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ONCOLOGY

Physical and Chemical Stability of Pemetrexed Solutions in Plastic Syringes

¹ Research Investigator, Pharmacy Laboratory, The University of Texas, MD Anderson Cancer Center, Houston, TX
² Director, Clinical Pharmaceutics Research, Division of Pharmacy, The University of Texas, MD Anderson Cancer Center

Reprints: Mr. Trissel, Division of Pharmacy, Unit 090, The University of Texas, MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030-4095, fax 713/563-2958

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.

Key Words: Alimta, pemetrexed, stability, syringe

Published Online, October 14, 2005. www.theannals.com, DOI 10.1345/aph.1G161

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