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    INSULIN FORMULATIONS FOR RAPID UPTAKE
    2.
    发明申请
    INSULIN FORMULATIONS FOR RAPID UPTAKE 有权
    胰岛素制剂用于快速摄取

    公开(公告)号：US20100227795A1

    公开(公告)日：2010-09-09

    申请号：US12397219

    申请日：2009-03-03

    Applicant: Solomon S. Steiner ,  Roderike Pohl ,  Ming Li ,  Robert Hauser

    Inventor： Solomon S. Steiner ,  Roderike Pohl ,  Ming Li ,  Robert Hauser

    IPC: A61K38/28 ,  A61P3/10

    CPC classification number: A61K9/0019 ,  A61K38/00 ,  A61K38/28 ,  A61K47/12 ,  A61K47/183 ,  C07K14/62

    Abstract: 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.

    Abstract translation: 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。

    RAPID ACTING AND LONG ACTING INSULIN COMBINATION FORMULATIONS
    3.
    发明申请
    RAPID ACTING AND LONG ACTING INSULIN COMBINATION FORMULATIONS 有权
    快速行动和长期行动胰岛素组合制剂

    公开(公告)号：US20090137455A1

    公开(公告)日：2009-05-28

    申请号：US12324717

    申请日：2008-11-26

    Applicant: Solomon S. Steiner ,  Roderike Pohl

    Inventor： Solomon S. Steiner ,  Roderike Pohl

    IPC: A61K38/28 ,  A61P3/00

    CPC classification number: A61K31/185 ,  A61K9/0014 ,  A61K31/19 ,  A61K31/385 ,  A61K38/28 ,  A61K47/02 ,  A61K47/10 ,  A61K47/12 ,  A61K47/18 ,  A61K47/183 ,  A61K47/26 ,  A61K2300/00

    Abstract: An injectable formulation containing a combination of a rapid acting insulin and a long acting insulin has been developed wherein the pH of the rapid acting insulin is adjusted so that the long acting insulin, e.g. insulin glargine, remains soluble when they are mixed together. In the preferred embodiment, this injectable basal bolus insulin is administered before breakfast, provides adequate bolus insulin levels to cover the meal, does not produce hypoglycemia after the meal and provides adequate basal insulin for up to 24 hours. Lunch and dinner can be covered by two bolus injections of a fast acting, or a rapid acting or a very rapid acting insulin. Alternatively, through adjustment of the ratio of rapid acting insulin to long acting insulin, the long acting insulin may be shortened to a 12 hour formulation. This rapid and long acting blend is re-administered to the patient at dinner time, providing a safe and effective basal insulin level until morning. As a result, a patient using intensive insulin therapy should only inject three, rather than four, times a day.

    Abstract translation: 已经开发了含有快速作用的胰岛素和长效胰岛素的组合的可注射制剂，其中调节快速作用的胰岛素的pH，使得长效胰岛素例如。 甘精胰岛素，当它们混合在一起时，保持可溶。 在优选的实施方案中，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以覆盖膳食，在餐后不产生低血糖并提供足够的基础胰岛素达24小时。 午餐和晚餐可以通过快速作用或快速作用或非常快速作用的胰岛素的两次快速注射来覆盖。 或者，通过调整速效胰岛素与长效胰岛素的比例，长效胰岛素可缩短至12小时制剂。 这种快速和长效的混合物在晚餐时间重新施用于患者，提供安全有效的基础胰岛素水平直到早晨。 因此，使用强化胰岛素治疗的患者每天只能注射三次，而不是四次。

    Compositions for treatment or prevention of bioterrorism
    4.
    发明授权
    Compositions for treatment or prevention of bioterrorism 有权
    用于治疗或预防生物恐怖主义的组成部分

    公开(公告)号：US06991779B2

    公开(公告)日：2006-01-31

    申请号：US10347932

    申请日：2003-01-17

    Applicant: Solomon S. Steiner ,  Cohava Gelber ,  Robert S. Feldstein ,  Roderike Pohl

