TIMOTHY D OSSLUND,オスランド，ティモシー，ディー．,オスランド,ティモシー,ディー.
申请号：
JP2017131572
公开号：
JP2017222674A
申请日:
2017.07.05
申请国别(地区):
JP
年份:
2017
代理人:
摘要：
PROBLEM TO BE SOLVED: To provide a method for reducing the viscosity of a high concentration anti-sclerostin immunoglobulin-containing formulation.SOLUTION: A sterile liquid formulation with an absolute viscosity of approximately 10 cP or less comprises: an anti-sclerostin immunoglobulin at a concentration of at least 70 mg/mL； and calcium acetate at a concentration ranging from approximately 1 to approximately 20 mM. Preferably, the sterile liquid formulation further comprises an acetate buffer, such as sodium acetate, at a concentration from approximately 5 to approximately 15 mM. Preferably, the sterile liquid formulation further comprises a polyol, such as sucrose, as a stabilizing excipient and/or isotonicity agent.SELECTED DRAWING: None【課題】高濃度の抗スクレロスチン免疫グロブリン含有製剤の粘度を低減する方法の提供。【解決手段】少なくとも７０ｍｇ／ｍＬの濃度の抗スクレロスチン免疫グロブリンと約１～約２０ｍＭの範囲の濃度の酢酸カルシウムとを含む、約１０ｃＰ以下の絶対粘度を有する、滅菌液体製剤。約５～約１５ｍＭの濃度の酢酸緩衝液、例えば、酢酸ナトリウムを更に含むことが好ましい、滅菌液体製剤。更に安定化賦形剤及び／又は等張性剤としてスクロース等のポリオール配合することが、好ましい滅菌液体製剤。【選択図】なし
