Claims
- 1. A solution formulation comprising:
a physiologically tolerated buffer selected from the group consisting of TRIS and arginine; a monomeric insulin analog; zinc; and a phenolic preservative.
- 2. The formulation of claim 1, wherein the monomeric insulin analog is LysB28ProB29-human insulin and the buffer is TRIS.
- 3. The formulation of claim 1, wherein the monomeric insulin analog is AspB28-human insulin and the buffer is TRIS.
- 4. The formulation of claim 2 further comprising an isotonicity agent and wherein the pH of the formulation is between pH 7.0 and pH 8.0 when measured at a temperature of 22° C.
- 5. The formulation of claim 4, wherein the concentration of LysB28ProB29-human insulin is between about 100 and about 400 units per milliliter.
- 6. The formulation of claim 5, wherein TRIS is present at a concentration of about 2 mg/mL; glycerol is the isotonicity agent and is present at a concentration of about 16 mg/mL; and m-cresol is present at a concentration of about 1.76 mg/mL and phenol is present at a concentration of about 0.715 mg/mL.
- 7. A stable, soluble formulation of a monomeric insulin analog for use in a continuous infusion system, consisting essentially of: an isotonicity agent; a buffer selected from the group consisting of TRIS and arginine; a monomeric insulin analog; zinc; and a phenolic preservative.
- 8. The insulin analog formulation of claim 1, which further comprises protamine.
- 9. The formulation of claim 8, wherein the insulin analog is LysB28ProB29.
- 10. The formulation of claim 8, wherein the insulin analog is AspB28.
- 11. A method for treating diabetes comprising administering an effective dose of the formulation of claim 1 to a patient in need thereof.
- 12. The method of claim 11, wherein the formulation is administered using a continuous infusion system.
- 13. A method for treating hyperglycemia comprising administering an effective dose of the formulation of claim 1 to a patient in need thereof.
- 14. The method of claim 13, wherein the formulation is administered using a continuous infusion system.
- 15. A method for treating diabetes comprising administering an effective dose of the formulation of claim 8 to a patient in need thereof.
- 16. A method for treating hyperglycemia comprising administering an effective dose of the formulation of claim 8 to a patient in need thereof.
CROSS-REFERENCE
[0001] This application claims the benefit of U.S. Provisional Application No. 60/053,089, filed Jun. 13, 1997.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60053089 |
Jun 1997 |
US |
Divisions (1)
|
Number |
Date |
Country |
Parent |
09096247 |
Jun 1998 |
US |
Child |
09450794 |
Nov 1999 |
US |
Continuations (1)
|
Number |
Date |
Country |
Parent |
09450794 |
Nov 1999 |
US |
Child |
10264176 |
Oct 2002 |
US |