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1. 发明申请

WO2010100179A2 SELF-FORMING GEL SYSTEM FOR SUSTAINED DRUG DELIVERY 审中-公开
标题翻译：用于持续输送药物的自发凝胶系统
公开(公告)号：WO2010100179A2
公开(公告)日：2010-09-10
申请号：PCT/EP2010/052665
申请日：2010-03-03
申请人： NOVARTIS AG , DANI, Bhas A. , MEINEL, Lorenz
发明人： DANI, Bhas A. , MEINEL, Lorenz
IPC分类号： A61K9/19
CPC分类号： A61K9/0019 , A61K9/19 , C07K16/18 , C07K16/22 , C07K2317/56 , C07K2317/565
摘要： Antibody formulations, and methods for their manufacture, which (i) are capable of preserving an antibody in a native and therapeutically active state while achieving a depot effect without the use of polymers or other complex formulation, reagents and (ii) provide very high loading capacity, thus offering the potential for increased dose per application to patient. These formulations take the form of a gel and are based on the surprising finding that some monoclonal antibodies have a gelation property under appropriate conditions.
摘要翻译：抗体制剂及其制备方法，其（i）能够在天然和治疗活性状态下保存抗体，同时在不使用聚合物或其它复合制剂，试剂的情况下实现储库效应，和（ii）提供非常高的载量容量，从而提供每个应用对患者的剂量增加的潜力。这些制剂采取凝胶的形式，并且基于惊人的发现，某些单克隆抗体在合适的条件下具有凝胶化性质。

2. 发明申请

WO2010100200A2 LYOPHILISED ANTIBODY FORMULATION 审中-公开
标题翻译： LYOPHILISED抗体配方
公开(公告)号：WO2010100200A2
公开(公告)日：2010-09-10
申请号：PCT/EP2010/052709
申请日：2010-03-03
申请人： NOVARTIS AG , DANI, Bhas A.
发明人： DANI, Bhas A.
IPC分类号： A61K9/19
CPC分类号： A61K9/0019 , A61K9/19 , A61K47/183 , C07K16/22
摘要： Anti-sclerostin antibodies are formulated as Iyophilisates. The lyophilisates can be reconstituted to give a solution with a high concentration of the antibody active ingredient for delivery to a patient without high levels of antibody aggregation. The lyophilisate can be reconstituted with an aqueous reconstituent to provide an aqueous composition in which the antibody has a concentration of at least 25 mg/ml. The lyophilisate may include one or more of a sugar, a buffering agent, a surfactant, and/or a free amino acid.
摘要翻译：抗硬化蛋白抗体配制为嗜酸性粒细胞。可以重构冻干物以产生具有高浓度抗体活性成分的溶液，用于递送至患者，而不需要高水平的抗体聚集。可以用水重构物重构冻干物，以提供其中抗体具有至少25mg / ml浓度的水性组合物。冻干物可以包括糖，缓冲剂，表面活性剂和/或游离氨基酸中的一种或多种。

3. 发明申请

WO2004060343A1 ANTIBODY-CONTAINING PARTICLES AND COMPOSITIONS 审中-公开
标题翻译：含抗菌物质和组合物
公开(公告)号：WO2004060343A1
公开(公告)日：2004-07-22
申请号：PCT/US2003/036188
申请日：2003-11-14
申请人： NEKTAR THERAPEUTICS , TZANNIS, Stelios , PLATZ, Robert, A. , DANI, Bhas, A.
发明人： TZANNIS, Stelios , PLATZ, Robert, A. , DANI, Bhas, A.
IPC分类号： A61K9/00
CPC分类号： A61K9/1617 , A61K9/1623 , A61K39/39591
摘要： A composition is provided comprising antibody-containing particles. These particles can be used to form antibody-containing powders useful for reconstitution with a suitable diluent. The reconstituted compositions, in turn, comprise an antibody in an amount suited for delivery by injection, such as subcutaneous injection. Methods for preparing the various compositions as well as methods of use are also provided.
摘要翻译：提供了包含抗体的颗粒的组合物。这些颗粒可用于形成用于与合适的稀释剂重建的含抗体的粉末。重组的组合物又包含适于通过注射递送的量的抗体，例如皮下注射。还提供了制备各种组合物的方法以及使用方法。

4. 发明申请

WO2010100179A3 SELF-FORMING GEL SYSTEM FOR SUSTAINED DRUG DELIVERY 审中-公开
标题翻译：用于持续输送药物的自发凝胶系统
公开(公告)号：WO2010100179A3
公开(公告)日：2011-05-12
申请号：PCT/EP2010052665
申请日：2010-03-03
申请人： NOVARTIS AG , DANI BHAS A , MEINEL LORENZ
发明人： DANI BHAS A , MEINEL LORENZ
IPC分类号： A61K9/19 , A61K9/00 , A61K39/00
CPC分类号： A61K9/0019 , A61K9/19 , C07K16/18 , C07K16/22 , C07K2317/56 , C07K2317/565
摘要： Antibody formulations, and methods for their manufacture, which (i) are capable of preserving an antibody in a native and therapeutically active state while achieving a depot effect without the use of polymers or other complex formulation, reagents and (ii) provide very high loading capacity, thus offering the potential for increased dose per application to patient. These formulations take the form of a gel and are based on the surprising finding that some monoclonal antibodies have a gelation property under appropriate conditions.
摘要翻译：抗体制剂及其制备方法，其（i）能够在天然和治疗活性状态下保存抗体，同时在不使用聚合物或其它复合制剂，试剂的情况下实现储库效应，和（ii）提供非常高的载量容量，从而提供每个应用对患者的剂量增加的潜力。这些制剂采取凝胶的形式，并且基于惊人的发现，某些单克隆抗体在合适的条件下具有凝胶化性质。

