Pharmaceutical formulation
AssigneeNovo Nordisk A/S
InventorsHans Holmegaard S.o slashed.rensen, Lars Skriver, Annie Rassing Hoelgaard
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Abstract
A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product 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.
Claims15
A method for treating a disorder associated with growth hormone deficiency, comprising administering a pharmaceutical composition which comprises a growth hormone and histidine or a derivative thereof in an amount of from about 0.1 to about 12 mg histidine per mg of growth hormone to a patient in an amount effective to treat said deficiency.
A method for treating a disorder associated with growth hormone deficiency, comprising administering a crystalline growth hormone or a derivative thereof comprising histidine or a derivative thereof and a cation to a patient in an amount effective to treat said disorder.
Dependencies are inferred from the claim text.