Stability of the Antiproliferative Effect of Mitomycin-C after Reconstitution


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Abstract

SummaryPurposeThe purpose of this study was to determine the long-term stability of the antiproliferative effect of mitomycin-C (MMC) following reconstitution.MethodsIdentical MMC preparations were reconstituted from the crystalline form and then stored at room temperature or 4°C. Cultured human Tenon's fibroblasts were exposed to MMC (0.5 mg/ml) for 2.5 min at 0, 3, 7, 10, 14, 21, 28, 35, and 42 days following reconstitution. After removal of the drug, fibroblast proliferation was measured by tritiated thymidine uptake.ResultsThe percentage of inhibition was maintained at >85% for both the room temperature and the 4°C groups, and this inhibition persisted for the duration of the experiment. There was no statistically significant difference in the results between the storage temperatures.ConclusionsThese data suggest that MMC retains its antiproliferative effect for at least 6 weeks following reconstitution and that this effect is not changed by storage temperature. Cost savings may be realized by storing MMC in unit-dose reconstituted aliquots for these longer periods, providing sterility can be assured.

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