FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-ALFA

Composiciones acuosas estables de almacenamiento a largo plazo de: - anticuerpos contra factor de necrosis tumoral alfa (anti-TNFa (alfa)) - tampón acetato, citrato o citrato-acetato; y - excipiente, disacárido, poliol o combinación de los mismos; cuando la solución tampón comprende o consiste en acetato, comprende un disacárido a una concentración menor a 240 mM; cuando es citrato o citrato-acetato, comprende un poliol a una concentración entre 50 mM - 300 mM; y el pH de la composición entre 4,0 - 7,0. uso de dicha composición en tratamiento de enfermedades inflamatorias, métodos de obtención y dispositivos que la comprenden. The present invention relates to aqueous stable antibody compositions suitable for long term storage, in particular comprising antibodies against Tumor Necrosis Factor alpha (anti-TNFα). More specifically, it provides an aqueous composition comprising: -an anti-TNFα antibody; -a buffer selected from the list consisting of an acetate buffer, a citrate buffer, and a citrate-acetate buffer; and -an excipient, wherein said excipient is at least selected from a disaccharide, a sugar alcohol and a combination thereof; wherein when the buffer comprises or consists of an acetate buffer, said composition comprises a disaccharide at a concentration of less than 240 mM; wherein when the buffer comprises or consists of a citrate or a citrate-acetate buffer, said composition comprises a sugar alcohol at a concentration from 50 mM to 300 mM; and wherein the pH of the composition is from pH 4.0 to pH 7.0. It further relates to the pharmaceutical use of said composition, in particular in the treatment of inflammatory and immune system mediated diseases associated to an increase of TNFα. In addition, the invention relates to methods for obtaining said composition and devices comprising thereof.