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Secukinumab injection and preparation method thereof

A technology of secukinumab and injection, applied in the direction of antibodies, pharmaceutical formulas, antibody medical components, etc., can solve the problems of poor substitutability and few types of drugs

Pending Publication Date: 2019-08-16
TONGHUA DONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a biological antibody drug, the stability of antibody preparations is a key item for drug quality control. The applicant found in the previous search that the original drug (CN201580076632.9) is usually prepared with trehalose as a stabilizer, and other stabilizers are not currently available. It is determined that there are very few international and domestic drug varieties for this drug, and the substitutability is poor

Method used

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  • Secukinumab injection and preparation method thereof
  • Secukinumab injection and preparation method thereof
  • Secukinumab injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1: Buffer

[0044] The effect of buffer type (phosphate, histidine, citrate) was evaluated in prefilled syringes.

[0045] Prescription 1: secukinumab 150mg / ml, sodium dihydrogen phosphate and disodium hydrogen phosphate 20mmol / L, methionine 5mmol / L, trehalose 200mmol / L, polysorbate 80 0.02%, pH5.8;

[0046]Prescription 2: secukinumab 150mg / ml, histidine and histidine hydrochloride 20mmol / L, methionine 5mmol / L, trehalose 200mmol / L, polysorbate 80 0.02%, pH5.8;

[0047] Prescription 3: secukinumab 150mg / ml, citric acid and sodium citrate 20mmol / L, methionine 5mmol / L, trehalose 200mmol / L, polysorbate 80 0.02%, pH5.8.

[0048] The above three groups of prescription injections were filled into prefilled syringes, and stability studies were carried out under long-term (4°C), accelerated (25°C) and high temperature (40°C) conditions to evaluate physical stability (SEC-HPLC (SEC Macromolecular protein: Chinese Pharmacopoeia 2015 general rule), visible particles measu...

experiment example 2

[0061] Experimental example 2: pH

[0062] Based on the prescription secukinumab 150mg / ml, histidine and histidine hydrochloride 20mmol / L, methionine 5mmol / L, trehalose 200mmol / L, polysorbate 80 0.02%, adjust the pH respectively To 4.5, 5.0, 5.5, 5.8, 6.0, 6.5, 7.0, to investigate the effect of different pH on the stability of secukinumab. The samples were stored under high temperature conditions for 4 weeks, and the stability of secukinumab was evaluated by SEC-HPLC and CEX-HPLC. It was determined from SEC-HPLC, CEX-HPLC that protein aggregation and hydrolysis were minimal around pH 6.0.

experiment example 3

[0063] Experimental Example 3: Stabilizer

[0064] Initial formulation development for an injectable dosage form aimed to evaluate the effect of different stabilizers on the formation of secukinumab soluble and insoluble aggregates (SEC - Effect of HPLC, DLS, Visible Particles and Insoluble Particles by Light Obscuration), Chemical Stability (CEX-HPLC). Stabilizers are selected from glycerin, propylene glycol, and trehalose, and the prescription is as follows:

[0065] Prescription 1: secukinumab 150mg / ml, histidine and histidine hydrochloride 20mmol / L, methionine 5mmol / L, glycerin 270mmol / L, polysorbate 80 0.02%, pH5.8;

[0066] Prescription 2: secukinumab 150mg / ml, histidine and histidine hydrochloride 20mmol / L, methionine 5mmol / L, propylene glycol 271mmol / L, polysorbate 80 0.02%, pH5.8;

[0067] Prescription 3: secukinumab 150mg / ml, histidine and histidine hydrochloride 20mmol / L, methionine 5mmol / L, trehalose 200mmol / L, polysorbate 80 0.02%, pH5.8.

[0068] Through the p...

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Abstract

The invention provides a secukinumab injection. The secukinumab injection is composed of 50 mg / ml-300 mg / ml of secukinumab, 5-50 mmol / L of histidine and histidine hydrochloride, 5-50 mol / L of methionine, 150 mmol / L-400 mmol / L of polyols, 0.01%-0.02% of polysorbate and water for injection as balance and has a pH of 5.0-7.0. Through stability test, the secukinumab injection is proved to be stable inquality and higher in stability than commercial products on the market and meets the relevant specifications of Chinese Pharmacopoeia on various indexes, thereby having a good application prospect.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals and preparations, and in particular relates to a secukinumab injection and a preparation method thereof. [0002] technical background [0003] Psoriasis is a chronic immune-mediated skin disease with approximately 125 million patients worldwide, and as many as 6.5 million patients with psoriasis in China. [0004] Secukinumab is a fully humanized monoclonal anti-IL-17A inflammatory cytokine IgG1 antibody that directly blocks the interaction of IL-17A with its receptor by binding to IL-17A, thus altering immunity and inflammation Response achieves therapeutic goals. [0005] (Active ingredient: Secukinumab, secukinumab) is the world's first blockbuster biological drug targeting IL-17A developed by Novartis, and it has been confirmed that its efficacy in the treatment of psoriasis surpasses that of traditional TNFα-targeting drugs such as Enbrel and Humira Biological agents are not currently on...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K9/08A61K47/10A61P17/06
CPCA61K39/3955A61K9/08A61K9/0019A61K47/10A61P17/06
Inventor 王德朋魏姗姗范馨丹张忠雨张楠冷春生常晓慧
Owner TONGHUA DONGBAO PHARMA
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