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Claims for Patent: 5,681,814

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Claims for Patent: 5,681,814

Title: Formulated IGF-I Composition
Abstract:A formulation for IGF-I is disclosed that is useful in treating hyperglycemic disorders and, in combination with growth hormone, in enhancing growth of a mammal. Also disclosed is a process for preparing a formulation of growth hormone and IGF-I from the IGF-I formulation. The IGF-I formulation comprises about 2-20 mg/ml of IGF-I, about 2-50 mg/ml of an osmolyte, about 1-15 mg/ml of a stabilizer, and a buffered solution at about pH 5-5.5, optionally with a surfactant.
Inventor(s): Clark; Ross G. (Pacifica, CA), Yeung; Douglas A. (Fremont, CA), Oeswein; James Q. (Moss Beach, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:08/071,819
Patent Claims: 1. An IGF-I-containing composition for subcutaneous administration comprising about 8-12 mg/ml of IGF-I, about 5-6 mg/ml of sodium chloride, a stabilizer consisting of about 8-10 mg/ml of benzyl alcohol or about 2-3 mg/ml of phenol, or both about 8-10 mg/ml of benzyl alcohol and about 2-3 mg/ml of phenol, and an about 50 mM sodium acetate buffered solution at a pH of about 5.4.

2. The composition of claim 1 additionally comprising about 1-5 mg/ml of a surfactant.

3. The composition of claim 2 wherein the surfactant is polysorbate or poloxamer in an amount of about 1-3 mg/ml.

4. The composition of claim 3 wherein the surfactant is polysorbate.

5. A method for treating diabetes comprising administering subcutaneously to a mammal having diabetes an amount of the composition of claim 1 effective to treat diabetes.

6. A method for treating diabetes comprising administering subcutaneously to a mammal having diabetes an amount of the composition of claim 2 effective to treat diabetes.

7. A method for treating diabetes comprising administering subcutaneously to a mammal having diabetes an amount of the composition of claim 3 effective to treat diabetes.

8. A method for treating diabetes comprising administering subcutaneously to a mammal having diabetes an amount of the composition of claim 4 effective to treat diabetes.
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