Stability of mycophenolate mofetil as an extemporaneous suspension.
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 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.


RESULTS
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.


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 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.
Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, PA 15261, USA.
R
R
Venkataramanan
J R
JR
McCombs
S
S
Zuckerman
B
B
McGhee
J
J
Pisupati
J E
JE
Dice
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006801:Humans; D007166:Immunosuppressive Agents / Q000737:chemistry*; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000737:chemistry; D013535:Suspensions / Q000032:analysis / Q000737:chemistry; D013696:Temperature; D013997:Time Factors
D007166:Immunosuppressive Agents; D013535:Suspensions; D009173:Mycophenolic Acid