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Freeze dried HGF preparations

A technology of freeze-dried preparations and stabilizers, which is applied in the field of freeze-dried preparations, can solve problems such as poor effect of stabilizers, and achieve the effects of good physical and chemical stability, excellent storage stability, and strong affinity

Inactive Publication Date: 2009-01-07
MITSUBISHI CHEM CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, glycine and alanine described in JP-A-9-25241 are very effective as stabilizers for lyophilization of high-concentration HGF, but are not effective as stabilizers for lyophilization of low-concentration HGF.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0044] Example 1: Preparation of low-concentration HGF freeze-dried preparation (comparative example)

[0045] HGF was dissolved in 10 mM phosphate buffer (pH 6.5) containing 140 mM sodium chloride and 0.01% polysorbate 80 to a final concentration of 1 mg / mL, and filtered to obtain an aqueous HGF solution. After adjusting the pH of the solution, fill each vial with 2 mL under aseptic conditions, and freeze-dry according to the conditions shown in Table 1 to obtain a low-concentration HGF freeze-dried preparation. "→" in the table indicates a change in temperature.

[0046] Table 1

[0047] Freezing process Primary drying process Secondary drying process

[0048] Temperature (°C) 20→-40 -40 -40→-20 -20 -20→20 20

[0049] Time (Hr) 1 5 3 48 2 24

[0050] Pressure (mmHg ) 760 760 <1 <1 <1 <1

example 2

[0051] Example 2: Preparation of low-concentration HGF freeze-dried preparation (comparative example)

[0052] HGF was dissolved by heating with 10 mM phosphate buffer (pH 6.5) containing 140 mM sodium chloride and 0.01% polysorbate 80, and the final concentration of HGF was 5 mg / mL. After sterilization by filtration, HGF aqueous solution was obtained. After adjusting the pH of this solution, fill 2 mL in each vial under aseptic conditions, and freeze-dry according to the conditions shown in Table 1 to obtain a low-concentration HGF freeze-dried cut agent.

example 3

[0053] Example 3: Preparation of high-concentration HGF freeze-dried preparation (comparative example)

[0054] Dissolve HGF with 10 mM phosphate buffer (pH 6.5) containing 140 mM sodium chloride, 100 mM arginine, 0.01% polysorbate 80, and make the final concentration of HGF 10 mg / mL, after filter sterilization, HGF is obtained aqueous solution. After adjusting the pH of this solution, fill 2 mL in each vial under aseptic conditions, and freeze-dry according to the conditions shown in Table 1 to obtain a high-concentration HGF freeze-dried preparation.

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PUM

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Abstract

Freeze dried preparations containing hepatocyte growth factor (HGF), a stabilizer such as arginine or lysine, sodium chloride and a buffer. These preparations, which are produced from an aqueous solution containing less than 5 mg / mL of HGF and / or to be used in producing an aqueous solution containing less than 5 mg / mL of HGF, are excellent in storage stability.

Description

technical field [0001] The present invention relates to a freeze-dried formulation containing hepatocyte growth factor. Background technique [0002] Hepatocyte growth factor (hepatocyte growth factor: in the present invention, hereinafter abbreviated as HGF) is known to exist in various animal species as a protein having an activity of promoting hepatocyte proliferation, and HGF is reported to have a different amino acid sequence. Since Dagongyuan and others discovered human hepatocyte growth factor (hereinafter abbreviated as hHGF) from the plasma of patients with acute hepatitis (Japanese Patent Application Publication No. 63-22526), ​​Kitamura and others clarified the amino acid sequence of the hHGF protein and its coding gene (cDNA ) sequence (JP-A-3-72883). In addition, a method for producing hHGF protein and a transformant using this cDNA have been reported (JP-A-3-285693). In this context, it is expected to realize the large-scale production of hHGF protein and its...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/22A61K9/19A61K47/02A61K47/18A61K47/36A61P31/14A61K38/18
CPCA61K38/1833A61K47/183A61K9/19A61K9/0019A61P31/14
Inventor 千叶雅俊
Owner MITSUBISHI CHEM CORP
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