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1. 发明申请

WO2011156476A2 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：WO2011156476A2
公开(公告)日：2011-12-15
申请号：PCT/US2011039608
申请日：2011-06-08
申请人： BIODEL INC , POHL RODERIKE , KASHYAP NANDINI , HAUSER ROBERT , OZHAN KORAY , STEINER SOLOMON S
发明人： POHL RODERIKE , KASHYAP NANDINI , HAUSER ROBERT , OZHAN KORAY , STEINER SOLOMON S
IPC分类号： A61K38/28
CPC分类号： A61K38/28
摘要： A basal insulin formulation composed of insulin (preferably human recombinant insulin), buffering agents, precipitating agents, and/or stabilizing agents for subcutaneous, intradermal or intramuscular administration. In one embodiment, 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. In one embodiment, the insulin formulation is prepared as a suspension for subcutaneous or intramuscular injection at neutral pH (e.g. pH 7), containing human recombinant insulin, a zinc compound, preferably zinc chloride, and a pH buffering agent, preferably sodium acetate. The suspension contains precipitated insulin particles prior to injection and provides a sustained release basal insulin profile following injection.
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基础胰岛素制剂。在一个实施方案中，将该制剂设计成在注射后形成胰岛素沉淀物，在12至24小时的时间段内产生缓慢释放的“基础胰岛素”。在一个实施方案中，胰岛素制剂制备为用于在含有人重组胰岛素，锌化合物，优选氯化锌和pH缓冲剂，优选乙酸钠的中性pH（例如pH 7）下皮下或肌内注射的悬浮液。注射前悬浮液含有沉淀的胰岛素颗粒，并在注射后提供持续释放的基础胰岛素分布。

2. 发明申请

WO2010028055A1 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：WO2010028055A1
公开(公告)日：2010-03-11
申请号：PCT/US2009/055746
申请日：2009-09-02
申请人： BIODEL, INC. , POHL, Roderike , KASHYAP, Nandini , HAUSER, Robert , OZHAN, Koray , STEINER, Solomon, S.
发明人： POHL, Roderike , KASHYAP, Nandini , HAUSER, Robert , OZHAN, Koray , STEINER, Solomon, S.
IPC分类号： A61K9/00 , A61K45/06 , 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。

3. 发明申请

WO2011156476A3 INSULIN WITH A BASAL RELEASE PROFILE 审中-公开
公开(公告)号：WO2011156476A3
公开(公告)日：2011-12-15
申请号：PCT/US2011/039608
申请日：2011-06-08
申请人： BIODEL INC. , POHL, Roderike , KASHYAP, Nandini , HAUSER, Robert , OZHAN, Koray , STEINER, Solomon, S.
发明人： POHL, Roderike , KASHYAP, Nandini , HAUSER, Robert , OZHAN, Koray , STEINER, Solomon, S.
IPC分类号： A61K38/28
摘要： A basal insulin formulation composed of insulin (preferably human recombinant insulin), buffering agents, precipitating agents, and/or stabilizing agents for subcutaneous, intradermal or intramuscular administration. In one embodiment, 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. In one embodiment, the insulin formulation is prepared as a suspension for subcutaneous or intramuscular injection at neutral pH (e.g. pH 7), containing human recombinant insulin, a zinc compound, preferably zinc chloride, and a pH buffering agent, preferably sodium acetate. The suspension contains precipitated insulin particles prior to injection and provides a sustained release basal insulin profile following injection.

4. 发明申请

WO2011143421A1 INSULIN WITH A STABLE BASAL RELEASE PROFILE 审中-公开
标题翻译：胰岛素具有稳定的基本释放特征
公开(公告)号：WO2011143421A1
公开(公告)日：2011-11-17
申请号：PCT/US2011/036241
申请日：2011-05-12
申请人： BIODEL INC. , POHL, Roderike , KASHYAP, Nandini , HAUSER, Robert , OZHAN, Koray , STEINER, Solomon, S.
发明人： POHL, Roderike , KASHYAP, Nandini , HAUSER, Robert , OZHAN, Koray , STEINER, Solomon, S.
IPC分类号： A61K38/28 , A61K47/02 , A61K9/00 , A61K47/12 , A61K47/36
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”。

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