STABILITY OF THE ANTIPROLIFERATIVE EFFECT OF MITOMYCIN-C AFTER RECONSTITUTION

Purpose: The purpose of this study was to determine the long-term stab ility of the antiproliferative effect of mitomycin-C (MMC) following r econstitution. Methods: Identical MMC preparations were reconstituted from the crystalline form and then stored at room temperature or 4 deg rees 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 w as measured by tritiated thymidine uptake. Results: The percentage of inhibition was maintained at >85% for both the room temperature and th e 4 degrees C groups, and this inhibition persisted for the duration o f the experiment. There was no statistically significant difference in the results between the storage temperatures. Conclusions: These 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 un it-dose reconstituted aliquots for these longer periods, providing ste rility can be assured.