Christian Luther Ofslager,Nataliya Bazhina,Mahdi Bakir Fawzi,Syed Muzafar Shah,Gurmukh Das Chanana
申请号：
US13539921
公开号：
US20120277197A1
申请日:
2012.07.02
申请国别(地区):
US
年份:
2012
代理人:
摘要：
The invention is directed to a frozen pharmaceutical formulation suitable for administration to a subject parenterally, comprising a therapeutically effective amount of tigecycline and an agent selected from the group consisting of lactose, dextrose, glucose, mannose, sucrose, ribose, xylose and a combination thereof, wherein the formulation in a pre-frozen state at about 22° C. or in an unfrozen state at about 22° C. has a pH in the range of from 4.0 to 5.5. Preferably, the formulation is suitable for storage at or below about −20° C. over a period of at least about 2 months, preferably 6 months, more preferably 26 months. Alternatively, the formulation is suitable for storage at about 22° C. over a period of about 24 hours.
