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.

主权项

1. A method for preparing an interferon-beta formulation, comprising the step of mixing a liquid composition comprising interferon-beta with a sterile diluent, wherein the liquid composition further comprises a stabilizing agent at between about 0.3% and 5% by weight, wherein the liquid composition has not been previously lyophilized, wherein the formulation does not comprise serum albumin, and wherein the stabilizing agent is either arginine or glycine.