Liraglutide composition and application thereof

A technology of liraglutide and polypeptide composition, which can be applied in the directions of drug combination, peptide/protein component, anhydride/acid/halide active ingredient, etc., and can solve the problems of inconvenient administration and the like

Active Publication Date: 2021-07-27
HEFEI TIANHUI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the inconvenient administration problem of liraglutide subcutaneous injection in the prior art, the present invention provides an alternative liraglutide administration method. On the one

Method used

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  • Liraglutide composition and application thereof
  • Liraglutide composition and application thereof
  • Liraglutide composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Composition A

[0073] Liraglutide 15mg Sodium N-(8-(2-hydroxybenzoyl)amino)octanoate 210mg fish oil 90mg

[0074] Preparation

[0075] Mix 15mg of liraglutide, 210mg of sodium N-(8-(2-hydroxybenzoyl)amino) octanoate, and 90mg of fish oil, put it into a capsule, and coat it. Weigh Eudragit L30D, talcum powder, and polyethylene glycol, dissolve with dichloromethane and isopropanol to obtain a coating solution, and spray the coating solution on the surface of the capsule to obtain an enteric-coated capsule. The flow rate of the coating solution is 0.5ml / min, the coating temperature is 30°C-40°C, and the coating weight gain is 7%.

Embodiment 2

[0077] Composition B

[0078] Liraglutide 15mg Sodium N-(8-(2-hydroxybenzoyl)amino)octanoate 210mg fish oil 0mg

[0079] Preparation

[0080] Mix 15 mg of liraglutide and 210 mg of sodium N-(8-(2-hydroxybenzoyl)amino) caprylate, put it into a capsule, and coat it. Weigh Eudragit L30D, talcum powder, and polyethylene glycol, dissolve with dichloromethane and isopropanol to obtain a coating solution, and spray the coating solution on the surface of the capsule to obtain an enteric-coated capsule. The flow rate of the coating solution is 0.5ml / min, the coating temperature is 30°C-40°C, and the coating weight gain is 7%.

Embodiment 3

[0082] Composition C

[0083] Liraglutide 15mg Sodium N-(8-(2-hydroxybenzoyl)amino)octanoate 0mg fish oil 90mg

[0084] Preparation

[0085] Mix 15mg liraglutide and 90mg fish oil, put it into a capsule, and coat it. Weigh Eudragit L30D, talcum powder, and polyethylene glycol, dissolve with dichloromethane and isopropanol to obtain a coating solution, and spray the coating solution on the surface of the capsule to obtain an enteric-coated capsule. The flow rate of the coating solution is 0.5ml / min, the coating temperature is 30°C-40°C, and the coating weight gain is 7%.

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PUM

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Abstract

Aiming at the problem of inconvenience in subcutaneous injection and administration of liraglutide in the prior art, the invention provides an alternative liraglutide administration mode, on one hand, the invention provides a polypeptide composition, and the polypeptide composition comprises a therapeutically effective amount of polypeptide, N-(8-(2-hydroxybenzoyl) amino) caprylate and fish oil. On the other hand, the invention provides application of the polypeptide composition in preparation of drugs for treating or preventing hyperglycemia, type 2 diabetes mellitus, type 1 diabetes mellitus, obesity and glucose tolerance reduction.

Description

technical field [0001] The present invention belongs to the field of administration of polypeptides, in particular, it relates to compositions of polypeptides and applications thereof. Background technique [0002] Glucagon-like peptide 1 is an incretin hormone secreted by intestinal L cells, with 30 amino acids, which promotes the release of postprandial insulin and inhibits glucagon secretion by relying on glucose levels. Glucagon-like peptide 1 will be cleaved by dipeptide kininase 4 soon after oral administration, with a half-life of 1 to 2 minutes. Therefore, liraglutide, which has a longer half-life and only needs to be injected once a day, was developed. Liraglutide is the 34th lysine of natural human glucagon-like peptide 1 replaced by arginine, and a glutamic acid-mediated 16-carbon palmitoyl fatty acid side chain is added to the 26-lysine . [0003] At present, the administration method of liraglutide is subcutaneous injection, and daily subcutaneous injection c...

Claims

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Application Information

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IPC IPC(8): A61K38/26A61K9/48A61P3/10A61P3/04A61K31/20A61K35/60
CPCA61K38/26A61K31/20A61K35/60A61K9/4891A61P3/10A61P3/04A61K2300/00
Inventor 孙磊张祖盛盛海圆王苗倪倩茹
Owner HEFEI TIANHUI BIOTECH CO LTD
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