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Pharmaceutical composition comprising GLP-1 agonist, insulin, and methionine
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A technology of methionine and GLP-1, which is applied in the manufacture of the composition according to the present invention, the application in medicine, and the field of the composition according to the present invention can solve the problems such as increase
Active Publication Date: 2017-11-03
SANOFI AVENTIS DEUT GMBH
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In addition, however, elevated blood glucose levels over many years without initial symptoms pose considerable health risks
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[0251] The physical and chemical stability of a composition comprising a GLP-1 agonist (AVE0010) and insulin (insulin glargine, Lantus) was tested.
[0252] 2. The formulations used
[0253] For the formulations tested, the substances were used in the following concentrations / amounts:
[0254]
[0255]
[0256] When referring to factors in conjunction with formulation components (e.g., 1 / 2, 1 / 4, 2x, 3x, 5x, as in 1 / 2 Acetate, 5x Lysine, 2x Lantus, and 3x Lantus) , the concentration of the substance involved is used in a decreasing or increasing concentration according to said factor.
[0260] Thioflavin T (THT) specifically binds protein fibrils, which results in a change in THT fluorescence. THT does not bind AVE0010 or insulin. The kinetics of fibril formation can be measured as a change in fluorescence in the presence of THT. Increased fluorescence corr...
Embodiment 2
[0321] "3 pens covering all" concept ( Figure 4 )
[0322] ● 3 pre-mixed pens with 3 different predetermined ratios:
[0323] (a) Mixture A: 100U Lantus+66.66μg AVE0010 per mL
[0324] (b) Mixture B: 100U Lantus+40μg AVE0010 per mL
[0325] (c) Mixture C: 100U Lantus+25μg AVE0010 per mL
[0326] ●With 3 pre-mixed pens: Figure 4 The exemplary table in is from the therapeutic range of 15 to 80 U Lantus and 10 to 20 μg AVE0010 per dose. The dose of Lantus to be administered is set or predetermined for a particular patient. Find your scheduled dose in the left hand column. Where the corresponding AVE0010 dose in the range of 10 to 20 μg is mentioned in the columns Mixture A - Mixture C, the corresponding mixture is selected, metered, and administered. The ranges overlap: for example, when 26 to 30 U Lantus is required, either blend A or blend B (with the higher dose of AVE0010) can be chosen. This applies to mixtures B and C accordingly. For example, if a dose of 50 U of ...
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Abstract
The invention relates to a pharmaceutical composition comprising a GLP-1 agonist, an insulin, and a methionine, and specifically to 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 adjuvant, the composition being characterised in that it contains methionine, optionally as add-on therapy with metformin.
Description
[0001] This application is a divisional application of an invention application with a filing date of November 11, 2010, a Chinese application number of 201080061411.1, and an invention title of "Pharmaceutical composition comprising a GLP-1 agonist, insulin and methionine". field of invention [0002] The present application relates to a liquid composition comprising a GLP-1 agonist or / and a pharmacologically acceptable salt thereof, insulin or / and a pharmacologically acceptable salt thereof, and optionally at least one pharmaceutically acceptable excipient, wherein the The composition comprises methionine. [0003] The present application further relates to compositions according to the invention for use in the treatment of diabetes. The present application further relates to the use of the composition according to the invention for the manufacture of a medicament for the treatment of diabetes. The present application further relates to a method for the manufacture of a com...
Claims
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