GB2371227A — Crystallisation - resistant aqueous growth hormone formulations

USPTO Abstract

The invention relates to aqueous growth hormone formulations comprising growth hormone and either citrate buffer at pH 5.6 or greater, or a non-citrate buffer at pH 6.0 or greater, which are substantially free of crystallisation on storage. Examples of such formulations use recombinant human growth hormone. Buffers other than citrate used include phosphate buffer, ammonium acetate and glycine. The formulations may in addition include agents for isotonicity, such as mannitol, propylene glycol, sodium chloride or ammonium chloride, non-ionic surfactants, such as Pluronic F-68 (RTM), and preservatives such as phenol or benzyl alcohol. The formulations are stable and exhibit little or no crystallisation when stored at temperatures above refrigeration temperatures, and may be used for the treatment of hypopituitary dwarfism.