Stable liquid interferon formulations

A liquid composition at pH 5.0 that comprises interferon-beta and 170 mM L-glutamic acid, the liquid not previously lyophilized.

A 20 mM phosphate buffer at pH 7.2 including interferon-beta plus a stabilizing agent selected from the group consisting of:

• (a) 140 mM arginine;
• and (b) 100 mM sodium chloride combined with 70 mM glycine, wherein the buffer has not been previously lyophilized.

A liquid pharmaceutical composition contained within a storage vessel, the liquid suitable for parenteral administration to mammals and comprising an effective amount of interferon-beta, a buffer maintaining the pH within the range of 4.0 to 6.0, and an amino acid stabilizing agent, wherein the interferon-beta has not been subjected to prior lyophilization and wherein the storage vessel has at least one surface thereof in contact with the liquid composition that is coated with a material selected from the group consisting of silicone and polytetrafluoroethylene.

A frozen liquid composition comprising an interferon and a stabilizing agent at between about 0.3% and 3.13%.by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine, wherein the composition has not been previously lyophilized.

A kit for parenteral administration of a liquid interferon formulation, wherein the kit comprises:

• a) a vessel containing a liquid formulation at a pH of between 4 and 6, the liquid comprising a pharmaceutically effective amount of interferon-beta that has not been previously lyophilized and a amino acid stabilizing agent at less than about 3.1% by weight;
• and b) instructions for use thereof.

A process for stabilizing interferon-beta in liquid pharmaceutical compositions so that it essentially retains its anti-viral activity during storage at a temperature of between about 2 and about 25 degrees C. for a period of at least 3 months, comprising admixing:

• a) interferon-beta;
• b) a buffer maintaining the pH within the range of 4.0 to 7.2;
• and c) an amino acid stabilizing agent, wherein the liquid has previously not been lyophilized and has not been cavitated.

The process of claim 42, further comprising admixing i salt to provide an appropriate ionic strength.