SOLUTION PREPARATION FOR INJECTION CONTAINING PEMETREXED

PROBLEM TO BE SOLVED: To solve a problem of creation of an analogous substance and its increase associated with decomposition of pemetrexed in solution preparation for injection containing pemetrexed, and to provide a preparation that has high storage stability, can hold efficacy of pemetrexed for a...

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Bibliographische Detailangaben
Hauptverfasser: HIDE TOSHIAKI, IMAI YOSHIHIRO
Format: Patent
Sprache:eng ; jpn
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Zusammenfassung:PROBLEM TO BE SOLVED: To solve a problem of creation of an analogous substance and its increase associated with decomposition of pemetrexed in solution preparation for injection containing pemetrexed, and to provide a preparation that has high storage stability, can hold efficacy of pemetrexed for a long period of time, and by which administration solution is easily prepared.SOLUTION: Solution preparation for injection contains pemetrexed or pharmaceutically acceptable salt thereof (A) and additive agent (B) being gluconate and/or sodium chloride, in which the preparation contains the additive agent (B) being gluconate and/or sodium chloride at 1 to 50 pts.mass for 100 pts.mass of the pemetrexed (A), and may contain another additive agent (C) other than the additive agent at 20 pts.mass or less.SELECTED DRAWING: None 【課題】 ペメトレキセドを含有する注射用溶液製剤は、ペメトレキセドの分解に伴う類縁物質の生成及びその増加が課題となっている。すなわち、保存安定性が高く、ペメトレキセドの効能を長期に亘って保持することができ、投与溶液の調製が容易な製剤を提供することが課題となっている。【解決手段】 ペメトレキセド又は薬学的に許容されるその塩(A)、グルコン酸塩及び/又は塩化ナトリウムである添加剤(B)を含有する注射用溶液製剤であって、前記ペメトレキセド(A)100質量部に対して、グルコン酸塩及び/又は塩化ナトリウムである添加剤(B)を1〜50質量部含有し、前記添加剤以外の他の添加剤(C)を20質量部以下で含有しても良いペメトレキセドを含有する注射用溶液製剤。【選択図】なし