5. 发明申请

WO2007062076A2 DEXRAZOXANE FORMULATIONS AND METHODS 审中-公开
标题翻译：异噻唑酮制剂和方法
公开(公告)号：WO2007062076A2
公开(公告)日：2007-05-31
申请号：PCT/US2006045125
申请日：2006-11-20
申请人： NOVARTIS AG , OKHAMAFE AUGUSTUS , HORA MININDER , FAKES DAVID , WEI REBECCA , DANI BHAS , HASHASH AHMAD
发明人： OKHAMAFE AUGUSTUS , HORA MININDER , FAKES DAVID , WEI REBECCA , DANI BHAS , HASHASH AHMAD
IPC分类号： A61K31/495 , A61K9/19 , A61P31/00
CPC分类号： A61K9/0019 , A61K9/19 , A61K31/495
摘要： Improved formulations of dexrazoxane for making injectable solutions in a clinical setting are provided. In some embodiments, high pH formulations are provided to reduce or eliminate pain upon injection. According to various embodiments, dexrazoxane may be formulated as a lyophilized or non-lyophilized acid salt or as a lyophilized or non-lyophilized free base. In some embodiments, dexrazoxane is provided as a sterile dry milled powder of a free base or an isolated acid salt crystal. Formulations that require significantly reduced clinical preparation time are provided. Single-container presentations of unit doses of dexrazoxane are also provided. The formulations of the present invention may be provided in a vial, infusion bottle or infusion bag. In some embodiments, the container may be directly attachable to a diluent-containing container for easy preparation. In other embodiments, diluent may be added directly to the container. Improved methods of manufacturing dexrazoxane that allow greater processing latitude are also provided.
摘要翻译：提供了用于在临床环境中制备可注射溶液的右旋唑烷的改进制剂。在一些实施方案中，提供高pH制剂以减少或消除注射时的疼痛。根据各种实施方案，地塞米松可以配制成冻干或非冻干的酸盐或冻干或非冻干的游离碱。在一些实施方案中，将脱甲硅烷作为游离碱或分离的酸盐晶体的无菌干研磨粉末提供。提供需要显着减少临床准备时间的制剂。还提供了单位剂量的地塞米松的单容器介绍。本发明的制剂可以提供在小瓶，输液瓶或输液袋中。在一些实施方案中，容器可以直接附接到含稀释剂的容器以便于制备。在其它实施方案中，可以将稀释剂直接加入到容器中。还提供了改进的允许更大加工纬度的地塞米松的制造方法。

6. 发明申请

WO2010100200A3 LYOPHILISED ANTIBODY FORMULATION 审中-公开
标题翻译： LYOPHILISED抗体配方
公开(公告)号：WO2010100200A3
公开(公告)日：2011-05-12
申请号：PCT/EP2010052709
申请日：2010-03-03
申请人： NOVARTIS AG , DANI BHAS A
发明人： DANI BHAS A
IPC分类号： A61K9/19 , A61K9/00 , A61K39/00 , A61K47/18
CPC分类号： A61K9/0019 , A61K9/19 , A61K47/183 , C07K16/22
摘要： Anti-sclerostin antibodies are formulated as Iyophilisates. The lyophilisates can be reconstituted to give a solution with a high concentration of the antibody active ingredient for delivery to a patient without high levels of antibody aggregation. The lyophilisate can be reconstituted with an aqueous reconstituent to provide an aqueous composition in which the antibody has a concentration of at least 25 mg/ml. The lyophilisate may include one or more of a sugar, a buffering agent, a surfactant, and/or a free amino acid.
摘要翻译：抗硬化蛋白抗体配制为嗜酸性粒细胞。可以重构冻干物以产生具有高浓度抗体活性成分的溶液，用于递送至患者，而不需要高水平的抗体聚集。可以用水重构物重构冻干物，以提供其中抗体具有至少25mg / ml浓度的水性组合物。冻干物可以包括糖，缓冲剂，表面活性剂和/或游离氨基酸中的一种或多种。

7. 发明申请

WO2007062076A3 DEXRAZOXANE FORMULATIONS AND METHODS 审中-公开
公开(公告)号：WO2007062076A3
公开(公告)日：2007-05-31
申请号：PCT/US2006/045125
申请日：2006-11-20
申请人： NOVARTIS AG , OKHAMAFE, Augustus , HORA, Mininder , FAKES, David , WEI, Rebecca , DANI, Bhas , HASHASH, Ahmad
发明人： OKHAMAFE, Augustus , HORA, Mininder , FAKES, David , WEI, Rebecca , DANI, Bhas , HASHASH, Ahmad
IPC分类号： A61K31/495 , A61K9/19 , A61P31/00
摘要： Improved formulations of dexrazoxane for making injectable solutions in a clinical setting are provided. In some embodiments, high pH formulations are provided to reduce or eliminate pain upon injection. According to various embodiments, dexrazoxane may be formulated as a lyophilized or non-lyophilized acid salt or as a lyophilized or non-lyophilized free base. In some embodiments, dexrazoxane is provided as a sterile dry milled powder of a free base or an isolated acid salt crystal. Formulations that require significantly reduced clinical preparation time are provided. Single-container presentations of unit doses of dexrazoxane are also provided. The formulations of the present invention may be provided in a vial, infusion bottle or infusion bag. In some embodiments, the container may be directly attachable to a diluent-containing container for easy preparation. In other embodiments, diluent may be added directly to the container. Improved methods of manufacturing dexrazoxane that allow greater processing latitude are also provided.

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