Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1222764 | Journal of Pharmaceutical and Biomedical Analysis | 2008 | 5 Pages |
Abstract
Paclitaxel eluting coronary stents were sterilized by e-beam in a closed system, to investigate sterilization related mass-balance issues and evaluate potential volatile paclitaxel degradation products. A solid-phase microextraction (SPME) method utilizing a polydimethyl-siloxane/divinyl-benzene (PDMS/DVB) fiber was optimized for extracting the volatiles from the head-space of the sterilized stents. GC-MS was used for separation, identification, and quantitation of the components. Benzaldehyde and benzoic acid were identified as paclitaxel related volatile degradation products. Three groups of stents were included in the study, a control group (not exposed to e-beam), a group sterilized at 25Â kGy, and a final group sterilized at 75Â kGy. The stents sterilized by e-beam at 75Â kGy contained significantly higher levels of benzoic acid relative to the controls and the stents at 25Â kGy contained intermediate levels of benzoic acid. The benzaldehyde levels increased in the 25Â kGy e-beam sterilized stents relative to the control but remained fairly constant in the 75Â kGy e-beam sterilized stents relative to the 25Â kGy e-beam results. Mechanism for the formation of benzoic acid and benzaldehyde from paclitaxel was proposed. The levels of benzoic acid and benzaldehyde observed on the stents did not resolve the original mass-balance issue, but most likely contribute to the lack of mass balance observed for paclitaxel.
Keywords
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
György Vas, Lori Alquier, Cynthia A. Maryanoff, Judith Cohen, Gail Reed,