Liquid formulation of g-csf conjugate

Details Liquid formulation of g-csf conjugate Liquid formulation of g-csf conjugate

C - Chemistry, Metallurgy

07

K

C07K 17/08 (2006.01) A61K 47/48 (2006.01) A61P 7/06 (2006.01) A61P 25/00 (2006.01)

Patent

CA 2696594

The present invention relates to a liquid pharmaceutical composition comprising a granulocyte colony stimulating factor polypeptide conjugated with a polymer, the composition having a pH value in the range of 4.5 to 5.5. The composition further comprises a surfactant and optionally one or more other pharmaceutically acceptable excipients. Further, the composition of the invention is free from tartaric acid or salts thereof and from succinic acid and salts thereof as buffering agents and does not contain amino acids as stabilizer. The composition has a good storage stability and is especially useful for the prophylaxis and treatment of disorders and medical indications where granulocyte colony stimulating factor preparations are considered as useful remedies.

L'invention concerne une composition pharmaceutique liquide contenant un polypeptide du facteur de stimulation de colonies de granulocytes (G-CSF) conjugué avec un polymère, cette composition présentant une valeur de pH comprise entre 4,5 et 5,5. Cette composition contient également un tensio-actif et facultativement au moins un autre excipient pharmaceutiquement acceptable. La composition selon l'invention est exempte d'acide tartrique ou de ses sels et d'acide succinique ou de ses sels comme tampons et elle ne contient pas d'acides aminés comme stabilisant. Cette composition présente une bonne stabilité au stockage et elle est particulièrement utile dans la prévention et le traitement de troubles et de pathologies contre lesquels les préparations de facteur de stimulation des colonies de granulocytes sont considérées comme des remèdes utiles.

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