Pharmaceutical composition comprising a GLP-1-agonist and methionine
A liquid composition comprising a GLP-1 agonist and/or a pharmacologically tolerable salt thereof and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin and/or with long-acting insulin/insulin derivatives where appropriate.
1. An aqueous liquid pharmaceutical composition comprising the following constituents per 1 mL volume of the composition:
(a) approximately 50 μg desPro 36 exendin-4(1-39)-Ly 56 -NH 2 (“AVE0010”) or a pharmacologically tolerable salt thereof;
(b) approximately 3.5 mg sodium acetate trihydrate;
(c) approximately 2.7 mg m-cresol;
(d) approximately 3.0 mg L-methionine;
(e) approximately 18.0 mg glycerol; and
(f) water,
wherein the composition is substantially free of histidine.
2. An aqueous liquid pharmaceutical composition comprising the following constituents per 1 mL volume of the composition:
(a) approximately 100 μg desPro 36 exendin-4(1-39)-Lys 6 -NH 2 (“AVE0010”) or a pharmacologically tolerable salt thereof;
(b) approximately 3.5 mg sodium acetate trihydrate;
(c) approximately 2.7 mg m-cresol;
(d) approximately 3.0 mg L-methionine;
(e) approximately 18.0 mg glycerol; and
(f) water,
wherein the composition is substantially free of histidine.
3. The aqueous liquid pharmaceutical composition of claim 1 or 2 , wherein the composition further comprises hydrochloric acid, sodium hydroxide, or a combination thereof in an amount sufficient to adjust the pH of the composition to approximately 4.5.
4. The aqueous liquid pharmaceutical composition of claim 1 or 2 , wherein the glycerol is 85% glycerol.