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Pemetrexed disodium freeze-dried injection and preparation method thereof

A technology of pemetrexed disodium and freeze-dried powder injection, which is applied in the field of pemetrexed disodium freeze-dried powder for injection and its preparation, can solve the problem that the infusion cannot be placed for a long time, and the pemetrexed disodium is stable Poor performance, no improvement of defects, etc., to achieve considerable economic and social benefits, uniform and stable quality, and low production costs

Active Publication Date: 2009-04-22
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Pemetrexed disodium has poor stability and is prone to degradation under high temperature, oxidation and light conditions, resulting in impurities that may cause toxic and side effects
Therefore, pemetrexed disodium is usually prepared as a freeze-dried powder injection, but we found that even if it is prepared as a freeze-dried preparation, during the transportation and storage of this variety, if the temperature control is not paid attention to, the related substances of the preparation will still be will increase significantly, and the infusion solution prepared during clinical use cannot be placed for a long time
Existing known technology also does not improve the suggestion of above defective

Method used

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  • Pemetrexed disodium freeze-dried injection and preparation method thereof
  • Pemetrexed disodium freeze-dried injection and preparation method thereof
  • Pemetrexed disodium freeze-dried injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] prescription

[0019]

[0020] Weigh the prescribed amount of pemetrexed disodium, mannitol and sodium sulfite, first put the mannitol in a sterile container, add 80% water for injection to dissolve it, and add sodium sulfite after the water for injection is cooled to 20°C, dissolve and Stir evenly, then add pemetrexed disodium, stir to make it all dissolve and mix evenly, adjust the pH to 7.5 with 1mol / L hydrochloric acid and 1mol / L sodium hydroxide solution, then add 0.1% activated carbon for needles in the total mass of the solution , stirred and adsorbed for 30 minutes, decarbonized by suction filtration, and after the intermediate inspection was qualified, add water for injection cooled to 20°C to make up to full volume. The solution is filtered through two 0.22μm microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on f...

Embodiment 2

[0022] prescription

[0023]

[0024]

[0025] Weigh the prescribed amount of pemetrexed disodium, mannitol and sodium sulfite, first put the mannitol in a sterile container, add 80% water for injection to dissolve it, and add sodium sulfite after the water for injection is cooled to 15°C, dissolve and Stir evenly, then add pemetrexed disodium, stir to make it all dissolve and mix evenly, adjust the pH to 8.0 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, and then add 0.1% activated carbon for needles in the total mass of the solution , stirred and adsorbed for 30 minutes, decarbonized by suction filtration, and after the intermediate inspection passed, add water for injection cooled to 15°C to make up to full volume. The solution is filtered through two 0.22μm microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and tur...

Embodiment 3

[0027] prescription

[0028]

[0029] Weigh the prescribed amount of pemetrexed disodium, mannitol and sodium sulfite, first put the mannitol in a sterile container, add 80% water for injection to dissolve it, and add sodium sulfite after the water for injection is cooled to 25°C, dissolve and Stir evenly, then add pemetrexed disodium, stir to make it all dissolve and mix evenly, adjust the pH to 7.0 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, and then add 0.1% activated carbon for needles in the total mass of the solution , stirred and adsorbed for 30 minutes, decarburized by suction filtration, and after the intermediate inspection passed, add water for injection cooled to 25°C to make up to full volume. The solution is filtered through two 0.22μm microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on for r...

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PUM

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Abstract

The invention relates to a pemetrexed disodium lyophilized powder injection, which consists of pemetrexed disodium, mannitol and sodium sulfite in the following weight portions: 50 portions of the pemetrexed disodium, 10 to 50 portions of mannitol, and 0.1 to 1 portions of sodium sulfite; and the pH value of the pemetrexed disodium lyophilized powder injection is between 7.0 and 8.0. The process for preparing the pemetrexed disodium lyophilized powder injection comprises the following steps: placing the mannitol in a sterile chamber; adding 80 percent of water for injection into the sterile chamber to dissolve the mannitol; adding the sodium sulfite to the mixture after the water for injection is cooled to a temperature of between 15 and 25 DEG C, and evenly stirring the solution for dissolving the sodium sulfite; then, adding the pemetrexed disodium into the solution, and stirring the solution to completely dissolve the pemetrexed disodium and evenly mixing the pemetrexed disodium, and adjusting the pH value of the solution to between 7.0 and 8.0; decarbidizing; after an intermediate compound passes examination, carrying out volume fixing, filtering, filling, partially stopping, traying, lyophilizing, nitrogen aerating, stopping and unboxing, sealing by a plastic-aluminum combined cap, and packaging after passes quality inspection to obtain the pemetrexed disodium lyophilized powder injection. The invention has the advantages of simple preparation process, convenience and practicality, good repeatability and low production cost, and can realize industrial large-scale production easily.

Description

technical field [0001] The invention relates to a pemetrexed disodium freeze-dried powder injection and a preparation method thereof, which can be used in combination with cisplatin to treat patients with malignant pleural mesothelioma who cannot be surgically removed or are not prepared for surgery. Background technique [0002] Pemetrexed disodium is a new generation of multi-target anti-folate antimetabolite, which has confirmed clinical effects in some human solid malignancies. [0003] Pemetrexed disodium is convenient and easy to administer, and it is safe when used alone and in combination with other drugs. Supplement with folic acid and B vitamins 12 May reduce side effects associated with pemetrexed. [0004] Especially for non-small cell lung cancer, this product is expected to replace the current standard placebo second-line treatment drug docetaxel (Taxotere from Aventis) due to its safety. In the supporting phase III clinical trial, the two products showed sim...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K9/19A61P35/00
Inventor 赵俊戴建国叶东李晓昕戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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