ADLER, MICHAEL,GRAUSCHOPF, ULLA,MAHLER, HANNS-CHRISTIAN,STAUCH, OLIVER BORIS
申请号：
NZ59719010
公开号：
NZ597190A
申请日:
2010.07.28
申请国别(地区):
NZ
年份:
2012
代理人:
摘要：
Disclosed is a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody for subcutaneous injection comprising: a. about 50 to 350 mgl/ml anti-HER2 antibody； b. about 1 to 100 mM of a buffering agent providing a pH of 5.5 +- 2.0； c. about 1 to 500 mM of a stabilizer or a mixture of two or more stabilizers； d. about 0.01 to 0.08 % of a nonionic surfactant and e. from >；150 to about 16,000 U/ml of a hyaluronidase enzyme.
