| Physical instability of frozen pemetrexed solutions in PVC bags. | |
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MedLine Citation:
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PMID: 16822897 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Pemetrexed is a multitargeted antifolate antineoplastic agent 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 stability of frozen pemetrexed solutions. OBJECTIVE: To evaluate the stability of pemetrexed admixtures in common infusion solutions frozen at -20 degrees C to determine the drug stability period up to 90 days. METHODS: Triplicate samples of pemetrexed were prepared in concentrations of 2, 10, and 20 mg/mL in dextrose 5% and NaCl 0.9% injection in polyvinyl chloride (PVC) bags. Evaluations for physical and chemical stability were performed initially and over 90 days of frozen storage. 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 throughout the 90 day study period, with little or no loss of pemetrexed. However, the pemetrexed admixtures in PVC bags developed large numbers of microparticulates during long-term frozen storage. CONCLUSIONS: Although pemetrexed is chemically stable for 90 days frozen at -20 degrees C, substantial numbers of microparticulates formed in pemetrexed diluted in the infusion solutions in PVC bags upon long-term frozen storage. The avoidance of freezing pemetrexed solutions in PVC bags is therefore warranted. |
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Authors:
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Yanping Zhang; Lawrence A Trissel |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2006-07-05 |
Journal Detail:
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Title: The Annals of pharmacotherapy Volume: 40 ISSN: 1060-0280 ISO Abbreviation: Ann Pharmacother Publication Date: 2006 Jul-Aug |
Date Detail:
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Created Date: 2006-08-02 Completed Date: 2007-02-21 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9203131 Medline TA: Ann Pharmacother Country: United States |
Other Details:
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Languages: eng Pagination: 1289-92 Citation Subset: IM |
Affiliation:
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Pharmacy Laboratory, The University of Texas MD Anderson Cancer Center, Houston, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Antineoplastic Agents
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chemistry Drug Stability Freezing Glucose / chemistry Glutamates / chemistry* Guanine / analogs & derivatives*, chemistry Nephelometry and Turbidimetry Particle Size Polyvinyl Chloride Sodium Chloride / chemistry |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Glutamates; 137281-23-3/pemetrexed; 50-99-7/Glucose; 73-40-5/Guanine; 7647-14-5/Sodium Chloride; 9002-86-2/Polyvinyl Chloride |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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