公开(公告)号：US20140314748A1

公开(公告)日：2014-10-23

申请号：US14207885

申请日：2014-03-13

Applicant: F. Hoffmann-La Roche AG ,  Genentech, Inc.

Inventor： Yatin GOKARN ,  Isidro E. ZARRAGA ,  Jonathan ZARZAR ,  Thomas PATAPOFF ,  Christine WURTH

IPC: A61K47/26 ,  A61K39/395

CPC classification number: A61K47/26 ,  A61K9/08 ,  A61K39/39591 ,  C07K16/22 ,  C07K16/2887

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

Abstract translation: 本发明提供了包含治疗性抗体，海藻糖，缓冲液和任选的表面活性剂，并且具有约5.5至约7.0范围内的pH的稳定的含水药物制剂。 本发明还提供了制备这些制剂的方法和使用这些制剂的方法。

公开(公告)号：US20180280514A1

公开(公告)日：2018-10-04

申请号：US15787265

申请日：2017-10-18

Applicant: Genentech, Inc.

Inventor： Yatin GOKARN ,  Isidro E. ZARRAGA ,  Jonathan ZARZAR ,  Thomas PATAPOFF ,  Christine WURTH

IPC: A61K47/26 ,  C07K16/28 ,  C07K16/22 ,  A61K39/395 ,  A61K9/08

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

公开(公告)号：US20230364020A1

公开(公告)日：2023-11-16

申请号：US18194542

申请日：2023-03-31

Applicant: Genentech, Inc.

Inventor： Purnendu Kumar NAYAK ,  Debby Pei-Shan CHANG ,  Karthikan RAJAGOPAL ,  Jonathan ZARZAR

IPC: A61K9/16 ,  C07K16/32 ,  C07K16/22 ,  C07K16/42

CPC classification number: A61K9/1652 ,  A61K9/1617 ,  A61K9/1623 ,  A61K9/1647 ,  C07K16/32 ,  C07K16/22 ,  C07K16/4291 ,  A61K9/1694

Abstract: The present invention provides formulations comprising polypeptides and hydroxypropyl methylcellulose acetate succinate (HPMCAS) derivatives. The formulations are stable; for example, during high temperature processing and in possible low pH environments. In addition, the HPMCAS derivatives provide protection to a pH sensitive protein against acidic degradation products from aqueous hydrolysis of poly(lactic-co-glycolic acid) (PLGA) in PLGA-based delivery systems.

公开(公告)号：US20200179516A1

公开(公告)日：2020-06-11

申请号：US16723864

申请日：2019-12-20

Applicant: Genentech, Inc.

Inventor： Yatin GOKARN ,  Isidro E. ZARRAGA ,  Jonathan ZARZAR ,  Thomas PATAPOFF

IPC: A61K47/26 ,  A61K39/395 ,  A61K9/08 ,  C07K16/22 ,  C07K16/28

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.