| Stability of extemporaneously prepared cytarabine, methotrexate sodium, and methylprednisolone sodium succinate. | |
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MedLine Citation:
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PMID: 22261946 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Purpose The short-term stability of extemporaneously prepared triple intrathecal therapy, containing cytarabine, methotrexate sodium, and methylprednisolone sodium succinate, was evaluated. Methods Three batches of triple intrathecal solution were prepared using commercially available products and stored in three different packaging materials (plastic syringe system, brown glass vials, and brown glass vials filled with metal needles). The solutions were protected from light and stored at 5 °C, 25 °C, and 40 °C or exposed to ultraviolet and visible light at 25 °C, compliant with the International Conference on Harmonisation. Samples were taken immediately before and after 4, 8, 24, 32, and 48 hours of storage. Simultaneous high-performance liquid chromatography- ultraviolet light/diode array detector assay of cytarabine, methotrexate sodium, and methylprednisolone sodium succinate was performed using a fused-core stationary phase and an acetonitrile-based gradient. First-order kinetic degradation values were calculated, and temperature dependence was evaluated using the Arrhenius equation. Results Cytarabine was stable under all storage conditions. Methotrexate sodium displayed significant degradation after light exposure but remained stable under the other storage conditions. Methylprednisolone sodium succinate was found to be the most labile component in the triple intrathecal solution. Temperature-dependent degradation was observed, resulting in 46% degradation after 48 hours at 40 °C. Two degradants were formed: methylprednisolone and methylprednisolone hydrogen succinate. Packaging material and batch-to-batch variability did not significantly influence the stability of the triple intrathecal solution. Conclusion Triple intrathecal solution of cytarabine, methotrexate sodium, and methylprednisolone sodium succinate was stable for up to 12 hours when stored at 5 °C and protected from light. |
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Authors:
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Matthias D'Hondt; Elien Vangheluwe; Sylvia Van Dorpe; Jente Boonen; Tiene Bauters; Brigitte Pelfrene; Johan Vandenbroucke; Hugo Robays; Bart De Spiegeleer |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists Volume: 69 ISSN: 1535-2900 ISO Abbreviation: Am J Health Syst Pharm Publication Date: 2012 Feb |
Date Detail:
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Created Date: 2012-01-20 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9503023 Medline TA: Am J Health Syst Pharm Country: United States |
Other Details:
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Languages: eng Pagination: 232-40 Citation Subset: IM |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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