Sampling article for determining quantitative and qualitative drug transfer to skin

• US 20030069482A1
• Filed: 10/09/2001
• Published: 04/10/2003
• Est. Priority Date: 10/09/2001
• Status: Abandoned Application

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Workman, Jerome James Jr., Adler, Terry William, Cunningham, Corey Thomas
• Application Number:
  US09/973,680
• Publication Number:
  US 20030069482A1
• Time in Patent Office: Days
• US Class Current: 600/306
• CPC Class Codes: A61B 10/00 Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis vaccination prophylaxis, vaccination therapy A61B17/20; Sex determination; Ovulation-period determination menstruation tables G06C3/00; Throat striking implements
• CPC Class Codes: A61K 49/0006 Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: G01N 2013/003 Diffusion; diffusivity between liquids

Abstract

An article for measuring external drug transfer to skin surfaces includes a high molecular weight polyolefin substrate film and a skin-adhering element attached to the polyolefin substrate film. The substrate film has a texture that simulates skin roughness and topography on the surface facing a drug delivery medium. The substrate film, skin-adhering element, and all other components of, or in contact with, the sampling article provide minimum interference with chemical analysis of the active drug being measured.

Claims

1. An article for measuring external drug transfer to skin surfaces, comprising:

a polyolefin substrate film including at least one of the group consisting of polyethylene and polypropylene, the film having a weight-average molecular weight between about 3 and about 6 kilograms/mole; and

a skin-adhering element attached to the polyolefin substrate film, wherein the article is free of aromatic organic compounds, polyenes, acrylates, esters, waxes, dimethicones and silicone-based compounds.

2. The article of claim 1, wherein the film has a weight-average molecular weight between about 3 and about 4 kilograms/mole.

3. The article of claim 1, wherein the polyolefin substrate film comprises a surface texture having a roughness, calculated as an arithmetic sum of all deviations about a best-fit mean plane through topographical surface data, of between about 19 and about 32 microns.

4. The article of claim 1, wherein the polyolefin substrate film comprises a surface texture having human skin topography.

5. The article of claim 1, wherein the skin-adhering element comprises an adhesive selected from the group consisting of a polyacrylate ester based hydrogel adhesive, a polymethacrylate ester based hydrogel adhesive, a high solids moisture resistant latex pressure-sensitive adhesive, and a polyalkyloxazoline-reinforced acrylic pressure-sensitive adhesive.

6. The article of claim 5, wherein the adhesive comprises components each having a minimum molecular weight of at least 1,500 daltons.

7. The article of claim 5, wherein the adhesive has a boiling point of at least 250°

Celsius.

8. The article of claim 1, wherein the skin-adhering element comprises an electrostatic adhesive.

9. The article of claim 8, wherein the polyolefin substrate film has a thickness of less than 80 microns.

10. The article of claim 1, further comprising packaging materials in contact with the polyolefin substrate film, wherein the packaging materials are non-interfering with respect to analysis of the drug being measured.

11. The article of claim 1, wherein the polyolefin substrate film has a shape selected from the group consisting of triangular, square, circular, oval, rectangular, octagonal, and hexagonal.

12. The article of claim 1, wherein the polyolefin substrate film has a maximum length of between about 1 centimeter and about 10 centimeters.

13. An article for measuring external drug transfer to skin surfaces, comprising:

a polytetrafluoroethylene substrate film having a weight-average molecular weight between about 35 and about 65 kilograms/mole; and

a skin-adhering element attached to the polytetrafluoroethylene substrate film, wherein the article is free of aromatic organic compounds, polyenes, acrylates, esters, waxes, dimethicones and silicone-based compounds.

14. The article of claim 13, wherein the film has a weight-average molecular weight between about 45 and about 55 kilograms/mole.

15. The article of claim 13, wherein the polytetrafluoroethylene substrate film comprises a surface texture having a roughness, calculated as an arithmetic sum of all deviations about a best-fit mean plane through topographical surface data, of between about 19 and about 32 microns.

16. The article of claim 13, wherein the polytetrafluoroethylene substrate film comprises a surface texture having human skin topography.

17. The article of claim 13, wherein the skin-adhering element comprises an adhesive selected from the group consisting of a polyacrylate ester based hydrogel adhesive, a polymethacrylate ester based hydrogel adhesive, a high solids moisture resistant latex pressure-sensitive adhesive, and a polyalkyloxazoline-reinforced acrylic pressure-sensitive adhesive.

18. The article of claim 17, wherein the adhesive has a minimum molecular weight of at least 1,500 daltons.

19. The article of claim 17, wherein the adhesive has a boiling point of at least 250°

Celsius.

20. The article of claim 13, wherein the skin-adhering element comprises an electrostatic adhesive.

21. The article of claim 20, wherein the polytetrafluoroethylene substrate film has a thickness of less than 80 microns.

22. The article of claim 13, further comprising packaging materials in contact with the polytetrafluoroethylene substrate film, wherein the packaging materials are non-interfering with respect to analysis of the drug being measured.

23. The article of claim 13, wherein the polytetrafluoroethylene substrate film has a shape selected from the group consisting of triangular, square, circular, oval, rectangular, octagonal, and hexagonal.

24. The article of claim 13, wherein the polytetrafluoroethylene substrate film has a maximum length of between about 1 centimeter and about 10 centimeters.

25. An article for measuring external drug transfer to skin surfaces, comprising:

a substrate including at least one of the group consisting of metallic foil film, metallized film, poly(methyl methacrylate), poly(vinyl alcohol), poly(ethylene oxide), poly(ethylene terephthalate), polycaprolactam, poly(hexamethylene adipamide), poly(α

-1,6-D-glucose), polydimethylsiloxanes, and poly(cis-1,4-isoprene); and

a skin-adhering element attached to the substrate, wherein the article is free of aromatic organic compounds, polyenes, acrylates, esters, waxes, dimethicones and silicone-based compounds.

26. The article of claim 25, wherein the substrate comprises a surface texture having a roughness, calculated as an arithmetic sum of all deviations about a best-fit mean plane through topographical surface data, of between about 19 and about 32 microns.

27. The article of claim 25, wherein the substrate comprises a surface texture having human skin topography.

28. The article of claim 25, wherein the skin-adhering element comprises an adhesive selected from the group consisting of a polyacrylate ester based hydrogel adhesive, a polymethacrylate ester based hydrogel adhesive, a high solids moisture resistant latex pressure-sensitive adhesive, and a polyalkyloxazoline-reinforced acrylic pressure-sensitive adhesive.

29. The article of claim 28, wherein the adhesive has a minimum molecular weight of at least 1,500 daltons.

30. The article of claim 28, wherein the adhesive has a boiling point of at least 250°

Celsius.

31. The article of claim 25, wherein the skin-adhering element comprises an electrostatic adhesive.

32. The article of claim 31, wherein the substrate has a thickness of less than 80 microns.

33. The article of claim 25, further comprising packaging materials in contact with the substrate, wherein the packaging materials are non-interfering with respect to analysis of the drug being measured.

34. The article of claim 25, wherein the substrate has a shape selected from the group consisting of triangular, square, circular, oval, rectangular, octagonal, and hexagonal.

35. The article of claim 25, wherein the substrate has a maximum length of between about 1 centimeter and about 10 centimeters.