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    Unit dose capsules for use in a dry powder inhaler
    31.
    发明授权
    Unit dose capsules for use in a dry powder inhaler 有权
    用于干粉吸入器的单位剂量胶囊

    公开(公告)号：US07305986B1

    公开(公告)日：2007-12-11

    申请号：US09621092

    申请日：2000-07-21

    申请人： Solomon S. Steiner ,  Robert Feldstein ,  Per B. Fog ,  Trent Poole

    发明人： Solomon S. Steiner ,  Robert Feldstein ,  Per B. Fog ,  Trent Poole

    IPC分类号： A61M15/00

    CPC分类号： A61M15/003 ,  A61M13/00 ,  A61M15/002 ,  A61M15/0021 ,  A61M15/0023 ,  A61M15/0025 ,  A61M15/0028 ,  A61M15/0043 ,  A61M16/0495 ,  A61M16/0825 ,  A61M2202/064 ,  A61M2205/43 ,  F16L37/252

    摘要： Described are capsules to contain a drug for use in an inhaler. The capsules may be two-part capsules where each half has apertures which may correspond to apertures in the other half. The first half fits snugly within the second half and the two halves may be rotated around their longitudinal axes with respect to each other to produce unlocked and locked positions. In the unlocked position, at least one aperture in the first half aligns with at least one aperture in the second half, which permits introduction of a medicament. In the locked position, at least two apertures in the first half align with at least two apertures in the second half, allowing air to pass through the capsule, releasing the medicament contained therein. Each capsule may have a unique key on each half that only fits with a particular inhaler or identifies the medicament contained therein.

    摘要翻译： 描述了容纳用于吸入器的药物的胶囊。 胶囊可以是两部分胶囊，其中每一半具有可对应于另一半中的孔的孔。 前半部分紧密地配合在第二半部分内，并且两个半部可以相对于彼此绕其纵向轴线旋转以产生解锁和锁定位置。 在解锁位置，前半部中的至少一个孔与第二半中的至少一个孔对准，这允许引入药物。 在锁定位置，第一半部中的至少两个孔与第二半部中的至少两个孔对准，允许空气通过胶囊，释放其中所含的药物。 每个胶囊可以在每一半上具有仅与特定吸入器匹配的识别钥匙，或识别其中包含的药物。

    Purification and stabilization of peptide and protein pharmaceutical agents
    32.
    发明授权
    Purification and stabilization of peptide and protein pharmaceutical agents 有权
    肽和蛋白质药剂的纯化和稳定

    公开(公告)号：US06444226B1

    公开(公告)日：2002-09-03

    申请号：US09606468

    申请日：2000-06-29

    申请人： Solomon S. Steiner ,  Rodney J. Woods ,  Joseph W. Sulner

    发明人： Solomon S. Steiner ,  Rodney J. Woods ,  Joseph W. Sulner

    IPC分类号： A61K914

    CPC分类号： A61K47/22 ,  A61K9/0019 ,  A61K9/0073 ,  A61K9/0075 ,  A61K9/14 ,  A61K9/145 ,  A61K9/1617 ,  A61K9/1676 ,  A61K38/28 ,  A61K47/6949 ,  B82Y5/00 ,  C07D241/08 ,  C07K1/30 ,  C07K1/32 ,  C07K14/605 ,  C07K14/62 ,  Y10S514/866

    摘要： Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, i.e. undesirable components, from the peptide or protein. In a preferred embodiment, a peptide, such as insulin, containing one or more impurities, e.g., zinc ions, is entrapped in diketopiperazine to form a precipitate of peptide/diketopiperazine/impurity, which is then washed with a solvent for the impurity to be removed, which is a nonsolvent for the diketopiperazine and a nonsolvent for the peptide. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In a preferred embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. The charge on the insulin molecule is masked by hydrogen bonding it to the diketopiperazine, thereby enabling the insulin to pass through the target membrane. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.

    摘要翻译： 提供了通过将肽或蛋白质掺入二酮哌嗪或竞争性络合剂来促进从肽或蛋白质中去除一种或多种杂质（即不合需要的组分）来纯化肽和蛋白质的方法。 在优选的实施方案中，将包含一种或多种杂质（例如锌离子）的肽例如包被在二酮哌嗪中以形成肽/二酮哌嗪/杂质的沉淀物，然后用溶剂洗涤以使杂质为 去除，这是二酮哌嗪的非溶剂和肽的非溶剂。 提供制剂和方法用于改善活性剂在生物膜上的转运，导致例如血药剂浓度的快速增加。 制剂包括由（i）可以带电或中性的活性剂形成的微粒，和（ii）掩蔽试剂的电荷和/或与靶生物膜形成氢键的运输增强剂，以便于 运输。 在优选的实施方案中，胰岛素经由包含富马酰二酮哌嗪和胰岛素的微粒的肺部递送以其生物活性形式施用。 胰岛素分子上的电荷被氢键键合到二酮哌嗪上，从而使胰岛素能够通过靶膜。 这种递送胰岛素的方法导致血浆胰岛素浓度的快速增加，其与由静脉内递送产生的增加相当。

    SMALL PEPTIDE SEQUENCES FOR STABILIZING BIOMOLECULES
    35.
    发明申请
    SMALL PEPTIDE SEQUENCES FOR STABILIZING BIOMOLECULES 审中-公开
    用于稳定生物分子的小肽序列

