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Pharmaceutical composition of humanized antibody for vascular endothelial growth factor

A composition and drug technology, applied in the field of medicine and chemical industry, can solve the problems of affecting product activity, potential safety risks, unsatisfactory stability of Avastin, etc., and achieve the effects of reducing polymers and degradants and improving stability.

Active Publication Date: 2016-03-30
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The stability of Avastin is not ideal, and the growth of polymers and degradation products is obvious during accelerated and long-term storage, especially the significant growth of polymers
High-molecular-weight polymers are prone to immunogenicity when entering the body, which poses a potential risk to the safety of clinical use; at the same time, low or inactive degradation products will affect the activity of the product

Method used

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  • Pharmaceutical composition of humanized antibody for vascular endothelial growth factor
  • Pharmaceutical composition of humanized antibody for vascular endothelial growth factor
  • Pharmaceutical composition of humanized antibody for vascular endothelial growth factor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] The preparation of embodiment 1 bevacizumab injection

[0094] prescription:

[0095]

[0096]

[0097] Preparation method: According to the above formula, a blank solution without bevacizumab was prepared, and the pH value was 5.2. The purified bevacizumab monoantigen solution was replaced with a blank solution for 6 times to prepare a solution of the above formula, sterilized and filtered, aseptically subpackaged, and passed the visual inspection to obtain the product.

Embodiment 2

[0098] The preparation of embodiment 2 bevacizumab injection

[0099] prescription:

[0100]

[0101] Preparation method: According to the above formula, a blank solution without bevacizumab was prepared, and the pH value was 5.2. The purified bevacizumab monoantigen solution was replaced with a blank solution for 6 times to prepare a solution of the above formula, sterilized and filtered, aseptically subpackaged, and passed the visual inspection to obtain the product.

Embodiment 3

[0102] The preparation of embodiment 3 bevacizumab injection

[0103] prescription:

[0104]

[0105] Preparation method: According to the above formula, a blank solution without bevacizumab was prepared, and the pH value was 5.2. The purified bevacizumab monoantigen solution was replaced with a blank solution for 6 times to prepare a solution of the above formula, sterilized and filtered, aseptically subpackaged, and passed the visual inspection to obtain the product.

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Abstract

The invention belongs to the fields of medicine chemical industry, relates to a pharmaceutical composition of a humanized antibody for a vascular endothelial growth factor, and specifically relates to a stability-improving bevacizumab pharmaceutical composition. The pharmaceutical composition adopts a combination buffer system of a sodium phosphate buffer agent and a second buffer agent, and adopts one or two of mannitol or sodium chloride as an osmotic pressure regulator; compared with Avastin only adopting a sodium phosphate buffer agent and adopting alpha,alpha-trehalose as an osmotic pressure regulator, the pharmaceutical composition has polymers and degraded materials significantly reduced and has the stability significantly improved, so that the pharmaceutical composition is particularly suitable for requirements of mass production and long-term storage.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and relates to a pharmaceutical composition of a humanized antibody against vascular endothelial growth factor, in particular to a pharmaceutical composition of bevacizumab with improved stability. Background technique [0002] Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), combined with 5-fluorouracil-based chemotherapy, is suitable for the treatment of patients with metastatic colorectal cancer. Bevacizumab injection produced by Roche, with the trade name Avastin, has been launched in the United States, Europe, China and other places. [0003] Avastin is a sterile solution for intravenous injection, pH is 6.1, colorless to slightly brown opalescent to clear liquid, the concentration is 25mg / mL, there are two specifications of 100mg and 400mg, and the corresponding volumes are 4mL and 16mL respectively , without preservatives, in s...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K47/10A61K47/02
Inventor 程艳菊赵伟张来芳郭莹莹曹宇虹恽丽红季剑芸
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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