发明名称 Stable liquid interferon beta formulations
摘要 Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3% and 5% by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contract with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.
申请公布号 US8932574(B2) 申请公布日期 2015.01.13
申请号 US201313944569 申请日期 2013.07.17
申请人 Biogen Idec MA Inc. 发明人 DiBiase Mary D.;Chung Wen-Li;Staples Mark;Scharin Eric
分类号 A61K38/21;A61K38/00;C07K14/565;A61K9/00;A61K47/18 主分类号 A61K38/21
代理机构 Ropes & Gray LLP 代理人 Ropes & Gray LLP
主权项 1. A liquid formulation comprising: (i) an interferon-beta, and (ii) a stabilizing agent at between about 0.3% and 5% by weight, wherein said stabilizing agent is L-glutamic acid, wherein the formulation does not comprise serum albumin, and wherein the formulation has not been previously lyophilized.
地址 Weston MA US