STABILISED GROWTH HORMONE FORMULATION AND METHOD OF PREPARATION THEREOF

摘要

A method for the preparation of a stable, liquid formulation of growth hormone, comprising growth hormone, a buffer and a stabilising effective amount of at least one stabilising agent selected from the group consisting of: (i) polyethylene-polypropylene glycol non-ionic surfactants, (ii) taurocholic acid or salts or derivatives thereof, and (iii) methyl cellulose derivatives, wherein the method comprises admixing the growth hormone with the buffer and the stabilising agent(s) under conditions such that the growth hormone is not exposed to concentrations of the buffer or stabilising agent(s) which are greater than 2x the final concentrations of the buffer or stabilising agent(s) in the formulation.