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Claims for Patent: 6,635,045

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Claims for Patent: 6,635,045

Title: Electrodes and method for manufacturing electrodes for electrically assisted drug delivery
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.
Inventor(s): Keusch; Preston (Hazlet, NJ), Jain; Uday K. (Mahway, NJ), Reddy; Vilambi Nrk (Tamil/Nadu, IN), Eliash; Bruce M. (Franklin Lakes, NJ), Carey; Kevin John (North Plainfield, NJ), Falevich; Vitaly (Ozone Park, NJ)
Assignee: Vyteris, Inc. (Fair Lawn, NJ)
Application Number:09/897,698
Patent 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 loading 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.

15. An electrode prepared according to a process for preparing the electrode 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 loading of a predetermined amount of the active electrode-corrosive ingredient into the reservoir.

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.
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