Claims
- 1. A pharmaceutical formulation comprising a polypeptide selected from the group consisting of bovine, porcine or human insulin, an insulin analogue, an insulin derivative, an active insulin metabolite and combinations thereof;
a surfactant or a combination of two or more surfactants; optionally a preservative or a combination of two or more preservatives; and optionally an isotonicizing agent, a buffer or buffers or a further excipient or excipients or a combination thereof; such pharmaceutical formulation being a clear solution having a pH in the range from 1 to 6.8.
- 2. A pharmaceutical formulation according to claim 1, having a pH in the range from pH 3.5-6.8.
- 3. A pharmaceutical formulation according to claim 1, having a pH in the range from pH 3.5-4.5.
- 4. A pharmaceutical formulation according to claim 1 wherein the surfactant is selected from the group consisting of partial and fatty acid esters and ethers of polyhydric alcohols, of glycerol, sorbitol and of sucrose, and polyols.
- 5. A pharmaceutical formulation according to claim 4, wherein the partial and fatty acid esters and ethers of polyhydric alcohols, of glycerol and sorbitol are selected from the group consisting of Span®, Tween®, polysorbate, Myrj®, Brij®, Triton®, and Cremophor®.
- 6. A pharmaceutical formulation according to claim 5, wherein the partial and fatty acid esters and ethers of polyhydric alcohols, of glycerol and sorbitol are selected from the group consisting of Tween® 20 and Tween® 80.
- 7. A pharmaceutical formulation according to claim 4, wherein the polyols are selected from the group consisting of polypropylene glycols, polyethylene glycols, poloxamers, Pluronics®, and Tetronics®.
- 8. A pharmaceutical formulation according to claim 1, wherein the preservative is selected from the group consisting of phenol, cresol, chlorocresol, benzyl alcohol, and parabens.
- 9. A pharmaceutical formulation according to claim 1, wherein the isotonicizing agent is selected from the group consisting of mannitol, sorbitol, lactose, dextrose, trehalose, sodium chloride, and glycerol.
- 10. A pharmaceutical formulation according to claim 1 wherein the excipients are selected from the group consisting of TRIS, phosphate, citrate, acetate, and glycylglycine
- 11. A pharmaceutical formulation according to claim 1 wherein the excipients are selected from the group consisting of acids, alkalis, and salts.
- 12. A pharmaceutical formulation according to claim 1, wherein the insulin analog is selected from the group consisting of Gly(A21), Arg(B31), Arg(B32)-human insulin, Lys(B3), Glu(B29)-human insulin, Asp(B28)-human insulin, Lys(B28) Pro(B29)-human insulin, and des(B30)-human insulin.
- 13. A pharmaceutical formulation according to claim 1, wherein the insulin derivative is selected from the group consisting of B29-N-myristoyl-des(B30) human insulin, B29-N-palmitoyl-des(B30) human insulin, B29-N-myristoyl human insulin, B29-N-palmitoyl human insulin, B28-N-myristoyl LysB28ProB29 human insulin, B28-N-palmitoyl-LysB28ProB29 human insulin, B30-N-myristoyl-ThrB29 LysB30 human insulin, B30-N-palmitoyl-ThrB29LysB30 human insulin, B29-N-(N-palmitoyl-γ-glutamyl)-des(B39) human insulin, B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin, B29-N-(ω-carboxy-heptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxy-heptadecanoyl) human insulin.
- 14. A pharmaceutical formulation according to claim 1, wherein the insulin is present in a concentration of 60 to 6000 nmol/ml.
- 15. A pharmaceutical formulation according to claim 1, wherein the insulin analog is present in a concentration of 60 to 6000 nmol/ml.
- 16. A pharmaceutical formulation according to claim 1, wherein the insulin derivative is present in a concentration of 60 to 6000 nmol/ml.
- 17. A pharmaceutical formulation according to claim 14, wherein the insulin is present in a concentration of 240 to 3000 nmol/ml.
- 18. A pharmaceutical formulation according to claim 15, wherein the insulin analog is present in a concentration of 240 to 3000 nmol/ml.
- 19. A pharmaceutical formulation according to claim 16, wherein the insulin derivative is present in a concentration of 240 to 3000 nmol/ml.
- 20. A pharmaceutical formulation according to claim 1 wherein the surfactant is present in a concentration of 5 to 200 μg/ml.
- 21. A pharmaceutical formulation according to claim 20, wherein the surfactant is present in a concentration of 5 to 120 μg/ml.
- 22. A pharmaceutical formulation according to claim 21, wherein the surfactant is present in a concentration of 20 to 75 μg/ml.
- 23. A pharmaceutical formulation according to claim 1, wherein the isotonicizing agent is selected from the group consisting of glycerol and mannitol and wherein the isotonicizing agent is present in a concentration of 100 to 250 mM.
- 24. A pharmaceutical formulation according to claim 23, wherein NaCl is present in a concentration of 0 to 150 mM.
- 25. A pharmaceutical formulation according to claim 1, wherein a buffer is present in a concentration of 5 to 250 mM.
Priority Claims (1)
Number |
Date |
Country |
Kind |
DE 10227232.8 |
Jun 2002 |
DE |
|
Parent Case Info
[0001] This application is entitled to the benefit of U.S. Provisional Application No. 60/409,338, filed Sep. 9, 2002, and Federal Republic of Germany Application 10227232.8-41, filed Jun. 18, 2002.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60409338 |
Sep 2002 |
US |