Cosmetic Neurotoxin Compositions and Methods

• US 20100129449A1
• Filed: 01/27/2010
• Published: 05/27/2010
• Est. Priority Date: 10/01/2004
• Status: Active Grant

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: First, Eric R.
• Granted Patent: US 8,647,639 B2
• Time in Patent Office: Days
• US Class Current: 424/484
• CPC Class Codes: A61K 2800/654 The particulate/core comprising macromolecular material
• CPC Class Codes: A61K 38/4893 Botulinum neurotoxin (3.4.24.69)
• CPC Class Codes: A61K 8/0241 Containing particulates characterized by their shape and/or structure see also A61K8/04, A61K8/11, and A61K8/14, further aspects are classified in A61K2800/40 and subcodes
• CPC Class Codes: A61K 8/025 Explicitly spheroidal or spherical shape
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/66 Enzymes
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations
• CPC Class Codes: C12Y 304/24069 Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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.

Claims

1. A composition useful for treating a cosmetic defect in an individual, comprising

a botulinum toxin component;

and

a microsphere component comprising a plurality of swellable microspheres.

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 being substantially free of a botulinum toxoid.

9. The composition of claim 1, wherein the microsphere component has an average microsphere diameter, and the average microsphere diameter after administration to the individual is between about one to about four times greater than the average microsphere diameter before administration.

10. The composition of claim 1, wherein the microspheres comprise crosslinked polymers.

11. The composition of claim 10, wherein the polymers are hydrophilic.

12. The composition of claim 1, wherein the microsphere component is a hydrogel material.

13. 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.

14. The composition of claim 1, wherein the microspheres comprise a cell adhesion promoter.

15. The composition of claim 1, wherein the microspheres comprise cells provided on the surface of the microspheres.

16. The composition of claim 15, wherein the cells are autologous cells.

17. The composition of claim 15, wherein the cells are selected from the group consisting of fat cells, muscle cells, subcutaneous cells, dermal cells, epidermal cells, and mixtures thereof.

18. 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.

19. The composition of claim 1, further comprising a carrier component.

20. The composition of claim 19, wherein the carrier component is an aqueous composition.

21. The composition of claim 19, wherein the carrier component is saline.

22. The composition of claim 1, 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.

23. 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.

30. A method of treating a cosmetic defect, comprising administering the composition of claim 1 to an individual.

31. The method of claim 30, wherein the cosmetic defect is a wrinkle.

32. The method of claim 30, wherein the cosmetic defect is a condition selected from the group consisting of marionette lines, glabellar lines, crows feet, brow furrows, and combinations thereof.

33. The method of claim 30, wherein the administering comprises subdermally injecting the composition in the individual.

34. The method of claim 33, wherein the administering comprises injecting the composition through a needle no greater than about 30 gauge.

35. The method of claim 30, further comprising administering an additional amount of a botulinum toxin to the individual.

36. The method of claim 30, wherein the administering comprises injecting a composition comprising a botulinum toxin type A.

37. The method of claim 30, 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.

24. A composition useful for treating a cosmetic defect in an individual, comprising:

a cosmetic defect treating amount of botulinum toxin type A; and

a plurality of swellable microspheres effective in treating a cosmetic defect of the individual.

25. The composition of claim 24, wherein the composition is an injectable composition effective in treating wrinkles.

26. The composition of claim 25, wherein the wrinkles are selected from a group consisting of marrionette lines, glabellar lines, crows feet, brow furrows, and combinations thereof.

27. The composition of claim 24, 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.

28. The composition of claim 24, further comprising at least one additional botulinum toxin selected from the group consisting of botulinum toxin types B, C, D, E, F, and G.

29. The composition of claim 24, wherein the plurality of microspheres have an average microsphere diameter, and wherein the average microsphere diameter increases after injection into the individual from about one time to about four times the average microsphere diameter prior to injection.