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Tamoxifen (TAM) was biotransformed in vivo to three polar metabolites (TM-1) in rat blood, urine and bile. The major route of excretion of TM-1 was in bile followed by urine. In vitro metabolism of [6-14C]TAM was studied in rat liver microsomes (MRP2) and cytosol (CYP3A), as well as in human placental microsomes (PRMP1). Metabolism of [6-14C]TAM was also studied in a known CYP3A/MRP2 metabolizing (cancerous) liver tissue (BDE) and in a known MRP2 metabolizing (non-cancerous) liver tissue (F-344). While both tissues metabolized [6-14C]TAM to TM-1, the BDE tissue was the major site of metabolism. Further, the rate of metabolism of [6-14C]TAM in BDE was much faster than in the non-cancerous F-344 tissue. In the presence of NADPH, the BDE microsomes were also able to metabolize [6-14C]TAM to a 5-hydroxy-tamoxifen (TM-2) metabolite. The role of CYP3A and MRP2 in the formation of TM-1 and TM-2 was further explored using cyclosporin A (1 microM) and dexamethasone (1 microM) to inhibit their respective enzymes. Treatment of rats with both drugs resulted in a 90% decrease in the formation of TM-1 and TM-2 from [6-14C]TAM in bile, demonstrating the important role of both enzymes in the formation of these metabolites. The results of this study indicate that both CYP3A and MRP2 are involved in the formation of TM-1 and TM-2 from [6-14C]TAM. While CYP3A and MRP2 are both present in both BDE and F-344 cells, the relative abundance of CYP3A to MRP2 is much higher in the BDE cells than in the F-344 cells. These findings may explain the greater systemic clearance of TM-1 in the

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