procedure for the screening of stabilizers for rta and rta immunkonjugatpraeparater and stable pharmaceutical association comprehensive rta immunkonjugater

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 106 to about 2 x 106 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.