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Claims for Patent: 5,096,885

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Claims for Patent: 5,096,885

Title: Human growth hormone formulation
Abstract:A stable pharmaceutically acceptable formulation containing human growth hormone, glycine, mannitol, a buffer, and optionally, a non-ionic surfactant is disclosed. The formulation contains human growth-hormone: glycine in 1:50-200 molar ratios. Also disclosed are associated means and methods for preparing and using such formulations.
Inventor(s): Pearlman; Rodney (El Granada, CA), Oeswein; James Q. (Montara, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:07/182,262
Patent Claims: 1. A stabilized pharmaceutically acceptable formulation of human growth hormone comprising:

a) human growth hormone,

b) glycine,

c) mannitol, and

d) a buffer

wherein the molar ratio of human growth hormone:glycine is 1:50-200.

2. A formulation as in claim 1 having a pH of 4-8.

3. A formulation as in claim 1 wherein said buffer is a phosphate buffer.

4. A formulation as in claim 1 wherein said buffer is a tris buffer.

5. A formulation as in claim 1 wherein the molar ratio of hGH:mannitol is 1:700-3000.

6. A formulation as in claim 3 wherein the molar ratio of hGH:phosphate buffer is 1:50-250.

7. A formulation as in claim 1 wherein said human growth hormone is met-hGH.

8. A formulation as in claim 1 additionally comprising a pharmaceutically acceptable diluent.

9. A formulation as in claim 1 which is dimer free.

10. A formulation as in claim 1 additionally comprising a pharmaceutically acceptable non-ionic surfactant.

11. A formulation as in claim 10 wherein the non-ionic surfactant is polysorbate 80.

12. A formulation as in claim 11 wherein the molar ratio of hGH:polysorbbate 80 is 1.0:0.7-30.

13. A stabilized pharmaceutically acceptable formulation of human growth hormone comprising a pharmaceutically effective amount of human growth hormone, glycine, mannitol, a buffer, and a non-ionic surfactant wherein the molar ratio of human growth hormone:glycine is 1:50-200, and wherein said formulation is capable of undergoing processing and storage with substantially no dimer formation.

14. A formulation as in claim 13 wherein said buffer is a phosphate buffer.

15. A formulation as in claim 3 wherein said non-ionic surfactant is polysorbate 80.

16. The formulation as in claim 13 wherein the non-ionic surfactant is a polysorbate or poloxamer.

17. The formulation as in claim 16 wherein said polysorbate is polysorbate 80.

18. The formulation as in claim 17 wherein the molar ratio of said hGH to said polysorbate 80 is 1:0.07-30.

19. The formulation as in claim 18 wherein said molar ratio is 1:0.1-10.

20. The formulation as in claim 19 wherein said molar ratio is 1:3.

21. The formulation as in claim 13 wherein said non-ionic surfactant concentration is 0.1-5% (w/v).

22. A method of administering human growth hormone comprising the steps of:

administering a formulation with an aerosol device or needleless injector gun, wherein the formulation comprises

a) human growth hormone,

b) mannitol,

c) glycine,

d) a buffer, and

e) a non-ionic surfactant,

wherein the molar ratio of human growth hormonne:glycine is 1:50.varies.200.

23. A method as in claim 22 wherein said non-ionic surfactant is a polysorbate or a poloxamer.

24. The method as in claim 23 wherein said administration is with an aerosol device.

25. The method as in claim 23 wherein said polysorbate is polysorbate 80.

26. The method as in claim 25 wherein the molar ratio of hGH to polysorbate 80 is 1:0.07-30.

27. The method as in claim 26 wherein said molar ratio is 1:0.1-10.

28. The method as in claim 27 wherein said molar ratio is 1:3.

29. The method as in claim 22 wherein said non-ionic surfactant concentration is 0.1-5% (w/v).
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