Claims for Patent: 11,357,820

Summary for Patent: 11,357,820

Title:	GIP/GLP1 agonist compositions
Abstract:	A composition of tirzepatide, comprising an agent selected from NaCl and propylene glycol; and dibasic sodium phosphate is provided.
Inventor(s):	Corvari; Vincent John (Carmel, IN), Minie; Christopher Sears (Zionsville, IN), Mishra; Dinesh Shyamdeo (Carmel, IN), Qian; Ken Kangyi (Carmel, IN)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	16/441,329
Patent Claims:	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.