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Human Anti-il-33 monoclonal-antibody-containing pharmaceutical composition

A technology for monoclonal antibodies and compositions, applied in the field of pharmaceutical compositions containing antibodies, can solve problems such as insufficient antibodies, and achieve the effects of stable long-term storage and excellent efficacy

Pending Publication Date: 2021-04-30
MITSUBISHI TANABE PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, especially in pharmaceutical compositions containing high concentrations of antibodies, techniques for preventing antibody aggregation, cloudiness, viscosity increase, and pH shift are still insufficient.

Method used

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  • Human Anti-il-33 monoclonal-antibody-containing pharmaceutical composition
  • Human Anti-il-33 monoclonal-antibody-containing pharmaceutical composition
  • Human Anti-il-33 monoclonal-antibody-containing pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0261] Example 1: Cloudiness suppression effect by adding sugar

[0262] In order to eliminate the cloudiness of the human anti-IL-33 monoclonal antibody (A10-1C04, A23-1A05, A25-2C02, A25-3H04, or A26-1F02), instead of adding 5% sorbitol, as Comparative Example 2, The following formulations obtained with sodium chloride contained in formulations A4N, A5N, H6N, P6N, P7N, and P8N were evaluated. The antibody concentration was set at 150 mg / ml.

[0263] 10 mM sodium acetate / pH4 / 5% (w / v) sorbitol / 0.02% (w / v) polysorbate 80 (hereinafter referred to as "A4S")

[0264] 10 mM sodium acetate / pH5 / 5% (w / v) sorbitol / 0.02% (w / v) polysorbate 80 (hereinafter referred to as "A5S")

[0265] 10 mM histidine / pH6 / 5% (w / v) sorbitol / 0.02% (w / v) polysorbate 80 (hereinafter referred to as "H6S")

[0266] 10 mM sodium phosphate / pH6 / 5% (w / v) sorbitol / 0.02% (w / v) polysorbate 80 (hereinafter referred to as "P6S")

[0267] 10 mM sodium phosphate / pH7 / 5% (w / v) sorbitol / 0.02% (w / v) polysorbate 80 (her...

Embodiment 2

[0274] Example 2: Salt concentration and cloudiness (1)

[0275] Human anti-IL-33 monoclonal antibodies (A10-1C04, A23-1A05, A25-2C02, A25-3H04 or A26-1F02) dissolved in 10 mM histidine / pH6.0 or pH5.5 buffer were determined Also, the interaction parameter (Kd value) as an index of cohesion when 0, 50, and 100 mM NaCl is added is shown. The measurement temperature was set at 25° C., and the antibody concentrations were prepared so as to be 0.5, 1, 2.5, 5, 10, and 20 mg / mL. As a result, when the NaCl addition amount was 50 mM or more, the Kd value was a negative number (agglomeration increased), so it was considered that the NaCl addition amount should be less than 50 mM (for example, about A10-1C04, shown in Table 4). It should be noted that the Kd value can be calculated as follows: the diffusion coefficient (Dm) is obtained by the dynamic light scattering method, the slope is obtained from the coordinate diagram of the antibody concentration (horizontal axis) and the diffu...

Embodiment 3

[0280] Example 3: Salt concentration and cloudiness (2)

[0281] 0, 5, 10, and 30 mM NaCl were added to 10 mM histidine / pH6.0 / 3.6% (w / v) sorbitol, and the Kd value, which was an index of cohesion, was measured. Antibodies used A10-1C04 ​​at 2.5, 5, 10, and 14 mg / mL. As a result, the Kd value was negative when the amount of NaCl added was above 30mM (the Kd values ​​of 0, 5, 10, and 30mM NaCl were 17.3, 7.3, 1.2, and -4.0mL / g, respectively). Less than 30mM. The Kd value was calculated by the method described in Example 2.

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Abstract

The purpose of the present invention is to provide a pharmaceutical composition containing a human anti-IL-33 monoclonal antibody suitable for administration to a subject. The present invention provides a pharmaceutical composition containing a human anti-IL-33 monoclonal antibody as an active ingredient, wherein the pharmaceutical composition is substantially free of sodium chloride or contains less than 30 mM of sodium chloride. The present invention also provides a freeze-dried form of the pharmaceutical composition.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing a human anti-IL-33 monoclonal antibody (A10-1C04, A23-1A05, A25-2C02, A25-3H04, or A26-1F02), and particularly relates to a composition that suppresses white turbidity, improves pH, etc. A storage-stable pharmaceutical composition containing an antibody. Background technique [0002] In recent years, various antibody-containing pharmaceutical compositions have been developed for practical use, and many antibody-containing pharmaceutical compositions are used as pharmaceutical compositions for intravenous injection. On the other hand, there is an increasing need to develop a pharmaceutical composition containing an antibody as a self-injectable pharmaceutical composition for hypodermic injection due to the needs of the medical field. [0003] When designing a pharmaceutical composition containing an antibody for subcutaneous injection, the amount of antibody administered per dose ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/08A61K9/19A61K47/02A61K47/10A61K47/12A61K47/18A61K47/26A61P11/06A61P15/00A61P17/00A61P37/08
CPCA61P17/00A61P15/00A61P11/06A61K47/02A61K47/26A61P37/08A61K9/19A61K47/183A61K9/0019C07K16/244C07K2317/565C07K2317/56C07K2317/94A61K47/10A61K47/22
Inventor 池本启祐森直树齐藤浩谷本昌彦
Owner MITSUBISHI TANABE PHARMA CORP
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