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Compounding an extended-stability admixture of Paclitaxel for long-term infusion.
L A Trissel1, Q Xu, J F Martinez
1The University of Texas, M.D. Anderson Cancer Center, Houston, TX.
International Journal of Pharmaceutical Compounding
|September 3, 2013
Summary
Increasing ethanol concentration in paclitaxel admixtures to 25% enhances physical and chemical stability. This extemporaneous compounding method supports longer continuous infusions, improving drug delivery for cancer treatment.
Area of Science:
- Pharmaceutical Sciences
- Oncology Drug Delivery
Background:
- Conventional paclitaxel admixtures exhibit poor physical stability, leading to precipitation.
- Precipitation complicates multiday continuous infusion protocols, hindering clinical application.
Purpose of the Study:
- To describe an extemporaneous compounding method for extending paclitaxel admixture stability.
- To document the pharmaceutical acceptability of these enhanced stability admixtures.
Main Methods:
- Compounding paclitaxel admixtures at 1 mg/mL with increased ethanol concentrations (20-25%) in 5% dextrose injection.
- Evaluating chemical and physical stability at various temperatures (4°C, 22°C, 32°C) for up to 31 days.
- Utilizing a stability-indicating high-performance liquid chromatography assay.
Main Results:
- Increased ethanol concentrations (≥25%) significantly improved physical stability, reducing precipitation.
- No chemical degradation of paclitaxel was observed in any samples.
- Admixtures with approximately 25% ethanol demonstrated stability for at least 7 days, potentially up to 14 days.
Conclusions:
- An extemporaneous compounding approach increasing final ethanol concentration to ~25% enhances paclitaxel admixture stability.
- This method supports the feasibility of extended continuous infusion of paclitaxel.
- The enhanced admixtures are physically and chemically stable for clinically relevant durations.
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