STABLE READY-TO-USE PHARMACEUTICAL COMPOSITION OF PEMETREXED

摘要

A stable ready-to-use pharmaceutical composition comprising pemetrexed or pharmaceutically acceptable salts thereof, wherein the composition is free from antioxidants, amino acids and chelating agents. Also provided is a process for preparing a stable ready-to-use pharmaceutical composition comprising the steps: i) purging inert gas into a parenterally acceptable aqueous solvent until the dissolved oxygen content of the solvent comes to less than 7 mg/L, preferably less than 3 mg/L; ii) adding pemetrexed disodium under stirring; iii) adjusting the pH of the resulting solution to between 4 to 9; iv) optionally adding additional aqueous solvent; wherein the composition is purged with inert gas throughout the entire process.

主权项

1. A stable ready-to-use pharmaceutical composition comprising pemetrexed or a pharmaceutically acceptable salt thereof, wherein the composition is free from antioxidants, amino acids and chelating agents.