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Paclitaxel stability and compatibility in polyolefin containers
A Chin1, R R Ramakrishnan, N N Yoshimura
1School of Pharmacy, University of Southern California (USC).
The Annals of Pharmacotherapy
|January 1, 1994
Summary
Paclitaxel is stable and compatible in polyolefin containers for up to 48 hours when diluted in dextrose 5% for injection (D5W) or sodium chloride 0.9% for injection (NS). This finding supports the safe use of these common intravenous solutions with paclitaxel in flexible packaging.
Area of Science:
- Pharmaceutical Science
- Drug Delivery Systems
- Materials Science
Background:
- Paclitaxel is a crucial chemotherapeutic agent.
- The use of polyolefin containers for drug storage is increasing.
- Ensuring drug stability and compatibility in novel packaging is essential.
Purpose of the Study:
- To evaluate the stability and compatibility of paclitaxel in polyolefin containers.
- To assess paclitaxel admixtures in dextrose 5% for injection (D5W) and sodium chloride 0.9% for injection (NS).
Main Methods:
- A stability-indicating HPLC method was used to determine paclitaxel concentrations.
- Solutions at 0.3 and 1.2 mg/mL in D5W or NS were prepared in polyolefin containers.
- Stability and compatibility were monitored for 48 hours at ambient temperature, assessing drug concentration, pH, and visual clarity.
Main Results:
- Paclitaxel concentrations remained between 96-99% of initial levels over 48 hours.
- No significant changes in color or visual clarity were observed.
- Minor pH variations were noted in the admixtures.
Conclusions:
- Paclitaxel at 0.3 and 1.2 mg/mL in D5W or NS is stable and compatible with flexible polyolefin containers for up to 48 hours.
- Polyolefin containers are suitable for short-term storage of paclitaxel admixtures.