Stable liquid interferon formulations

Details Stable liquid interferon formulations Stable liquid interferon formulations

A - Human Necessities

61

K

A61K 38/21 (2006.01) A61K 9/08 (2006.01) A61K 47/18 (2006.01)

Patent

CA 2275890

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 contact 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.

L'invention concerne des compositions liquides d'interféron, ayant un pH compris entre 4,0 et 7,2. Ces compositions comprennent de l'interféron .beta. et un stabilisant, en une quantité comprise entre environ 0,3 et 5 % en poids, qui est un acide aminé choisi dans le groupe comprenant des acides aminés acides, l'arginine et la glycine. Si nécessaire, on ajoute un sel pour donner une force ionique suffisante. La composition liquide n'a pas été préalablement lyophilisée ou cavitée. Le liquide est de préférence contenu dans un récipient dont au moins une surface en contact avec le liquide est revêtue d'une matière inerte en ce qui concerne l'adsorption de l'interféron .beta.. L'invention concerne également un kit destiné à l'administration parentérale d'une formulation liquide d'interféron et un procédé permettant de stabiliser lesdites compositions liquides d'interféron.

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