GLP-1 compositions and uses thereof
The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.1% (w/w) phenol and above 6.4 mg/ml sodium chloride, their preparation, kits comprising such compositions as well as uses thereof.
1. A liquid pharmaceutical composition comprising:
0.5 to 10 mg/mL semaglutide,
0.0% (w/w) to 0.1% (w/w) phenol, and
8.2 to 8.9 mg/mL sodium chloride.
2. The liquid pharmaceutical composition according to claim 1 comprising: 0.5 to 3.5 mg/mL semaglutide.
3. The liquid pharmaceutical composition according to claim 1 comprising: 3.2 mg/mL semaglutide.
4. The liquid pharmaceutical composition according to claim 1 further comprising: 0.1 to 50 mM of a buffer.
5. The liquid pharmaceutical composition according to claim 4 , wherein the buffer is a phosphate buffer.
6. The liquid pharmaceutical composition according to claim 5 , wherein the phosphate buffer is present in a concentration of 1 to 2 mg/mL.
7. The liquid pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition has a pH in the range of 6.0 to 10.0.
8. The liquid pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition is a parenteral composition.
9. The liquid pharmaceutical composition according to claim 1 further comprising:
0.5 to 3.5 mg/mL semaglutide,
0.01 to 50 mM buffer, and
pH in the range of about 7 to about 8.
10. The liquid pharmaceutical composition according to claim 1 further comprising:
0.5 to 3.5 mg/mL semaglutide,
1 to 2 mg/mL of phosphate buffer, and
pH in the range of about 7 to about 8.
11. The liquid pharmaceutical composition according to claim 1 further comprising:
0.5 to 3.5 mg/mL semaglutide,
8.25 mg/mL sodium chloride, and
1.42 mg/mL disodium hydrogen phosphate dihydrate.
12. The liquid pharmaceutical composition according to claim 1 further comprising:
histidine.
13. A kit comprising a liquid pharmaceutical composition according to claim 1 , wherein the kit further comprises an injection device for administration of the composition to a subject in need of such pharmaceutical composition.
14. The kit according to claim 13 , wherein the injection device comprises a needle and prefilled syringe or syringe cartridge.
15. A method of treating diabetes, obesity, Alzheimer's disease, nonalcoholic steatohepatitis (NASH) and/or cardiovascular diseases comprising administering to a subject in need thereof a therapeutically effective amount of the liquid pharmaceutical composition according to claim 1 .
16. A liquid pharmaceutical composition consisting of:
0.5 to 3.5 mg/mL semaglutide,
0% (w/w) to 0.1% (w/w) phenol,
buffer,
6.5 to 12 mg/mL sodium chloride,
at least 60% water,
optionally histidine, and
optionally one or more agents for adjusting pH.
17. The liquid pharmaceutical composition according to claim 16 , wherein sodium chloride is in the amount of 8.1 to 12 mg/mL.
18. The liquid pharmaceutical composition according to claim 16 , wherein sodium chloride is in the amount of 8.2 to 8.9 mg/mL.
19. The liquid pharmaceutical composition according to claim 16 , wherein the buffer is a phosphate buffer.
20. The liquid pharmaceutical composition according to claim 19 , wherein the buffer is in the amount of 0.01 to 50 mM.
21. The liquid pharmaceutical composition according to claim 19 , wherein the buffer is in the amount of 1 to 2 mg/mL.
22. A method of treating diabetes, obesity, Alzheimer's disease, nonalcoholic steatohepatitis (NASH) and/or cardiovascular diseases comprising administering to a subject in need thereof a therapeutically effective amount of the liquid pharmaceutical composition according to claim 16 .
23. A liquid pharmaceutical composition consisting of:
3.2 mg/mL semaglutide,
0% (w/w) to 0.1% (w/w) phenol,
1.42 mg/mL disodium hydrogen phosphate dihydrate buffer,
8.25 mg/mL sodium chloride,
pH of 7.4,
at least 60% water, and
optionally one or more agents for adjusting pH.
24. The liquid pharmaceutical composition according to claim 23 , wherein the pharmaceutical composition is a parenteral composition.
25. The liquid pharmaceutical composition according to claim 23 , wherein the pharmaceutical composition has a visual analogue scale (VAS) score below 15 on a 100 mm scale.
26. A method of treating diabetes, obesity, Alzheimer's disease, nonalcoholic steatohepatitis (NASH) and/or cardiovascular diseases comprising administering to a subject in need thereof a therapeutically effective amount of the liquid pharmaceutical composition according to claim 23 .