DEL RIO, ALESSANDRA,FRATARCANGELI, SILVIA,RINALDI, GIANLUCA
申请号：
CA3050875
公开号：
CA3050875A1
申请日:
2015.05.15
申请国别(地区):
CA
年份:
2015
代理人:
摘要：
The present invention relates to liquid pharmaceutical compositions of a humanmonoclonal antibody that inhibits TNF-.alpha. activity (such as adalimumab),which includeadalimumab or a biosimilar thereof, an histidine buffering agent such ashistidine (orhistidine buffer system such as histidine/imidiazolium-histidine), and a sugarstabilisersuch as trehalose. Such a combination of components furnishes formulationshaving astability (e.g. on storage and when exposed to stress) which is comparable toor animprovement upon those known in the art, and with fewer ingredients. Suchadvances willhelp adalimumab treatments to become more widely available at lower cost, andprolongthe viability of pre-loaded delivery devices (e.g. pre-filled syringes) toreduce unnecessarywaste of the drug.
