GLP-1 compositions and uses thereof
The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01% (w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.
1. A liquid pharmaceutical composition comprising semaglutide and phenol, wherein said composition
(a) is for parenteral administration;
(b) is an aqueous solution comprising at least 60% w/w) water; or
(c) further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent;
wherein the semaglutide is in the range of 0.5 mg/ml-5.0 mg/ml;
wherein the phenol is no more than 0.1 mg/ml; and
wherein the pH of the composition is in between 7.0 and 7.8.
2. The composition according to claim 1 , wherein said composition comprises one or more pharmaceutically acceptable excipients.
3. The composition according to claim 2 , wherein said one or more pharmaceutically acceptable excipients are selected from the group consisting of a buffer or an isotonic agent.
4. The composition according to claim 3 , wherein said buffer is a phosphate buffer.
5. The composition according to claim 3 , wherein said isotonic agent is selected from propylene glycol or sodium chloride.
6. The composition according to claim 1 , wherein said composition comprises no preservative.
7. The composition according to claim 1 , wherein said composition has a pH in the range of 7.0-7.4.
8. The composition according to claim 1 , wherein said parenteral administration is subcutaneous administration.
9. The composition according to claim 1 , wherein said composition comprises 0.5 mg/ml-5.0 mg/ml semaglutide, propylene glycol and 1.42 mg/ml disodiumhydrogenphosphate dihydrate.
10. The composition according to claim 1 , wherein said composition comprises 0.5 mg/ml-5.0 mg/ml semaglutide, sodium chloride and 1.42 mg/ml disodiumhydrogenphosphate dihydrate.
11. A kit comprising a liquid pharmaceutical composition of claim 1 and instructions for use.
12. A kit comprising a liquid pharmaceutical composition of claim 1 and an injection device for administration of said composition to a subject, wherein said injection device is selected from the group consisting of a durable pen and a prefilled pen.
13. A method of treating diabetes comprising administering to a subject in need of such treatment a therapeutically effective amount of a composition according to claim 1 .
14. A method of treating obesity comprising administering to a subject in need of such treatment a therapeutically effective amount of a composition according to claim 1 .