PREPARATION CONCENTRATED SOLUTION AND LYOPHILIZED OF PTX FOR INTRAVENOUS DOSAGE FORMS.

Abstract

               The aim of this research was to enhance aqueous solubility of PTX (PTX) and develop PTX formulations for intravenous (IV) infusion. Two PTX dosage form for IV infusion, concentrated solution and lyophilized powder, were formulated by 2 different methods: using solubilized agents (Kolliphor ELP®) and complexation (using 2-hydroxyl propyl β cyclodextrin - HPβCD), respectively. PTX plasma concentration and tissues distribution (rabbits were used as test animals) of the concentrated solution were similar to those of Stragen® (reference sample); while PTX plasma concentration of the lyophilized powder was lower than Stragen®’s, the former’s tissues distribution were higher than those of the latter. Short-term stability tests under normal and stress conditions showed that the two dosage forms meet expected standards.