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1. 发明申请

WO2007041481A1 RAPID ACTING AND PROLONGED ACTING INSULIN PREPARATIONS 审中-公开
标题翻译：快速作用和促进胰岛素制备
公开(公告)号：WO2007041481A1
公开(公告)日：2007-04-12
申请号：PCT/US2006/038410
申请日：2006-09-29
申请人： BIODEL, INC. , STEINER, Solomon, S. , POHL, Roderike
发明人： STEINER, Solomon, S. , POHL, Roderike
IPC分类号： A61K38/28
CPC分类号： A61K38/28 , A61K9/0019 , A61K9/0031 , A61K9/0034 , A61K9/006 , A61K9/0075 , A61K9/0078 , A61K47/12 , A61K47/183
摘要： It has been discovered that by combining a chelator such as ethylenediaminetetraacetic acid with an acidifier such as citric acid, that the insulin is absorbed much more rapidly than in the absence of the chelator and acidifier. It has also been determined that by combining insulin with a chelator and acidifier, with a commercially available rapid, intermediate or long lasting insulin such as glargine, one can increase and/or prolong the bioavailability of the insulin mixture. The formulations are suitable for administration by injection or to a mucosal surface such as the pulmonary or oral regions, although subcutaneous injection is preferred.
摘要翻译：已经发现，通过将诸如乙二胺四乙酸的螯合剂与酸化剂如柠檬酸组合，胰岛素被吸收得比不存在螯合剂和酸化剂时快得多。还已经确定，通过将胰岛素与螯合剂和酸化剂与市售的快速，中等或长效胰岛素如甘精胰岛组合，可以增加和/或延长胰岛素混合物的生物利用度。制剂适合于通过注射施用或粘膜表面如肺部或口腔区域，尽管皮下注射是优选的。

2. 发明申请

WO2010102020A1 INSULIN FORMULATIONS FOR RAPID UPTAKE 审中-公开
标题翻译：胰岛素制剂用于快速摄取
公开(公告)号：WO2010102020A1
公开(公告)日：2010-09-10
申请号：PCT/US2010/026073
申请日：2010-03-03
申请人： BIODEL INC. , STEINER, Solomon, S. , POHL, Roderike , LI, Ming , HAUSER, Robert
发明人： STEINER, Solomon, S. , POHL, Roderike , LI, Ming , HAUSER, Robert
IPC分类号： A61K38/28 , A61K47/12 , A61K47/18 , A61K9/00
CPC分类号： A61K9/0019 , A61K38/00 , A61K38/28 , A61K47/12 , A61K47/183 , C07K14/62
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 or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection.
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。制剂含有胰岛素与螯合剂和溶解剂以及任选的其它赋形剂。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，这些制剂被迅速地吸收到血流中。

3. 发明申请

WO2009048959A1 RAPID ACTING INJECTABLE INSULIN COMPOSITIONS 审中-公开
标题翻译：快速注射胰岛素组合物
公开(公告)号：WO2009048959A1
公开(公告)日：2009-04-16
申请号：PCT/US2008/079213
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 , 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的胰岛素制剂。制剂可用于皮下，皮内或肌肉内给药。在优选的实施方案中，制剂通过皮下注射给药。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。当通过皮下注射给药时，这些制剂被迅速地吸收到血流中。在优选的实施方案中，将胰岛素作为无菌小瓶中的干粉提供。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。

4. 发明申请

WO2007121256A2 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：WO2007121256A2
公开(公告)日：2007-10-25
申请号：PCT/US2007/066452
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： Λ 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 moπomerie form by addition of a chelator such as KDTΛ. As.shown by the examples, the preferred acids are aspαrtie. malcic, succinic, glutamic and citric acid. l hese are added in addition to a chelator, preferably ethylenedianimetctraacctic acid (IiDTA). i he results show that the citric acid formulation was more effective ut dropping Ih e blood glucose rapidly than the identical rapid acting formulation prepared with I ICI in swine. Charge masking by the polyacid appears to be responsible for rapid insulin absorption, I7DTA Λ\as not effective when used with adipic acid, oxalic acid or 1 ICI at hastening the absorption of insulin, These results confirm the results seen in clinical subjects and patients with diabetes treated w ith the rapid αcÍna insulin in combination with citric acid and FJDTΛ.
摘要翻译：？已经开发了组合的快速胰岛素 - 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，长效益气碱仍然是可溶的，在优选实施方案中，该可注射的基础推注胰岛素在早餐之前施用，提供足够的推注胰岛素水平来覆盖膳食，不会产生低血糖，并且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体胰岛素中加入特定酸的重要性，以增加速度和吸收量，并通过加入KDTα等螯合剂解离成异构体形式来维持生物活性。如实施例所示，优选的酸是天冬氨酸。苹果酸，琥珀酸，谷氨酸和柠檬酸。除了螯合剂之外，还加入了一些，优选亚乙基二氢吡啶酸（IdDTA）。我结果显示，柠檬酸配方比用IICI在猪中制备的快速作用配方更为有效。多糖的电荷掩蔽似乎是快速胰岛素吸收的原因，当与己二酸，草酸或1个ICI一起使用时，加速胰岛素的吸收，I7DTA？\ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ 用快速胰岛素与柠檬酸和FJDT？联合治疗的糖尿病。

