Patent ID: 9345661
Filing Date: 2016-05-24
CPC Classification: A61K,A61P,C07K,C12Y

Claim Text:
1. A highly concentrated, stable liquid pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody for subcutaneous injection comprising: a. 120±18 mg/ml anti-HER2 antibody, wherein said antibody is Trastuzumab; b. 1 to 50±5% mM of a buffering agent providing a pH of 5.5±2.0; c. 150 to 250±5% mM of α,α-trehalose dihydrate or sucrose as a first stabilizer and 5 to 15±5% mM methionine as a second stabilizer; d. 0.01 to 0.08%±5% of a nonionic surfactant; and e. 1′000 to 16′000±5% U/ml of at least one hyaluronidase enzyme.