Electrodes and method for manufacturing electrodes for electrically assisted drug delivery

• US 20020062102A1
• Filed: 06/29/2001
• Published: 05/23/2002
• Est. Priority Date: 06/30/2000
• Status: Active Grant

• Current Assignee: Bruce M. Eliash, Kevin John Carey, Preston Keusch, Uday K. Jain, Vilambi Nrk Reddy, Vitaly Falevich
• Original Assignee: Bruce M. Eliash, Kevin John Carey, Preston Keusch, Uday K. Jain, Vilambi Nrk Reddy, Vitaly Falevich
• Inventors: Falevich, Vitaly, Jain, Uday K., Carey, Kevin John, Reddy, Vilambi Nrk, Keusch, Preston, Eliash, Bruce M.
• Granted Patent: US 6,635,045 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

Abstract

Provided is a method for loading electrode-corroding ingredients into an un-loaded donor gel reservoir of an electrode for an electrically assisted drug delivery system. The method provides that a salt, such as sodium chloride or an organic salt, is provided in the un-loaded donor gel reservoir, contrary to convention. Related electrically assisted drug delivery electrode assemblies also are provided.

Claims

1. A method for making an electrode assembly for electrically assisted transmembrane delivery of an active ingredient, comprising the steps of:

a. providing an unloaded electrode assembly comprising a Ag/AgCl electrode and a reservoir comprising a polymer having an aqueous composition dispersed therein, the aqueous composition comprising an amount of salt effective to inhibit electrode corrosion; and

b. contacting a surface of the reservoir with an aqueous loading solution comprising an active electrode-corrosive ingredient for an amount of time effective to permit absorption and/or diffusion of a predetermined amount of the active electrode-corrosive ingredient into the reservoir.

2. The method of claim 1, wherein the salt contains an ion that is the same as a counterion of said active electrode-corrosive ingredient.

3. The method of claim 1, wherein the electrode-corrosive ingredient comprises chloride ions.

4. The method of claim 1, wherein the electrode-corrosive ingredient is a drug.

5. The method of claim 1, wherein the electrode-corrosive ingredient is a hydrochloride salt.

6. The method of claim 1, wherein the electrode-corrosive ingredient is lidocaine HCl.

7. The method of claim 6, the aqueous solution further comprising epinephrine.

8. The method of claim 1, wherein the loading solution is applied to the reservoir as one or more droplets.

9. The method of claim 1, wherein the reservoir comprises a polyvinylpyrrolidone hydrogel.

10. The method of claim 1, in which the loading solution comprises:

about 30% wt. lidocaine HCl;

about 0.57% wt. L-epinephrine bitartrate; and

about 0.06% to about 0.9% wt. NaCl.

11. The method of claim 10, in which the loading solution further comprises a chelating agent;

a humectant, and an antioxidant.

12. The method of claim 1, wherein the reservoir comprises about 24% wt. ±

1% wt. of a polyvinylpyrrolidone hydrogel and about 0.06% wt. NaCl and wherein the reservoir is contacted with about 33% wt. ±

10% wt. of a loading solution, comprising;

about 30% wt. lidocaine HCl;

about 0.57% wt. L-epinephrine bitartrate; and

about 0.06% wt. to about 0.9% wt. NaCl.

13. The method of claim 12, wherein the loading solution further comprises:

about 0.03% wt. EDTA;

about 0.06% wt. citric acid;

about 30% wt. glycerin; and

about 0.15% wt. sodium metabisulfite.

14. The method of claim 1 in which the loading solution comprises:

about 30% wt. lidocaine HCl;

about 0.57% wt. L-epinephrine bitartrate;

about 0.06% wt. NaCl;

about 0.03% wt. EDTA;

about 0.06% wt. citric acid;

about 30% wt. glycerin; and

about 0.15% wt. sodium metabisulfite.

16. The electrode of claim 15, wherein the reservoir comprises about 24% wt. ±

1% wt. of a polyvinylpyrrolidone hydrogel and about 0.06% wt. NaCl and wherein the reservoir is contacted with about 33% wt. ±

10% wt. of a loading solution, comprising;

about 30% wt. lidocaine HCl;

about 0.57% wt. L-epinephrine bitartrate; and

about 0.06% wt. to about 0.9% wt. NaCl.

