Physical and Chemical Stability of Pemetrexed Solutions in Plastic Syringes

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 °C and over 31 days of storage at 4 °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.