Liquid buffered gdf-5 formulations

A - Human Necessities – 61 – K

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A61K 9/00 (2006.01) A61K 38/18 (2006.01) A61K 47/12 (2006.01)

Patent

CA 2720845

Improved formulations and methods are provided for stabilizing a solution of bone morphogenetic protein. The compositions comprise an acetate buffered solution of GDF-5 and other excipients wherein the solution has a pH of from about 4.2 to about 5.3, thereby providing for a biologically isotonic solution having improved stability of the GDF-5 protein during stor-age, handling, and use.

La présente invention concerne des formulations et des procédés améliorés pour la stabilisation dune solution de protéine morphogénétique osseuse. Les compositions renferment une solution tamponnée par de lacétate de GDF-5 et dautres excipients où la solution a un pH denviron 4,2 à environ 5,3, produisant de cette manière une solution biologiquement isotonique présentant une amélioration de la stabilité de la protéine GDF-5 au cours du stockage, de la manipulation et de lutilisation.

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