Chemical stability of admixtures combining ziconotide with morphine or hydromorphone during simul ated intrathecal administration

被引:33
作者
Shields, D
Montenegro, R
Ragusa, M
机构
[1] Elan Pharmaceut Inc, San Francisco, CA 94080 USA
[2] Gilead Sci Inc, Foster City, CA 94404 USA
来源
NEUROMODULATION | 2005年 / 8卷 / 04期
关键词
hydromorphone; intrathecal; morphine; stability; ziconotide;
D O I
10.1111/j.1525-1403.2005.00034.x
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Objective. To determine the stability of admixtures combining ziconotide with morphine or hydromorphone under simulated intrathecal infusions. Materials and Methods. Admixtures of ziconotide (25 mu g/mL) with morphine or hydromorphone (both at 35 mg/mL) were stored in Medtronic SynchroMed(R) II pumps at 37 degrees C, and in control vials at 37 degrees C and 5 degrees C. Drug concentrations were determined using high-performance liquid chromatography. Results. The ziconotide pump concentration with morphine declined to 79% of initial in 17 days, and to 88% of initial after 25 days with hydromorphone. Ziconotide concentrations in control vials stored at 37 degrees C displayed similar rates of decay, but vials stored at 5 degrees C exhibited no ziconotide loss. A statistical evaluation of the two combinations shows ziconotide-hydromorphone retaining 80% stability for 40 days (extrapolated), compared to 15 days for ziconotide-morphine. Morphine and hydromorphone were stable in the presence of ziconotide under all conditions. Conclusions. Ziconotide-hydromorphone admixtures were more stable than ziconotide-morphine admixtures.
引用
收藏
页码:257 / 263
页数:7
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