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    • 4. 发明申请
    • INSULIN FORMULATIONS FOR INSULIN RELEASE AS A FUNCTION OF TISSUE GLUCOSE LEVELS
    • 胰岛素释放作为组织葡萄糖水平的功能的胰岛素制剂
    • US20090175840A1
    • 2009-07-09
    • US12348839
    • 2009-01-05
    • Nandini KashyapSolomon S. SteinerRoderike Pohl
    • Nandini KashyapSolomon S. SteinerRoderike Pohl
    • A61K38/44A61K38/28A61K38/43A61P3/10
    • A61K9/0019A61K38/28A61K47/46
    • 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.
    • 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。
    • 6. 发明申请
    • INSULIN FORMULATIONS FOR RAPID UPTAKE
    • 胰岛素制剂用于快速摄取
    • US20100227795A1
    • 2010-09-09
    • US12397219
    • 2009-03-03
    • Solomon S. SteinerRoderike PohlMing LiRobert Hauser
    • Solomon S. SteinerRoderike PohlMing LiRobert Hauser
    • A61K38/28A61P3/10
    • A61K9/0019A61K38/00A61K38/28A61K47/12A61K47/183C07K14/62
    • 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.
    • 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。
    • 7. 发明授权
    • Insulin formulations for rapid uptake
    • 胰岛素配方快速吸收
    • US09060927B2
    • 2015-06-23
    • US12397219
    • 2009-03-03
    • Solomon S. SteinerRoderike PohlMing LiRobert Hauser
    • Solomon S. SteinerRoderike PohlMing LiRobert Hauser
    • A61K38/28C07K14/62A61K9/00A61K38/00
    • A61K9/0019A61K38/00A61K38/28A61K47/12A61K47/183C07K14/62
    • 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.
    • 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。