5. 发明申请

WO2007098058A2 METHOD AND 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方法和装置
公开(公告)号：WO2007098058A2
公开(公告)日：2007-08-30
申请号：PCT/US2007/004202
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. Preferably up to 4 mA of current are applied to the sublingual region. Different time ranges can be used to administer iontophoresis; preferably iontophoresis is administered for up to 2 minutes at a time. Any suitable device for administering iontophoresis to the sublingual region may be used. The preferred device is a hand-held device that contains a handle, two electrodes, 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. A kit contains the device for administering iontophoresis and one or more solid oral dosage forms, preferably in the form of one or more tabs or wafers. The tabs or wafers may be completely dissolvable or edible, or may contain a non-edible and non-dissolvable component. In a preferred embodiment, the solid oral dosage form contains insulin or an analog thereof and one or more excipients, preferably EDTA and citric acid.
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。优选地，最多将4mA的电流施加到舌下区域。不同的时间范围可用于管理离子电渗疗法; 优选每次一次给予离子电渗疗法达2分钟。可以使用用于向舌下区域施用离子电渗疗法的任何合适的装置。优选的装置是手持装置，其包括手柄，两个电极，其中一个电极位于手柄上，另一个电极连接到手柄的端部，并且连接到电源。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。试剂盒包含用于施用离子电渗疗法的装置和一种或多种固体口服剂型，优选以一个或多个片或晶片的形式。标签或晶片可以是完全可溶的或可食用的，或者可以包含不可食用和不可溶的组分。在优选的实施方案中，固体口服剂型含有胰岛素或其类似物和一种或多种赋形剂，优选EDTA和柠檬酸。

6. 发明申请

WO2005089722A1 RAPID ACTING DRUG DELIVERY COMPOSITIONS 审中-公开
标题翻译：快速行动药物输送组合物
公开(公告)号：WO2005089722A1
公开(公告)日：2005-09-29
申请号：PCT/US2005/008187
申请日：2005-03-11
申请人： BIODEL, INC. , POHL, Roderike , STEINER, Solomon, S.
发明人： POHL, Roderike , STEINER, Solomon, S.
IPC分类号： A61K9/20
CPC分类号： A61K9/006 , A61K9/0019 , A61K9/0056 , A61K38/28 , Y10S514/866 , Y10S514/951 , Y10S514/953 , Y10S514/959
摘要： Drug formulations for systemic drug delivery with improved stability and rapid onset of action are described herein. The formulations may be administered via buccal administration, sublingual administration, pulmonary delivery, nasal administration, subcutaneous administration, rectal administration, vaginal administration, or ocular administration. In the preferred embodiments, the formulations are administered sublingually or via subcutaneous injection. The formulations contain an active agent and one or more excipients, selected to increase the rate of dissolution. In the preferred embodiment, the drug is insulin, and the excipients include a metal chelator such as EDTA and an acid such as citric acid.
摘要翻译：本文描述了具有改善的稳定性和快速起效的全身药物递送的药物制剂。制剂可以通过口腔给药，舌下给药，肺部输送，鼻内给药，皮下给药，直肠给药，阴道给药或眼部给药来施用。在优选的实施方案中，制剂是舌下给药或通过皮下注射给药。制剂含有活性剂和一种或多种赋形剂，其被选择以增加溶解速率。在优选的实施方案中，药物是胰岛素，赋形剂包括金属螯合剂如EDTA和酸如柠檬酸。

7. 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。

8. 发明申请

WO2009048945A8 RAPID MUCOSAL GEL OR FILM INSULIN COMPOSITIONS 审中-公开
公开(公告)号：WO2009048945A8
公开(公告)日：2009-04-16
申请号：PCT/US2008/079196
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 , A61K38/47 , A61K47/12
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.

