Botulinum toxin neurotoxic components formulations

Abstract

The invention provides for the use of a presynaptic neurotoxin (for example a bacterial neurotoxin such as botulinum toxin A) for the manufacture of a medicament for the treatment of cerebral palsy in juvenile patients. The juvenile patients are preferably juveniles of up to 6 years in age.

1 - 16 . (canceled)  
     
     
         17 . A vacuum dried, sterile, lyophilised, powdered formulation for therapeutic use in humans comprising: 
 (a) the neurotoxic component of a  botulinum  toxin purified from a complex of non-toxic proteins and haemagglutinins, wherein the neurotoxic component has a molecular weight of about 150 kilodaltons and comprises a short polypeptide chain of about 50 kD and a larger polypeptide chain of about 100 kD;    (b) saline, and;    (c) pasteurised human serum albumin.    
     
     
         18 . A method for making a neurotoxic component  botulinum  toxin formulation comprising the steps of: 
 (a) establishing a culture of an anaerobic bacterium of  Clostridium botulinum;      (b) growing a culture of the Clostridium  botulinum  in a fermenter;    (c) harvesting a  botulinum  toxin type A mixture from the fermenter, wherein the  botulinum  toxin type A harvested comprises; 
 (i) a neurotoxic polypeptide component with 
 ( 1 ) a molecular weight of about 150 kilodaltons,  
 ( 2 ) a short polypeptide chain of about 50 kD, and  
 ( 3 ) a larger polypeptide chain of about 100 kD,  
 ( 4 ) the two chains being linked together by a disulphide bridge,  
 
 (ii) a complex comprising 
 ( 5 ) non-toxic proteins and  
 ( 6 ) haemagglutinins,  
 ( 7 ) the complex having a molecular weight of about 900 kD;  
 
   (d) purifying the  botulinum  toxin type A neurotoxic component from the fermented mixture;    (e) adding human serum albumin as a stabilizer to the  botulinum  toxin type A;    (f) adding saline as a tonicity adjusting agent to the  botulinum  toxin type A to form a solution;    (g) sterile filtering the solution;    (h) vacuum drying the solution to form a powder;    (i) reconstituting the powder with sterile unpreserved normal saline to form a sterile, pyrogen-free aqueous solution or dispersion of a  botulinum  toxin type A neurotoxic component.    
     
     
         19 . A product made by the method of  claim 18.