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.

1 . A pharmaceutical composition, comprising
 (a) a  botulinum  toxin;   (b) NAT;   (c) zinc;   (d) caprylate   (e) rHSA, and   (f) polysorbate 80.   
   
   
       2 . The pharmaceutical composition of  claim 1 , wherein the  botulinum  toxin is present as a  botulinum  toxin complex. 
   
   
       3 . The pharmaceutical composition of  claim 11 , wherein the  botulinum  toxin is present as a pure  botulinum  toxin. 
   
   
       4 . The pharmaceutical composition of  claim 11 , wherein the  botulinum  toxin is selected from a group consisting of a  botulinum  toxin serotype A, B, C 1 , E, F and G. 
   
   
       5 . The pharmaceutical composition of  claim 1 , wherein the  botulinum  toxin is  botulinum  toxin type A. 
   
   
       6 . The pharmaceutical composition of  claim 1 , wherein the zinc is zinc chloride. 
   
   
       7 . The pharmaceutical composition of  claim 1 , wherein the caprylate is a sodium caprylate. 
   
   
       8 . The pharmaceutical composition of  claim 11 , further comprising sodium chloride. 
   
   
       9 . The pharmaceutical composition of  claim 8 , wherein for each 100 units of the  botulinum  toxin there is present in the pharmaceutical composition about 10 micrograms of NAT, about 4 micrograms of zinc, about 13 micrograms of caprylate, about 500 micrograms of rHSA, about 0.04 micrograms of P80 and about 900 micrograms of sodium chloride. 
   
   
       10 . A pharmaceutical composition, comprising
 (a) a  botulinum  toxin,   (b) N-acetyl-tryptophan (NAT);   (c) zinc;   (d) caprylate   (e) recombinant human serum albumin (rHSA), and   (f) polysorbate 80 (P80), wherein the pharmaceutical composition exhibits both an enhanced antimicrobial activity and an enhanced potency and the  botulinum  toxin is  botulinum  toxin type A.   
   
   
       11 . A pharmaceutical composition, comprising
 (a) a  botulinum  toxin;   (b) a tryptophan, and;   (c) a recombinant albumin (rA), wherein the pharmaceutical composition exhibits an enhanced potency.   
   
   
       12 . The pharmaceutical composition of  claim 11 , wherein the  botulinum  toxin is present as a  botulinum  toxin complex. 
   
   
       13 . The pharmaceutical composition of  claim 11 , wherein the  botulinum  toxin is present as a pure  botulinum  toxin. 
   
   
       14 . The pharmaceutical composition of  claim 11 , wherein the  botulinum  toxin is selected from a group consisting of a  botulinum  toxin serotype A, B, C 1 , E, F and G. 
   
   
       15 . The pharmaceutical composition of  claim 11 , wherein the  botulinum  toxin is  botulinum  toxin type A. 
   
   
       16 . The pharmaceutical composition of  claim 11 , further comprising zinc. 
   
   
       17 . A pharmaceutical composition, comprising
 (a) a  botulinum  toxin;   (b) caprylate;   (c) recombinant human serum albumin (rHSA), and;   (d) polysorbate 80 (P80), wherein the  botulinum  toxin present in the pharmaceutical composition is stabilized.   
   
   
       18 . The pharmaceutical composition of  claim 17 , further comprising sodium chloride. 
   
   
       19 . The pharmaceutical composition of  claim 17 , wherein the  botulinum  toxin is  botulinum  toxin type A. 
   
   
       20 . The pharmaceutical composition of  claim 17 , wherein for each 100 units of the  botulinum  toxin there is present in the pharmaceutical composition, about 13 micrograms of caprylate, about 500 micrograms of is rHSA, about 0.04 micrograms of P80 and about 900 micrograms of sodium chloride.