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    CONTROLLED ABSORPTION OF STATINS IN THE INTESTINE
    5.
    发明申请
    CONTROLLED ABSORPTION OF STATINS IN THE INTESTINE 审中-公开
    控制在INTESTINE中吸收统计数据

    公开(公告)号：WO2006103661A2

    公开(公告)日：2006-10-05

    申请号：PCT/IL2006/000387

    申请日：2006-03-27

    申请人： DEXCEL PHARMA TECHNOLOGIES LTD. ,  PENHASI, Adel ,  RUDERMAN, Marina ,  GOMBERG, Maxim

    发明人： PENHASI, Adel ,  RUDERMAN, Marina ,  GOMBERG, Maxim

    IPC分类号： A61K9/56

    CPC分类号： A61K31/00 ,  A61K9/2846 ,  A61K9/2866

    摘要： A delayed onset controlled release formulation is provided in which controlled release of the active ingredient occurs preferentially in the lower gastrointestinal tract including the colon. The formulation supports a significantly higher bioavailability of the active ingredient in the body of the subject than can be achieved from the currently used conventional formulation, such that therapeutically significant plasma levels of statin are maintained for an extended period after administration. The formulation preferably features a core, over which an outer coating is layered. The core is optionally and preferably in the form of a tablet.

    摘要翻译： 提供延迟发作控制释放制剂，其中活性成分的控制释放优先在包括结肠的下胃肠道中。 该制剂支持比目前使用的常规制剂可以实现的受试者体内活性成分显着更高的生物利用度，使得他汀在给药后长时间内维持治疗上显着的血浆水平。 制剂优选具有芯，其上层叠有外涂层。 芯可选地优选为片剂的形式。

    THERAPEUTIC PEPTIDE FORMULATIONS WITH IMPROVED STABILITY
    6.
    发明申请
    THERAPEUTIC PEPTIDE FORMULATIONS WITH IMPROVED STABILITY 审中-公开
    具有改善稳定性的治疗肽制剂

    公开(公告)号：WO2006079019A2

    公开(公告)日：2006-07-27

    申请号：PCT/US2006002262

    申请日：2006-01-19

    申请人： ALZA CORP ,  CORMIER MICHEL J N ,  AMERI MAHMOUD

    发明人： CORMIER MICHEL J N ,  AMERI MAHMOUD

    IPC分类号： A61K9/19 ,  A61K9/56 ,  A61K38/00

    CPC分类号： A61K9/0021 ,  A61K38/25 ,  A61K47/02 ,  A61K47/12 ,  A61M37/0015 ,  A61M2037/0046 ,  A61M2037/0061

    摘要： Compositions of and methods for formulating and delivering peptide, polypeptide and protein therapeutic agent formulations having enhanced physical stability, and wherein fibril formation is minimized and/or controlled, to yield a consistent and predictable composition viscosity. The compositions of and methods for formulating and delivering peptide, polypeptide and protein therapeutic 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 peptide therapeutic agents.

    摘要翻译： 用于配制和递送具有增强的物理稳定性的肽，多肽和蛋白质治疗剂制剂的组合物和方法，并且其中原纤维形成被最小化和/或控制以产生一致且可预测的组合物粘度。 用于配制和递送本发明的肽，多肽和蛋白质治疗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突出物或多个角质层刺穿的微突起 的递送装置，用于通过受试者的皮肤递送生物相容性涂层，从而提供递送肽治疗剂的有效手段。

    METHYLPHENIDATE MODIFIED RELEASE FORMULATIONS
    10.
    发明申请
    METHYLPHENIDATE MODIFIED RELEASE FORMULATIONS 审中-公开
    甲基苯酚改性释放配方

    公开(公告)号：WO02034234A2

    公开(公告)日：2002-05-02

    申请号：PCT/US2001/042561

    申请日：2001-10-09

    IPC分类号： A61K9/22 ,  A61K9/50 ,  A61K9/54 ,  A61K9/56 ,  A61K9/58 ,  A61K9/62 ,  A61K31/4458 ,  A61K47/14 ,  A61K47/26 ,  A61K47/30 ,  A61K47/32 ,  A61K47/36 ,  A61K47/38 ,  A61K9/00

    CPC分类号： A61K31/4458 ,  A61K9/5078 ,  A61K9/5084

    摘要： A pharmaceutical MR (modified release) multiparticulate dosage form such as a capsule (once-a-day MR Capsule) of Methylphenidate indicated for the treatment of children with attention deficit hyperactivity disorder (ADHD), capable of delivering a portion of the dose for rapid onset of action and the remainder of the dose in a controlled manner for about 12 hours, is composed of a multitude of multicoated particles made of two populations of drug layered beads, IR (immediate release) and ER (extended release) Beads. The IR beads preferably are made by layering an aqueous solution comprising a drug and a binder on to non-pareil sugar spheres and then applying a seal coat to the drug coated cores. The ER Beads are made by applying an extended release coating of a water insoluble dissolution rate controlling polymer such as ethylcellulose to IR Beads. The MR Capsules are manufactured by filling IR and ER Beads in a proper ratio; the dose and the ratio required for an efficacious, cost effective and patient compliant treatment of children with ADHD were determined from extensive clinical investigations and in vitro/in vivo correlations performed as per FDA Guidelines, Guidance for Industry: Extended Release Oral Dosage Forms.

    摘要翻译： 药物MR（改性释放）多颗粒剂型，例如哌甲酯的胶囊（每日一次MR胶囊），用于治疗注意缺陷多动障碍（ADHD）的儿童，能够递送一部分剂量用于快速 起始作用和其他剂量以受控方式进行约12小时，由多个由多种药物分层珠，IR（即时释放）和ER（延长释放）珠组成的多层颗粒组成。 IR珠优选通过将包含药物和粘合剂的水溶液层压到非帕里儿糖球上，然后将涂层涂覆到药物包衣的核心上来制备。 ER珠是通过将不溶于水的溶解速率控制聚合物如乙基纤维素的延长释放涂层施加到IR珠而制成的。 MR胶囊通过以适当的比例填充IR和ER珠来制造; 根据FDA指南“行业指南”进行的广泛临床研究和体外/体内相关性测定了对ADHD儿童进行有效，成本效益和患者适应性治疗所需的剂量和比例。 延长口服剂型。