    公开(公告)号：US20120087985A1

    公开(公告)日：2012-04-12

    申请号：US13253410

    申请日：2011-10-05

    申请人： Solomon S. Steiner

    发明人： Solomon S. Steiner

    IPC分类号： A61K9/50 ,  B01J13/04 ,  A61K38/26 ,  A61P3/10 ,  A61K38/02 ,  A61K38/28

    CPC分类号： A61K38/26 ,  A61K9/0019 ,  A61K9/10 ,  A61K9/1617

    摘要： Disclosed herein are a class of small molecules, referred to as Small Peptide Sequences (SPS), that can stabilize biomolecules, particles containing the SPS and biomolecules, and compositions and methods of making the particles. The SPS are composed solely of amino acids common to humans and too small to trigger an immunological response (typically less than seven amino acids in total) and which will self assemble into particles sufficiently small to stay in liquid suspension at a first pH, typically a non-physiological pH, but which dissociate, releasing the biomolecule entrapped therein into solution, at a second pH, typically a physiological pH. The particles contain a SPS and a biomolecule, wherein the biomolecule is entrapped with the particle, immobilized on the surface of the particle, or combinations thereof. The particle releases the biomolecule upon contact with physiological fluids.

    摘要翻译： 本文公开了一类称为小肽序列（SPS）的小分子，其可以稳定生物分子，含有SPS和生物分子的颗粒，以及制备颗粒的组合物和方法。 SPS仅由人类常见的氨基酸组成，太小而不能触发免疫应答（通常总共小于7个氨基酸），并且其将自我组装成足够小的颗粒，以在第一pH下停留在液体悬浮液中，通常为 非生理pH，但其解离，在第二个pH（通常为生理pH）下将包埋在其中的生物分子释放到溶液中。 颗粒含有SPS和生物分子，其中生物分子被捕获，固定在颗粒的表面上，或其组合。 颗粒在与生理液体接触时释放生物分子。

    Methods and compositions for delivering peptides
    37.
    发明授权
    Methods and compositions for delivering peptides 有权
    用于递送肽的方法和组合物

    公开(公告)号：US07943178B2

    公开(公告)日：2011-05-17

    申请号：US12635380

    申请日：2009-12-10

    申请人： Solomon S. Steiner ,  Rodney J. Woods ,  Joseph W. Sulner

    发明人： Solomon S. Steiner ,  Rodney J. Woods ,  Joseph W. Sulner

    IPC分类号： A61K9/14 ,  A61K9/19 ,  A61K9/00 ,  A61K38/00 ,  A61K38/02 ,  A61K38/16

    CPC分类号： A61K47/22 ,  A61K9/0019 ,  A61K9/0073 ,  A61K9/0075 ,  A61K9/14 ,  A61K9/145 ,  A61K9/1617 ,  A61K9/1676 ,  A61K38/28 ,  A61K47/6949 ,  B82Y5/00 ,  C07D241/08 ,  C07K1/30 ,  C07K1/32 ,  C07K14/605 ,  C07K14/62 ,  Y10S514/866

    摘要： Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.

    摘要翻译： 提供了通过将肽或蛋白质掺入二酮哌嗪或竞争性络合剂来促进从肽或蛋白质中去除一种或多种杂质来纯化肽和蛋白质的方法。 提供制剂和方法用于改善活性剂在生物膜上的转运，导致例如血药剂浓度的快速增加。 制剂包括由（i）可以带电或中性的活性剂形成的微粒，和（ii）掩蔽试剂的电荷和/或与靶生物膜形成氢键的运输增强剂，以便于 运输。 在一个实施方案中，胰岛素经由包含富马酰二酮基哌嗪和胰岛素的微粒的肺部递送以其生物活性形式施用。 这种递送胰岛素的方法导致血浆胰岛素浓度的快速增加，其与由静脉内递送产生的增加相当。

    Dry powder formulations of antihistamine for nasal administration
    38.
    发明授权
    Dry powder formulations of antihistamine for nasal administration 有权

    公开(公告)号：US07833550B2

    公开(公告)日：2010-11-16

    申请号：US11842863

    申请日：2007-08-21

    申请人： Solomon S. Steiner ,  Bryan R. Wilson

    发明人： Solomon S. Steiner ,  Bryan R. Wilson

    IPC分类号： A61K9/14 ,  A61K9/16

    CPC分类号： A61K31/4402 ,  A61K9/0043 ,  A61K9/145 ,  A61K9/146 ,  A61K9/1617 ,  A61K9/1629 ,  A61K9/19 ,  A61K31/55

    摘要： Dry powder formulations of drugs such as antihistamine for nasal administration are provided where the drug is retained in the nasal cavity, and systemic side effects minimized or eliminated, through the selection of a narrow particle size range, between approximately 10 and 20 microns in diameter. In a preferred embodiment wherein the drug is an antihistamine, retention of the antihistamine at the nasal mucosa is improved and the bitter aftertaste associated with liquid antihistamine formulations significantly reduced. By making a dry powder formulation of an antihistamine (e.g., azelastine) having an average particle size of between 10 and 20 microns, the antihistamine is restricted primarily to the desired target organ, the nasal mucosa. Because the active ingredient stays in the nasal region, a lower dose can be used to achieve the same desired effect. As demonstrated by the examples, this lower dose reduces the incidence of somnolence, and because the active ingredient remains at the target organ and does not accumulate in the back of the throat and mouth, this formulation does not impart a bitter taste.