Subcutaneous anti-HER2 antibody formulations and uses thereof
US9345661B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Jul 27, 2010 |
| Grant date | May 24, 2016 |
| Priority date | — |
| Expiry date | Jul 27, 2030 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC12Y302/01035
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
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.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.