂被设计成在患者注射后，例如常规人胰岛素释放曲线或餐时释放曲线，随着时间推移胰岛素进入体循环随着非基础释放曲线。

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