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Last Updated: November 25, 2020

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Claims for Patent: 10,029,011

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Summary for Patent: 10,029,011
Title:Pharmaceutical composition comprising a GLP-1 agonist, an insulin and methionine
Abstract: 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.
Inventor(s): Hagendorf; Annika (Frankfurt am Main, DE), Hauck; Gerrit (Frankfurt am Main, DE), Mueller; Werner (Frankfurt am Main, DE), Schoettle; Isabell (Frankfurt am Main, DE), Siefke-Henzler; Verena (Frankfurt am Main, DE), Tertsch; Katrin (Frankfurt am Main, DE)
Assignee: SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:13/509,542
Patent Claims: 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.sup.36exendin-4(1-39)-Lys.sub.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.degree. 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.degree. 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.degree. 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.degree. 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.

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