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Last Updated: December 12, 2025

Claims for Patent: 12,396,953

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Summary for Patent: 12,396,953

Title:	Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Abstract:	The invention relates to pharmaceutical compositions comprising a peptide, such as a GLP-1 peptide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. The invention further relates to processes for the preparation of such compositions, and their use in medicine.
Inventor(s):	Betty Lomstein Pedersen, Birgitte Nissen
Assignee:	Novo Nordisk AS
Application Number:	US18/386,839
Patent Claims:	1. A pharmaceutical composition comprising semaglutide, sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC), and magnesium stearate, P1 wherein the semaglutide is in an amount of 0.2 to 100 mg, wherein the pharmaceutical composition comprises 2-5 mg of the magnesium stearate per 100 mg of the SNAC; and wherein the SNAC constitutes at least 95% (w/w) of the excipients of the composition. 2. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 1.5 mg of the semaglutide. 3. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 4 mg of the semaglutide. 4. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 2 to 20 mg of the semaglutide. 5. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 25 mg of the semaglutide. 6. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 50 mg of the semaglutide. 7. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 100 mg of the SNAC. 8. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 300 mg of the SNAC. 9. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 1.5 mg of the semaglutide and 100 mg of the SNAC. 10. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 1.5 mg of the semaglutide and 2-3 mg of the magnesium stearate. 11. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 1.5 mg of the semaglutide, 100 mg of the SNAC, and 2-3 mg of the magnesium stearate. 12. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 1.5 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 13. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 4 mg of the semaglutide and 100 mg of the SNAC. 14. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 4 mg of the semaglutide and 2-3 mg of the magnesium stearate. 15. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 4 mg of the semaglutide, 100 mg of the SNAC, and 2-3 mg of the magnesium stearate. 16. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 4 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 17. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 2 to 20 mg of the semaglutide and 100 mg of the SNAC. 18. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 2 to 20 mg of the semaglutide and 2-3 mg of the magnesium stearate. 19. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 2 to 20 mg of the semaglutide, 100 mg of the SNAC, and 2-3 mg of the magnesium stearate. 20. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 2 to 20 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 21. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 25 mg of the semaglutide and 300 mg of the SNAC. 22. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 25 mg of the semaglutide 100 to 300 mg of SNAC, and 2-8 mg of the magnesium stearate. 23. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 25 mg of the semaglutide, 300 mg of the SNAC, and 7.7 mg of the magnesium stearate. 24. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 50 mg of the semaglutide and 300 mg of the SNAC. 25. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 50 mg of the semaglutide 100 to 300 mg of SNAC, and 2-8 mg of the magnesium stearate. 26. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises 50 mg of the semaglutide, 300 mg of the SNAC, and 7.7 mg of the magnesium stearate. 27. A method of treating type 2 diabetes, comprising administering to a subject in need thereof the pharmaceutical composition according to claim 1. 28. The method according to claim 27, wherein the composition comprises 1.5 mg of the semaglutide. 29. The method according to claim 27, wherein the composition comprises 4 mg of the semaglutide. 30. The method according to claim 27, wherein the composition comprises 2-20 mg of the semaglutide. 31. The method according to claim 27, wherein the composition comprises 25 mg of the semaglutide. 32. The method according to claim 27, wherein the composition comprises 50 mg of the semaglutide. 33. The method according to claim 27, wherein the composition comprises 100 mg of the SNAC. 34. The method according to claim 27, wherein the composition comprises 300 mg of the SNAC. 35. The method according to claim 27, wherein the composition comprises 2.6 mg of the magnesium stearate. 36. The method according to claim 27, wherein the composition comprises 7.7 mg of the magnesium stearate. 37. The method according to claim 27, wherein the composition comprises 1.5 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 38. The method according to claim 27, wherein the composition comprises 4 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 39. The method according to claim 27, wherein the composition comprises 2-20 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 40. The method according to claim 27, wherein the composition comprises 25 mg of the semaglutide, 300 mg of the SNAC, and 7.7 mg of the magnesium stearate. 41. The method according to claim 27, wherein the composition comprises 50 mg of the semaglutide, 300 mg of the SNAC, and 7.7 mg of the magnesium stearate. 42. A method of reducing body weight, comprising administering to a subject in need thereof the pharmaceutical composition according to claim 1. 43. The method according to claim 42, wherein the composition comprises 1.5 mg of the semaglutide. 44. The method according to claim 42, wherein the composition comprises 4 mg of the semaglutide. 45. The method according to claim 42, wherein the composition comprises 2-20 mg of the semaglutide. 46. The method according to claim 42, wherein the composition comprises 25 mg of the semaglutide. 47. The method according to claim 42, wherein the composition comprises 50 mg of the semaglutide. 48. The method according to claim 42, wherein the composition comprises 100 mg of the SNAC. 49. The method according to claim 42, wherein the composition comprises 300 mg of the SNAC. 50. The method according to claim 42, wherein the composition comprises 2.6 mg of the magnesium stearate. 51. The method according to claim 42, wherein the composition comprises 7.7 mg of the magnesium stearate. 52. The method according to claim 42, wherein the composition comprises 1.5 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 53. The method according to claim 42, wherein the composition comprises 4 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 54. The method according to claim 42, wherein the composition comprises 2-20 mg of the semaglutide, 100 mg of the SNAC, and 2.6 mg of the magnesium stearate. 55. The method according to claim 42, wherein the composition comprises 25 mg of the semaglutide, 300 mg of the SNAC, and 7.7 mg of the magnesium stearate. 56. The method according to claim 42, wherein the composition comprises 50 mg of the semaglutide, 300 mg of the SNAC, and 7.7 mg of the magnesium stearate.

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