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    Subcutaneous anti-HER2 antibody formulations and uses thereof
    1.
    发明授权
    Subcutaneous anti-HER2 antibody formulations and uses thereof 有权
    皮下抗HER2抗体制剂及其用途

    公开(公告)号：US09345661B2

    公开(公告)日：2016-05-24

    申请号：US12804703

    申请日：2010-07-27

    申请人： Michael Adler ,  Ulla Grauschopf ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    发明人： Michael Adler ,  Ulla Grauschopf ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    IPC分类号： C07K16/00 ,  A61K9/00 ,  A61K9/19 ,  A61K39/395 ,  A61K47/18 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32

    CPC分类号： A61K39/39558 ,  A61K9/0019 ,  A61K9/08 ,  A61K9/19 ,  A61K38/47 ,  A61K39/39591 ,  A61K45/06 ,  A61K47/18 ,  A61K47/183 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32 ,  C12Y302/01035

    摘要： The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

    摘要翻译： 本发明涉及药物活性抗HER2抗体的高浓度，稳定的药物制剂，例如， 曲妥珠单抗（HERCEPTIN TM），Pertuzumab或T-DM1，或用于皮下注射的这种抗体分子的混合物。 特别地，本发明涉及包含除合适量的抗HER2抗体之外的有效量的至少一种透明质酸酶作为组合制剂或用于共同制剂形式的制剂。 制剂还包含至少一种缓冲剂，例如， 组氨酸缓冲液，稳定剂或两种或更多种稳定剂的混合物（例如糖，例如α，α-海藻糖二水合物或蔗糖，以及任选的甲硫氨酸作为第二稳定剂），非离子表面活性剂和有效量的至少 一种透明质酸酶。 还提供了制备这些制剂的方法及其用途。

    Subcutaneous anti-HER2 antibody formulations and uses thereof
    2.
    发明申请
    Subcutaneous anti-HER2 antibody formulations and uses thereof 有权
    皮下抗HER2抗体制剂及其用途

    公开(公告)号：US20110044977A1

    公开(公告)日：2011-02-24

    申请号：US12804703

    申请日：2010-07-27

    申请人： Michael Adler ,  Ulla Grauschopf ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    发明人： Michael Adler ,  Ulla Grauschopf ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    IPC分类号： A61K39/395 ,  A61P35/00

    CPC分类号： A61K39/39558 ,  A61K9/0019 ,  A61K9/08 ,  A61K9/19 ,  A61K38/47 ,  A61K39/39591 ,  A61K45/06 ,  A61K47/18 ,  A61K47/183 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32 ,  C12Y302/01035

    摘要： The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

    摘要翻译： 本发明涉及药物活性抗HER2抗体的高浓度，稳定的药物制剂，例如， 曲妥珠单抗（HERCEPTIN TM），Pertuzumab或T-DM1，或用于皮下注射的这种抗体分子的混合物。 特别地，本发明涉及包含除合适量的抗HER2抗体之外的有效量的至少一种透明质酸酶作为组合制剂或用于共同制剂形式的制剂。 制剂还包含至少一种缓冲剂，例如， 组氨酸缓冲液，稳定剂或两种或更多种稳定剂的混合物（例如糖，例如α，α-海藻糖二水合物或蔗糖，以及任选的甲硫氨酸作为第二稳定剂），非离子表面活性剂和有效量的至少 一种透明质酸酶。 还提供了制备这些制剂的方法及其用途。

    Highly Concentrated Pharmaceutical Formulations
    5.
    发明申请
    Highly Concentrated Pharmaceutical Formulations 审中-公开
    高浓度药物制剂

    公开(公告)号：US20110076273A1

    公开(公告)日：2011-03-31

    申请号：US12879486

    申请日：2010-09-10

    申请人： Michael Adler ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    发明人： Michael Adler ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    IPC分类号： A61K39/395 ,  A61P35/00

    CPC分类号： C07K16/2887 ,  A61K9/0019 ,  A61K9/19 ,  A61K38/47 ,  A61K39/3955 ,  A61K45/06 ,  A61K47/10 ,  A61K47/183 ,  A61K47/20 ,  A61K47/22 ,  A61K47/26 ,  A61K47/42 ,  A61K2039/505 ,  C07K16/3061 ,  C07K2317/21 ,  C07K2317/24 ,  C07K2317/734 ,  C07K2317/94

    摘要： The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab , or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

    摘要翻译： 本发明涉及药物活性抗CD20抗体的高浓度，稳定的药物制剂，例如， 利妥昔单抗，奥昔布单抗或HuMab ，或用于皮下注射的这种抗体分子的混合物。 特别地，本发明涉及除了合适量的抗CD20抗体外，还包含有效量的至少一种作为组合制剂的透明质酸酶或用于共同制剂形式的制剂。 所述制剂还包含至少一种缓冲剂，例如， 组氨酸缓冲液，稳定剂或两种或更多种稳定剂的混合物（例如糖，例如α，α-海藻糖二水合物或蔗糖，以及任选的甲硫氨酸作为第二稳定剂），非离子表面活性剂和有效量的至少 一种透明质酸酶。 还提供了制备这些制剂的方法及其用途。