STABLE, AEROSOLIZABLE SUSPENSIONS OF PROTEINS IN ETHANOL.

摘要

Stable suspensions of a biologically active protein are disclosed that are suited for aerosol delivery to the lungs of a patient in need of treatment, which comprise particles of biologically active protein suspended in ethanol. In a preferred embodiment, the invention describes a stable suspension of insulin useful for aerosol delivery to the lungs of a patient in need of treatment comprising particles of a pharmaceutically effective amount of insulin suspended in ethanol. A method of delivering a therapeutically effective amount of a protein to the respiratory tract Of a patient is described which comprises producing an aerosol of a stable liquid suspension of a protein using an electrohydrodynamic spraying means wherein the liquid suspension comprises particles of the protein suspended in ethanol. The stable ethanol suspensions of the invention may optionally contain up to about 20 % (V/V) of a pharmaceutically acceptable formulation additive such as glycerol, propylene glycol and polyethylene glycol as well as minor amounts (from about 0.05 % to about 5.0 % (W/V) of a pharmaceutically acceptable excipient.