Preparation method of infliximab freeze-dried preparation for injection

A technology for freeze-dried preparations and injections, which is applied in the field of preparation of infliximab freeze-dried preparations for injection, which can solve the problems of increased immunogenicity and multimer content, and achieve the reduction of polymer content and reduction of polymer content. content, risk reduction effect

Pending Publication Date: 2022-02-11
KINDOS PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this patent has prepared a freeze-dried preparation of inflixime suitable for subcutaneous administration, it is known from the test results of the preparation that the polymer content of the just-made finished product is close to 1%, and after high-temperature light, the polymer content of Body content significantly increased
In addition, compared with intravenous injection, the immunogenic effect of subcutaneous injection is stronger. Although the viscosity and osmotic pressure of the formulation are suitable for subcutaneous administration, subcutaneous administration of a formulation with a high polymer content will produce The potential for immunogenicity would be greatly increased

Method used

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  • Preparation method of infliximab freeze-dried preparation for injection
  • Preparation method of infliximab freeze-dried preparation for injection
  • Preparation method of infliximab freeze-dried preparation for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0027] A method for preparing a freeze-dried preparation of infliximab for injection. The liquid before freeze-drying contains the following components: the concentration of infliximab is 20 mg / mL, the concentration of sodium phosphate is 10 mM, and the concentration of polysorbate 80 is 0.1 mg / mL, the sucrose concentration is 100mg / mL, and the pH value of the liquid medicine is 6.0.

[0028] Load the drug solution into the freeze dryer, keep in the freeze drying chamber at 5°C for 2h; cool down to -50°C, keep for 5h; vacuumize, sublimation and dry: heat up to -20°C once, keep for 50h, heat up to -20°C for the second time -10°C, keep for 8h; desorption: heat up to 20°C, keep for 10h, cool down to 5°C, keep for 20min.

Embodiment 2

[0030] A method for preparing a freeze-dried preparation of infliximab for injection. The liquid before freeze-drying contains the following components: the concentration of infliximab is 20 mg / mL, the concentration of sodium phosphate is 10 mM, and the concentration of polysorbate 80 is 0.1 mg / mL, the sucrose concentration is 100mg / mL, and the pH value of the liquid medicine is 5.8.

[0031] Load the drug solution into the freeze dryer, keep in the freeze drying chamber at 5°C for 2h; cool down to -40°C, keep for 8h; vacuumize, sublimation and dry: heat up to -20°C once, keep for 70h, heat up to -20°C for the second time 0°C, keep for 10h; desorption: heat up to 30°C, keep for 15h, cool down to 5°C, keep for 20min.

Embodiment 3

[0033] A method for preparing a freeze-dried preparation of infliximab for injection. The liquid before freeze-drying contains the following components: the concentration of infliximab is 20 mg / mL, the concentration of sodium phosphate is 10 mM, and the concentration of polysorbate 80 is 0.1 mg / mL, the sucrose concentration is 100mg / mL, and the pH value is 6.2.

[0034] Load the drug solution into the freeze dryer, keep it in the freeze drying chamber at 5°C for 2h; cool it down to -45°C, keep it for 6h; vacuumize, sublimation drying: raise the temperature to -20°C once, keep it for 60h, and raise the temperature twice to -8°C, keep for 9h; desorption: heat up to 25°C, keep for 12h, cool down to 5°C, keep for 20min.

[0035] The dosing method of medicinal liquid of the present invention:

[0036] A. Add water for injection into the solution bottle to keep the solution temperature at room temperature;

[0037] B. Add polysorbate 80, stir evenly, add sodium phosphate, stir unt...

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Abstract

The invention discloses a preparation method of an infliximab freeze-dried preparation for injection. Before freeze-drying, a liquid medicine contains the following components: infliximab with the concentration of 20 mg / mL, sodium phosphate with the concentration of 10 mM, polysorbate 80 with the concentration of 0.1 mg / mL and cane sugar with the concentration of 100 mg / mL; feeding the liquid medicine to a freeze dryer, and keeping a freeze drying chamber at 5 DEG C for 2 hours; cooling to -50 - -40 DEG C, and keeping for 5-8 hours; vacuumizing and sublimation drying: heating to -20 - -15 DEG C for the first time and keeping for 50-70 hours, heating to -10-0 DEG C for the second time and keeping for 8-10 hours; desorption: raising the temperature to 20-30 DEG C, keeping the temperature for 10-15 hours, reducing the temperature to 5 DEG C, and keeping the temperature for 20 minutes. The polymer content is reduced, the risk of immunogenicity of the product is reduced, the collapse problem of the product in the freeze-drying process is solved, and a freeze-drying preparation product with excellent quality is produced.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a preparation method of a freeze-dried preparation of infliximab for injection. Background technique [0002] Infliximab is a human-mouse chimeric monoclonal antibody, which specifically binds TNF-α in the human body and prevents TNF-α from binding to its cell surface receptors, thereby blocking the biological activity of TNF-α, and ultimately Reduce the inflammatory response and reduce the activation of osteoclasts to achieve the purpose of controlling and relieving symptoms. Infliximab can be used to treat rheumatoid arthritis, psoriasis, ankylosing spondylitis, ulcerative colitis and Crohn's disease, etc. [0003] Like many proteins, mAbs are susceptible to multiple physical and chemical degradations, and in many cases these degradations may occur simultaneously. Physical instability mainly includes denaturation, aggregation and precipitation. The che...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/19A61K47/02A61K47/26A61P29/00A61P19/02A61P17/06A61P19/08A61P1/00A61P1/04
CPCC07K16/241A61K9/19A61K9/0019A61K47/02A61K47/26A61P29/00A61P19/02A61P17/06A61P19/08A61P1/00A61P1/04A61K2039/505A61K2039/54
Inventor 文娅娅史宣宇田欣欣
Owner KINDOS PHARM CO LTD
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