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|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|
|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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