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
does not contain phenol;
is for parenteral administration;
is an aqueous solution comprising at least 60% (w/w) water; or
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 0.01 mg/ml-10.0 mg/ml; and
wherein the pH of the composition is in between 7.0 and 7.8;
wherein the liquid pharmaceutical composition exhibits improved chemical and/or physical stability as compared to a liquid pharmaceutical composition that contains phenol.
2. The liquid pharmaceutical composition according to claim 1 , wherein the concentration of semaglutide is selected from 0.5-10 mg/ml or 0.01-5 mg/ml of said composition.
3. The liquid pharmaceutical composition according to claim 1 , wherein said composition comprises no added pharmaceutical preservative.
4. The liquid pharmaceutical composition according to claim 1 , wherein said parenteral administration is subcutaneous administration.
5. A kit comprising the liquid pharmaceutical composition according to claim 1 and instructions for use.
6. A kit comprising the liquid pharmaceutical composition according to 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.
7. A method of treating diabetes comprising administering to a subject in need of such method a therapeutically effective amount of the pharmaceutical composition according to claim 1 .
8. A method of treating obesity comprising administering to a subject in need of such method a therapeutically effective amount of the pharmaceutical composition according to claim 1 .
9. The liquid pharmaceutical composition according to claim 1 , wherein said composition has a pH in the range of 7.0-7.4.