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;
wherein said composition
(a) does not contain phenol; and
(b) is for subcutaneous administration; and
(c) (i) is an aqueous solution comprising at least 60% (w/w) water or (ii) further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent; and
wherein the semaglutide is in the range of 0.50 mg/mL −3.2 mg/mL; and
wherein the pH of the composition is about 7.4.
2 . A method of treating diabetes comprising administering to a subject in need of such method a therapeutically effective amount of the liquid pharmaceutical composition according to claim 1 .
3 . A method of treating obesity comprising administering to a subject in need of such method a therapeutically effective amount of the liquid pharmaceutical composition according to claim 1 .
4 . The liquid pharmaceutical composition of claim 1 , wherein the semaglutide is 0.5 mg/mL.
5 . The liquid pharmaceutical composition of claim 1 , wherein the semaglutide is 1.0 mg/mL.
6 . The liquid pharmaceutical composition of claim 1 , wherein the semaglutide is 1.7 mg/0.75 mL.
7 . The liquid pharmaceutical composition of claim 1 , where in the semaglutide is 2.0 mg/mL.
8 . The liquid pharmaceutical composition of claim 1 , wherein the semaglutide is 3.2 mg/mL.
9 . The liquid pharmaceutical composition of claim 1 , wherein the buffer comprises disodiumhydrogenphosphate dihydrate or trisodiumcitrate dihydrate.
10 . The liquid pharmaceutical composition of claim 9 , wherein the disodiumhydrogenphosphate dihydrate is 1.42 mg/mL.
11 . The liquid pharmaceutical composition of claim 9 , wherein the trisodiumcitrate dihydrate is 2.35 mg/mL.
12 . The liquid pharmaceutical composition of claim 1 , wherein the isotonic agent is propylene glycol or sodium chloride.
13 . The liquid pharmaceutical composition of claim 12 , wherein the propylene glycol is 14 mg/mL.
14 . The liquid pharmaceutical composition of claim 12 , wherein the sodium chloride is 8.25 mg/mL.
15 . The liquid pharmaceutical composition of claim 12 , wherein the sodium chloride is 6.3 mg/mL.
16 . The liquid pharmaceutical composition of claim 1 , further comprising one or more pharmaceutically acceptable excipients to adjust the pH.
17 . The liquid pharmaceutical composition of claim 16 , wherein the one or more pharmaceutically acceptable excipients comprise hydrochloric acid or sodium hydroxide.
18 . The liquid pharmaceutical composition of claim 16 , wherein the one or more pharmaceutically acceptable excipients comprise hydrochloric acid and sodium hydroxide.
19 . The liquid pharmaceutical composition of claim 1 , wherein said liquid pharmaceutical composition comprises no preservative.