Lyophilized composition containing S(+)-4,4'-(1-methyl-1,2-ethanediyl)-bis(2,6-piperazinedione)

摘要

A process of making a stable lyophilized, white to off-white, crack-free preparation of ICRF-187 in which the cake of ICRF-187 is protected against the deleterious effect of light, has a moisture content of not more than about 2% wherein the process comprises lyophilization using a starting solution of a therapeutically acceptable acid salt of ICRF-187 having a concentration of up to about 25 mg/ml and in which the primary drying stage lasts at least 30 hours, preferably at least 40 hours, and/or uses a primary drying temperature of from about 30 DEG C. to about 40 DEG C.