PREPARATION OF PACLITAXEL INTRAVENOUS DRUG AT CONCENTRATED SOLUTION AND LYOPHILIZED POWDER DOSAGE FORMS

Abstract

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.