Physical and Chemical Stability of Pemetrexed in Infusion Solutions
| Autor: | Yanping Zhang, Lawrence A. Trissel |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Guanine
Light Drug Compounding Drug Storage medicine.medical_treatment Antineoplastic Agents Pemetrexed 030204 cardiovascular system & hematology Pharmacology 030226 pharmacology & pharmacy 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Drug Stability Glutamates Fluorescent light Freezing medicine Pharmacology (medical) Infusions Intravenous Polyvinyl Chloride Lung cancer Chromatography High Pressure Liquid Drug Packaging Cisplatin Chemotherapy Chemistry Temperature Reproducibility of Results medicine.disease Pharmaceutical Solutions Anesthesia Antifolate Chemical stability Physical stability Drug Contamination medicine.drug |
| Zdroj: | Annals of Pharmacotherapy. 40:1082-1085 |
| ISSN: | 1542-6270 1060-0280 |
| DOI: | 10.1345/aph.1g715 |
| Popis: | Background: Pemetrexed is a multitargeted, antifolate, antineoplastic agent that is indicated for single-agent use in locally advanced or metastatic non-small-cell lung cancer after prior chemotherapy 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 beyond 24 hours. Objective: To evaluate the longer-term physical and chemical stability of pemetrexed 2, 10, and 20 mg/mL in polyvinyl chloride (PVC) bags of dextrose 5% injection and NaCI 0.9% injection. Methods: Triplicate samples of pemetrexed were prepared in the concentrations and infusion solutions required. Evaluations for physical and chemical stability were performed initially and over 2 days at 23 °C protected from light and exposed to fluorescent light, and over 31 days of storage at 4 °C protected from light. Physical stability was assessed using turbidimetric and particulate measurement as well as visual observation. Chemical stability was evaluated by HPLC. Results: All pemetrexed solutions remained chemically stable, with little or no loss of pemetrexed over 2 days at 23 °C, protected from light and exposed to fluorescent light, and over 31 days of storage at 4°C, protected from light. The room temperature samples were physically stable throughout the 48 hour test period. However, pemetrexed admixtures developed large numbers of microparticulates during refrigerated storage exceeding 24 hours. Conclusions: Pemetrexed is chemically stable for 2 days at room temperature and 31 days refrigerated in dextrose 5% injection and NaCI 0.9% injection. However, substantial numbers of microparticulates may form in pemetrexed diluted in the infusion solutions in PVC bags, especially during longer periods of refrigerated storage. Limiting the refrigerated storage period to the manufacturer-recommended 24 hours will limit particulate formation. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|