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Stability of mycophenolate mofetil as an extemporaneous suspension
R Venkataramanan1, J R McCombs, S Zuckerman
1Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, PA 15261, USA.
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.
Insights
Hospital-prepared mycophenolate mofetil (MMF) suspensions demonstrate good physical and chemical stability. This compounded MMF formulation is clinically acceptable for pediatric and early post-operative adult patients.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Formulation Development
Background:
- Mycophenolate mofetil (MMF) is an immunosuppressant drug.
- Hospital compounding of MMF suspensions offers a flexible dosage form.
- Evaluating the stability of compounded medications is crucial for patient safety.
Purpose of the Study:
- To assess the physical and chemical stability of MMF suspensions prepared from capsules.
- To determine the shelf-life of compounded MMF suspensions under various storage conditions.
Main Methods:
- MMF suspensions were prepared and stored at temperatures ranging from 5°C to 45°C.
- High-performance liquid chromatography (HPLC) was used to quantify MMF and its primary degradation product, mycophenolic acid.
Main Results:
- MMF suspensions maintained >90% of the labeled amount for at least 11 days at 45°C, 28 days at 37°C and 25°C, and 210 days at 5°C.
- Physical stability was confirmed at 5°C throughout the 210-day study period.
Conclusions:
- Compounded MMF suspensions exhibit acceptable stability for clinical use.
- The formulation provides a viable and convenient option for pediatric patients and adults in the early post-operative phase.
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