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Pralatrexate injection as well as preparation method and application thereof

A technology of pralatrexate injection and pralatrexate, which is applied in the field of pralatrexate injection and its preparation, can solve the problems of inconvenient production, transportation and use, and achieve a wide range of applicable people, low production cost, good safety and stability Effect

Inactive Publication Date: 2020-08-21
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pralatrexate is extremely sensitive to light and temperature, and it is easy to degrade under light or high temperature conditions. Therefore, it has strict requirements on light and temperature during its production and storage, which brings a lot of inconvenience to the production, transportation and use of the preparation

Method used

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  • Pralatrexate injection as well as preparation method and application thereof
  • Pralatrexate injection as well as preparation method and application thereof
  • Pralatrexate injection as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0043] components Prescription 1 Prescription 2 Prescription 3 Prescription 4 Prescription 5 Pralatrexate 2g 2g 2g 2g 2g Sodium chloride 0.9g 0.9g 0.9g 0.9g 0.9g stabilizer Hydrochloric acid 0.4g Lactic acid 0.4g Acetic acid 0.4g Citric acid 0.4g Phosphoric acid 0.4g sodium hydroxide Adjust pH6.8 Adjust pH6.8 Adjust pH6.8 Adjust pH6.8 Adjust pH6.8 Water for Injection Add to 100mL Add to 100mL Add to 100mL Add to 100mL Add to 100mL

[0044] Prepare prescriptions according to the above table and store them for 30 days at 25°C±2°C / 60%RH±5%RH. The results are as follows:

[0045]

[0046] According to the results, it can be seen that when lactic acid is selected as the stabilizer, the content of related substances is lower.

Embodiment 1

[0049] A pralatrexate injection. The injection is composed of: 2 g of pralatrexate, 4 g of sorbitol, 0.5 g of lactic acid, an appropriate amount of sodium hydroxide to adjust the pH to 6.8, and water for injection to 100 mL.

[0050] Take 70%-80% of the target volume of sterile water for injection, add 4g of sorbitol while stirring, add 2g of pralatrexate raw material to the solution, and stir until completely dissolved, add 0.5g of lactic acid, adjust with appropriate amount of sodium hydroxide pH to 6.8, continue stirring. Finally, add sterile water for injection to reach the target volume. After the preparation, the solution was clarified by filtering the solution with a 0.22 μm disposable sterile PVDF membrane filter. After clarification and filtration, the clarified medicinal solution was passed through two sets of hydrophilic 0.22 μm PVDF membrane filters for sterilization. The filtered medicinal solution is filled into sterile vials and sealed to obtain the product. ...

Embodiment 2

[0052] A pralatrexate injection. The injection consists of: 2 g of pralatrexate, 4.5 g of sorbitol, 0.5 g of lactic acid, an appropriate amount of sodium hydroxide to adjust the pH to 6.8, and water for injection to 100 mL.

[0053] Take sterile water for injection with a target volume of 70%-80%, add 4.5g of sorbitol while stirring, add 2g of pralatrexate raw material to the solution, and stir until completely dissolved, add 0.5g of lactic acid and appropriate amount of sodium hydroxide Adjust the pH to 6.8 and continue stirring. Finally, add sterile water for injection to reach the target volume. After the preparation, the solution was clarified by filtering the solution with a 0.22 μm disposable sterile PVDF membrane filter. After clarification and filtration, the clarified medicinal solution was passed through two sets of hydrophilic 0.22 μm PVDF membrane filters for sterilization. The filtered medicinal solution is filled into sterile vials and sealed to obtain the prod...

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Abstract

The invention relates to a pralatrexate composition, and especially relates to a stable pralatrexate injection as well as a preparation method and application thereof. The pralatrexate injection comprises pralatrexate, a pH regulator, an isotonic agent and water for injection, and optionally further comprises a stabilizer, wherein the pH value of the pralatrexate injection is 6.5-7.3. The pralatrexate injection prepared by the invention has the advantages of simple process, low cost, safety, reliability, good stability, convenience in clinical use, suitability for industrial production and thelike.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, more specifically, to pralatrexate injection and its preparation method and application. Background technique [0002] Pralatrexate (pralatrexate), chemically named 10-propargyl-10-deazaminopterin, is an antineoplastic folic acid analogue, and is the first drug for the treatment of peripheral T-cell lymphoma (PTCL). dihydrofolate reductase inhibitors. The structural formula is as follows: [0003] [0004] In the United States, PTCL is identified as a rare disease, with approximately 9,500 patients per year, while it has a higher incidence in Asian countries. Clinically, pralatrexate is of great significance for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. [0005] Pralatrexate is a new targeted folic acid preparation, which can preferentially accumulate in cancer cells. It can treat relapsed and refractory PTCL alone. It can not only completel...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/519A61K47/12A61K47/26A61K47/02A61P35/00
CPCA61K9/0019A61K9/08A61K31/519A61K47/02A61K47/12A61K47/26A61P35/00
Inventor 王佩钟春华赵娜李倩
Owner JIANGSU HANSOH PHARMA CO LTD
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