Anti a beta antibody formulation

Details Anti a beta antibody formulation Anti a beta antibody formulation

A - Human Necessities

61

K

A61K 39/395 (2006.01) C07K 16/18 (2006.01)

Patent

CA 2593122

The present invention provides formulations for maintaining the stability of A.beta. binding polypeptides, for example, A.beta. antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.

La présente invention concerne des préparations permettant de maintenir la stabilité de polypeptides de liaison Aß, par ex., des anticorps anti-Aß. Des préparations exemplaires renferment un agent de tonicité, tel que le mannitol, et un agent tampon ou un acide aminé, tel que l'histidine. D'autres préparations exemplaires contiennent un antioxydant dans une quantité suffisante de manière à inhiber la formation de sous-produits, par exemple, la formation d'agrégats de polypeptides à poids moléculaire élevé, de fragments de dégradation de polypeptides à poids moléculaire faible et des mélanges associés. Les préparations de cette invention renferment, facultativement, un agent de tonicité, tel que le mannitol, et un agent tampon ou un acide aminé, tel que l'histidine. Ces préparations sont appropriées à plusieurs différentes voies d'administration.

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