LEE, Joon Won,이준원,HAN, Won Yong,한원용,KIM, Su Jung,김수정,OH, Jun Seok,오준석,KIM, So Young,김소영,KIM, Kwang Woo,김광우,SHIN, Yeon Kyeong,신연경
申请号：
KRKR2017/011909
公开号：
WO2018/080196A3
申请日:
2017.10.26
申请国别(地区):
KR
年份:
2018
代理人:
摘要：
A stable pharmaceutical formulation according to the present invention comprises a fusion protein in which an extracellular ligand bonding domain of a human p75 tumor necrosis factor receptor is fused to an Fc domain of a human IgG, and a succinate buffer, and does not comprise a stabilizer. The stable pharmaceutical formulation according to the present invention allows long-term storage of a TNFR-Fc fusion protein formulation, and provides excellent storage stability without the need to strictly maintain storage conditions. The present invention is a simple formulation that does not comprise a stabilizer, and is more economical than other formulations that comprise a stabilizer.L'invention concerne une formulation pharmaceutique stable comportant une protéine hybride dans laquelle un domaine de liaison au ligand extracellulaire d'un récepteur de facteur de nécrose tumorale de p75 humain est fusionné à un domaine Fc d'une IgG humaine, et un tampon succinate, et ne comprend pas de stabilisant. La formulation pharmaceutique stable selon la présente invention permet le stockage à long terme d'une formulation de protéine hybride TNFR-Fc, et offre une excellente stabilité au stockage sans qu'il soit nécessaire de maintenir strictement des conditions de stockage. La présente invention est une formulation simple qui ne comporte pas de stabilisant, et est plus économique que d'autres formulations qui comprennent un stabilisant.본 발명에 따른 안정한 약제학적 제제는 인간 p75 종양괴사인자 수용체의 세포외 리간드 결합부가 인간 IgG의 Fc 도메인에 융합된 융합 단백질 및 숙신산염 완충제를 포함하고, 안정화제를 포함하지 않은 안정한 약제학적 제제이다. 본 발명에 따른 안정한 약제학적 제제는 TNFR-Fc 융합 단백질 제제를 장기간 보관 가능하게 하고, 보관 조건을 까다롭게 유지하지 않아도 되는 우수한 저장 안정성을 제공한다. 본 발명은 안정화제를 포함하지 않는 간단한 제제로 다른 안정화 포함 제제에 비해 경제적이다.
