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    Preservative-free Treprostinil Formulations and Methods and Devices for Use with Same
    2.
    发明申请
    Preservative-free Treprostinil Formulations and Methods and Devices for Use with Same 审中-公开

    公开(公告)号：US20170340647A1

    公开(公告)日：2017-11-30

    申请号：US15528452

    申请日：2015-11-15

    Applicant: SteadyMed Ltd.

    Inventor： Jonathan Rigby ,  Peter Noymer ,  Robert Zwolinski

    IPC: A61K31/5575 ,  C07C39/17 ,  A61K9/00 ,  A61M5/142 ,  C07C405/00 ,  C07C59/72

    CPC classification number: A61K31/5575 ,  A61K9/0019 ,  A61M5/14248 ,  C07C39/17 ,  C07C59/72 ,  C07C405/0075

    Abstract: This invention provides for a unit dosage form of treprostinil at a dosage of between 0.1 mg/mL and 25 mg/mL in a sterile fluid composition formulated for subcutaneous or intravenous injection, which composition does not comprise an antimicrobial preservative. Selectively activatable patch-pump assemblies comprising a sealed prefilled drug-reservoir containing the unit dosage form is described as are methods for reducing pain at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof, and methods of reducing irritation, inflammation or a combination thereof at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof. The invention also provides a method of treating pulmonary hypertension, and methods for treating, or reducing the severity or reducing the pathogenesis of Pulmonary arterial hypertension (PAH) in a subject making use of the compositions as herein described.

    INFUSION SET
    3.
    发明申请
    INFUSION SET 审中-公开
    输液套装

    公开(公告)号：US20160361491A1

    公开(公告)日：2016-12-15

    申请号：US14737204

    申请日：2015-06-11

    Applicant: STEADYMED LTD.

    Inventor： Assaf Shaked ,  Inna Dekel ,  Jon Guillaume Jamin ,  Stephen Edward Augustyn ,  Stewart Maddison Fox ,  Peter Noymer

    IPC: A61M5/168 ,  A61M39/12 ,  A61M39/08 ,  A61M5/14 ,  A61M5/145

    Abstract: An exemplary infusion set includes a tubing, a first connector, and a second connector. The first connector connects a first terminus of the tubing to an exit port of an infusion pump, providing fluid communication between fluid being conveyed by the infusion pump and the tubing. The second connector connects a second terminus of the tubing to a delivery module, providing fluid communication between the tubing and the delivery module. Full engagement of the first connector and the exit port of the infusion pump actuates operation of the infusion pump.

    Abstract translation: 示例性输液器包括管道，第一连接器和第二连接器。 第一连接器将管道的第一末端连接到输注泵的出口，从而提供由输注泵输送的流体与管道之间的流体连通。 第二连接器将管道的第二端连接到输送模块，从而在管道和输送模块之间提供流体连通。 输液泵的第一连接器和出口的完全接合致动输液泵的操作。

    ENHANCED SOLUBILITY DRUG-CONTAINING FORMULATIONS
    4.
    发明申请
    ENHANCED SOLUBILITY DRUG-CONTAINING FORMULATIONS 审中-公开

    公开(公告)号：US20200054754A1

    公开(公告)日：2020-02-20

    申请号：US16609544

    申请日：2018-05-10

    Applicant: SteadyMed Ltd.

    Inventor： Michael Laird Hurrey ,  Drazen Ostovic ,  Peter Noymer

    IPC: A61K47/12 ,  A61K47/02 ,  A61P23/02 ,  A61K31/445

    Abstract: This invention describes compositions comprising at least 75 mg/mL of solubilized otherwise poorly soluble drug in an aqueous environment, wherein the composition further comprises a combination of 3 or more acids. Methods of providing analgesia, anti-pyretic effects or reducing pain in a subject presenting with a pain condition, and methods of reducing administration site irritation, inflammation or a combination thereof in a subject presenting with a pain condition, comprising the steps of administering such compositions and infusion pumps containing such compositions are also described.

    ENHANCED STABILITY KETOROLAC FORMULATIONS AND METHODS AND DEVICES FOR USE WITH SAME
    5.
    发明申请
    ENHANCED STABILITY KETOROLAC FORMULATIONS AND METHODS AND DEVICES FOR USE WITH SAME 审中-公开

    公开(公告)号：US20180193460A1

    公开(公告)日：2018-07-12

    申请号：US15866345

    申请日：2018-01-09

    Applicant: SteadyMed, Ltd.

    Inventor： Michael Laird Hurrey ,  Peter Noymer

    IPC: A61K47/18 ,  A61K31/407 ,  A61K9/00 ,  A61M5/142

    CPC classification number: A61K47/183 ,  A61K9/0019 ,  A61K31/407 ,  A61K47/12 ,  A61M5/14248 ,  A61P29/00

    Abstract: Embodiments provide a more efficacious and/or more comfortable, consistent and reliable Ketorolac treatment for patients in need of same, which in some aspects yields a formulation that is much more stable over time. In some aspects, there is provided a Ketorolac-containing formulation adapted to contain specific stabilizers in an ethanol free setting and/or sodium chloride free setting, which provides for enhanced formulation stability. In some aspects, such formulation is characterized by enhanced stability even when the formulation is stored at room temperature, or in some embodiments, when the formulation is stored at higher temperatures, such as, for example, that experienced in the United States in various states, in various seasons outdoors, etc. In some aspects, such enhanced stability is in addition to other advantages as described herein, for example, for example, in terms of a dose sparing effect, and others, as described herein.

    Preservative-free treprostinil devices
    7.
    发明授权
    Preservative-free treprostinil devices 有权

    公开(公告)号：US11318148B2

    公开(公告)日：2022-05-03

    申请号：US16828145

    申请日：2020-03-24

    Applicant: SteadyMed, Ltd.

    Inventor： Jonathan Rigby ,  Peter Noymer ,  Robert Zwolinski

    IPC: A61K31/5575 ,  A61K9/00 ,  A61M5/142 ,  C07C39/17 ,  C07C59/72 ,  C07C405/00

    Abstract: Embodiments include a system including a sealed prefilled drug-reservoir. The drug-reservoir may include a unit dosage of treprostinil in a sterile fluid composition. The composition may not include an antimicrobial preservative. The treprostinil may be present at a dosage of between 0.1 mg/mL and 25 mg/mL. In addition, the treprostinil may be treprostinil sodium Furthermore, the composition may include sodium chloride. The composition may also include a sodium ion from sodium chloride in a concentration from 3000 to 4500 ppm. The composition may not include metacresol.

    Preservative-free Treprostinil Devices
    8.
    发明申请
    Preservative-free Treprostinil Devices 审中-公开

    公开(公告)号：US20200237780A1

    公开(公告)日：2020-07-30

    申请号：US16828145

    申请日：2020-03-24

    Applicant: SteadyMed, Ltd.

    Inventor： Jonathan Rigby ,  Peter Noymer ,  Robert Zwolinski

    IPC: A61K31/5575 ,  C07C405/00 ,  C07C59/72 ,  C07C39/17 ,  A61M5/142 ,  A61K9/00

    Abstract: Embodiments include a system including a sealed prefilled drug-reservoir. The drug-reservoir may include a unit dosage of treprostinil in a sterile fluid composition. The composition may not include an antimicrobial preservative. The treprostinil may be present at a dosage of between 0.1 mg/mL and 25 mg/mL. In addition, the treprostinil may be treprostinil sodium Furthermore, the composition may include sodium chloride. The composition may also include a sodium ion from sodium chloride in a concentration from 3000 to 4500 ppm. The composition may not include metacresol.

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