Yanping Zhang1, Lawrence A Trissel. 1. Pharmacy Laboratory, The University of Texas, MD Anderson Cancer Center, Houston, 77030, USA.
Abstract
BACKGROUND: Pemetrexed is a multitargeted antifolate antineoplastic agent that is indicated for single-agent use in advanced or metastatic non-small-cell lung cancer and in combination with cisplatin for the treatment of malignant pleural mesothelioma not treatable by surgery. Currently, there is no information on the long-term stability of pemetrexed solutions beyond 24 hours. OBJECTIVE: To evaluate the stability of pemetrexed reconstituted with NaCl 0.9% injection to a concentration of 25 mg/mL and packaged in polypropylene syringes. METHODS: Triplicate samples of reconstituted pemetrexed 25 mg/mL were packaged in 20-mL polypropylene syringes and evaluated for physical and chemical stability performed initially and over 2 days of storage at 23 degrees C and over 31 days of storage at 4 degrees C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual observation. Chemical stability was evaluated by HPLC. RESULTS: The reconstituted pemetrexed solutions remained physically and chemically stable throughout the respective study periods, with no precipitation or color change and little or no loss of pemetrexed. CONCLUSIONS: Pemetrexed reconstituted with NaCl 0.9% to a concentration of 25 mg/mL packaged in polypropylene syringes was found to be stable for 2 days at room temperature and 31 days refrigerated.
BACKGROUND:Pemetrexed is a multitargeted antifolate antineoplastic agent that is indicated for single-agent use in advanced or metastatic non-small-cell lung cancer and in combination with cisplatin for the treatment of malignant pleural mesothelioma not treatable by surgery. Currently, there is no information on the long-term stability of pemetrexed solutions beyond 24 hours. OBJECTIVE: To evaluate the stability of pemetrexed reconstituted with NaCl 0.9% injection to a concentration of 25 mg/mL and packaged in polypropylene syringes. METHODS: Triplicate samples of reconstituted pemetrexed 25 mg/mL were packaged in 20-mL polypropylene syringes and evaluated for physical and chemical stability performed initially and over 2 days of storage at 23 degrees C and over 31 days of storage at 4 degrees C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual observation. Chemical stability was evaluated by HPLC. RESULTS: The reconstituted pemetrexed solutions remained physically and chemically stable throughout the respective study periods, with no precipitation or color change and little or no loss of pemetrexed. CONCLUSIONS:Pemetrexed reconstituted with NaCl 0.9% to a concentration of 25 mg/mL packaged in polypropylene syringes was found to be stable for 2 days at room temperature and 31 days refrigerated.
Authors: Alan L Myers; Yan-Ping Zhang; Jitesh D Kawedia; Ximin Zhou; Stacey M Sobocinski; Michael J Metcalfe; Mark A Kramer; Colin P N Dinney; Ashish M Kamat Journal: Drugs R D Date: 2017-06