Iontophoresis electrode device

• US 6,330,471 B1
• Filed: 02/10/1999
• Issued: 12/11/2001
• Est. Priority Date: 03/17/1996
• Status: Expired due to Fees

• Current Assignee: Hisamitsu Pharmaceutical Company Incorporated
• Original Assignee: Hisamitsu Pharmaceutical Company Incorporated
• Inventors: Meno, Tatsuya, Higo, Naruhito
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): HAYES, MICHAEL J
• Application Number:
  US09/142,758
• Time in Patent Office: 1,035 Days
• Field of Search: 604/20, 607/149, 607/153, 424/4.49
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0444 Membrane

Abstract

The object of the present invention is to provide an iontophoresis electrode device with superior performance which avoids entrance of metal ions from the electrode into the body, is reusable and can be mass produced at low cost, minimizes gas generation which causes polarization, can notably improve transport current, and can prevent skin injury by pH changes during prolonged application.

The iontophoresis electrode device of the present invention has a construction provided with a backing 1 having an edge section 1a around an opening and a packing chamber 4 inside, an electrode terminal 2 situated in the packing chamber 4, a non-adhesive gel 5 containing an electrolyte solvent, depolarizer, pH regulator and drug packed in the packing chamber 4, an inert electrode member 3 covering the base of the electrode terminal 2, and a liner 7 attached to the adhesive layer 6 coated on the edge section 1a and covering the opening.

Claims

1. An iontophoresis electrode device comprising an inert electrode member, an electrolyte solvent, a depolarizer preventing polarization of said inert electrode member and a pH regulator which is poorly soluble in said electrolyte solvent for use in said device.

2. An iontophoresis electrode device according to claim 1, characterized by including a buffering agent dispersed or dissolved in a gel packed in said device, or mixed with said electrolyte solvent.

3. An iontophoresis electrode device according to claim 2 characterized by being further provided with a backing having an edge section defining an opening, said backing being formed in a cup shape with a packing chamber inside the cup shape, an electrode terminal situated at a hole formed from said backing in a ceiling of said packing chamber, said inert electrode member covering a base of said electrode terminal in said packing chamber, an adhesive layer formed on said edge section, and a liner which is attached to said adhesive layer and covers said opening.

4. An iontophoresis electrode device according to claim 3, characterized by being provided with a non-adhesive gel containing an electrolyte solvent packed in said packing chamber.

5. An iontophoresis electrode device according to claim 4, characterized in that said non-adhesive gel contains at least one of said depolarizer, said pH regulator and a drug.

6. An iontophoresis electrode device according to claim 5, characterized by being provided with said drug contained in said non-adhesive gel and a holding material which holds said depolarizer and/or said pH regulator.

7. An iontophoresis electrode device according to claim 3, characterized by being provided with a powder mixture included in said packing chamber, a cover member covering said opening, an adhesive layer formed on said cover member across said cover member and said edge section, an injection hole open from said backing surface to the ceiling side of said packing chamber, and a stopper for sealing said injection hole.

8. An iontophoresis electrode device according to claim 1 characterized by being further provided with a backing having an edge section defining an opening, said backing being formed in a cup shape with a packing chamber inside the cup shape, an electrode terminal situated at a hole formed from said backing in a ceiling of said packing chamber, said inert electrode member covering a base of said electrode terminal in said packing chamber, an adhesive layer formed on said edge section, and a liner which is attached to said adhesive layer and covers said opening.

9. An iontophoresis electrode device according to claim 8, characterized by being provided with a non-adhesive gel containing an electrolyte solvent packed in said packing chamber.

10. An iontophoresis electrode device according to claim 9, characterized in that said non-adhesive gel contains at least one of said depolarizer, said pH regulator and a drug.

11. An iontophoresis electrode device according to claim 10, characterized by being provided with said drug contained in said non-adhesive gel and a holding material which holds said depolarizer and/or said pH regulator.

12. An iontophoresis electrode device according to claim 8, characterized by being provided with a powder mixture included in said packing chamber, a cover member covering said opening, an adhesive layer formed on said cover member across said cover member and said edge section, an injection hole open from said backing surface to the ceiling side of said packing chamber, and a stopper for sealing said injection hole.

13. An iontophoresis electrode device according to claim 12, characterized in that the powder mixture included in said packing chamber contains at least one of said depolarizer, said pH regulator and a drug.

14. An iontophoresis electrode device according to claim 12, characterized in that an electrolyte solution injected through said injection hole contains at least one of the depolarizer and drug in said electrolyte solvent.