    Inventor： Solomon S. Steiner ,  Cohava Gelber ,  Robert S. Feldstein ,  Roderike Pohl

    IPC: A61K9/12 ,  A61K9/72

    CPC classification number: A61K9/0075 ,  A61K9/1617 ,  A61K9/1641 ,  A61K31/46 ,  A61K31/495 ,  A61K39/00 ,  A61K39/07 ,  A61K2039/505 ,  A61K2039/55555 ,  C07K16/12

    Abstract: Compositions containing biologically active molecules encapsulated in self-assembling, diketopiperazine microspheres (TECHNOSPHEREs™) and methods for making and administering such compositions are described herein. The compositions can be used to immunize individuals against agents of biological warfare. The biologically active molecules include atropine, antibodies, antigens, and antibiotics. The compositions can be placed in an inhalation device for self-administration. Pulmonary delivery of TECHNOSPHERE™ encapsulated atropine, antibodies, vaccines, and antibiotics provides an accelerated onset of immunity to the targeted disease. Furthermore, the TECHNOSPHERE™ encapsulated atropine, antibodies, vaccines, and antibiotics are stable formulations, suitable for stockpiling, rapid dissemination and mass treatment.

    Abstract translation: 包含自组装，二酮哌嗪微球体（TECHNOSPHERE TM）中的生物活性分子的组合物以及制备和施用此类组合物的方法在本文中描述。 组合物可用于免疫个体对生物战的药剂。 生物活性分子包括阿托品，抗体，抗原和抗生素。 组合物可以放置在用于自我给药的吸入装置中。 包含阿托品，抗体，疫苗和抗生素的TECHNOSPHERE TM的肺转运提供了对目标疾病免疫的加速发作。 此外，TECHNOSPHERE（TM）包裹阿托品，抗体，疫苗和抗生素是稳定的配方，适合储存，快速传播和大量治疗。

    Rapid Mucosal Gel or Film Insulin Compositions
    7.
    发明申请
    Rapid Mucosal Gel or Film Insulin Compositions 审中-公开
    快速粘膜凝胶或薄膜胰岛素组合物

    公开(公告)号：US20080085298A1

    公开(公告)日：2008-04-10

    申请号：US11869724

    申请日：2007-10-09

    Applicant: Roderike Pohl ,  Solomon Steiner

    Inventor： Roderike Pohl ,  Solomon Steiner

    IPC: A61K38/28 ,  A61K9/70 ,  A61P3/00

    CPC classification number: A61K9/0056 ,  A61K9/006 ,  A61K9/06 ,  A61K9/107 ,  A61K38/28 ,  A61K47/12 ,  A61K47/183 ,  A61K2300/00

    Abstract: 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.

    Abstract translation: 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。

    Method and Device for Sublingual Drug Delivery Using Iontophoresis
    8.
    发明申请
    Method and Device for Sublingual Drug Delivery Using Iontophoresis 审中-公开
    使用离子电渗法进行舌下给药的方法和装置

    公开(公告)号：US20070191757A1

    公开(公告)日：2007-08-16

    申请号：US11675430

    申请日：2007-02-15

    Applicant: Solomon Steiner ,  Robert Feldstein ,  Roderike Pohl ,  David Rhodes ,  Erik Steiner

    Inventor： Solomon Steiner ,  Robert Feldstein ,  Roderike Pohl ,  David Rhodes ,  Erik Steiner

    IPC: A61N1/30

    CPC classification number: A61N1/306 ,  A61M2210/0625 ,  A61M2210/0643

    Abstract: 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.

