Stable formulation of a therapeutic protein

Details Stable formulation of a therapeutic protein Stable formulation of a therapeutic protein

A - Human Necessities

61

K

A61K 38/27 (2006.01) A61K 9/08 (2006.01) A61K 47/14 (2006.01)

Patent

CA 2726232

An aqueous composition comprising a therapeutic protein further characterized in that (i) the pH of the composi-tion is adjusted to be between about 5.9 and 6.3, preferably about 6.1; (ii) the composition comprises at least one displaced buffer having a pKa within 1 to 3 pH units of the pH of the composition such as lactate and TRIS; (iv) the osmolarity of the composition is between 150 - 500 mOsm/L.

L'invention concerne une composition aqueuse comprenant une protéine thérapeutique également caractérisée en ce que (i) le pH de la composition est ajusté pour être compris entre environ 5,9 et 6,3, de préférence égal à environ 6,1; (ii) la composition comprend au moins un tampon déplacé présentant un pKa compris entre 1 et 3 unités de pH du pH de la composition tel que du lactate et du TRIS; (iv) l'osmolarité de la composition est comprise entre 150 et 500 mOsm/L.

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