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Stability of cyclosporine in an extemporaneously compounded paste
L T Ghnassia1, D F Yau, K I Kaye
1University of Pharmacy, Paris, France.
Summary
Extemporaneously compounded cyclosporine paste demonstrated excellent stability, retaining over 90% of its initial concentration for 31 days. This finding supports the long-term viability of this compounded medication for patient use.
Area of Science:
- Pharmaceutical Sciences
- Compounding Pharmacy
- Drug Stability
Background:
- Cyclosporine is a vital immunosuppressant medication.
- Assessing the stability of extemporaneously compounded formulations is crucial for ensuring therapeutic efficacy and patient safety.
- Adhesive gels offer potential for topical drug delivery, but their compatibility with active pharmaceutical ingredients like cyclosporine requires investigation.
Purpose of the Study:
- To evaluate the stability of cyclosporine in an extemporaneously compounded paste.
- To determine the shelf-life of cyclosporine paste stored under various temperature conditions.
- To compare analytical methods for quantifying cyclosporine concentration in the compounded formulation.
Main Methods:
- Cyclosporine oral solution (100 mg/mL) was compounded into a paste with an adhesive gel at a concentration of 9.6 mg/g.
- Six aluminum-lined ointment tubes containing the paste were stored at 37°C, 21°C, and 2°C (two tubes per condition).
- Cyclosporine concentration was quantified using high-performance liquid chromatography and fluorescence polarization immunoassay over a 31-day period.
Main Results:
- The compounded cyclosporine paste maintained >90% of its initial concentration throughout the 31-day study period across all tested storage temperatures.
- Both high-performance liquid chromatography and fluorescence polarization immunoassay consistently indicated high cyclosporine recovery rates.
- No significant degradation of cyclosporine was observed in the paste formulation under refrigerated, room temperature, or accelerated (37°C) conditions.
Conclusions:
- Extemporaneously compounded cyclosporine paste at 9.6 mg/g is stable for at least 31 days when stored in aluminum-lined ointment tubes.
- The formulation is suitable for storage at various temperatures, including 37°C, 21°C, and 2°C.
- This study validates the stability of cyclosporine in this specific compounded topical preparation, supporting its clinical use.