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Last Updated: April 8, 2025

Claims for Patent: 11,759,503

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Summary for Patent: 11,759,503

Title:	Compositions of GLP-1 peptides and preparation thereof
Abstract:	The invention relates to pharmaceutical compositions comprising a first type of granules and a second type of granules, wherein said first type of granules comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and no GLP-1 peptide, and wherein said second type of granules comprises a GLP-1 peptide and no salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, as well as the intermediate granules, processes for the preparation of the granules and compositions, and use thereof in medicine.
Inventor(s):	Thomas Vilhelmsen, Helle Eliasen, Tue Hansen
Assignee:	Novo Nordisk AS
Application Number:	US17/719,629
Patent Claims:	1. A solid dosage pharmaceutical composition comprising: (a) a first type of granules comprising at least 75% (w/w) of sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC) and less than 10% (w/w) of a lubricant; and (b) a second type of granules comprising semaglutide, at least 15% (w/w) of a filler, and less than 40% (w/w) of a binder. 2. The composition according to claim 1, wherein the lubricant is magnesium stearate. 3. The composition according to claim 1, wherein the lubricant is 1-3% (w/w) of the first granule. 4. The composition according to claim 3, wherein the lubricant is magnesium stearate. 5. The composition according to claim 1, wherein the filler is microcrystalline cellulose. 6. The composition according to claim 1, wherein the filler is 50-75% (w/w) of the second granule. 7. The composition according to claim 6, wherein the filler is microcrystalline cellulose. 8. The composition according to claim 1, wherein the binder is povidone. 9. The composition according to claim 1, wherein the binder is 15-25% (w/w) of the second granule. 10. The composition according to claim 9, wherein the binder is povidone. 11. The composition according to claim 1, further comprising a filler in the first granule. 12. The composition according to claim 11, wherein the filler is microcrystalline cellulose. 13. The composition according to claim 11, wherein the filler is less than 20% (w/w) of the first granule. 14. The composition according to claim 13, wherein the filler is microcrystalline cellulose. 15. The composition according to claim 11, wherein the filler is 10-20% (w/w) of the first granule. 16. The composition according to claim 15, wherein the filler is microcrystalline cellulose. 17. The composition according to claim 14, wherein the filler is 14-17% (w/w) of the granule. 18. The composition according to claim 17, wherein the filler is microcrystalline cellulose. 19. The composition according to claim 1, wherein the weight of the composition is in the range of 150 mg to 1000 mg. 20. The composition according to claim 1, wherein the lubricant is magnesium stearate, the filler is microcrystalline cellulose, and the binder is povidone. 21. The composition according to claim 1, wherein the SNAC is 80-86% (w/w) of the first granule, the lubricant is 1-3% (w/w) of the first granule, the filler is 50-75% (w/w) of the second granule, and the binder is 15-25% (w/w) of the second granule. 22. The composition according to claim 21, wherein the lubricant is magnesium stearate, the filler is microcrystalline cellulose, and the binder is povidone. 23. The composition according to claim 1, further comprising lubricant outside the first type of granules and second type of granules. 24. The composition according to claim 23, wherein the lubricant is magnesium stearate. 25. The composition according to claim 22, further comprising magnesium stearate outside the first type of granules and second type of granules. 26. The composition according to claim 25, wherein the magnesium stearate outside the first type of granules and the second type of granules is in an amount of 2 mg. 27. The composition according to claim 1, wherein the composition comprises at least 60% (w/w) of the SNAC. 28. The composition according to claim 27, wherein the composition comprises at least 70% (w/w) of the SNAC. 29. The composition according to claim 22, wherein the composition comprises at least 60% (w/w) of the SNAC. 30. The composition according to claim 29, wherein the composition comprises at least 70% (w/w) of the SNAC.

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