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Last Updated: April 5, 2025

Claims for Patent: 11,759,501

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Summary for Patent: 11,759,501

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:	US17/157,363
Patent Claims:	1. A solid dosage pharmaceutical composition comprising (1) semaglutide and (2) a granule; wherein the granule comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (salt of NAC), a lubricant, and no semaglutide; wherein the salt of NAC is at least 75% (w/w) of the granule; and wherein the lubricant is less than 10% (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 salt of NAC is 80-86% (w/w) of the granule. 4. The composition according to claim 3, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC). 5. The composition according to claim 1, wherein the lubricant is magnesium stearate. 6. The composition according to claim 1, wherein the lubricant is 1-3% (w/w) of the granule. 7. The composition according to claim 6, wherein the lubricant is magnesium stearate. 8. The composition according to claim 1, wherein the granule further comprises a filler. 9. The composition according to claim 8, wherein the filler is microcrystalline cellulose. 10. The composition according to claim 8, wherein the microcrystalline cellulose is 10-20% (w/w) of the granule. 11. The composition according to claim 8, wherein the microcrystalline cellulose is less than 20% (w/w) of the granule. 12. The composition according to claim 11, wherein the microcrystalline cellulose is 14-17% (w/w) of the granule. 13. The composition according to claim 1, wherein the weight of the composition is in the range of 150 mg to 1000 mg. 14. The composition according to claim 13, wherein the weight of the composition is in the range of 300 mg to 600 mg. 15. The composition according to claim 14, wherein the weight of the composition is in the range of 350 mg to 450 g. 16. The composition according to claim 1, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC), and wherein the lubricant is magnesium stearate. 17. The composition according to claim 16, wherein the salt of NAC is 80-86% (w/w) of the granule, and wherein the lubricant is 1-3% (w/w) of the granule. 18. The composition according to claim 17, wherein the granule further comprises a filler, wherein the filler is microcrystalline cellulose, and wherein the microcrystalline cellulose is 10-20% (w/w) of the granule. 19. The composition according to claim 18, wherein the microcrystalline cellulose is 14-17% (w/w) of the granule. 20. The composition according to claim 17, wherein the granule further comprises a filler, wherein the filler is microcrystalline cellulose, and wherein the microcrystalline cellulose is less than 20% (w/w) of the granule. 21. The composition according to claim 1, wherein the composition comprises at least 60% (w/w) of the salt of NAC. 22. The composition according to claim 21, wherein the salt of NAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC). 23. The composition according to claim 21, wherein the composition comprises at least 70% (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 16, wherein the composition comprises at least 60% (w/w) of the SNAC. 26. The composition according to claim 25, wherein the composition comprises at least 70% (w/w) of the SNAC.

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