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Last Updated: April 8, 2025

Claims for Patent: 11,759,502

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Summary for Patent: 11,759,502

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:	US17/719,610
Patent Claims:	1. A solid dosage pharmaceutical composition comprising (1) a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (salt of NAC) and (2) a granule; wherein the granule comprises semaglutide, a binder, a filler, and no salt of NAC; wherein the filler is at least 15% (w/w) of the granule; and wherein the binder is less than 40% (w/w) of the granule. 2. The composition according to claim 1, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC). 3. The composition according to claim 1, wherein the filler is microcrystalline cellulose. 4. The composition according to claim 1, wherein the filler is 50-75% (w/w) of the granule. 5. The composition according to claim 4, wherein the filler is microcrystalline cellulose. 6. The composition according to claim 1, wherein the binder is povidone. 7. The composition according to claim 1, wherein the binder is 15-25% (w/w) of the granule. 8. The composition according to claim 7, wherein the binder is povidone. 9. The composition according to claim 1, further comprising a lubricant that is not in the granule. 10. The composition according to claim 9, wherein the lubricant is magnesium stearate. 11. The composition according to claim 1, wherein the weight of the composition is in the range of 150 mg to 1000 mg. 12. The composition according to claim 11, wherein the weight of the composition is in the range of 300 mg to 600 mg. 13. The composition according to claim 12, wherein the weight of the composition is in the range of 350 mg to 450 g. 14. The composition according to claim 1, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC), the filler is microcrystalline cellulose, and the binder is povidone. 15. The composition according to claim 1, wherein the filler is 50-75% (w/w) of the granule, and wherein the binder is 15-25% (w/w) of the granule. 16. The composition according to claim 15, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC), the filler is microcrystalline cellulose, and the binder is povidone. 17. The composition according to claim 14, further comprising magnesium stearate that is not in the granule. 18. The composition according to claim 15, further comprising magnesium stearate that is not in the granule. 19. The composition according to claim 16, further comprising magnesium stearate that is not in the granule. 20. The composition according to claim 14, wherein the weight of the composition is in the range of 300 mg to 600 mg. 21. The composition according to claim 15, wherein the weight of the composition is in the range of 300 mg to 600 mg. 22. The composition according to claim 16, wherein the weight of the composition is in the range of 300 mg to 600 mg. 23. The composition according to claim 1, wherein the composition comprises at least 60% (w/w) of the salt of NAC. 24. The composition according to claim 23, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC). 25. The composition according to claim 23, wherein the composition comprises at least 70% (w/w) of the salt of NAC. 26. The composition according to claim 25, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC). 27. The composition according to claim 16, 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.

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