Stable formulations of ricin toxin a chain and of...

A - Human Necessities – 61 – K

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A61K 39/395 (2006.01) A61K 47/00 (2006.01) A61K 47/26 (2006.01) A61K 47/48 (2006.01) G01N 33/14 (2006.01)

Patent

CA 1305417

Abstract of the Disclosure 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.

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