Animal Protein-Free Pharmaceutical Compositions

Abstract

Animal protein-free, solid-form Clostridial toxin pharmaceutical compositions comprising a Clostridial toxin active ingredient and at least two excipients.

1 . An animal-protein free, solid-form Clostridial toxin pharmaceutical composition comprising a Clostridial toxin active ingredient, an effective amount of lactose, an effective amount of sucrose, and an effective amount of sodium chloride; and
 wherein after storage for one year the pharmaceutical composition exhibits a recovered potency of the Clostridial toxin active ingredient of at least 20% when reconstituted into a form suitable for injection.   
     
     
         2 . The composition according to  claim 1 , wherein the storage temperature is below freezing. 
     
     
         3 . The composition according to  claim 1 , wherein the storage temperature is at ambient temperatures. 
     
     
         4 . The composition according to  claim 1 , wherein the storage temperature is below freezing and the recovered potency is at least 40%. 
     
     
         5 . The composition according to  claim 1 , wherein the storage temperature is at ambient temperatures and the recovered potency is at least 40%.