Method for terminal sterilization of transdermal delivery devices
    13.
    发明申请
    Method for terminal sterilization of transdermal delivery devices 审中-公开
    透皮给药装置终末灭菌方法

    公开(公告)号:US20060275170A1

    公开(公告)日:2006-12-07

    申请号:US11446487

    申请日:2006-06-01

    IPC分类号: A61L2/08

    摘要: An method and system for providing a terminally sterilized transdermal device adapted to delivery a PTH-based agent. A microprojection member that includes a plurality of stratum comeum-piercing microprojections is coated with PTH-based agent formulation an exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient activity of the PTH-based agent. Preferably, the microprojection member is sealed in packing with an inert atmosphere and reduced moisture. The sterilizing radiation can be gamma radiation or e-beam, preferably delivered in a dose in the range of approximately 5-50 kGy. Also preferably, the irradiation is performed at −78.5-25° C. In preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.

    摘要翻译: 一种用于提供适于输送基于PTH的药剂的终末灭菌的透皮装置的方法和系统。 包括多个层起始微孔的微喷射构件涂覆有暴露于足够辐射的基于PTH的试剂制剂,以在保留足够活性的PTH基剂的同时对微喷射体构件进行灭菌。 优选地,微喷射构件以惰性气氛密封在包装中并减少水分。 灭菌辐射可以是γ辐射或电子束,优选以约5-50kGy的剂量递送。 还优选地,在-78.5-25℃下进行照射。在优选的实施方案中,以大于3.0kGy / hr的速率递送辐射。

    Stable Therapeutic Formulations
    14.
    发明申请
    Stable Therapeutic Formulations 有权
    稳定的治疗配方

    公开(公告)号:US20070184096A1

    公开(公告)日:2007-08-09

    申请号:US11617639

    申请日:2006-12-28

    IPC分类号: A61K48/00 A61K9/70 A61K31/716

    摘要: Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.

    摘要翻译: 用于配制和递送具有增强的物理稳定性的生物活性剂制剂的组合物和方法,并且其中由氧和/或水的存在引起的劣化被最小化和/或控制,以产生稳定的制剂。 用于配制和递送本发明的生物活性剂的组合物和方法进一步促进它们掺入生物相容性涂层中,所述生物相容性涂层可用于涂覆角质层刺穿的微喷射体,或多个角质层刺穿的输送装置的微突出物 ,用于通过受试者的皮肤递送生物相容性涂层,从而提供递送生物活性剂的有效手段。

    Method and formulation for transdermal delivery of immunologically active agents
    15.
    发明申请
    Method and formulation for transdermal delivery of immunologically active agents 审中-公开
    用于透皮递送免疫活性剂的方法和制剂

    公开(公告)号:US20050266011A1

    公开(公告)日:2005-12-01

    申请号:US11112311

    申请日:2005-04-21

    摘要: A method for formulating an immunologically active agent and an apparatus for delivery same, the method comprising the steps of providing a bulk immunologically active agent, subjecting the bulk immunologically active agent to tangential-flow filtration to provide an immunologically active agent solution, adding at least one excipient to the agent solution and spray-drying the agent solution to form an immunologically active agent product; the apparatus comprising a microprojection member that includes a plurality of microprojections having a biocompatible coating disposed thereon that includes a spray-dried immunologically active agent. In a preferred embodiment, the immunologically active agent comprises an influenza vaccine, more preferably, a split-varion influenza vaccine.

    摘要翻译: 用于配制免疫活性剂的方法和用于递送免疫活性剂的装置,所述方法包括以下步骤:提供本体免疫活性剂,使本体免疫活性剂经受切向流过滤以提供免疫活性剂溶液,至少加入 将一种赋形剂加入到试剂溶液中并喷雾干燥试剂溶液以形成免疫活性剂产品; 所述装置包括微突出物构件,所述微突出物构件包括多个具有布置在其上的生物相容性涂层的微喷射体,其包括喷雾干燥的免疫活性剂。 在优选的实施方案中,免疫活性剂包含流感疫苗,更优选分裂型流感疫苗。

    Apparatus and method for transdermal delivery of fentanyl-based agents
    16.
    发明申请
    Apparatus and method for transdermal delivery of fentanyl-based agents 审中-公开
    用于透皮递送芬太尼基药剂的装置和方法

    公开(公告)号:US20050226922A1

    公开(公告)日:2005-10-13

    申请号:US11084636

    申请日:2005-03-18

    IPC分类号: A61K9/70 A61K31/445 A61M37/00

    摘要: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the fentanyl-based agent is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a gel pack having a fentanyl-based agent-containing hydrogel formulation that is disposed on the microprojection member after application to the skin of a patient. In an alternative embodiment, the fentanyl-based agent is contained in both the coating and the hydrogel formulation.

    摘要翻译: 一种用于透皮递送生物活性剂的装置和方法,包括具有微突出物构件(或系统)的递送系统,所述微突出物构件(或系统)包括多个微突出物(或阵列),所述微突出物构件(或阵列)适于穿透角质层穿入下面的表皮层,或 表皮和真皮层。 在一个实施方案中,基于芬太尼的药剂包含在施加到微突出物构件的生物相容性涂层中。 在另一个实施方案中,递送系统包括具有含有基于芬太尼的药剂的水凝胶制剂的凝胶包,其在施用到患者皮肤之后设置在微突出物构件上。 在替代实施方案中,基于芬太尼的药剂包含在包衣和水凝胶制剂中。

    Transdermal sustained release drug delivery
    20.
    发明申请
    Transdermal sustained release drug delivery 审中-公开
    透皮缓释药物递送

    公开(公告)号:US20090117158A1

    公开(公告)日:2009-05-07

    申请号:US12288760

    申请日:2008-10-23

    CPC分类号: A61K9/0021 A61K38/29

    摘要: Provided herein are microprojections and microprojection arrays wherein a microprojection is coated with at least two layers. One layer comprises a biologically active agent, for example, a PTH agent and optionally other excipients. Another layer, which is generally, initially devoid of active agent comprises a polymer or a mix of polymers to provide controlled release, for example sustained release, of the biologically active agent contained in the first layer. Microprojections coated with multiple layers, some layers containing a biologically active agent and other layers containing a polymer for controlled release are also contemplated herein.

    摘要翻译: 本文提供了微喷射和微喷射阵列,其中微喷射体涂覆有至少两层。 一层包括生物活性剂,例如PTH剂和任选的其它赋形剂。 通常最初没有活性剂的另一层包括聚合物或聚合物混合物,以提供包含在第一层中的生物活性剂的受控释放,例如缓释。 涂覆有多层的微喷射剂,含有生物活性剂的一些层和含有用于控制释放的聚合物的其它层也在本文中考虑。