A stabilized pharmaceutical formulation comprising growth...

A - Human Necessities – 61 – K

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A61K 38/27 (2006.01) A61K 9/14 (2006.01) A61K 47/22 (2006.01) A61K 47/42 (2006.01) A61P 5/06 (2006.01) C07K 14/61 (2006.01)

Patent

CA 2125855

A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffer- ing substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the pro- duct allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.

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