Stable formulations of ricin toxin A chain and of RTA-immunoconjugates and stabilizer screening methods therefor.

摘要

Highly stable pharmaceutical compositions suitable for parenteral administration to animals or humans comprising a therapeutically effective amount of an RTA-immunoconjugate dissolved in an inert carrier method comprising a stabilizer are claimed. Screening methods for selecting stabilizers effective in preventing precipitation and aggregation of such compositions are described. Preferred stabilizers include glycerol at a concentration (v/v) of from about 25 to about 35%; dextran sulfates having molecular weights from about 0.1 x 10<6> to about 2 x 10<6> daltons; and human serum albumin. The invention further comprises such compositions which have been lyophilized and/or reconstituted wherein the stabilizer is non-volatile, and may further comprise a carbohydrate stabilizer. The invention further comprises stabilized RTA compositions.