17. the electrode of claim 15, in which the loading solution further comprises a chelating agent, a humectant and an antioxidant.

18. The electrode of claim 15, wherein the loading solution comprises:

about 30% wt. lidocaine HCl;

about 0.57% wt. L-epinephrine bitartrate; and

about 0.06% wt. NaCl.

19. The electrode assembly of claim 18, wherein the loading solution further comprises:

about 0.03% wt. EDTA;

about 0.06% wt. citric acid;

about 30% wt. glycerin; and

about 0.15% wt. sodium metabisulfite.

15. An electrode prepared according to a process comprising the steps of:

a. providing an unloaded electrode assembly comprising a Ag/AgCl electrode and a reservoir comprising a polymer having an aqueous composition dispersed therein, the aqueous composition comprising an amount of salt effective to inhibit electrode corrosion; and

b. contacting a surface of the reservoir with an aqueous loading solution comprising an active electrode-corrosive ingredient for an amount of time effective to permit absorption and/or diffusion of a predetermined amount of the active electrode-corrosive ingredient into the reservoir.

20. An electrode assembly for electrically assisted transmembrane delivery of an active ingredient comprising:

(a) a silver/silver chloride anode having a hydrogel reservoir in electrical contact therewith; and

(b) a silver/silver chloride cathode having a hydrogel reservoir in electrical contact therewith;

wherein the hydrogel reservoirs are unloaded.

21. An electrode assembly for electrically assisted transmembrane delivery of an active ingredient, comprising a donor electrode assembly comprising a silver/silver chloride electrode and a reservoir in contact with said silver/silver chloride electrode, said reservoir containing a post-loaded aqueous composition comprising one of lidocaine HCl and an epinephrine salt and an amount of salt effective to inhibit electrode corrosion during post-loading of the reservoir aqueous composition.

22. The electrically assisted transmembrane delivery electrode assembly of claim 21, wherein said halide is a chloride.

23. The electrically assisted transmembrane delivery electrode assembly of claim 21, wherein said aqueous composition of the donor electrode comprises lidocaine HCl and epinephrine.

24. The electrically assisted transmembrane delivery electrode assembly of claim 21, wherein said aqueous composition of the donor electrode comprises lidocaine HCl and L-epinephrine bitartrate.

25. The electrically assisted transmembrane delivery electrode assembly of claim 21, wherein said aqueous composition of said donor electrode further comprises at least one of an antioxidant, a metal chelator and a humectant.

26. The electrically assisted transmembrane delivery electrode assembly of claim 21, wherein said aqueous composition of said donor electrode further comprises at least one of sodium metabisulfite, EDTA and glycerin.

27. The electrically assisted transmembrane delivery electrode assembly of claim 21, wherein said reservoir comprises a hydrogel polymer composition selected from the group consisting of a polyvinylpyrrolidone, a polyethyleneoxide, a polyacrylamide, a polyacrylonitrile and a polyvinyl alcohol.

28. The electrically assisted transmembrane delivery electrode assembly of claim 21, further comprising a return electrode assembly comprising an electrode and a reservoir containing a conductive aqueous composition.

29. The electrically assisted transmembrane delivery electrode assembly of claim 28, further comprising an electrical power source electrically connected to the donor electrode assembly and the return electrode assembly.

30. The electrically assisted transmembrane delivery electrode assembly of claim 28, wherein the electrodes of the donor electrode assembly and return electrode assembly are attached to a single piece of backing material.

31. The electrically assisted transmembrane delivery electrode assembly of claim 21, wherein said electrode is printed with Ag/AgCl ink.

32. An electrically assisted transmembrane delivery apparatus, comprising a donor electrode assembly comprising a polymer film backing, an Ag/AgCl electrode printed on a surface of said backing, an electrically isolated conductive trace connected to the electrode for connection of the electrode to a power source, and a reservoir in contact with the electrode, said reservoir comprising a polyvinylpyrrolidone hydrogel matrix having a volume of about 0.8 mL and containing an aqueous composition comprising about 462 mM lidocaine HCl, about 7.2 mM epinephrine bitartrate and about 12.8 mM NaCl.