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1. 发明申请

WO2009048945A1 RAPID MUCOSAL GEL OR FILM INSULIN COMPOSITIONS 审中-公开
标题翻译：快速粘膜凝胶或薄膜胰岛素组合物
公开(公告)号：WO2009048945A1
公开(公告)日：2009-04-16
申请号：PCT/US2008079196
申请日：2008-10-08
申请人： BIODEL INC , POHL RODERIKE , STEINER SOLOMON S
发明人： POHL RODERIKE , STEINER SOLOMON S
IPC分类号： A61P3/10 , A61K9/00 , A61K9/14 , A61K9/20 , A61K9/48 , A61K38/18 , A61K38/19 , A61K38/20 , A61K38/23 , A61K38/26 , A61K38/27 , A61K38/28 , A61K38/29 , A61K38/47 , A61K47/12
CPC分类号： A61K9/0056 , A61K9/006 , A61K9/06 , A61K9/107 , A61K38/28 , A61K47/12 , A61K47/18 , A61K47/183
摘要： Gel, powder, suspension, emulsions or film formulations for systemic delivery of insulin with improved stability and rapid onset of action are described herein. The formulations are preferably absorbed to a mucosal surface, most preferably via buccal or sublingual administration, although rectal, vaginal, nasal or ocular administration is possible. 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. Following administration, these formulations are rapidly absorbed into the blood stream. The formulation is preferably a polymeric gel, powder or film which adheres to the mucosal surface, thereby enhancing uptake of the incorporated drug. In the preferred embodiment, this formulation is administered sublingually, most preferably before a meal or after a meal.
摘要翻译：本文描述了具有改善的稳定性和快速起效的胰岛素全身递送的凝胶，粉末，悬浮液，乳剂或膜制剂。制剂优选被吸收到粘膜表面，最优选通过颊或舌下施用，尽管可以进行直肠，阴道，鼻或眼睛给药。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。给药后，这些制剂被快速吸收到血液中。制剂优选是粘附到粘膜表面的聚合物凝胶，粉末或膜，从而增强所掺入的药物的摄取。在优选的实施方案中，该制剂是舌下给药，最优选在饭前或饭后服用的。

2. 发明申请

WO2011049713A3 STABILIZED GLUCAGON SOLUTIONS 审中-公开
标题翻译：稳定的胰高血糖素溶液
公开(公告)号：WO2011049713A3
公开(公告)日：2011-12-01
申请号：PCT/US2010050386
申请日：2010-09-27
申请人： BIODEL INC , STEINER SOLOMON S , HAUSER ROBERT , LI MING , FELDSTEIN ROBERT , POHL RODERIKE
发明人： STEINER SOLOMON S , HAUSER ROBERT , LI MING , FELDSTEIN ROBERT , POHL RODERIKE
IPC分类号： A61K38/26 , A61K9/00 , A61K9/107 , A61K47/24 , A61K47/26
CPC分类号： A61K9/0019 , A61K9/1075 , A61K38/26 , A61K47/24 , A61K47/26
摘要： A formulation composed of a sugar such as glucose and a surfactant such as myristoyl lysophosphocholine (LMPC) has been designed to stabilize both hydrophilic and hydrophobic portions of the glucagon molecule, under prolonged physiological conditions, in a formulation that is sufficiently similar to the pH and osmolarity of plasma so as not to induce or to minimize site irritation. The combination of a simple sugar and an surfactant stabilizes the glucagon molecule in an aqueous solution for seven days at 370C.
摘要翻译：已经设计了由诸如葡萄糖之类的糖和诸如肉豆蔻酰基溶血磷酸胆碱（LMPC）之类的表面活性剂组成的制剂，以在延长的生理条件下稳定胰高血糖素分子的亲水部分和疏水部分两者，等离子体的渗透压以免诱发或最小化部位刺激。单糖和表面活性剂的组合使胰高血糖素分子在37℃水溶液中稳定7天。

3. 发明申请

WO2007121256A3 RAPID ACTING AND LONG ACTING INSULIN COMBINATION FORMULATIONS 审中-公开
标题翻译：快速行动和长期行动胰岛素组合制剂
公开(公告)号：WO2007121256A3
公开(公告)日：2008-07-10
申请号：PCT/US2007066452
申请日：2007-04-11
申请人： BIODEL INC , STEINER SOLOMON S , POHL RODERIKE
发明人： STEINER SOLOMON S , POHL RODERIKE
IPC分类号： A61K38/28 , A61P3/10
CPC分类号： A61K38/28 , A61K9/0019 , A61K9/0031 , A61K9/0034 , A61K9/0043 , A61K9/006 , A61K47/12 , A61K47/183
摘要： Lambda combined rapid ueting-long acting insulin formulation has been developed wherein the pll of the rapid acting insulin is adjusted so that the long acting giargine remains soluble when they are mixed together, tn the preferred embodiment, this injectable basal bolus insulin, is administered before breakfast, prm ides adequate bolus insulin levels to cover the meal, does not produce hypogly cemia alter tbc 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 v ery rapid acting insulin. As a result, a patieni using intensive insulin iherap) should only inject three, rather than four, times a day. Fxperiments have been performed to demonstrate the importance of the addition of specific acids to hexameric insulin to enhance speed and amount of absorption and preserve bioactivity follow ing dissociation into the mopiomerie form by addition of a chelator such as KDTLambda.
摘要翻译：已经开发了Lambda组合的快速作用的长效胰岛素制剂，其中调节快速作用的胰岛素的pll，使得当它们混合在一起时，长效的合成谷氨酸保持溶解，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，适量推注胰岛素水平以覆盖膳食，不会产生低血糖变化tbc餐，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快速作用的胰岛素的两次快速注射来覆盖。因此，一个使用强化胰岛素的陪审员）只能每天注射三次，而不是四次。已经进行了实验以证明向六聚胰岛素中添加特定酸的重要性，以增加速度和吸收量，并通过加入KDTLambda等螯合剂解离成莫曲霉形式来维持生物活性。

