Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
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.
1. A solid composition for oral administration comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein
the amount of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is in the range of 0.8-1.3 mmol, and the GLP-1 agonist is N-epsilon26-[2-(2-{2-[2-(2-{2-[(S)-4-carboxy-4-(17-carboxyheptadecanoylamino) butyrylamino] ethoxy} ethoxy)acetylamino] ethoxy} ethoxy)acetyl] [Aib8, Arg34] GLP-1(7-37).
2. The composition according to claim 1 , wherein said composition is in the form of a tablet.
3. The composition according to claim 1 , wherein the amount of the GLP-1 agonist is in the range of 5 to 20 mg.
4. The composition according to claim 1 , wherein said salt of N-(8-(2-hydroxybenzoyl) amino)caprylic acid is selected from the group consisting of the sodium salt, potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
5. The composition according to claim 4 , wherein the amount of the GLP-1 agonist is in the range of 5 to 20 mg.
6. The composition according to claim 4 , wherein said salt of N-(8-(2-hydroxybenzoyl) amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC).
7. The composition according to claim 6 , wherein the amount of the GLP-1 agonist is in the range of 5 to 20 mg.
8. A method for treatment of type II diabetes or obesity comprising administering a composition according to claim 1 to a patient in need thereof.
9. A solid composition for oral administration comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein the amount of said GLP-1 agonist is in the range of from 5 to 20 mg, and the GLP-1 agonist is N-epsilon26-[2-(2-{2-[2-(2-{2-[(S)-4-carboxy-4-(17-carboxyheptadecanoylamino) butyrylamino]ethoxy}ethoxy)acetylamino]ethoxy}ethoxy)acetyl][Aib8, Arg34]GLP-1(7-37).
10. The composition according to claim 9 , wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is selected from the group consisting of the sodium salt, potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
11. The composition according to claim 10 , wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC).
12. The composition according to claim 11 , wherein the amount of SNAC is in the range of 250 mg to 400 mg.
13. The composition according to claim 11 , wherein the amount of SNAC is 300 mg.
14. The composition according to claim 9 , wherein said composition is in the form of a tablet.
15. A method for treatment of type II diabetes or obesity comprising administering a composition according to claim 9 to a patient in need thereof.
16. A solid composition for oral administration comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein
the amount of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is in the range of 0.6-2.1 mmol, and the GLP-1 agonist is N-epsilon26-[2-(2-{2-[2-(2-{2-[(S)-4-carboxy-4-(17-carboxyheptadecanoylamino) butyrylamino]ethoxy}ethoxy)acetylamino]ethoxy}ethoxy)acetyl][Aib8, Arg34]GLP-1(7-37), wherein the amount of the GLP-1 agonist is in the range of 5 to 20 mg.
17. The composition according to claim 16 , wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is selected from the group consisting of the sodium salt, potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
18. The composition according to claim 17 , wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC).
19. The composition according to claim 18 , wherein said composition is in the form of a tablet.