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Details for Patent: 5,374,620

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Details for Patent: 5,374,620

Title: Growth-promoting composition and its use
Abstract:A combined formulation for IGF-I and growth hormone (GH) is useful for enhancing growth of a mammal. This formulation, which may be administered by infusion or injection to enhance growth, comprises IGF-I and GH, each in amounts of 0.1 to 100 mg/ml, in a pharmaceutically acceptable carrier at a pH of about 5-6 containing a surfactant, wherein the amounts of IGF-I and GH in the composition are effective to promote growth of a mammal more than an equivalent dose of IGF-I or GH alone, and wherein the weight ratio of IGF-I to GH in the composition ranges from 0.002:1 to 240:1.
Inventor(s): Clark; Ross G. (Pacifica, CA), Cronin; Michael J. (San Mateo, CA), Yeung; Douglas A. (Fremont, CA), Oeswein; James Q. (Moss Beach, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Filing Date:Jun 04, 1993
Application Number:08/071,818
Claims:1. A growth-promoting composition comprising IGF-I and growth hormone, each in an amount of 0.1 to 100 mg/ml, in a pharmaceutically acceptable carrier at a pH of about 6 containing a surfactant, wherein the amounts of IGF-I and growth hormone in the composition are effective to promote growth of a mammal more than an equivalent dose of IGF-I or growth hormone alone, and wherein the weight ratio of IGF-I to growth hormone in the composition ranges from 0.002:1 to 240:1.

2. The composition of claim 1 wherein the amounts of IGF-I and growth hormone in the composition are about 1 to 10 mg/ml each and the weight ratio of IGF-I to growth hormone in the composition ranges from 0.048:1 to 30:1.

3. The composition of claim 1 wherein the carrier is an acetic acid salt buffer comprising a sodium counterion.

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

5. The composition of claim 4 further comprising a stabilizer.

6. A method for enhancing growth of a mammal comprising administering to the mammal by injection an effective amount of the composition of claim 1 so as to enhance the growth of the mammal over the enhancement in growth achieved using an equivalent dose of IGF-I or GH alone.

7. A method for enhancing growth of a mammal comprising administering to the mammal by infusion an effective amount of the composition of claim 1 so as to enhance the growth of the mammal over the enhancement in growth achieved using an equivalent dose of IGF-I or GH alone.

8. A composition comprising IGF-I and growth hormone in a weight ratio of IGF-I:growth hormone of between about 2:1 and 100:1 (w/w), about 0.05-0.3of an osmolyte, about 0.1-10 mg/ml of a stabilizer, about 1-5 mg/ml of a surfactant, and about 5-100 mM of a buffer at about pH 5-6.

9. The composition of claim 8 wherein the osmolyte is an inorganic salt and the surfactant is nonionic.

10. The composition of claim 9 wherein the inorganic salt sodium chloride or potassium chloride, the stabilizer is phenol or benzyl alcohol, the surfactant is polysorbate or poloxamer, the buffer is sodium acetate or sodium citrate or both, and the amounts of IGF-I and growth hormone are about 2-20 mg/ml and about 0.2-10 mg/ml, respectively, with the weight ratio of IGF-I:growth hormone being between about 2:1 and 50:1.

11. The composition of claim 10 wherein the amount of IGF- I is about 7-10 mg/ml, the amount of growth hormone is about 0.2-1.5 mg/ml, the weight ratio of IGF-I: growth hormone is about 3:1 to 20:1, the amount of sodium chloride is about 5-7 mg/ml, the amount of phenol is about 0.1-3 mg/ml or the amount of benzyl alcohol is about 6-10 mg/ml, the surfactant is polysorbate in an amount of about 1-3 mg/ml, the amount of sodium acetate is about 2.5-4 mg/ml, and the amount of sodium citrate is about 0.1-1 mg/ml.

12. The composition of claim 8 that is lyophilized.

13. A method for enhancing growth of a mammal comprising administering to the mammal by injection an effective amount of the composition of claim 8 so as to enhance the growth of the mammal over the enhancement in growth achieved using an equivalent dose of IGF-I or GH alone.

14. A method for enhancing growth of a mammal comprising administering to the.mu.l by infusion an effective amount of the composition of claim 8 so as to enhance the growth of the mammal over the enhancement in growth achieved using an equivalent dose of IGF-I or GH alone.

15. A composition comprising IGF-I and growth hormone in a weight ratio of IGF-I:growth hormone of between about 2:1 and 100:1 (w/w), about 0.05-0.3 mM of an inorganic salt, about 0.1-10 mg/ml of a stabilizer, about 1-5mg/ml of a nonionic surfactant, and about 5-100 mM of a buffer at about pH

16. A method for enhancing growth of a mammal comprising administering Go the mammal by injection an effective amount of the composition of claim 8, wherein the weight ratio of IGF-I:growth hormone administered is between about 2:1 and 100:1.
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