    Abstract translation: 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。 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中并施用离子电渗疗法适当的时间段来向舌下施用活性剂。 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。

    Sublingual drug delivery device
    9.
    发明申请
    Sublingual drug delivery device 失效
    舌下给药装置

    公开(公告)号：US20050155601A1

    公开(公告)日：2005-07-21

    申请号：US11037737

    申请日：2005-01-18

    Applicant: Solomon Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

    Inventor： Solomon Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

    IPC: A61K9/14 ,  A61L9/04 ,  A61M11/00 ,  A61M15/00

    CPC classification number: A61M11/00 ,  A61M15/0028 ,  A61M15/0048 ,  A61M15/0051 ,  A61M2202/064 ,  A61M2205/073 ,  A61M2205/8225

    Abstract: 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: (i) a compressed gas canister, (ii) a dispenser body (also referred to herein as the main housing), (iii) a means for storing one or more doses of a drug formulation, (iv) a means for releasing a dose of the drug formulation such as a gas canister or spring piston and (v) a mouthpiece. 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 one embodiment, the means for storing the active agent is in the form of one or more drug discs, where the drug discs contain a plurality of blister packs, each storing one dose of the drug formulation. In another embodiment, the means for storing the active agent is a dosage cartridge containing a single dose of the drug formulation. In yet another embodiment, the drug formulation is stored on a ribbon containing a plurality of blister packs, each storing one dose of the drug formulation.

    Abstract translation: 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：（i）压缩气体罐，（ii）分配器主体（在本文中也称为主壳体），（iii）用于存储一个或多个剂量的 药物制剂，（iv）用于释放剂量的药物制剂如气体罐或弹簧活塞的装置，（v）口器。 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。 在一个实施方案中，用于储存活性剂的装置是一种或多种药物盘的形式，其中药物盘包含多个泡罩包装，每个存储一剂药物制剂。 在另一个实施方案中，用于储存活性剂的装置是含有单剂量药物制剂的剂量筒。 在另一个实施方案中，药物制剂储存在含有多个泡罩包装的条带上，每个存在一剂药物制剂。

    Sublingual drug delivery device
    10.
    发明授权
    Sublingual drug delivery device 失效
    舌下给药装置

    公开(公告)号：US07658721B2

    公开(公告)日：2010-02-09

    申请号：US11037737

    申请日：2005-01-18

    Applicant: Solomon S. Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

    Inventor： Solomon S. Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

    IPC: A61M37/00 ,  A61M15/00 ,  A61M16/10 ,  A61M16/00 ,  A61M11/00

    CPC classification number: A61M11/00 ,  A61M15/0028 ,  A61M15/0048 ,  A61M15/0051 ,  A61M2202/064 ,  A61M2205/073 ,  A61M2205/8225

    Abstract: 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: (i) a compressed gas canister, (ii) a dispenser body (also referred to herein as the main housing ), (iii) a means for storing one or more doses of a drug formulation, (iv) a means for releasing a dose of the drug formulation such as a gas canister or spring piston and (v) a mouthpiece. 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 one embodiment, the means for storing the active agent is in the form of one or more drug discs, where the drug discs contain a plurality of blister packs, each storing one dose of the drug formulation. In another embodiment, the means for storing the active agent is a dosage cartridge containing a single dose of the drug formulation. In yet another embodiment, the drug formulation is stored on a ribbon containing a plurality of blister packs, each storing one dose of the drug formulation.

    Abstract translation: 本文描述了使干燥粉末制剂雾化以使其在口腔中形成细小涂层并且更具体地在口腔的舌下区域中的药物递送装置。 在优选实施例中，该装置包含五个主要部分：（i）压缩气体罐，（ii）分配器主体（在本文中也称为主壳体），（iii）用于存储一个或多个剂量的 药物制剂，（iv）用于释放剂量的药物制剂如气体罐或弹簧活塞的装置，（v）口器。 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。 在一个实施方案中，用于储存活性剂的装置是一种或多种药物盘的形式，其中药物盘包含多个泡罩包装，每个存储一剂药物制剂。 在另一个实施方案中，用于储存活性剂的装置是含有单剂量药物制剂的剂量筒。 在另一个实施方案中，药物制剂储存在含有多个泡罩包装的条带上，每个存在一剂药物制剂。

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