A high-concentration nimotuzumab preparation for subcutaneous or intramuscular injection and its preparation method and application

A Nimotuzumab and intramuscular injection technology, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, antibodies, etc., to achieve the effect of system stability

Active Publication Date: 2020-11-20
TOT BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, nimotuzumab injection can only be injected intravenously at present, and there are no reports on subcutaneous injection or intramuscular injection.

Method used

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  • A high-concentration nimotuzumab preparation for subcutaneous or intramuscular injection and its preparation method and application
  • A high-concentration nimotuzumab preparation for subcutaneous or intramuscular injection and its preparation method and application
  • A high-concentration nimotuzumab preparation for subcutaneous or intramuscular injection and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] In this example, the formula of the Nimotuzumab preparation is as follows: 30 mg / mL Nimotuzumab, 10 mM phosphate buffer (pH7.0), 60 mM trehalose dihydrate, 0.02% polysorbate 20, 1000IU / mL hyaluronidase.

[0042] The preparation method is as follows:

[0043] (1) Nimotuzumab is added to the buffer solution of the buffer, a nonionic surfactant is added thereto, and then hollow fiber ultrafiltration is performed to obtain a buffer system of Nimotuzumab;

[0044] (2) Add hyaluronidase and a stabilizer to the buffer system of Nimotuzumab obtained in step (1), and mix to obtain the Nimotuzumab preparation.

[0045] The stability data of the nimotuzumab preparations prepared in this example are shown in Table 1.

[0046] Formulation stability data described in table 1 embodiment 1

[0047]

[0048] As can be seen from Table 1, the preparation formula described in Example 1 is stable under storage conditions (2-8° C.).

Embodiment 2

[0050] In this embodiment, the formulation of the Nimotuzumab preparation is as follows: 50 mg / mL Nimotuzumab, 15 mM phosphate buffer (pH6.8), 80 mM trehalose dihydrate, 0.04% polysorbate 20 , 1500IU / mL hyaluronidase.

[0051] The preparation method is as follows:

[0052] (1) Nimotuzumab is added to the buffer solution of the buffer, a nonionic surfactant is added thereto, and then hollow fiber ultrafiltration is performed to obtain a buffer system of Nimotuzumab;

[0053] (2) Add hyaluronidase and a stabilizer to the buffer system of Nimotuzumab obtained in step (1), and mix to obtain the Nimotuzumab preparation.

[0054] The stability data of the nimotuzumab preparations prepared in this example are shown in Table 2.

[0055] Formulation stability data described in table 2 embodiment 2

[0056]

[0057] As can be seen from Table 2, the formula described in Example 2 is stable under its storage conditions (2-8° C.).

Embodiment 3

[0059] In this embodiment, the formulation of the Nimotuzumab preparation is as follows: 100 mg / mL Nimotuzumab, 20 mM phosphate buffer (pH7.0), 100 mM trehalose dihydrate, 0.05% polysorbate 20 , 1500IU / mL hyaluronidase.

[0060] The preparation method is as follows:

[0061] (1) Nimotuzumab is added to the buffer solution of the buffer, a nonionic surfactant is added thereto, and then hollow fiber ultrafiltration is performed to obtain a buffer system of Nimotuzumab;

[0062] (2) Add hyaluronidase and a stabilizer to the buffer system of Nimotuzumab obtained in step (1), and mix to obtain the Nimotuzumab preparation.

[0063] The stability data of the Nimotuzumab preparation prepared by this embodiment are shown in Table 3

[0064] Formulation stability data described in table 3 embodiment 3

[0065]

[0066]

[0067] As can be seen from Table 3, the formula described in Example 3 is stable under its storage conditions (2-8° C.).

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Abstract

The invention provides a high-concentration Nimotuzumab preparation for subcutaneous or intramuscular injection as well as a preparation method and application of the high-concentration Nimotuzumab preparation. The high-concentration Nimotuzumab preparation for subcutaneous or intramuscular injection is prepared from the following components: 15-150mg / mL of Nimotuzumab, 150-20,000IU / mL of hyaluronidase, 10-100mM of buffer agent, 5-200mM of stabilizer and 0.01-0.1% (w / v) nonionic surfactant. In the invention, the Nimotuzumab cooperates with the hyaluronidase, the nonionic surfactant, the bufferagent and the stabilizer to obtain the high-concentration Nimotuzumab preparation, and the obtained Nimotuzumab preparation is suitable for subcutaneous or intramuscular injection when high-concentration Nimotuzumab is contained.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals and relates to a nimotuzumab preparation and its preparation method and application, in particular to a high-concentration nimotuzumab preparation for subcutaneous or intramuscular injection and its preparation method and application. Background technique [0002] Nimotuzumab is a monoclonal antibody drug targeting the epidermal growth factor receptor (EGFR). It is a humanized monoclonal antibody used for the treatment of malignant tumors. Downstream signal transduction pathways, thereby inhibiting tumor cell proliferation, inducing differentiation, promoting cell apoptosis, inhibiting tumor angiogenesis, and enhancing the efficacy of radiotherapy and chemotherapy. So far, Nimotuzumab has been injected intravenously (IV), and intravenous injection needs to be completed under the guidance of medical staff, which takes a long time. By changing the route of administration, such as subcutaneous inje...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/42A61K47/32A61K47/26A61K39/395A61P35/00
CPCA61K9/0019A61K9/08A61K39/39591A61K47/26A61K47/32A61K47/42
Inventor 刘冬连孙健聂浩宋国伟陈茂林刘军黄纯莹
Owner TOT BIOPHARM CO LTD
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