Method for the stabilizing of biomolecules (e.g. insulin) in...

A - Human Necessities – 61 – K

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Details

A61K 38/28 (2006.01) A61K 9/12 (2006.01) A61K 47/10 (2006.01) A61K 47/26 (2006.01) A61P 11/00 (2006.01)

Patent

CA 2430137

The invention is directed to a stable formulation of a biologically active protein useful for aerosol delivery to the respiratory tract of a patient in need of treatment comprising: (a) a carrier liquid comprising from about 10 % to from about 100 % V/V water and from about 0 % to from about 90 % V/V of an organic liquid; (b) a biologically effective amount of a protein suspended or dissolved in a carrier liquid; and (c) a stabilizing effective amount of a derivatized carbohydrate stabilizing agent suspended or dissolved in said carrier liquid. The stable formulations of the invention may optionally contain about 0.1 % to about 5.0 % W/V of a pharmaceutically acceptable excipient.

L'invention porte sur une formulation stable d'une protéine biologiquement active utilisée pour être distribuée par aérosol dans les voies respiratoires d'un patient nécessitant un traitement. Cette formulation comprend : (a) un liquide support comprenant entre environ 10 % et environ 100 % v/v d'eau et entre environ 0 % et environ 90 % v/v d'un liquide organique; (b) une quantité efficace d'un point de vue biologique d'une protéine en suspension ou dissoute dans un liquide support ; et (c) une quantité efficace stabilisante d'un agent de stabilisation de glucides dérivatisés, en suspension ou dissous dans le liquide support. Ces formulations stables peuvent éventuellement contenir d'environ 0,1 % à environ 5,0 % m/m d'un excipient acceptable d'un point de vue pharmaceutique.

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