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Liquid preparation containing anti-IL-17 antibody

A liquid preparation, antibody technology, applied in the direction of antibodies, medical preparations containing active ingredients, anti-inflammatory agents, etc., can solve the problems of inconvenient drug administration, poor compliance, dehydration of blood cells and tissue cells, etc. Injection problems, strong patient compliance, and the effect of meeting drug delivery needs

Active Publication Date: 2021-06-08
LIVZON MABPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Hypertonic solution will cause temporary atrophy of red blood cells when injected, causing dehydration of blood cells and tissue cells. Therefore, clinically, it is usually required that the injection should be an isotonic solution as much as possible. Therefore, the hyperosmotic pressure of Taltz has greater risks and disadvantages in its application. place
Furthermore, Taltz needs to be administered twice each time, which is inconvenient for patients to administer and the compliance is not strong.

Method used

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  • Liquid preparation containing anti-IL-17 antibody
  • Liquid preparation containing anti-IL-17 antibody
  • Liquid preparation containing anti-IL-17 antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Example 1 pH Screening (LZM012 20170815-Liq1)

[0074]The pH screening experiment of LZM012 formulation was based on the platform formulation (100mg / mL LZM012, 25mM histidine, 80mg / mL trehalose, 0.5mg / mL polysorbate 80), and multiple pH gradients (5.0, 5.5, 6.0) were designed , 6.5), to screen out the most suitable pH value.

[0075] The prescription design is shown in Table 1.

[0076] Table 1. LZM012 formulation

[0077]

[0078] In the ultra-clean bench, take 12 mL of the platform formulation with pH 5.5, add 0-300 μL of 0.5M HCl or 0.5M NaOH solution to adjust the pH of the platform formulation to 5.0, 5.5, 6.0, 6.5, respectively, and filter with a 0.22 μm syringe filter. Filling volume of 1mL / bottle: Fill the filtered preparation into a 2mL injection bottle, stopper and crimp the cap.

[0079] The DSC test results are shown in Table 2. The results show that: in the range of pH 5.0-6.5, with the increase of pH, Tonset and Tm1 increase; there is basically no ...

Embodiment 2

[0092] Example 2 Viscosity Study (LZM012 20170829-Liq3)

[0093] The study found that the protein hydrophobicity and concentration in the formulation of LZM012 were higher, and the platform formulation (100mg / mL LZM012, 25mM histidine, 80mg / mL trehalose, 0.5mg / mL polysorbate 80, pH 6.0) was found. The viscosity of the liquid is 14cP, which exceeds the internal control standard by 10cP. Consider adding a viscosity reducer to reduce the viscosity of the liquid.

[0094] The purpose of this example is to investigate the viscosity-reducing ability of NaCl and Arginine. The prescription and viscosity test results are shown in Table 4.

[0095] Table 4. LZM012 20170829-Liq3 viscosity test results

[0096]

[0097] Take the required amount of protein stock solution (130mg / mL LZM012, 25mM histidine, 80mg / mL trehalose, 0.5mg / mL polysorbate 80), add preparation buffer 1 (25mM histidine, 80mg / mL seaweed) respectively Sugar, 39.15 mg / mL NaCl, 0.5 mg / mL polysorbate 80), formulation...

Embodiment 3

[0099] Example 3 Prescription Screening (LZM012 20170925-Liq4)

[0100] Referring to biological products listed at home and abroad, the commonly used concentration of polysorbate 80 (PS80) is 0.05mg / mL-2mg / mL. Within this range, 0.5mg / mL PS80 was selected to be added to the LZM012 formulation to achieve solubilization and prevent protein aggregation and adsorption.

[0101] On the basis of determining pH 6.0 and 0.5mg / mL PS80, continue to screen the types of buffer systems and stabilizers, mainly examining three buffers: Histidine, Citrate, and Acetate (HAc). The system and trehalose (Trehalose), sucrose (Sucrose), arginine (Arginine) three stabilizers. Due to the high viscosity of LZM012, 9mg / mL NaCl was added to reduce the viscosity in the formulations without arginine in this example, and the specific formulation information is shown in Table 5.

[0102] Table 5. LZM012 20170925-Liq4 Prescribing Information

[0103]

[0104] Take an appropriate amount of LZM012 puri...

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Abstract

The invention provides a liquid preparation. The liquid preparation includes an anti-IL-17 antibody with the concentration of 20-200 mg / mL, a citrate buffering agent with the concentration of 10-50 mM, sucrose with the concentration of 20-120 mg / mL or arginine with the concentration of 50-250 mM and polysorbate 80 with the concentration of 0.1-5 mg / mL; and the pH value of the liquid preparation is 6.0 + / - 0.5, and the anti-IL-17 antibody is the monoclonal antibody of anti-IL-17A / F. The liquid preparation can be a stable subcutaneous injection preparation and used for treating IL-17A and / or IL-17F related diseases, such as psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, osteoarthritis or inflammatory bowel disease.

Description

technical field [0001] The present invention relates to the field of biological pharmaceutical preparations, in particular, the present invention relates to a stable liquid pharmaceutical preparation containing anti-IL-17 antibody. Background technique [0002] Anti-IL-17 monoclonal antibody drugs are known to be useful in the treatment of autoimmune diseases and inflammatory disorders, such as psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, Systemic lupus erythematosus, osteoarthritis or inflammatory bowel disease, etc., patients can be effectively treated by subcutaneous injection of anti-IL-17 monoclonal antibody drugs. [0003] The anti-IL-17 monoclonal antibody drugs currently on the market include Novartis' anti-inflammatory drug Cosentyx and Eli Lilly's anti-inflammatory drug Taltz, both of which are anti-IL-17A subtype monoclonal antibodies , the prescription composition includes histidine or citrate buffer system, n...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K9/08A61K47/26A61K47/18A61P17/06A61P19/02A61P29/00A61P37/02
CPCA61K39/3955A61K9/08A61K9/0019A61K47/26A61K47/183A61P17/06A61P19/02A61P29/00A61P37/02A61K47/02A61K47/12C07K16/244A61K39/39591C07K2317/94A61K2039/505C07K2317/565
Inventor 卢懿冷靖宇何登辉黄慧瑜
Owner LIVZON MABPHARM
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