GIP/GLP1 agonist compositions
A composition of tirzepatide, comprising an agent selected from NaCl and propylene glycol; and dibasic sodium phosphate is provided.
1. A pharmaceutical composition comprising
tirzepatide, or a pharmaceutically acceptable salt thereof;
NaCl at a concentration from 6.2 mg/mL to 9.5 mg/mL;
and
dibasic sodium phosphate.
2. A pharmaceutical composition as claimed by claim 1 , wherein the tirzepatide, or a pharmaceutically acceptable salt thereof, concentration is from 5 to 30 mg/mL.
3. A pharmaceutical composition as claimed by claim 2 wherein the dibasic sodium phosphate concentration is from 1 mg/mL to 3 mg/mL.
4. A pharmaceutical composition as claimed by claim 1 wherein the dibasic sodium phosphate concentration is from 0.67 mg/mL to 2.68 mg/mL.
5. A pharmaceutical composition as claimed by claim 4 wherein the dibasic sodium phosphate concentration is about 1.34 mg/mL.
6. A pharmaceutical composition as claimed by claim 1 wherein the tirzepatide, or a pharmaceutically acceptable salt thereof, concentration is selected from the group consisting of 5, 10, 15, 20, 25, and 30 mg/mL.
7. A pharmaceutical composition as claimed by claim 6 wherein the tirzepatide, or pharmaceutically acceptable salt thereof, concentration is selected from the group consisting of 10, 20, and 30 mg/mL.
8. A pharmaceutical composition as claimed by claim 1 wherein the concentration of NaCl is from about 7 mg/mL to about 9 mg/m L.
9. A pharmaceutical composition as claimed by claim 8 wherein the NaCl concentration is about 8.2 mg/mL.
10. A pharmaceutical composition as claimed by claim 1 wherein the tirzepatide, or pharmaceutically acceptable salt thereof, concentration is from 5 mg/mL to 30 mg/mL; the dibasic sodium phosphate concentration is from 0.67 mg/mL to 2.68 mg/mL; and the NaCl concentration is from 6.2 mg/mL to 9.5 mg/m L.
11. A pharmaceutical composition as claimed by claim 10 wherein the tirzepatide, or pharmaceutically acceptable salt thereof, concentration is from about 5 mg/mL to 30 mg/mL; the dibasic sodium phosphate concentration is about 1.34 mg/mL; and the NaCl concentration is about 8.2 mg/mL.
12. A pharmaceutical composition as claimed by claim 11 wherein the pH of the composition is from 6.5 to 7.5.
13. A pharmaceutical composition as claimed by claim 12 wherein the pH is from 6.7 to 7.3.
14. A pharmaceutical composition as claimed by claim 1 further comprising one or more preservatives.
15. A pharmaceutical composition as claimed by claim 14 , comprising at least one of metacresol and phenol.
16. A pharmaceutical composition as claimed by claim 14 comprising metacresol.
17. A pharmaceutical composition as claimed by claim 16 wherein the metacresol concentration is from 2 mg/mL to 4 mg/mL.
18. A pharmaceutical composition as claimed by claim 17 wherein the metacresol concentration is about 3.15 mg/m L.
19. A pharmaceutical composition as claimed by claim 14 comprising phenol.
20. A pharmaceutical composition as claimed by claim 19 wherein the phenol concentration is from 3 mg/mL to 7 mg/m L.
21. A pharmaceutical composition as claimed by claim 20 wherein the phenol concentration is about 5 mg/mL.
22. A pharmaceutical composition as claimed by claim 1 wherein the tirzepatide, or pharmaceutically acceptable salt thereof, concentration is from 5 mg/mL to 30 mg/mL; the dibasic sodium phosphate concentration is from 0.67 to 2.68 mg/mL; further comprising from 2 mg/mL to 4 mg/mL metacresol.
23. A pharmaceutical composition as claimed by claim 1 wherein the tirzepatide, or pharmaceutically acceptable salt thereof, concentration is from 5 mg/mL to 30 mg/mL; the dibasic sodium phosphate concentration is from 0.67 to 2.68 mg/mL; further comprising from 3 mg/mL to 7 mg/mL phenol.
24. A pharmaceutical composition as claimed by claim 23 wherein the volume of a dose of the composition is about 0.5 mL.
25. A pharmaceutical composition as claimed by claim 24 wherein the composition is suitable for administration using an automatic injection apparatus.
26. A pharmaceutical composition as claimed by claim 23 for use in the treatment of diabetes.
27. A pharmaceutical composition as claimed by claim 23 for use in the treatment of obesity.
28. A pharmaceutical composition as claimed by claim 1 wherein the NaCl concentration is from about 8.2 mg/mL to about 8.8 mg/mL.
29. A pharmaceutical composition as claimed by claim 8 wherein the NaCl concentration is 8.8 mg/mL.
30. A pharmaceutical composition comprising tirzepatide, or a pharmaceutically acceptable salt thereof, in a concentration selected from the group consisting of 5, 10, 15, 20, 25, and 30 mg/mL; NaCl in a concentration of 8.2 mg/mL; and dibasic sodium phosphate in a concentration from 0.67 mg/mL to 2.68; and having a pH of 6.5 to 7.5.
31. The pharmaceutical composition of claim 29 wherein the dibasic sodium phosphate is in a concentration of about 1.34 mg/mL.
32. A method of treating diabetes comprising administering to a human in need thereof an effective dose of the pharmaceutical composition as claimed by claim 23 .
33. A method of treating diabetes as claimed by claim 32 wherein the dose is administered using an automatic injection apparatus.
34. A method of treating diabetes as claimed by claim 33 wherein the dose is administered once weekly.
35. A method of treating obesity comprising administering to a human in need thereof an effective dose of the pharmaceutical composition as claimed by claim 23 .
36. A method of treating obesity as claimed by claim 35 wherein the dose is administered using an automatic injection apparatus.
37. A method of treating obesity as claimed by claim 36 wherein the dose is administered once weekly.