Pharmaceutical composition comprising a GLP-1 agonist, an insulin and methionine
A liquid composition comprising a GLP-1 agonist or/and a pharmacologically tolerable salt thereof, an insulin or/and a pharmacologically tolerable salt thereof, and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin where appropriate.
1. An aqueous liquid composition comprising the following constituents per 1 ml of the composition:
(a) about 0.025 mg to about 0.1 mg desPro 36 exendin-4(1-39)-Lys 6 -NH2 or a pharmacologically tolerable salt thereof;
(b) about 3.64 mg insulin glargine or a pharmacologically tolerable salt thereof;
(c) about 3.0 mg methionine
(d) water is present in a quantity sufficient for the volume of the composition to total about 1 mL;
(e) about 2.7 mg m-cresol;
(f) about 20.0 mg 85% glycerol; and
(g) about 0.06 mg zinc chloride,
wherein the composition has a pH in the range from 3.5 to 4.5, and wherein the composition comprises no buffer substances.
2. The aqueous liquid composition of claim 1 , wherein the composition exhibits chemical integrity after storage for 6 months at a temperature of +25° C.
3. The aqueous liquid composition of claim 1 , wherein the composition exhibits physical integrity after storage for 6 months at a temperature of +25° C.
4. The aqueous composition of claim 1 , wherein the composition is suitable for parenteral an injectable composition.
5. The aqueous liquid composition of claim 1 , wherein at least 80% of the composition's active ingredients are in a substantially chemically unchanged form after storage for 6 months at a temperature of +25° C.
6. The aqueous liquid composition of claim 1 , wherein at least 80% of the composition's active ingredients are in a substantially physically unchanged form after storage for 6 months at a temperature of +25° C.
7. The aqueous liquid composition of claim 1 , wherein the composition has a pH of 4.5.
8. The aqueous liquid composition of claim 1 , wherein the composition comprises an oxidized content if about 1% or less after 1 month of storage.
9. The aqueous liquid composition of claim 1 , wherein the composition is pharmacologically tolerable.