申请人:Eagle Biologics, Inc.
公开号:US10646571B2
公开(公告)日:2020-05-12
Concentrated, low-viscosity, low-volume liquid pharmaceutical formulations of proteins have been developed. Such formulations can be rapidly and conveniently administered by subcutaneous or intramuscular injection, rather than by lengthy intravenous infusion. These formulations include low-molecular-weight and/or high-molecular-weight proteins, such as mAbs, and viscosity-lowering agents that are typically bulky polar organic compounds, such as many of the GRAS (US Food and Drug Administration List of compounds generally regarded as safe) and inactive injectable ingredients and FDA approved therapeutics.
目前已开发出浓缩、低粘度、低容量的液体蛋白质药物制剂。这些制剂可以通过皮下注射或肌肉注射快速方便地给药,而不需要长时间的静脉注射。这些制剂包括低分子量和/或高分子量蛋白质(如 mAbs),以及通常为大体积极性有机化合物的降粘剂,如许多 GRAS(美国食品和药物管理局一般认为安全的化合物清单)和非活性注射成分以及美国食品及药物管理局批准的治疗药物。