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    Method and Device for Sublingual Drug Delivery Using Iontophoresis
    1.
    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

    申请人： Solomon Steiner ,  Robert Feldstein ,  Roderike Pohl ,  David Rhodes ,  Erik Steiner

    发明人： Solomon Steiner ,  Robert Feldstein ,  Roderike Pohl ,  David Rhodes ,  Erik Steiner

    IPC分类号： A61N1/30

    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。 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。

    STABILIZED GLUCAGON SOLUTIONS
    8.
    发明申请
    STABILIZED GLUCAGON SOLUTIONS 审中-公开
    稳定的GLUCAGON解决方案

    公开(公告)号：US20110097386A1

    公开(公告)日：2011-04-28

    申请号：US12715203

    申请日：2010-03-01

    申请人： Solomon S. Steiner ,  Robert Hauser ,  Ming Li ,  Robert Feldstein ,  Roderike Pohl

    发明人： Solomon S. Steiner ,  Robert Hauser ,  Ming Li ,  Robert Feldstein ,  Roderike Pohl

    IPC分类号： A61K38/26 ,  A61K9/127 ,  A61P3/08

    CPC分类号： A61K38/26 ,  A61K9/0019 ,  A61K9/1075 ,  A61K9/127 ,  A61K9/19 ,  A61K47/24

    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 37° C.

    摘要翻译： 已经设计了由糖如葡萄糖和表面活性剂如肉豆蔻酰溶血磷脂酰胆碱（LMPC）组成的制剂，以在长时间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，其浓度与pH和pH足够相似， 血浆的渗透压，以免诱发或最小化部位刺激。 单糖和表面活性剂的组合使得胰高血糖素分子在37℃下在水溶液中稳定7天。

    Methods for fine powder formation
    10.
    发明申请
    Methods for fine powder formation 有权

    公开(公告)号：US20060191375A1

    公开(公告)日：2006-08-31

    申请号：US11385513

    申请日：2006-03-21

    申请人： Robert Feldstein ,  Solomon Steiner

    发明人： Robert Feldstein ,  Solomon Steiner

    IPC分类号： B22F9/08

    CPC分类号： A61K9/0073 ,  A61K9/1652 ,  A61K9/1658 ,  A61K9/1688 ,  A61K9/1694 ,  F26B5/065

    摘要： Improved methods for forming fine particles of a material have been developed, wherein the method steps include dissolving the material in a solvent to form a dilute solution, immobilizing the dilution solution, and then removing the solvent to yield particles of the material. Methods of immobilizing the dilute solution include freezing, gelation, and chelation. In a preferred embodiment, the immobilized solvent is removed by lyophilization, i.e. reducing the ambient pressure while avoiding application of sufficient heat to power a phase transition. Essentially any material and solvent for the material can be used in the methods described herein. Proteins and peptides in an aqueous solvent are the preferred systems.