ALESSANDRA DEL RIO,GIANLUCA RINALDI,SILVIA FRATARCANGELI
申请号:
PT15724974
公开号:
PT3148510T
申请日:
2015.05.15
申请国别(地区):
PT
年份:
2018
代理人:
摘要:
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an histidine buffering agent such as histidine (or histidine buffer system such as histidine/imidiazolium-histidine), and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.