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Claims for Patent: 5,849,700

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Claims for Patent: 5,849,700

Title: Pharmaceutical formulation
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.
Inventor(s): S.o slashed.rensen; Hans Holmegaard (Virum, DK), Skriver; Lars (Ved.ae butted.k, DK), Hoelgaard; Annie Rassing (Holte, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:08/458,385
Patent Claims: 1. 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.

2. The method of claim 1 in which said composition is in the form of a bufferred aqueous solution.

3. The method of claim 2 in which said solution is buffered with histidine or a histidine derivative buffer at a concentration from about 1 mM to about 100 mM.

4. The method of claim 2 in which said composition has a pH from about 2 to about 8.

5. The method of claim 2 in which said composition has a pH from about 5 to about 7.

6. The method of claim 1 in which said composition has a pH of about 6.8.

7. The method of claim 2 in which the solution is buffered with histidine or a histidine derivative buffer at a concentration from about 1M to about 10 mM.

8. The method of claim 2 in which the solution is buffered with histidine or a histidine derivative buffer at a concentration from about 2 mM to about 6 mM.

9. The method of claim 2 in which the solution is buffered with histidine or a histidine derivative buffer at a concentration from about 3 mM to about 5 mM.

10. The method of claim 1 in which said composition further comprises a sugar alcohol or a disaccharide or a mixture thereof.

11. The method of claim 10 in which the sugar alcohol is mannitol.

12. The method of claim 10 in which the disaccharide is sucrose or trehalose.

13. The method of claim 1 in which the growth hormone is human growth hormone.

14. The method of claim 1 in which said composition is in lyophilized form.

15. 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.
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