Solid glp-1 derivative compositions for oral administration
US-11167014-B2 · Nov 9, 2021 · US
US11622996B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-11622996-B2 |
| Application number | US-201917053511-A |
| Country | US |
| Kind code | B2 |
| Filing date | May 6, 2019 |
| Priority date | May 7, 2018 |
| Publication date | Apr 11, 2023 |
| Grant date | Apr 11, 2023 |
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The invention relates to pharmaceutical compositions comprising a GLP-1 agonist 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.
Opening claim text (preview).
The invention claimed is: 1. A composition comprising i) semaglutide, ii) sodium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC), and iii) nicotinamide, wherein the nicotinamide increases the solubility of SNAC at least 5-fold when the solubility is measured at a concentration of 200 mg/ml of the nicotinamide at a pH of 6. 2. The composition according to claim 1 , wherein the ratio of the SNAC/nicotinamide (w/w) (w/w) is 0.5-10. 3. The composition according to claim 2 , wherein the ratio of the SNAC/nicotinamide (w/w) is 0.5-8. 4. The composition according to claim 3 , wherein the ratio of the SNAC/nicotinamide (w/w) is 0.5-5. 5. The composition according to claim 4 , wherein the composition further comprises a lubricant selected from the group consisting of magnesium stearate and glyceryl dibehenate. 6. The composition according to claim 3 , wherein the composition further comprises a lubricant selected from the group consisting of magnesium stearate and glyceryl dibehenate. 7. The composition according to claim 1 , wherein the composition further comprises a lubricant. 8. The composition according to claim 7 , wherein a unit dosage is: i) 0.1-30 mg of the semaglutide, ii) 50-600 mg of the SNAC, iii) 20-200 mg of the nicotinamide, and iv) 0-10 mg of the lubricant. 9. The composition according to claim 8 , wherein the lubricant is selected from the group consisting of magnesium stearate and glyceryl dibehenate. 10. The composition according to claim 7 , wherein the lubricant is selected from the group consisting of magnesium stearate and glyceryl dibehenate. 11. The composition according to claim 1 , wherein the composition is a solid composition. 12. The composition according to claim 1 wherein the composition is a pharmaceutical composition suitable for oral administration.
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