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Claims for Patent: 5,866,538

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Claims for Patent: 5,866,538

Title: Insulin preparations containing NaCl
Abstract:Insulin preparations of superior chemical stability, comprising human insulin or an analogue or derivative thereof, glycerol and/or mannitol, and 5 to 100 mM of a halogenide are disclosed.
Inventor(s): Norup; Elsebeth (Jyllinge, DK), Langkj.ae butted.r; Liselotte (Klampenborg, DK), Havelund; Svend (Bagsvaerd, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:08/879,991
Patent Claims: 1. A pharmaceutical formulation comprising:

a polypeptide selected from the group consisting of human insulin, an analogue thereof, a derivative thereof, and combinations of any of the foregoing;

glycerol, mannitol, or glycerol and mannitol; and

5 to 100 mM of a halogenide.

2. A pharmaceutical formulation according to claim 1, wherein the halogenide is an alkali or alkaline earth halogenide.

3. A pharmaceutical formulation according to claim 1, wherein said glycerol or mannitol is present at a concentration of 100 to 250 mM.

4. A pharmaceutical formulation according to claim 1, wherein said polypeptide is an analogue of human insulin selected from the group consisting of: (i) an analogue wherein position B28 is Asp, Lys, Leu, Val or Ala and position B29 is Lys or Pro; and (ii) des(B28-B30), des(B27) or des(B30) human insulin.

5. A pharmaceutical formulation according to claim 4, wherein said polypeptide is an analogue of human insulin wherein position B28 is Asp or Lys, and position B29 is Lys or Pro.

6. A pharmaceutical formulation according to claim 4, wherein said polypeptide is des(B30) human insulin.

7. A pharmaceutical formulation according to claim 1, wherein said halogenide is present at a concentration of 5 to 60 mM.

8. A pharmaceutical formulation according to claim 1, wherein said polypeptide is a derivative of human insulin having one or more lipophilic substituents.

9. A pharmaceutical formulation according to claim 8, wherein the insulin derivative is selected from the group consisting of B29-N.sup..epsilon. -myristoyl-des(B30) human insulin, B29-N.sup..epsilon. -palmitoyl-des(B30) human insulin, B29-N.sup..epsilon. -myristoyl human insulin, B29-N.sup..epsilon. -palmitoyl human insulin, B28-N.sup..epsilon. -myristoyl Lys.sup.B28 Pro.sup.B29 human insulin, B28-N.sup..epsilon. -palmitoyl-Lys.sup.B28 Pro.sup.B29 human insulin, B30-N.sup..epsilon. -myristoyl-Thr.sup.B29 Lys.sup.B30 human insulin, B30-N.sup..epsilon. -palmitoyl-Thr.sup.B29 Lys.sup.B30 human insulin, B29-N.sup..epsilon. -(N-palmitoyl-.gamma.-glutamyl)-des(B30) human insulin, B29-N.sup..epsilon. (N-lithocholyl-.gamma.-glutamyl)-des(B30) human insulin, B29-N.sup..epsilon. -(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and B29-N.sup..epsilon. -(.omega.-carboxyheptadecanoyl) human insulin.

10. A pharmaceutical formulation according to claim 9, wherein the insulin derivative is B29-N.sup..epsilon. -myristoyl-des(B30) human insulin.

11. A pharmaceutical formulation according to claim 8, wherein said halogenide is present at a concentration of 10 to 100 mM.

12. A pharmaceutical formulation according to claim 1, comprising an insulin analogue as well as an insulin derivative.

13. A pharmaceutical formulation according to claim 1, wherein said polypeptide is present at a concentration of 60 to 3000 nmol/ml.

14. A pharmaceutical formulation according to claim 1, further comprising:

10 to 40 ug Zn/100 U insulin.

15. A pharmaceutical formulation according to claim 1, further comprising:

0 to 5 mg/ml of a phenolic compound.

16. A pharmaceutical formulation according to claim 15, comprising:

0. 5 to 4.0 mg/ml of m-cresol or 0.5 to 4.0 mg/ml of phenol, or a mixture thereof.

17. A pharmaceutical formulation according to claim 1, wherein the halogenide is sodium chloride.
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