IP Library Granted Patent US 8,748,376
Granted Patent B2
US 8,748,376 · App. 12/643,330 · Granted Jun 10, 2014

Stable formulations of peptides

Inventors: Svend Ludvigsen (Lynge, DK); Morten Schlein (København, DK); Tine Elisabeth Gottschalk Bøving (Lyngby, DK); Claude Bonde (Lyngby, DK); Anne-Mette Lilleøre (Charlottenlund, DK); Dorthe Kot Engelund (Holte, DK); Bjarne Rønfeldt Nielsen (Virum, DK)
Assignee: Novo Nordisk A/S
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Quick Facts
Patent No.
US 8,748,376
App. No.
12/643,330
Granted
Jun 10, 2014
Kind
B2
Abstract

Stable pharmaceutical composition comprising insulinotropic peptide.

Claims (14)

1. A method for the preparation of a shelf-stable pharmaceutical composition of a GLP-1 compound comprising: dissolving said GLP-1 compound in aqueous medium, adjusting the pH of the solution to between about 8.0 and about 10.5, and heating the solution to a temperature between about 50° C. and about 95° C. for a period of time from about 3 minutes to about 180 minutes to result in a shelf-stable pharmaceutical solution.

2. The method according to claim 1 , wherein the temperature is between 60° C. and 95° C.

3. The method according to claim 1 , wherein the temperature is between 50° C. and 80° C.

4. The method according to claim 1 , wherein the temperature is between 70° C. and 80° C.

5. The method according to claim 1 , wherein the temperature is between 60° C. and 80° C.

6. The method according to claim 1 , wherein the pH is between about 8.0 to 10.0.

7. The method according to claim 1 , wherein the pH is about 8.15.

8. The method according to claim 1 wherein the heating is continued for a period of time which is between 15 minutes and 120 minutes.

9. The method according to claim 1 wherein the heating is continued for a period of time which is between 10 minutes and 90 minutes.

10. The method according to claim 1 wherein the heating is continued for a period of time which is between 3 minutes and 30 minutes.

11. The method according to claim 1 wherein the heating is continued for a period of time which is between 5 minutes and 15 minutes.

12. The method according to claim 1 , further comprising freeze drying the solution after the heating step; wherein the resulting freeze-dried composition is shelf-stable.

13. The method according to claim 1 , further comprising the addition of a pharmaceutically acceptable excipient after the heating step; wherein the resulting pharmaceutical composition is shelf-stable.

14. The method according to claim 1 , wherein said GLP-1 compound is Arg 34 , Lys 26 (N ε -(γ-Glu(N α -hexadecanoyl)))-GLP-1(7-37).

Priority Claims (5)
DK 2004 01753 · Nov 12, 2004 · national
DK 2004 01906 · Dec 8, 2004 · national
EP 05104050 · May 13, 2005 · regional
EP 05104172 · May 18, 2005 · regional
WO PCT/EP2005/055916 · Nov 11, 2005 · international
Continuity (4)
Division 11667040
Provisional Application 60635311 · Dec 10, 2004
Provisional Application 60682724 · May 19, 2005
Related Publication 20100173844A1 · Jul 8, 2010