Clostridial toxin pharmaceutical compositions

Abstract

A botulinum toxin pharmaceutical formulation free of animal derived proteins, comprising a botulinum toxin and a recombinant albumin, suitable for therapeutic administration to a human patient, and methods for treating patients with various diseases and afflictions with the formulation.

I claim:  
     
         1 . A pharmaceutical composition, comprising: 
 (a) a botulinum toxin, and;    (b) a recombinant stabilizer.    
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the botulinum toxin is present as a botulinum toxin complex.  
     
     
         3 . The pharmaceutical composition of  claim 1  wherein the botulinum toxin is present as a pure botulinum toxin.  
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the recombinant stabilizer is selected from the group consisting of a recombinant albumin, a recombinant collagen and a recombinant gelatin  
     
     
         5 . The pharmaceutical composition of  claim 1 , further comprising a secondary stabilizer.  
     
     
         6 . The pharmaceutical composition of  claim 5  wherein the secondary stabilizer comprises a metal.  
     
     
         7 . The pharmaceutical composition of  claim 6  wherein the metal is zinc.  
     
     
         8 . The pharmaceutical composition of  claim 5  wherein the secondary stabilizer is NAT.  
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition has an enhanced potency or stability.  
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition has an enhanced anti-microbial activity.  
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein the recombinant stabilizer is a recombinant albumin.  
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the botulinum toxin is selected from the group consisting of botulinum toxins types A, B, C, D, E, and F.  
     
     
         13 . A pharmaceutical composition, comprising: 
 (a) a botulinum toxin type A, and;    (b) a recombinant albumin.    
     
     
         14 . A pharmaceutical composition, comprising 
 (a) a botulinum toxin;    (b) a non-oxidizing amino acid derivative, and;    (c) zinc.    
     
     
         15 . A pharmaceutical composition, comprising 
 (a) a botulinum toxin    (b) a primary stabilizer, and;    (c) and a secondary stabilizer, wherein the secondary stabilizer is a metal.    
     
     
         16 . the pharmaceutical composition of  claim 13  wherein the pharmaceutical composition has an enhanced antimicrobial activity  
     
     
         17 . A pharmaceutical composition, comprising: 
 (a) a botulinum toxin, and;    (b) rHSA, wherein pharmaceutical composition exhibits an enhanced antimicrobial activity.    
     
     
         18 . A pharmaceutical composition, comprising: 
 (a) a botulinum toxin, and;    (b) rHSA, wherein the pharmaceutical composition exhibits an enhanced potency.    
     
     
         19 . A pharmaceutical composition, comprising 
 (a) a botulinum toxin;    (b) NAT;    (c) zinc;    (d) caprylate    (e) rHSA, and    (f) P80, wherein the pharmaceutical composition exhibits both an enhanced antimicrobial activity and an enhanced potency.