4. 发明申请

WO2007098058A3 DEVICE FOR SUBLINGUAL DRUG DELIVERY USING IONTOPHORESIS 审中-公开
标题翻译：使用IOPOPHORESIS进行次级药物递送的设备
公开(公告)号：WO2007098058A3
公开(公告)日：2007-10-18
申请号：PCT/US2007004202
申请日：2007-02-15
申请人： BIODEL INC , STEINER SOLOMON S , FELDSTEIN ROBERT , POHL RODERIKE , RHODES DAVID , STEINER ERIK
发明人： STEINER SOLOMON S , FELDSTEIN ROBERT , POHL RODERIKE , RHODES DAVID , STEINER ERIK
IPC分类号： A61N1/30 , A61M37/00
CPC分类号： A61N1/306 , A61M2210/0625 , A61M2210/0643
摘要： Methods, devices and kits for sublingual drug delivery using iontophoresis are described herein. An active agent can be administered sublingually by placing a solid oral dosage form containing the active agent in the sublingual region of a patient and applying iontophoresis for a suitable period of time. The preferred device is a hand-held device (10) that contains a handle (12) , two electrodes (20, 30) , one of which is located on the handle and the other of which is attached to the end of the handle, and a connection to a power source. Optionally, the device contains a timer, which can be used turn off the current at a preset time. The device can be used to administer an active agent by iontophoresis to the sublingual region of a patient, by attaching the second electrode of the device to a solid oral dosage form containing the active agent to be administered.
摘要翻译：本文描述了使用离子电渗法进行舌下药物递送的方法，装置和试剂盒。活性剂可以通过将含有活性剂的固体口服剂型置于患者的舌下区域并施用离子电渗疗法适当的时间段来进行舌下给药。优选的装置是手持式装置（10），其包括手柄（12），两个电极（20,30），其中一个电极位于手柄上，另一个电极附接到手柄的端部，以及与电源的连接。可选地，设备包含定时器，其可以在预设时间关闭电流。该装置可用于通过将装置的第二电极连接到含有待施用的活性剂的固体口服剂型，通过离子电渗法向患者的舌下区域施用活性剂。

5. 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。

6. 发明申请

WO2009048959A8 RAPID ACTING INJECTABLE INSULIN COMPOSITIONS 审中-公开
标题翻译：快速活动注射胰岛素组合物
公开(公告)号：WO2009048959A8
公开(公告)日：2009-05-28
申请号：PCT/US2008079213
申请日：2008-10-08
申请人： BIODEL INC , POHL RODERIKE , STEINER SOLOMON S
发明人： POHL RODERIKE , STEINER SOLOMON S
IPC分类号： A61P3/10 , A61K9/00 , A61K9/14 , A61K9/20 , A61K9/48 , A61K38/18 , A61K38/19 , A61K38/20 , A61K38/23 , A61K38/26 , A61K38/27 , A61K38/28 , A61K38/29 , A61K38/47 , A61K47/12
CPC分类号： A61K47/183 , A61K9/0056 , A61K38/28 , A61K47/12 , A61K2300/00
摘要： 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. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection, In the preferred embodiment, the insulin is provided as a dry 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.
摘要翻译：本文描述了具有改善的稳定性和快速起效的可注射胰岛素制剂。该制剂可以用于皮下，皮内或肌肉内施用。在优选的实施方案中，制剂通过皮下注射施用。该制剂含有胰岛素与螯合剂和溶解剂以及任选的其他赋形剂。在优选的实施方案中，制剂含有人胰岛素，锌螯合剂例如EDTA和溶解剂例如柠檬酸。当通过皮下注射施用时，这些制剂迅速被吸收到血流中。在优选的实施方案中，胰岛素以无菌小瓶中的干粉提供。在施用之前或施用时，将其与含有药学上可接受的载体如水，锌螯合剂如EDTA和稀释剂如柠檬酸的稀释剂混合。在另一个实施方案中，胰岛素作为冷冻混合物储存，准备在解冻时使用。

7. 发明申请

WO2005023348A2 UNIT DOSE CARTRIDGE AND DRY POWDER INHALER 审中-公开
标题翻译：单位剂量桶和干粉吸入器
公开(公告)号：WO2005023348A2
公开(公告)日：2005-03-17
申请号：PCT/US2004028699
申请日：2004-09-03
申请人： MANNKIND CORP , STEINER SOLOMON S , POOLE TRENT A , FOG PER B , POHL RODERIKE , CRICK MICHAEL , FELDSTEIN ROBERT
发明人： STEINER SOLOMON S , POOLE TRENT A , FOG PER B , POHL RODERIKE , CRICK MICHAEL , FELDSTEIN ROBERT
IPC分类号： A61M15/00
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。

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