Venkataramanan R, McCombs J R, Zuckerman S, McGhee B, Pisupati J, Dice J E
Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, PA 15261, USA.
Ann Pharmacother. 1998 Jul-Aug;32(7-8):755-7. doi: 10.1345/aph.17213.
To evaluate the physical and chemical stability of a suspension of mycophenolate mofetil (MMF) prepared in the hospital from commercially available MMF capsules.
Suspensions of MMF were prepared at room temperature and stored at 5, 25, 37, and 45 degrees 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.
MMF suspensions were stable (as determined by the presence of > or = 90% of the labeled amount) 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 degrees C during the entire test period.
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 degrees 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.
评估医院使用市售霉酚酸酯（MMF）胶囊配制的MMF混悬液的物理和化学稳定性。
在室温下制备MMF混悬液，并在5、25、37和45摄氏度下储存50至210天。在不同时间点通过高效液相色谱法测定混悬液中MMF及其降解产物霉酚酸的含量。
MMF混悬液在45摄氏度下至少11天、37摄氏度下至少28天、25摄氏度下至少28天以及5摄氏度下至少210天内稳定（以标示量的≥90%存在来确定）。在整个测试期间，该混悬液在5摄氏度下物理性质也稳定。
配制的MMF混悬液在所研究的所有温度下至少稳定11天，在5摄氏度下长达210天。该制剂似乎在临床上是可接受的，为儿科患者和术后早期的成人提供了一种方便的剂型。
