IP Library Patent Application 11062055
Patent Application
App. No. 11/062,055

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

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Patent No.
US None
App. No.
11/062,055
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.

Claims (29)

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.