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Details for Patent: 6,448,225

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Details for Patent: 6,448,225

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 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)
Filing Date:Jun 25, 1999
Application Number:09/344,225
Claims:1. A stable aqueous formulation of human growth hormone comprising: a) 1 mg/ml to 20 mg/ml human growth hormone; b) buffer providing pH 5.5 to pH 7; c) 0.1% w/v to 1 % w/v nonionic surfactant; and d) mannitol; wherein said aqueous formulation is free of glycine and is stable upon storage for 6 to 18 months at 2 to 8.degree. C.

2. The formulation of claim 1 further comprising a preservative.

3. The formulation of claim 2 wherein said preservative is selected from the group consisting of phenol, benzyl alcohol, meta-cresol, methyl paraben, propyl paraben, benzalkonium chloride, and benzethonium chloride.

4. The formulation of claim 3 wherein said preservative is phenol.

5. The formulation of claim 3 wherein the concentration of phenol in the formulation is 0.2% (w/v) to 0.4% (w/v).

6. The formulation of claim 1 which further comprises neutral salt.

7. The formulation of claim 1 wherein the concentration of mannitol in said formulation is 5 mg/ml to 50 mg/ml.

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

9. The formulation of claim 8 wherein said buffer is citrate buffer.

10. The formulation of claim 8 wherein said buffer is histidine buffer.

11. The formulation of claim 1 wherein the non-ionic surfactant is poloxamer or polysorbate.

12. A method of making a storage stable aqueous formulation of human growth hormone comprising mixing said human growth hormone and an aqueous, pharmaceutically acceptable vehicle which includes a) said human growth hormone at a concentration of 1 mg/ml to 20 mg/ml; b) buffer providing pH 5.5 to pH 7; c) 0.1% w/v to 1% w/v nonionic surfactant; and d) mannitol; wherein said aqueous formulation is free of glycine and is stable upon storage for 6 to 18 months at 2 to 8.degree. C.
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