Process for manufacturing crystals of growth hormone and...

C - Chemistry – Metallurgy – 07 – K

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C07K 14/61 (2006.01) A61K 9/14 (2006.01) A61K 9/22 (2006.01) A61K 38/27 (2006.01) C07K 1/30 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2147482

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.

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