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A kind of pharmaceutical composition containing adalimumab

A technology of adalimumab and a composition, applied in the biological field, can solve problems such as the impact of biopharmaceutical safety, reduce the efficacy of biological drugs, patient death, etc., and achieve broad market application prospects, high stability, and the effect of improving stability.

Active Publication Date: 2019-04-16
HISUN BIOPHARMACEUTICAL CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These degradation products will have a great impact on the safety of biopharmaceuticals
In particular, some protein aggregates can stimulate the body's immune response, which can reduce the efficacy of biological drugs in mild cases, and even cause the death of patients in severe cases

Method used

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  • A kind of pharmaceutical composition containing adalimumab
  • A kind of pharmaceutical composition containing adalimumab
  • A kind of pharmaceutical composition containing adalimumab

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 Stability Study (1)

[0029] Biopharmaceuticals will experience various destructive conditions during production, transportation, storage and use, such as high temperature, light and freeze-thaw. To be safe, they must be able to maintain structural integrity, especially higher-level structures. Aggregates and insoluble particles of biopharmaceuticals are very critical factors that cause immune responses to biopharmaceuticals. The appearance of biopharmaceuticals is also a very important indicator. Pharmacopoeias of various countries stipulate that biological drugs must be free of visible foreign matter, because the presence or absence and content of particles in biological drugs are directly related to the safety of biological drugs, and they are considered to be one of the most important factors that cause the immune response of biological drugs.

[0030] SEC-HPLC is an analytical method that uses the relative relationship between the pore size of the ge...

Embodiment 2

[0060] Embodiment 2 stability study (two)

[0061] We have designed several preparation prescriptions 5-9, combined with the experimental results of preparation 2 and preparation 4 in Example 1, compared the freeze-thaw stability of the preparations with mannitol, sucrose and trehalose at different concentrations of adalimumab Among them, these preparations do not contain sodium chloride, and the other components in the preparation are: 0.35mg / ml sodium citrate, 1.3mg / ml citric acid, 0.86mg / ml sodium dihydrogen phosphate, 1.53mg / ml Disodium hydrogen phosphate, 1 mg / ml polysorbate 80, pH value of the solution is 5.2. The prescriptions of these preparations were frozen at -20°C for 5 hours, thawed at 4°C for 10 hours, and tested by SEC-HPLC after repeated freezing and thawing 8 times. The results are shown in Table 6.

[0062] Table 6 Effects of mannitol, sucrose and trehalose on the freeze-thaw stability of formulations under different adalimumab concentrations

[0063]

...

Embodiment 3

[0065] Embodiment 3: the preparation of low concentration (1mg / ml) and high concentration (100mg / ml) adalimumab preparation of sucrose and trehalose as structural protection agent

[0066] We designed and formulated formulations 10-13 containing low (1 mg / ml) and high (100 mg / ml) concentrations of adalimumab, respectively (Table 7), for validation of sucrose and trehalose as structural protectors Ability to formulate low and high concentration adalimumab formulations. These preparations do not contain sodium chloride, other components are: 0.35mg / ml sodium citrate, 1.3mg / ml citric acid, 0.86mg / ml sodium dihydrogen phosphate, 1.53mg / ml disodium hydrogen phosphate, 1mg / ml polysorbate 80, the solution pH value is 5.2.

[0067] Table 7 Preparations containing high and low concentrations of adalimumab with sucrose and trehalose as structural protective agents

[0068]

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Abstract

The invention relates to a pharmaceutical composition containing adalimumab and a structure protecting agent. In the present invention, sucrose or trehalose is selected as the structural protection agent, so that the stability of the pharmaceutical composition is greatly improved, and has a very broad market application prospect.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a pharmaceutical composition containing adalimumab. Background technique [0002] Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by joint synovitis. Synovitis is persistent and recurrent, which can lead to the destruction of cartilage and bone in the joint, joint dysfunction, and even disability. Vasculitis lesions involve various organs of the whole body, so the disease is also called rheumatoid disease. The age of onset of about 80% of the patients is 20-45 years old, most of them are young adults, and the ratio of male to female is 1:2-4. There are 355 million people with photoarthritis worldwide. In Asia, 1 in 6 people will suffer from arthritis, the world's number one disabling disease, at some point in their lives. At present, it is estimated that there are more than 100 million arthritis patients in mainland China, and the numb...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/26A61K39/395A61P29/00A61P19/02A61P17/06A61P19/08A61P1/00
CPCC07K16/24A61K39/39591A61P1/00A61P17/06A61P19/02A61P19/08A61P29/00A61P37/00A61K39/395A61K47/26
Inventor 方伟杰裘敏虹黄春辉王诏郑洪健王海彬应跃斌白骅
Owner HISUN BIOPHARMACEUTICAL CO LTD
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