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Details for Patent: 5,981,485

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Details for Patent: 5,981,485

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. (S. San Francisco, CA)
Filing Date:Jul 14, 1997
Application Number:08/891,823
Claims:1. An 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) 50 nM to 200 nM neutral salt, wherein said aqueous formulation is free of glycine and mannitol and is capable of storage for 6 to 18 months at 2 to 8.degree. C.

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

3. The formulation of claim 1 wherein said nonionic surfactant is a polysorbate.

4. The formulation of claim 1 wherein said neutral salt is sodium chloride.

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

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

7. The formulation of claim 6 wherein said preservative is selected from the group consisting of phenol, benzyl alcohol, meta-cresol, methyl paraben, propyl paraben, benzalkonium chloride, and benzethonium chloride.

8. A method of making a storage stable aqueous formulation of human growth hormone comprising mixing said human growth hormone into an aqueous, pharmaceutically acceptable vehicle which includes

a) 1 mg/ml to 20 mg/ml of said 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) 50 nM to 200 nM neutral salt;

wherein said aqueous, pharmaceutically acceptable vehicle is free of glycine and mannitol and is capable of storage for 6 to 18 months at 2 to 8.degree. C.
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