Invention Grant
- Patent Title: Highly concentrated pharmaceutical formulations
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Application No.: US16450906Application Date: 2019-06-24
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Publication No.: US10752696B2Publication Date: 2020-08-25
- Inventor: Michael Adler , Hanns-Christian Mahler , Oliver Boris Stauch
- Applicant: Genentech, Inc.
- Applicant Address: US CA South San Francisco
- Assignee: GENENTECH, INC.
- Current Assignee: GENENTECH, INC.
- Current Assignee Address: US CA South San Francisco
- Agent Wendy M. Lee
- Priority: com.zzzhc.datahub.patent.etl.us.BibliographicData$PriorityClaim@19875634
- Main IPC: A61K39/395
- IPC: A61K39/395 ; C07K16/28 ; A61K9/00 ; A61K9/19 ; A61K47/10 ; A61K47/18 ; A61K47/26 ; A61K38/47 ; A61K45/06 ; A61K47/20 ; A61K47/22 ; A61K47/42 ; C07K16/30 ; A61K39/00

Abstract:
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.
Public/Granted literature
- US20190367629A1 HIGHLY CONCENTRATED PHARMACEUTICAL FORMULATIONS Public/Granted day:2019-12-05
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