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    IGF-I composition and its use
    3.
    发明授权
    IGF-I composition and its use 失效
    IGF-I组成及其用途

    公开(公告)号：US07067485B2

    公开(公告)日：2006-06-27

    申请号：US09187661

    申请日：1998-11-06

    申请人： Bret A. Shirley ,  Maninder S. Hora

    发明人： Bret A. Shirley ,  Maninder S. Hora

    IPC分类号： A61K38/00 ,  A61K38/30 ,  C07K14/00

    CPC分类号： A61K38/30 ,  A61K9/0024 ,  A61K9/1647 ,  A61K9/1694

    摘要： A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.

    摘要翻译： 提供了高浓度，低含盐，生物活性糖浆形式的IGF-I或其变体及其制备方法。 IGF-I的这种新型糖浆形式具有至少约250mg / ml的IGF-I浓度，约1.0g / ml至约1.2g / ml的密度，约13,000厘泊（cps）至约 在环境温度（23℃）下测量的19,000cps。 IGF-I糖浆通过从溶液中沉淀或分配IGF-I来制备，优选通过调节溶液pH或通过使用溶解度增强剂将IGF-I浓缩在溶液中，然后除去溶解度增强剂。 沉淀的糖浆可用作以稳定形式存储IGF-I的手段，并且作为制备包含生物活性IGF-I的组合物的手段。 提供了包含该浓缩的IGF-1糖浆的药物组合物和试剂盒。 从IGF-I糖浆重建的沉淀的IGF-1糖浆，IGF-I，药物组合物和试剂盒可用于针对IGF-1反应性条件的IGF-1治疗。

    Stabilized liquid polypeptide-containing pharmaceutical compositions
    5.
    发明授权
    Stabilized liquid polypeptide-containing pharmaceutical compositions 失效
    含稳定液体多肽的药物组合物

    公开(公告)号：US06525102B1

    公开(公告)日：2003-02-25

    申请号：US09677643

    申请日：2000-10-03

    申请人： Bao-Lu Chen ,  Maninder S. Hora

    发明人： Bao-Lu Chen ,  Maninder S. Hora

    IPC分类号： A01N2500

    CPC分类号： A61K9/08 ,  A61K9/0019 ,  A61K31/198 ,  A61K38/2013 ,  A61K38/215 ,  A61K38/57 ,  A61K47/12 ,  A61K47/183 ,  Y10S514/97

    摘要： Stabilized liquid polypeptide-containing pharmaceutical compositions are provided. The compositions comprise an amino acid base, which serves as the primary stabilizing agent of the polypeptide, and an acid and/or its salt form to buffer the solution within an acceptable pH range for stability of the polypeptide. The compositions are near isotonic. Methods for increasing stability of a polypeptide in a liquid pharmaceutical composition and for increasing storage stability of such a pharmaceutical composition are also provided.

    摘要翻译： 提供了含稳定液体多肽的药物组合物。 组合物包含用作多肽的主要稳定剂的氨基酸碱，以及酸和/或其盐形式，以在多肽的稳定性的可接受的pH范围内缓冲该溶液。 组合物接近等渗。 还提供了增加液体药物组合物中多肽的稳定性和提高这种药物组合物的储存稳定性的方法。

    Stabilized interferon compositions
    7.
    发明授权
    Stabilized interferon compositions 有权
    稳定的干扰素组合物

    公开(公告)号：US07662369B2

    公开(公告)日：2010-02-16

    申请号：US11188257

    申请日：2005-07-22

    申请人： Sidney N. Wolfe ,  Maninder S. Hora

    发明人： Sidney N. Wolfe ,  Maninder S. Hora

    IPC分类号： A61K38/21 ,  C07K14/00 ,  A61K38/00

    CPC分类号： A61K47/26 ,  A61K9/0019 ,  A61K9/08 ,  A61K9/19 ,  A61K38/215 ,  A61K47/42 ,  A61K2300/00

    摘要： Stabilized pharmaceutical formulations comprising IFN-β and highly purified mannitol are provided. The highly purified mannitol stabilizes the compositions by reducing the formation of IFN-β adducts in comparison with IFN-β formulated with mannitol that has not been highly purified. Methods for increasing the stability of IFN-β or a variant thereof in a liquid or lyophilized composition and for increasing storage stability of such a composition are also provided.