15. An iontophoresis electrode device according to claim 12, characterized in that the powder mixture included in the packing chamber contains at least one of said depolarizer, a pH regulator and a drug, and said electrolyte solution is prepared by dissolving in said electrolyte solvent at least one of a depolarizer and a drug other than said depolarizer or said drug in said powder mixture.

16. An ioncophoresis electrode device according to claim 7, characterized in that the powder mixture included in said packing chamber contains at least one of said depolarizer, said pH regulator and a drug.

17. An iontophoresis electrode device according to claim 7, characterized in that an electrolyte solution injected through said injection hole contains at least one of the depolarizer and drug in said electrolyte solvent.

18. An iontophoresis electrode device according to claim 7, characterized in that the powder mixture included in the packing chamber contains at least one of said depolarizer, a pH regulator and a drug, and an electrolyte solution is prepared by dissolving in said electrolyte solvent at least one of a depolarizer and a drug other than said depolarizer or said drug in said powder mixture.

19. An iontophoresis electrode device according to any one of claims 1, 10, 13, 14, 15 and 16 through 18 characterized in that said depolarizer is an electrode reactive substance which has electrode reactivity such that it is preferentially oxidized over hydroxide ions and chloride ions at said inert electrode member, and whose reaction product readily dissolves in said electrolyte solvent.

20. An iontophoresis electrode device according to claim 19, characterized in that said depolarizer is at least one depolarizer selected from the group consisting of ascorbic acid, erythorbic acid, cysteine, acetylcysteine, thioglycolic acid, thiomalic acid or their salts, sulfites, bisulfites, thiosulfates, pyrosulfites, nitrites, iodides and α

-thioglycerine.

21. An iontophoresis electrode device according to any one of claims 1, 10, 13, 14, 15 and 16 through 18 characterized in that said depolarizer is an electrode reactive substance which has electrode reactivity such that it is preferentially reduced over hydrogen ions at said inert electrode member, and whose reaction product readily dissolves or has high conductivity in said electrolyte solvent.

22. An iontophoresis electrode device according to claim 21, characterized in that said depolarizer is at least one selected from the group consisting of iron (III) compounds, copper (II) compounds and hydrogen peroxide.

23. An iontophoresis electrode device according to claim 22, wherein said iron III compound is ferric chloride and said copper II compound is copper sulfate.

24. An iontophoresis electrode device according to any one of claims 1, 10, 11, 13, 14, 15 and 16 through 18 characterized in that said pH regulator is a basic oxide or basic hydroxide or a mixture thereof.

25. An iontophoresis electrode device according to claim 24, wherein the basic oxide is at least one selected from the group consisting of calcium oxide and magnesium oxide and/or the basic hydroxide is at least one hydroxide selected from the group consisting of calcium hydroxide, magnesium hydroxide and hydroxyapatite.

26. An iontophoresis electrode device according to any one of claims 1, 10, 11, 13, 14, 15 and 16 through 18 characterized in that said pH regulator is a silicic acid or acid anhydride or a mixture thereof.

27. An iontophoresis electrode device according to claim 25, wherein the silicic acid or acid anhydride is selected from the group consisting of silica gel, light silicic anhydride, phthylic anhydride and isobutylene-maleic anhydride copolymer.

28. An iontophoresis electrode device according to any one of claims 1, 10, 11, 13, 14, 15 and 16 through 18 characterized in that said pH regulator is an amphoteric oxide, amphoteric hydroxide, aluminate, aluminosilicate or silicate or compound salt thereof, or a mixture thereof.

29. An ioniophoresis electrode device according to claim 28, wherein the amphoteric oxide, amphoteric hydroxide, aluminate, aluminosilicate or silicate or compound salt thereof is selected from the group consisting of γ

-alumina, aluminum hydroxide, dry aluminum hydroxide gel, magnesium aluminum hydroxide, aluminum glycinate, synthetic hydrotalcite, zeolite, synthetic aluminum silicate, natural aluminum silicate, magnesium aluminosilicate, magnesium aluminometasilicate, bismuth magnesium aluminosilicate, magaldrate, calcium silicate, magnesium silicate and zinc oxide.

30. An iontophoresis electrode device according to any one of claims 10, 13, 14, 15 and 16 through 18 characterized in that said drug is a cationic drug.

31. An iontophoresis electrode device according to any one of claims 10, 11, 14, 15 and 16 through 18 characterized in that said drug is an anionic drug.