Method for stabilizing protein in liquid formulations for aerosol delivery

摘要

A stable formulation of a biologically active protein useful for aerosol delivery to the respiratory tract comprises: (a) a carrier liquid comprising from about 10% to about 100% V/V water and from about 0% to about 90% V/V of an organic liquid; (b) a biologically effective amount of a protein suspended or dissolved in the carrier liquid; and (c) a stabilizing effect amount of a derivatized carbohydrate stabilizing agent suspended or dissolved in the carrier liquid. Preferably the protein is a hormone such as insulin or a cytokine such as Factor VIII and the derivatized carbohydrate is C8-trehalose, C16-trehalose, C8-glycopyranoside or C12-glucopyranoside.