    摘要翻译： 提供了包含IFN-β和高度纯化的甘露醇的稳定药物制剂。 与通过未高度纯化的甘露醇配制的IFN-β相比，高度纯化的甘露醇通过减少IFN-β加合物的形成来稳定组合物。 还提供了用于增加液体或冻干组合物中IFN-β或其变体的稳定性并提高这种组合物的储存稳定性的方法。

    Novel IGF-1 composition and its use
    8.
    发明申请
    Novel IGF-1 composition and its use 审中-公开
    新型IGF-1组合物及其用途

    公开(公告)号：US20080171071A1

    公开(公告)日：2008-07-17

    申请号：US12002513

    申请日：2007-12-17

    申请人： Bret A. Shirley ,  Maninder S. Hora

    发明人： Bret A. Shirley ,  Maninder S. Hora

    IPC分类号： A61K38/18 ,  A61K9/00

    CPC分类号： A61K38/30 ,  A61K9/0024 ,  A61K9/1647 ,  A61K9/1694

    摘要： A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.

    摘要翻译： 提供了高浓度，低含盐，生物活性糖浆形式的IGF-I或其变体及其制备方法。 IGF-I的这种新型糖浆形式具有至少约250mg / ml的IGF-I浓度，约1.0g / ml至约1.2g / ml的密度，约13,000厘泊（cps）至约 在环境温度（23℃）下测量的19,000cps。 IGF-I糖浆通过从溶液中沉淀或分配IGF-I来制备，优选通过调节溶液pH或通过使用溶解度增强剂将IGF-I浓缩在溶液中，然后除去溶解度增强剂。 沉淀的糖浆可用作以稳定形式存储IGF-I的手段，并且作为制备包含生物活性IGF-I的组合物的手段。 提供了包含该浓缩的IGF-1糖浆的药物组合物和试剂盒。 从IGF-I糖浆重建的沉淀的IGF-1糖浆，IGF-I，药物组合物和试剂盒可用于针对IGF-1反应性条件的IGF-1治疗。

    IGF-1 composition and its use
    9.
    发明授权
    IGF-1 composition and its use 失效
    IGF-1组成及其用途

    公开(公告)号：US07335639B2

    公开(公告)日：2008-02-26

    申请号：US11195008

    申请日：2005-08-02

    申请人： Bret A. Shirley ,  Maninder S. Hora

    发明人： Bret A. Shirley ,  Maninder S. Hora

    IPC分类号： A61K38/00 ,  A61K38/30 ,  C07K14/00

    CPC分类号： A61K38/30 ,  A61K9/0024 ,  A61K9/1647 ,  A61K9/1694

    摘要： A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.

    摘要翻译： 提供了高浓度，低含盐，生物活性糖浆形式的IGF-I或其变体及其制备方法。 IGF-I的这种新型糖浆形式具有至少约250mg / ml的IGF-I浓度，约1.0g / ml至约1.2g / ml的密度，约13,000厘泊（cps）至约 在环境温度（23℃）下测量的19,000cps。 IGF-I糖浆通过从溶液中沉淀或分配IGF-I来制备，优选通过调节溶液pH或通过使用溶解度增强剂将IGF-I浓缩在溶液中，然后除去溶解度增强剂。 沉淀的糖浆可用作以稳定形式存储IGF-I的手段，并且作为制备包含生物活性IGF-I的组合物的手段。 提供了包含该浓缩的IGF-1糖浆的药物组合物和试剂盒。 从IGF-I糖浆重建的沉淀的IGF-1糖浆，IGF-I，药物组合物和试剂盒可用于针对IGF-1反应性条件的IGF-1治疗。