Abstract:
The aim of this research is to enhance solubility of Paclitaxel (PTX) and develop PTX formulations for intravenous (IV) infusion. The two PTX dosage
forms for IV infusion, concentrated solution and lyophilized powder, have been formulated by 2 different methods: using solubilized agent (Kolliphor ELP®) and complexation (using 2-hydroxyl propyl β cyclodextrin - HPβCD) respectively. PTX plasma concentration and tissue distribution (rabbits have been used as test animals) of the concentrated solution have been similar to those of Stragen® (reference drug), while PTX plasma concentration of the lyophilized powder has been lower than Stragen®’s; the former’s tissue distribution has been higher than those of the latter. Short-term stability tests under normal and stress conditions have shown that the two dosage forms meet expected standards.
Keywords:
Kolliphor ELP, lyophilization, Paclitaxel, 2-hydroxyl propyl β cyclodextrin.