STABILITY OF MYCOPHENOLATE MOFETIL AS AN EXTEMPORANEOUS SUSPENSION

OBJECTIVE: To evaluate the physical and chemical stability of a suspen sion of mycophenolate mofetil (MMF) prepared in the hospital from comm ercially available MMF capsules. METHODS: Suspensions of MMF were prep ared at room temperature and stored at 5, 25, 37, and 45 degrees C ove r a period of 50 to 210 days. The contents of MMF and its degradation product, mycophenolic acid in the suspension were measured at various time points by HPLC. RESULTS: MMF suspensions were stable (as determin ed by the presence of greater than or equal to 90% of the labeled amou nt) at 45 degrees C for at least 11 days, at 37 degrees C for at least 28 days, at 25 degrees C for at least 28 days, and at 5 degrees C for at least 210 days. The suspension was also physically stable at 5 deg rees C during the entire test period. CONCLUSIONS: The compounded MMF suspension was stable for at least 11 days at all the temperatures stu died and for as long as 210 days at 5 degrees C. This formulation appe ars to be clinically acceptable and provides a convenient dosage form for pediatric patients and for adults during the early postoperative p eriod.