Stability of Mycophenolate Mofetil as an Extemporaneous Suspension

Autor: Venkataramanan, Raman, McCombs, Jacqueline R, Zuckerman, Sheila, McGhee, Bill, Pisupati, Jaya, Dice, James E
Zdroj: The Annals of Pharmacotherapy; July 1998, Vol. 32 Issue: 7-8 p755-757, 3p
Abstrakt: OBJECTIVE: To evaluate the physical and chemical stability of a suspension of mycophenolate mofetil (MMF) prepared in the hospital from commercially available MMF capsules.METHODS: Suspensions of MMF were prepared at room temperature and stored at 5, 25, 37, and 45 °C over 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 determined by the presence of ≥90% of the labeled amount) at 45 °C for at least 11 days, at 37 °C for at least 28 days, at 25 °C for at least 28 days, and at 5 °C for at least 210 days. The suspension was also physically stable at 5 °C during the entire test period.CONCLUSIONS: The compounded MMF suspension was stable for at least 11 days at all the temperatures studied and for as long as 210 days at 5 °C. This formulation appears to be clinically acceptable and provides a convenient dosage form for pediatric patients and for adults during the early postoperative period.
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