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Stability of amphotericin B in 5% dextrose ophthalmic solution
International Journal of Pharmaceutical Compounding
|August 30, 2013
Summary
Amphotericin B ophthalmic solution remains stable for up to 120 days when refrigerated and protected from light. Refrigerated storage ensures amphotericin B stability, while room temperature storage limits its shelf life.
Area of Science:
- Ophthalmology
- Pharmaceutical Sciences
- Drug Stability
Background:
- Amphotericin B is a critical antifungal agent for ocular infections.
- Standardized stability data for ophthalmic formulations are essential for clinical use.
- Hospital pharmacy compounding requires rigorous stability assessments.
Purpose of the Study:
- To evaluate the stability of amphotericin B 5 mg/mL in 5% dextrose ophthalmic solution.
- To determine optimal storage conditions and shelf-life for compounded ophthalmic amphotericin B.
- To assess the impact of light, temperature, and air exposure on drug integrity.
Main Methods:
- Aseptically prepared amphotericin B solutions in polyethylene dropper bottles.
- Stability testing under refrigeration (4°C) and room temperature (22°C), with and without light protection.
- Simulated use conditions involving daily opening and dispensing.
- Analysis of drug concentration (HPLC), pH, osmolality, sterility, and visual inspection for degradation.
Main Results:
- No loss or deterioration of amphotericin B was observed in refrigerated samples (unopened for 120 days, opened daily for 15 days).
- Precipitation and degradation occurred after 13 days at room temperature exposed to light and 16 days protected from light.
- pH and osmolality remained stable; all samples were sterile.
Conclusions:
- Aseptically prepared amphotericin B ophthalmic solution is stable for up to 120 days when unopened and refrigerated (4°C) protected from light.
- At room temperature (22°C), the ophthalmic solution is stable for 16 days protected from light and 13 days exposed to light.
- Refrigeration and protection from light are crucial for maximizing the shelf-life of ophthalmic amphotericin B.
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