PROCESS FOR MANUFACTURING CRYSTALS OF GROWTH HORMONE AND CRYSTALS THEREBY OBTAINED

摘要

The invention relates to a process for manufacturing crystals of growth hormone (GH) or functional derivatives thereof characterised by the steps: (i) mixing GH or functional derivatives thereof with an aqueous solution comprising a buffer and a chemical compound with the general formula (I): Ar-¢-CR1R2-!n-¢-CR3R4-!m-CR5R6-OH in which Ar is phenyl, alkyl-substi-tuted phenyl, naphthyl, alkyl-substituted naphthyl, R1 to R6 is H, OH or alkyl and n and m is 0 or 1; (ii) incubating; (iii) isolating the crystals by known methods. It also relates to the use of the chemical compound with general formula (I) in the preparation of crystals of GH from a buffert solution, crystals of growth hormone or any functional analogue thereof in the form of needles, trigonal forms, cubes or parallelepipeds with a length of at least 20 microns, and suspension for injection, depot formulation and dry formulation comprising the crystals.