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Medicinal composition containing pemetrexed

A technology for pemetrexed and a composition is applied in the field of liquid preparations containing pemetrexed and an antioxidant to achieve the effects of avoiding degradation, high stability and maintaining expected concentration

Inactive Publication Date: 2007-12-05
海南天源康泽医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, we found in our research that the three antioxidants disclosed in Eli Lilly's CN1396828A patent do not have the best protective effect on pemetrexed

Method used

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  • Medicinal composition containing pemetrexed

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The liquid preparation comprises pemetrexed, an antioxidant and pharmaceutically acceptable excipients, wherein the antioxidant is L-arginine. Pemetrexed is selected from pemetrexed disodium.

[0044] Dissolve 10 mg of L-arginine in 8 ml of water for injection, adjust the pH to 8.0 with hydrochloric acid, then add 400 mg of pemetrexed disodium (calculated as pemetrexed) to dissolve, then add water for injection to 10 ml.

[0045] Protect the product solution from light. Nitrogen was bubbled through the solution for 20 minutes, followed by sterile filtration. The formulations were dispensed into pre-washed depyrogenated bottles, which were subsequently stoppered with pre-washed, pre-sterilized Teflon-coated stoppers. The cover is installed with a crimping machine. Sterile filtration and aliquot steps were performed using nitrogen barrier gas (5% V / V oxygen).

[0046] The solution filled in the bottle is heat sterilized.

Embodiment 2

[0047] Example 2. As described in Example 1, the difference is that the antioxidant is 0.02 mg / ml L-arginine.

Embodiment 3

[0048] Example 3. As described in Example 1 except that the antioxidant is 5 mg / ml L-arginine.

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Abstract

The present invention provides one kind of medicine composition, which contains Pemetrexed, at least one kind of antioxidant selected from L-arginine, L-glutathione, L-methionine and L-tryptophan, and pharmaceutically acceptable excipient. The medicine composition has high stability and acceptable storing period, and is suitable for liquid administration through no gastrointestinal tract.

Description

technical field [0001] The present invention relates to a kind of pharmaceutical composition containing compound pemetrexed (PEMETREXED), specifically, the present invention relates to a kind of liquid preparation containing pemetrexed and antioxidant. Background technique [0002] Pemetrexed is a folic acid antimetabolite antineoplastic agent that inhibits enzymatic conversions involving metabolic derivatives of folic acid. It was first developed by Eli Lilly and marketed as a freeze-dried powder injection for the treatment of mesothelioma and non-small cell lung cancer. [0003] It is highly desirable to formulate it into a concentrated liquid and administer it as an infusion dosage form, so as to reduce possible infections during the dilution process of the lyophilized powder injection. A ready-to-use, stable, easily reconstituted solution that can be stored at room temperature is particularly desirable for pemetrexed, wherein the ready-to-use formulation provides easier...

Claims

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Application Information

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IPC IPC(8): A61K47/16A61K31/519A61K9/08A61P35/00
Inventor 于艳玲杨清敏刘洪艳张明会王晶翼
Owner 海南天源康泽医药科技有限公司
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