| | Paclitaxel Injection quality control, 21CEC |
 | | Paclitaxel is a white to off-white crystalline powder and is highly lipophilic, insoluble in water, and melts at around 216-217°C. Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. |
 | | In five patients administered a 225 or 250 mg/m2 dose of radio-labeled paclitaxel as a 3 hour infusion, a mean of 71% of the radioactivity was excreted in the feces in 120 hours, and 14% was recovered in the urine. |
 | | Paclitaxel remained active in patients who had developed resistance to platinum-containing therapy (defined as tumor progression while on, or tumor relapse within 6 months from completion of, platinum containing regimen) with response rate of 14% in the Phase 3 study and 31% in the Phase 1 and 2 clinical studies. |
| www.21cecpharm.com /px/pxinj.htm (1845 words) |