Etanercept formulations stabilized with meglumine

摘要

The present invention is an aqueous stabilized formulation of etanercept comprising: etanercept; and stabilizing ingredients to retard instability, aggregation and/or fragmentation of the etanercept in the formulation, said stabilizing ingredients being comprised of at least one of the following: {a) meglumine; or (b) meglumine in combination with sucrose; or {c) meglumine in combination with sodium chloride; or (d) meglumine in combination with sodium chloride and sucrose. Various technical terms used in the following discussion are defined below in the section entitled "Definitions'' and throughout the remainder of the specification. The stabilized etanercept formulations of the present invention elicit long term storage stability.