Formulations of human growth hormone comprising a non-naturally encoded amino acid at position 35
Formulations of modified human growth hormone polypeptides are provided.
1. A pharmaceutical formulation of a human growth hormone (hGH) variant wherein said formulation comprises: a) a buffer; b) at least one carrier, excipient, or stabilizer, and; c) a pharmaceutically effective quantity of the hGH variant wherein the hGH variant comprises a non-naturally encoded amino acid at position 35 and wherein the non-naturally encoded amino acid is p-acetyl phenylalanine.
2. The formulation of claim 1 wherein the hGH is PEGylated.
3. The formulation of claim 1 , wherein the pH of the buffer is between about pH 4.0 and about pH 8.5.
4. The formulation of claim 1 , wherein the pH of the buffer is between about pH 6.0 and about pH 7.3.
5. The formulation of claim 1 , wherein the pH of the buffer is between about pH 5.5 and about 8.0.
6. The formulation of claim 1 , wherein the pharmaceutically effective quantity of hGH is between about 2mg/mL and about 50 mg/mL.
7. The formulation of claim 1 , wherein the buffer is between about pH 5.0 and about pH 7.5.
8. The formulation of claim 1 , wherein the buffer is histidine.
9. The formulation of claim 8 , wherein the histidine is at a concentration of about 0.1 mM to about 200 mM.
10. The formulation of claim 9 , wherein the histidine is at a concentration of about 1 mM to about 75 mM.
11. The formulation of claim 10 , wherein the histidine is at a concentration of about 5 mM to about 30 mM.
12. The formulation of claim 1 , wherein the formulation further comprises d) a surfactant.
13. The formulation of claim 12 , wherein the surfactant is a non-ionic surfactant.
14. The formulation of claim 13 , wherein the non-ionic surfactant is at about 0.0001% to about 10%.
15. The formulation of claim 13 , wherein the non-ionic surfactant is at about 0.01% to about 10%.
16. The formulation of claim 13 , wherein the non-ionic surfactant is at about 0.1% to about 5%.
17. The formulation of claim 13 , wherein the non-ionic surfactant is at about 0.1% to about 1%.
18. The formulation of claim 13 , wherein the non-ionic surfactant is at about 0.0001% to about 1%.