IP Library › Patent Application 10976690
Patent Application
App. No. 10/976,690

Botulinum toxin formulations

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Patent No.
US None
App. No.
10/976,690
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.

Claims (38)

1 - 16 . (canceled)

17 . A method for making a botulinum toxin formulation suitable for use in a child seven years of age or younger 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 from the fermented mixture;

(e) adding human serum albumin as a stabilizer to the botulinum toxin type A;

(f) adding a tonicity adjusting agent, selected from the group consisting of sodium chloride, glycerol and a sugar, 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) preparing the powder in a unit dosage form selected from the group consisting of (1) a sterile solution in a vial made by reconstituting the powder with sterile unpreserved normal saline to thereby form a sterile, pyrogen-free aqueous solution or dispersion of a botulinum toxin type A, and; (2) a vial or sachet containing a lyophilised powder for reconstitution with a carrier, thereby making a high potency botulinum toxin formulation suitable for use in a child seven years of age or younger, the high potency of the botulinum toxin formulation being expressed in multiple LD 50 units per nanogram of the formulation.

18 . A high potency botulinum toxin formulation made by the method of claim 17 .

19 . A high potency botulinum toxin formulation suitable for use in a child seven years of age or younger comprising:

(a) a botulinum toxin type A, the botulinum toxin type A being made by

(i) establishing a culture of an anaerobic bacterium of Clostridium botulinum;

(ii) growing a culture of the Clostridium botulinum in a fermenter, and;

(iii) harvesting a botulinum toxin type A mixture from the fermenter;

(iv) purifying the botulinum toxin type A from the fermented mixture, wherein the botulinum toxin type A comprises;

(A) 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, and

(B) a complex comprising

(5) non-toxic proteins and

(6) haemagglutinins,

(7) the complex having a molecular weight of about 900 kD;

(b) human serum albumin to act as a stabilizer to the botulinum toxin type A;

(c) a tonicity adjusting agent, selected from the group consisting of sodium chloride, glycerol and a sugar, thereby making a high potency botulinum toxin formulation suitable for use in a child seven years of age or younger, the high potency of the botulinum toxin formulation being expressed in multiple LD 50 units per nonogram of the formulation.