Stable liquid preparation containing GLP-1 analogue fusion protein and preparation thereof

A technology for liquid preparations and fusion proteins, which can be used in medical preparations containing active ingredients, medical preparations without active ingredients, and drug combinations, and can solve problems such as safety, problems, and inconvenience for patients to use.

Inactive Publication Date: 2018-02-06
JIANGSU T MAB BIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freeze-dried powder injection must be dissolved before use, which is

Method used

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  • Stable liquid preparation containing GLP-1 analogue fusion protein and preparation thereof
  • Stable liquid preparation containing GLP-1 analogue fusion protein and preparation thereof
  • Stable liquid preparation containing GLP-1 analogue fusion protein and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] The influence of embodiment 1 different pH on preparation stability

[0019] 1.1pH preliminary screening

[0020] Each group contained 5.0 mg / ml GLP-1 analogue fusion protein, 20 μmol / ml acetic acid / sodium acetate buffer or Tris-HCl buffer at different pH, pH 4.0-10.0, 13 groups were set up, as shown in Table 1. After sterile filtration, the samples of each group were divided into sterile non-pyrogenic vials, and placed in a 37°C incubator after capping and capping. Samples were taken on the 15th and 30th days, and detected by 10% non-reducing SDS-PAGE For the samples, see Table 2 for details.

[0021] Table 1pH preliminary screening form

[0022] group

1

2

3

4

5

6

7

8

9

10

11

12

13

pH

4.0

4.4

5.0

5.4

6.0

6.4

7.0

7.4

8.0

8.4

9.0

9.4

10.0

[0023] Table 2 10% non-reducing SDS-PAGE results at different pH

[0024]

[0025] The results showed t...

Embodiment 2

[0031] The influence of embodiment 2 sodium octanoate on the stability of GLP-1 analog fusion protein

[0032] The effect of sodium octanoate on the stability of GLP-1 analog fusion protein was investigated. The GLP-1 analogue fusion protein was substituted into 30 μmol / ml phosphate buffer (pH 6.5), with a final concentration of 25 mg / ml, and processed according to Table 4. After the treatment, the samples were aseptically filtered and packed into sterile pyrogen-free vials, and then placed in a constant temperature incubator at 37°C for accelerated investigation. Samples were taken on the 15th and 30th days, and 10% non-reducing SDS was used. -PAGE method detection, the results are shown in Table 5.

[0033] Table 4 Addition of sodium octanoate and heat treatment of each group of samples

[0034] group

processing method

1

Without adding sodium caprylate and heat treatment at 50℃ for 1h

2

Add sodium octanoate (0.3mg / ml) and heat treatment a...

Embodiment 3

[0038] Embodiment 3 Different protective agents (amino acids) affect the stability of GLP-1 analog fusion protein

[0039]Amino acids are beneficial to inhibit protein degradation and aggregate formation. This example examines the effects of various amino acids on the stability of GLP-1 analog fusion proteins. The fusion protein containing GLP-1 analogs in each group was substituted into 30 μmol / ml phosphate buffer (pH6.5) to a final concentration of 5 mg / ml, and the amino acid single component of each group was added and the pH was appropriately adjusted to 6.5, type and concentration See Table 6 for details. All groups were aseptically dispensed into vials, capped and placed in a constant temperature incubator at 37°C for accelerated investigation. Samples were taken on the 15th day and 30th day respectively, and detected by 10% non-reducing SDS-PAGE and SEC-HPLC methods. The results are shown in Table 7.

[0040] Table 6 Adding concentration of different amino acids

[0...

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Abstract

The invention discloses a stable liquid preparation containing GLP-1 analogue fusion protein and preparation thereof. The stable liquid preparation is prepared from the effective components of: the GLP-1 analogue fusion protein, a pharmaceutical buffering agent, an osmotic-pressure regulating agent, a protective agent, a surface active agent, sodium caprylate and the like. The stable liquid preparation can be used for treating the diabetes and relevant diseases thereof.

Description

technical field [0001] The invention relates to a stable liquid preparation of GLP-1 analog fusion protein and a preparation method thereof. The preparation is used for treating diabetes and various related diseases. Background technique [0002] Glucagon-like peptide-1 (GLP-1) and its analogs such as Exendin-4 are widely used in the treatment of type 2 diabetes, but due to glucagon-like peptide-1 (GLP-1) and its analogs The sensitivity of the drug to the protease dipeptidyl peptidase IV (DPP-IV) leads to its short half-life in plasma, which results in high frequency of administration and inconvenience to clinical application. At present, the technical means to solve the above problems mainly include slow-release microspheres, PEG modification, fatty acid chain modification, albumin fusion, etc. Among them, human albumin fusion technology is widely used, and this technology can maintain the biological activity and therapeutic function of the target protein. At the same time...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/26A61K47/12A61K47/18A61K47/26A61K47/02A61P3/10
CPCA61K9/08A61K38/26A61K47/02A61K47/12A61K47/183A61K47/26
Inventor 严守升郭斌谢宁李虎
Owner JIANGSU T MAB BIOPHARMA
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