Pharmaceutical composition comprising a GLP-1-agonist and methionine
First Claim
Patent Images
1. An aqueous liquid pharmaceutical composition comprising the following constituents per 1 mL volume of the composition:
- (a) approximately 50 μ
g desPro36exendin-4(1-39)-Ly56-NH2 (“
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.
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Abstract
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.
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Citations
4 Claims
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1. An aqueous liquid pharmaceutical composition comprising the following constituents per 1 mL volume of the composition:
-
(a) approximately 50 μ
g desPro36exendin-4(1-39)-Ly56-NH2 (“
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. - View Dependent Claims (3, 4)
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2. An aqueous liquid pharmaceutical composition comprising the following constituents per 1 mL volume of the composition:
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(a) approximately 100 μ
g desPro36exendin-4(1-39)-Lys6-NH2 (“
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.
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Specification
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Current AssigneeSanofi-Aventis Deutschland GmbH (Sanofi )
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Original AssigneeSanofi-Aventis Deutschland GmbH (Sanofi )
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InventorsBrunner-Schwarz, Anette, Mueller, Werner, Siefke-Henzler, Verena
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Primary Examiner(s)Chandra, Gyan
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Application NumberUS15/595,929Publication NumberTime in Patent Office435 DaysField of SearchUS Class CurrentCPC Class CodesA61K 38/2278 Vasoactive intestinal pepti...A61K 38/26 GlucagonsA61K 47/10 Alcohols; Phenols; Salts th...A61K 47/20 containing sulfur, e.g. dim...A61K 9/0019 Injectable compositions; In...A61K 9/08 Solutions composition of so...A61P 3/10 for hyperglycaemia, e.g. an...
