Claims for Patent: 8,647,639

Summary for Patent: 8,647,639

Title:	Cosmetic neurotoxin compositions and methods
Abstract:	Cosmetic compositions include a Clostridial neurotoxin component and a microsphere component. In certain compositions, the composition includes a botulinum toxin and a plurality of swellable microspheres. The compositions are administered to individuals, by injection and the like, to treat a cosmetic defect of deficiency.
Inventor(s):	First; Eric R. (Boston, MA)
Assignee:	Allergan, Inc. (Irvine, CA)
Application Number:	12/695,105
Patent Claims:	1. A composition useful for treating a cosmetic defect in an individual, comprising a botulinum toxin component mixed with a microsphere component comprising a plurality of swellable microspheres, wherein the plurality of swellable microspheres have a first average microsphere diameter before administration to the individual and a second average microsphere diameter after administration to the individual, the second average microsphere diameter being greater than the first average microsphere diameter, and wherein the botulinum toxin component is associated with the microsphere component so that the composition is effective in treating a cosmetic defect of the individual for a period of time ranging from about one month to about six years after administration to the individual; wherein the composition is free of a botulinum toxoid. 2. The composition of claim 1, wherein the botulinum toxin component is associated with the microsphere component so that the composition is effective in augmenting a cosmetic feature of the individual by the combination of the swelling of the microspheres and by proteolytic activity of a botulinum toxin of the botulinum toxin component. 3. The composition of claim 1, wherein the botulinum toxin component comprises a botulinum toxin selected from the group consisting of botulinum toxins types A, B, C, D, E, F, G, and mixtures thereof. 4. The composition of claim 1, wherein the botulinum toxin component comprises only botulinum toxin type A. 5. The composition of claim 1, wherein the botulinum toxin component comprises an amount of botulinum toxin in a range from about 1 unit to about 50,000 units. 6. The composition of claim 1, wherein the botulinum toxin component comprises an amount of botulinum toxin in a range from about 10 units to about 2,000 units of a botulinum toxin type A. 7. The composition of claim 1, wherein the botulinum toxin component comprises an amount of botulinum toxin in a range from about 100 units to about 30,000 units of a botulinum toxin type B. 8. The composition of claim 1, wherein the second average microsphere diameter is between about one to about four times greater than the first average microsphere diameter. 9. The composition of claim 1, wherein the microspheres comprise crosslinked polymers. 10. The composition of claim 9, wherein the polymers are hydrophilic. 11. The composition of claim 1, wherein the microsphere component is a hydrogel material. 12. The composition of claim 1, wherein the microspheres comprise at least one polymer selected from the group consisting of sodium acrylate polymer, acrylamide polymers, acrylamide derivative polymers or copolymers, sodium acrylate and vinyl alcohol copolymer, saponification products of copolymer of vinyl acetate and acrylic acid ester, vinyl acetate and acrylic acid ester copolymer, vinyl acetate and methyl maleate copolymer, isobutylene-maleic anhydride crosslinked copolymer, starch-acrylonitrile graft copolymer and its saponification products, crosslinked sodium polyacrylate polymer, and crosslinked polyethylene oxide. 13. The composition of claim 1, wherein the microspheres comprise a cell adhesion promoter. 14. The composition of claim 1, wherein the microspheres comprise cells provided on the surface of the microspheres. 15. The composition of claim 14, wherein the cells are autologous cells. 16. The composition of claim 14, wherein the cells are selected from the group consisting of fat cells, muscle cells, subcutaneous cells, dermal cells, epidermal cells, and mixtures thereof. 17. The composition of claim 1, wherein the micropsheres comprise an agent selected from the group consisting of radio-pacifying agents, contrast agents, targeting agents, and mixtures thereof. 18. The composition of claim 1, further comprising a carrier component. 19. The composition of claim 18, wherein the carrier component is an aqueous composition. 20. The composition of claim 18, wherein the carrier component is saline. 21. The composition of claim 1, wherein the botulinum toxin component is associated with the microsphere component so that the botulinum toxin retains a enzymatic activity after passing through a needle of about 30 gauge or smaller. 22. A composition useful for treating a cosmetic defect in an individual, comprising: a cosmetic defect treating amount of botulinum toxin type A-mixed with a plurality of swellable microspheres effective in treating a cosmetic defect of the individual, wherein the plurality of swellable microspheres have a first average microsphere diameter before administration to the individual and a second average microsphere diameter after administration to the individual, the second average microsphere diameter being greater than the first average microsphere diameter, and wherein the botulinum toxin component is associated with the microsphere component so that the composition is effective in treating a cosmetic defect of the individual for a period of time ranging from about one month to about six years after administration to the individual; and wherein the composition is free of a botulinum toxoid. 23. The composition of claim 22, wherein the composition is an injectable composition effective in treating wrinkles. 24. The composition of claim 23, wherein the wrinkles are selected from a group consisting of marrionette lines, glabellar lines, crows feet, brow furrows, and combinations thereof. 25. The composition of claim 22, wherein the botulinum toxin type A is provided in an amount effective in providing a longer lasting anti-wrinkle effect relative to a substantially identical composition without a botulinum toxin. 26. The composition of claim 22, further comprising at least one additional botulinum toxin selected from the group consisting of botulinum toxin types B, C, D, E, F, and G. 27. The composition of claim 22, wherein the second average microsphere diameter is about one time to about four times the first average microsphere diameter. 28. A method of treating a cosmetic defect, comprising administering the composition of claim 1 to an individual. 29. The method of claim 28, wherein the cosmetic defect is a wrinkle. 30. The method of claim 28, wherein the cosmetic defect is a condition selected from the group consisting of marionette lines, glabellar lines, crows feet, brow furrows, and combinations thereof. 31. The method of claim 28, wherein the administering comprises subdermally injecting the composition in the individual. 32. The method of claim 31, wherein the administering comprises injecting the composition through a needle no greater than about 30 gauge. 33. The method of claim 28, further comprising administering an additional amount of a botulinum toxin to the individual. 34. The method of claim 28, wherein the administering comprises injecting a composition comprising a botulinum toxin type A. 35. The method of claim 28, wherein the administering is effective in treating a cosmetic defect for a longer time relative to administering a substantially identical composition without a botulinum toxin.

Details for Patent 8,647,639

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846	12/08/2000		2024-10-01