Botulinum toxin compositions

Abstract

A high potency botulinum toxin pharmaceutical composition comprising two excipients (such as albumin and sodium chloride) in a weight to weight ratio of between about 1 and about 100.

I claim: 
     
         1 . A pharmaceutical composition comprising:
 (a) a botulinum toxin;   (b) a first excipient, wherein the first excipient is an albumin, and;   (c) a second excipient, wherein the second excipient is sodium chloride;   (d) wherein the weight to weight ratio of the first excipient to the second excipient present in the pharmaceutical composition is between 0.7 and 5.6, or between 7.4 and 55.6.   
     
     
         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 first excipient is a serum albumin. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the first excipient is recombinant albumin. 
     
     
         6 . A process for making a pharmaceutical composition, the process comprising the step of:
 (a) combining about 2.5 ng of a botulinum toxin type A complex with an albumin and sodium chloride in a weight to weight ration of the albumin to the sodium chloride in the pharmaceutical composition of between 0.7 and 5.6, or between 7.4 and 55.6, to form a mixture, and;   (b) vacuum drying the mixture, to thereby obtain a pharmaceutical composition with a potency after reconstitution of between about 70 units and about 130 units.   
     
     
         7 . The process of  claim 6 , further comprising the step, before the vacuum drying step, lyophilizing the mixture. 
     
     
         8 . The pharmaceutical composition obtainable by the process of  claim 6 .