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Claims for Patent: 5,763,394

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Claims for Patent: 5,763,394

Title: Human growth hormone aqueous formulation
Abstract:A stable pharmaceutically acceptable aqueous formulation containing human growth hormone, a buffer, a non-ionic surfactant, and, optionally, a neutral salt, mannitol, or, a preservative, is disclosed. Also disclosed are associated means and methods for preparing, storing, and using such formulations.
Inventor(s): O'Connor; Barbara H. (San Carlos, CA), Oeswein; James Q. (Moss Beach, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:08/117,156
Patent Claims: 1. A human growth hormone formulation comprising:

a) 1 mg/ml to 20 mg/ml human growth hormone,

b) buffer system providing pH 5.5 to pH 7,

c) 0.1% w/v to 1% w/v nonionic surfactant, and

d) 50 mM to 200 mM of neutral salt

in a sterile injectable aqueous vehicle,

wherein said formulation is a long term cold temperature storage stable for 6 to 18 months at 2.degree. to 8.degree. C., directly injectable, pharmaceutically acceptable liquid, free of glycine and mannitol.

2. The formulation of claim 1 wherein the nonionic surfactant is a poloxamer.

3. The formulation of claim 2 wherein the poloxamer is poloxamer 188 or poloxamer 184.

4. The formulation of claim 1 wherein the nonionic surfactant is a polysorbate.

5. The formulation of claim 4 wherein the polysorbate is polysorbate 20 or polysorbate 80.

6. The formulation of claim 1 wherein the neutral salt is sodium chloride or potassium chloride.

7. The formulation of claim 1 wherein the buffer buffers the formulation to about pH 6.

8. The formulation of claim 1 wherein the buffer is selected from the group consisting of citrate, phosphate, Tris, succinate, acetate, and histidine buffers.

9. A human growth hormone formulation consisting essentially of:

a) 1 mg/ml to 20 mg/ml human growth hormone,

b) buffer system providing pH 5.5 to pH 7,

c) 0.1% w/v to 1% w/v nonionic surfactant,

d) 50 mM to 200 mM of neutral salt and

e) a preservative,

in a sterile injectable aqueous vehicle,

wherein said formulation is a long term cold temperature storage stable for 6 to 18 months at 2.degree. to 8.degree. C., directly injectable, pharmaceutically acceptable liquid free of glycine and mannitol.

10. The formulation of claim 9 wherein the nonionic surfactant is a poloxamer.

11. The formulation of claim 10 wherein the poloxamer is poloxamer 188 or poloxamer 184.

12. The formulation of claim 9 wherein the nonionic surfactant is a polysorbate.

13. The formulation of claim 12 wherein the polysorbate is polysorbate 20 or polysorbate 80.

14. The formulation of claim 9 wherein the neutral salt is sodium chloride or potassium chloride.

15. The formulation of claim 9 wherein the buffer buffers the formulation to about pH 6.

16. The formulation of claim 9 wherein the buffer is selected from the group consisting of citrate, phosphate, Tris, succinate, acetate, and histidine buffers.

17. The formulation of claim 9 wherein the preservative is selected from the group consisting of phenol, benzyl alcohol, meta-cresol, methyl paraben, propyl paraben, benzalkonium chloride, and benzethonium chloride.

18. A directly injectable aqueous! human growth hormone formulation consisting of

5 mg/ml human growth hormone,

8.8 mg/ml sodium chloride,

2.0 mg/ml polysorbate 20,

2.5 mg/ml sodium citrate, and

0.5 mg/ml phenol

in a pH 6 buffered aqueous vehicles

wherein said formulation is a long term cold temperature storage stable for 6 to 18 months at 2.degree. to 8.degree. C., directly injectable, pharmaceutically acceptable liquid, free of glycine and mannitol.

19. The formulation of claim 18 packaged in stoppered and capped sterile glass vials.

20. A method for using human growth hormone comprising the steps of

A) formulating said human growth hormone into an aqueous liquid formulation comprising:

a) 1 mg/ml to 20 mg/ml human growth hormone,

b) buffer system providing pH 5.5 to pH 7,

c) 0.1% w/v to 1% w/v non-ionic surfactant, and

d) 50 mM to 200 mM of neutral salt

in a pharmaceutically acceptable, injectable sterile aqueous vehicle, said formulation being free of glycine and mannitol;

B) storing said formulation as an aqueous liquid for from six to 18 months at 2.degree. C. to 8.degree. C. thereby forming a stored formulation; and

C) directly injecting said stored formulation into a patient in need of human growth hormone therapy.

21. A method for using human growth hormone comprising the steps of

A) formulating said human growth hormone into an aqueous liquid formulation consisting essentially of:

a) 1 mg/ml to 20 mg/ml human growth hormone,

b) buffer system providing pH 5.5 to pH 7,

c) 0.1% w/v to 1% w/v nonionic surfactant,

d) 50 mM to 200 mM of neutral salt and

e) a preservative,

in a pharmaceutically acceptable, injectable sterile aqueous vehicle said formulation being free of glycine and mannitol;

B) storing said formulation as an aqueous liquid for from six to 18 months at 2.degree. C. to 8.degree. C. thereby forming a stored formulation; and

C) directly injecting said stored formulation into a patient in need of human growth hormone therapy.

22. The method of claim 21 wherein in the aqueous liquid formulation

the human growth hormone is present at 5 mg/ml,

the buffer system is a sodium citrate buffer providing pH 6,

the polysorbate nonionic surfactant is 2.0 mg/ml polysorbate 20,

the neutral salt is 8.8 mg/ml sodium chloride and

the preservative is 0.5 mg/ml phenol.

23. A method for using human growth hormone comprising the steps of

A) formulating said human growth hormone into an aqueous liquid formulation comprising:

a) 1 mg/ml to 20 mg/ml human growth hormone,

b) buffer system providing pH 5.5 to pH 7,

c) 0.1% w/v to 1% w/v non-ionic surfactant, and

d) 50 mM to 200 mM of neutral salt

in a pharmaceutically acceptable, injectable sterile aqueous vehicle;

B) storing said formulation as an aqueous liquid for from six to at least 18 months at 2.degree. C. to 8.degree. C. thereby forming a stored formulation; and

C) directly injecting said stored formulation into a patient in need of human growth hormone therapy.
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