Claims for Patent: 10,960,052
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Summary for Patent: 10,960,052
| Title: | Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid |
| Abstract: | The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine. |
| Inventor(s): | Sauerberg; Per (Farum, DK), Bjerregaard; Simon (Hilleroed, DK), Nielsen; Flemming Seier (Federikssund, DK) |
| Assignee: | Novo Nordisk A/S (Bagsvaerd, DK) |
| Application Number: | 16/118,381 |
| Patent Claims: |
1. A solid composition for oral administration comprising a GLP-1 agonist, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, magnesium stearate, povidone, and
microcrystalline cellulose, wherein the GLP-1 agonist is semaglutide, wherein the composition comprises at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
2. The composition according to claim 1, wherein the composition comprises 0.1-10% (w/w) of the magnesium stearate, 0.1-10% (w/w) of the povidone, and 5-40% (w/w) of the microcrystalline cellulose; and wherein the sum of the magnesium stearate, the povidone, and the microcrystalline cellulose is no more than 40% (w/w) of the composition. 3. The composition according to claim 2, wherein the composition comprises 0.5-5% (w/w) of the magnesium stearate. 4. The composition according to claim 3, wherein the composition comprises 1-3.5% (w/w) of the magnesium stearate. 5. The composition according to claim 4, wherein the composition comprises 1% (w/w) of the magnesium stearate. 6. The composition according to claim 2, wherein the composition comprises 0.2-4% (w/w) of the povidone. 7. The composition according to claim 6, wherein the composition comprises 0.5-3% (w/w) of the povidone. 8. The composition according to claim 7, wherein the composition comprises 1% (w/w) or 2% (w/w) of the povidone. 9. The composition according to claim 2, wherein the composition comprises 10-30% (w/w) of the microcrystalline cellulose. 10. The composition according to claim 9, wherein the composition comprises 5-25% (w/w) of the microcrystalline cellulose. 11. The composition according to claim 10, wherein the composition comprises a percentage (w/w) of the microcrystalline cellulose selected from the group consisting of 10.9% (w/w), 18% (w/w), 19.5% (w/w), and 20.5% (w/w). 12. A solid composition for oral administration comprising a semaglutide, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, a lubricant, a binder, and a filler, wherein the composition comprises at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein the composition comprises 1-3.5% (w/w) of the magnesium stearate, wherein the composition comprises 0.5-3% (w/w) of the povidone, and wherein the composition comprises 5-25% (w/w) of the microcrystalline cellulose. 13. The composition according to claim 12, wherein the composition comprises 2% (w/w) of the povidone. 14. The composition according to claim 12, wherein the composition comprises at least 70% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. 15. The composition according to claim 14, wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC). 16. The composition according to claim 15, wherein the composition comprises 2% (w/w) of the povidone. 17. A solid composition for oral administration comprising semaglutide, N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC), a lubricant, a binder, and a filler, wherein the composition comprises 300 mg of SNAC, wherein the composition comprises 1-3.5% (w/w) of the magnesium stearate, wherein the composition comprises 0.5-3% (w/w) of the povidone, and wherein the composition comprises 5-25% (w/w) of the microcrystalline cellulose. 18. The composition according to claim 17, wherein the composition comprises 2% (w/w) of the povidone. |