9. 发明申请

WO2005072803A1 SUBLINGUAL DRUG DELIVERY DEVICE 审中-公开
标题翻译：次级药物递送装置
公开(公告)号：WO2005072803A1
公开(公告)日：2005-08-11
申请号：PCT/US2005/001351
申请日：2005-01-18
申请人： BIODEL INC. , STEINER, Solomon, S. , BROWN, Craig , POHL, Roderike , POOLE, Trent , STEINER, Erik
发明人： STEINER, Solomon, S. , BROWN, Craig , POHL, Roderike , POOLE, Trent , STEINER, Erik
IPC分类号： A61M15/00
CPC分类号： A61M11/00 , A61M15/0028 , A61M15/0048 , A61M15/0051 , A61M2202/064 , A61M2205/073 , A61M2205/8225
摘要： A drug delivery device that aerosolizes a dry powder formulation so that it forms a fine coating in the oral cavity and, more specifically, in the sublingual region of the oral cavity is described herein. In the preferred embodiment, the device contains five main parts: a compressed gas canister, (14) a dispenser body (10) a means for storing one or more doses of a drug formulation (16), a means for releasing a dose of the drug formulation such as a gas canister or spring piston and a mouthpiece (12). Preferred configurations include circular, tubular, and rectangular. The means for storing the drug formulation may be configured to separately store one or more materials. In the form of one or more drug discs or a ribbon containing a plurality of blister packs, or in the form of a dosage cartridge containing a single dose of the drug formulation.
摘要翻译：本文描述了使干燥粉末制剂气雾化以使其在口腔中，更具体地在口腔舌下区域中形成细小涂层的药物递送装置。在优选实施例中，该装置包含五个主要部分：压缩气体罐，（14）分配器主体（10）用于存储一个或多个剂量的药物制剂（16）的装置，用于释放剂量的药物制剂如气体罐或弹簧活塞以及吸嘴（12）。优选的构造包括圆形，管状和矩形。用于储存药物制剂的方法可以被配置成分开存储一种或多种材料。以一种或多种药物盘或含有多个泡罩包装的带的形式，或以含有单剂量药物制剂的剂量盒形式。

10. 发明申请

WO2012006283A1 COMPOSITIONS AND METHODS FOR MODULATING THE PHARMACOKINETICS AND PHARMACODYNAMICS OF INSULIN 审中-公开
标题翻译：调节胰岛素药物动力学和药物动力学的组合物和方法
公开(公告)号：WO2012006283A1
公开(公告)日：2012-01-12
申请号：PCT/US2011/042957
申请日：2011-07-05
申请人： BIODEL INC. , POHL, Roderike , STEINER, Solomon, S. , HAUSER, Robert , SEIBERT, Richard , LI, Ming
发明人： POHL, Roderike , STEINER, Solomon, S. , HAUSER, Robert , SEIBERT, Richard , LI, Ming
IPC分类号： A61K38/28 , C07K14/62
CPC分类号： C07K14/62 , A61K9/0019 , A61K38/28 , A61K47/183
摘要： Compositions and methods for modulating the pharmacokinetics and pharmacodynamics of rapid acting injectable insulin formulations are described herein. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a zinc chelator such as ethylenediaminetetraacetic acid ("EDTA") and a dissolution/stabilization agent, and optionally additional excipients. Calcium disodium EDTA is less likely to remove calcium from the body, and typically has less pain on injection in the subcutaneous tissue. Modulating the type and quantity of EDTA can change the insulin absorption profile. Increasing the quantity of citrate can further enhance absorption and chemically stabilize the formulation. In the preferred embodiment, the formulation contains human insulin, calcium disodium EDTA and a dissolution/stabilization agent such as citric acid or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection.
摘要翻译：本文描述了用于调节快速作用的可注射胰岛素制剂的药代动力学和药效学的组合物和方法。在优选的实施方案中，通过皮下注射施用制剂。制剂含有与锌螯合剂如乙二胺四乙酸（“EDTA”）和溶解/稳定剂以及任选的其它赋形剂组合的胰岛素。 EDTA二钠不太可能从体内去除钙，并且通常在皮下组织中注射时疼痛较少。调节EDTA的类型和数量可以改变胰岛素吸收特征。增加柠檬酸盐的量可以进一步增强吸收和化学稳定制剂。在优选的实施方案中，制剂含有人胰岛素，EDTA二钠钙和溶解/稳定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。

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