Composition for therapeutic and cosmetic botulinum toxin
View Patent ↗This invention relates to a composition of botulinum based pharmaceuticals used for therapeutic and cosmetic treatment. This invention offers an improvement on the prior art by eliminating the potential of blood-borne contamination with botulinum based pharmaceuticals. Recombinant serum albumin is taught for use in the place of human serum albumin as a stabilizing or enhancing agent.
1. A composition comprising a botulinum neurotoxin formulated with a recombinant serum albumin for administration to a patient in need thereof, wherein said composition induces an allergic response of less than 1% of administrations.
2. The composition of claim 1 , wherein said composition induces an allergic response of less than 1% after three injections.
3. The composition of claim 1 , wherein said induced allergic response is local.
4. The composition of claim 3 , wherein said allergic response is erythema or edema or both.
5. The composition of claim 1 , wherein said allergic response is inflammation.
6. The composition of claim 1 , wherein said allergic response is systemic.
7. The composition of claim 1 , wherein said injections occur at three to four month intervals.
8. The composition of claim 1 , wherein the concentration of said recombinant serum albumin is greater than 0.5 mg per 100 International Units botulinum neurotoxin.
9. The composition of claim 1 , wherein the concentration of said recombinant serum albumin is greater than 0.5 mg/cc using 20-1000 mouse LD 50 units.
10. The composition of claim 1 , wherein the concentration of said recombinant serum albumin is greater than 0.5 mg/cc using 10-300 mouse LD 50 units.
11. The composition of claim 1 , wherein the concentration of said recombinant serum albumin is greater than 0.5 mg/cc using 10-400 mouse LD 50 units.
12. The composition of claim 1 , wherein the concentration of said recombinant serum albumin is greater than 0.5 mg/cc using 5-150 mouse LD 50 units.
13. The composition of claim 1 , wherein said botulinum neurotoxin is selected from the group consisting of immunotypes A, B, C, D, E, F and G.
14. The composition of claim 1 , wherein said recombinant serum albumin is isolated from yeast.
15. The composition of claim 14 , wherein said yeast is Saccharomyces cerevisiae or Picchia pastoris.
16. The composition of claim 1 , wherein said botulinum neurotoxin is a chimeric protein or a combination of various botulinum toxin immunotypes.
17. The composition of claim 1 , wherein said serum albumin is recombinant human serum albumin.
18. A method of treating blepharospasm comprising administering a therapeutically effective amount of the composition of claim 1 to a patient in need thereof to thereby treat said blepharospasm.
19. A method of effacing glabellar frown lines comprising administering a therapeutically effective amount of the composition of claim 1 to a patient in need thereof to thereby efface said glabellar frown lines.
20. A method of effacing transverse forehead lines comprising administering a therapeutically effective amount of the composition of claim 1 to a patient in need thereof to thereby efface said transverse forehead lines.
21. A method of treating spasmodic torticollis comprising administering a therapeutically effective amount of the composition of claim 1 to a patient in need thereof to thereby treat spasmodic torticollis.
22. A method of treating myofascial pain comprising administering a therapeutically effective amount of the composition of claim 1 to a patient in need thereof to thereby treat said myofascial pain.