IP Library › Patent Application 12498293
Patent Application
App. No. 12/498,293

CLOSTRIDIAL TOXIN PHARMACEUTICAL COMPOSITIONS

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Quick Facts
Patent No.
US None
App. No.
12/498,293
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 (39)

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.