LYOPHILIZED PREPARATION CONTAINING 1,1',1''-PHOSPHINOTHIOYLIDINTRISAZIRIDINE AND PROCESS FOR PREPARING THEREOF

摘要

Disclosed is a lyophilised preparation containing 1,1',1''-phosphinothioylidintrisaziridine (thiotepa) for parenteral administration prepared by the process which comprises: (a) preparing an aqueous solution of 1,1',1''-phosphinothioylidintrisaziridine (thiotepa); (b) adding a sufficient amount of a pharmaceutically acceptable base to render the pH of the resulting solution to a level of 7 - 9; and then (c) freeze drying the aqueous solution. In a process for preparing said thiotepa composition is added with an acceptable amount of a pharmaceutically acceptable base prior to freeze drying the composition to facilitate the intimate contact of the base with thiotepa crystals.