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Claims for Patent: 6,629,968

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Claims for Patent: 6,629,968

Title: Shelf storage stable iontophoresis reservoir-electrode and iontophoretic system incorporating the reservoir-electrode
Abstract:A reservoir-electrode for an iontophoretic delivery device of the present invention includes an electrode; and a hydrophilic reservoir situated in electrically conductive relation to the electrode. The reservoir is formed from a bibulous hydrophilic cross-linked polymeric material having a substantially uniform concentration of an alkali metal chloride salt therein thereby substantially eliminating concentration gradients of the salt with respect to the electrode. The polymeric material has a first surface and a second surface that is adhesively adherent to the electrode. The first surface of the polymeric material is releasably adhesive to an applied area of a patient's skin. The polymeric material has a cohesive strength, wherein a bond strength of an adhesive bond between the second surface of the polymeric material to the electrode is greater than the cohesive strength of the polymeric material and an adhesive bond strength of the first surface of the polymeric material to the applied area of the patient is less than the cohesive strength of the polymeric material so that upon removal of the reservoir-electrode from the applied area of the patient, substantially no polymeric material remains on the applied area and the reservoir remains substantially intact and adhesively adherent to the electrode.
Inventor(s): Jain; Uday K. (Mahway, NJ), Reddy; Vilambi N R K (Trichy TamiNadu, IN), Eliash; Bruce M. (Franklin Lakes, NJ), Carey; Kevin John (North Plainfield, NJ), Falevich; Vitaly (Ozone Park, NY), Keusch; Preston (Hazlet, NJ)
Assignee: Vyteris, Inc. (Fair Lawn, NJ)
Application Number:09/610,563
Patent Claims: 1. A method for preparing a reservoir-electrode assembly for an iontophoretic delivery device, comprising the step of adding an aliquot of a medicament solution including ions of an alkali metal halide salt to an electrode reservoir formed from an absorbent material having a substantially uniform concentration of the alkali metal halide salt therein.

2. The method of claim 1, wherein the alkaline metal halide salt is sodium chloride.

3. The method of claim 1, wherein the medicament solution comprises lidocaine HCl.

4. The method of claim 3, wherein medicament solution further comprises epinephrine.

5. The method of claim 1, wherein the absorbent electrode reservoir comprises from about 0.001% (w/w) to about 1% (w/w) sodium chloride.

6. The method of claim 1, wherein the absorbent electrode reservoir comprises about 0.06% (w/w) sodium chloride.

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

8. The method of claim 1, wherein the reservoir comprises a bibulous hydrophilic cross-linked material.

9. The method of claim 8, wherein the bibulous hydrophilic cross-linked material comprises poly(vinylpyrolidone).

10. The method of claim 1, wherein the electrode is a metal/metal halide electrode.

11. The method of claim 10, wherein the metal/metal halide electrode comprises silver and silver chloride.

12. The method of claim 1, wherein the medicament solution comprises a pharmacologically effective amount of lidocaine hydrochloride and epinephrine bitartrate.

13. A reservoir-electrode prepared according to a process for preparing the reservoir-electrode comprising the step of adding an aliquot of a medicament solution including ions of an alkali metal halide salt to an electrode reservoir formed from an absorbent material having a substantially uniform concentration of the alkali metal halide salt therein.
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