Botulinum toxin pharmaceutical compositions with enhanced potency with regard to a reference botulinum toxin pharmaceutical composition

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.

1 - 19 . (canceled)  
     
     
         20 . A  botulinum  toxin pharmaceutical composition with an enhanced potency with regard to a reference  botulinum  toxin pharmaceutical composition, wherein: 
 (a) the  botulinum  toxin pharmaceutical composition comprises: 
 (i) a  botulinum  toxin, and;  
 (ii) a recombinant albumin, and;  
   (b) the reference  botulinum  toxin pharmaceutical composition comprises: 
 (i) a  botulinum  toxin, and  
 (ii) a serum albumin.  
   
     
     
         21 . The  botulinum  toxin pharmaceutical composition of  claim 20 , wherein the  botulinum  toxin present in the  botulinum  toxin pharmaceutical composition and the  botulinum  toxin present in the reference  botulinum  toxin pharmaceutical composition are the same types of  botulinum  toxin.  
     
     
         22 . The  botulinum  toxin pharmaceutical composition of  claim 20 , wherein the amount of the  botulinum  toxin present in the  botulinum  toxin pharmaceutical composition and the amount of  botulinum  toxin present in the reference  botulinum  toxin pharmaceutical composition are the same.  
     
     
         23 . The  botulinum  toxin pharmaceutical composition of  claim 20 , wherein the amount of the albumin toxin present in the  botulinum  toxin pharmaceutical composition and the amount of albumin present in the reference  botulinum  toxin pharmaceutical composition are the same.  
     
     
         24 . The  botulinum  toxin pharmaceutical composition of  claim 20 , wherein the  botulinum  toxin pharmaceutical composition and the reference  botulinum  toxin pharmaceutical composition also further contain sodium chloride.  
     
     
         25 . The  botulinum  toxin pharmaceutical composition of  claim 24 , wherein the  botulinum  toxin pharmaceutical composition and the reference  botulinum  toxin pharmaceutical composition both contain are same amount of the sodium chloride.  
     
     
         26 . The  botulinum  toxin pharmaceutical composition of  claim 20 , wherein the  botulinum  toxin pharmaceutical composition has a potency which is from at least 5% and up to 40% greater than the potency of the reference  botulinum  toxin pharmaceutical composition.  
     
     
         27 . A  botulinum  toxin pharmaceutical composition with an enhanced potency with regard to a reference  botulinum  toxin pharmaceutical composition, wherein: 
 (a) the  botulinum  toxin pharmaceutical composition comprises: 
 (i) a  botulinum  toxin,  
 (ii) a recombinant albumin, and  
 (iii) sodium chloride  
   (b) the reference  botulinum  toxin pharmaceutical composition comprises: 
 (i) a  botulinum  toxin,  
 (ii) a serum albumin, and  
 (iii) sodium chloride, and wherein;  
   (c) the  botulinum  toxin present in the  botulinum  toxin pharmaceutical composition and the  botulinum  toxin present in the reference  botulinum  toxin pharmaceutical composition are the same types of  botulinum  toxin;    (d) the amount of the  botulinum  toxin present in the  botulinum  toxin pharmaceutical composition and the amount of  botulinum  toxin present in the reference  botulinum  toxin pharmaceutical composition are the same;    (e) the amount of the albumin toxin present in the  botulinum  toxin pharmaceutical composition and the amount of albumin present in the reference  botulinum  toxin pharmaceutical composition are the same;    (f) the  botulinum  toxin pharmaceutical composition and the reference  botulinum  toxin pharmaceutical composition both contain are same amount of the sodium chloride, and;    (g) the  botulinum  toxin pharmaceutical composition has a potency which is from at least 5% and up to 40% greater than the potency of the reference  botulinum  toxin pharmaceutical composition.    
     
     
         28 . A  botulinum  toxin pharmaceutical composition with an enhanced potency with regard to a reference  botulinum  toxin pharmaceutical composition, wherein the compositions of the  botulinum  toxin pharmaceutical composition and of the reference  botulinum  toxin pharmaceutical composition are identical except that whereas the  botulinum  toxin pharmaceutical composition contains a recombinant albumin, the reference  botulinum  toxin pharmaceutical composition contains a serum albumin.