Iontophoretic drug delivery device and reservoir and method of making same

• US 6,862,473 B2
• Filed: 02/28/2002
• Issued: 03/01/2005
• Est. Priority Date: 09/30/1993
• Status: Expired due to Fees

• Current Assignee: Vyteris, Inc.
• Original Assignee: Vyteris, Inc.
• Inventors: Nrk, Vilambi, Keusch, Preston, Eliash, Bruce Michael
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/085,428
• Publication Number:
  US 20030055405A1
• Time in Patent Office: 1,097 Days
• Field of Search: 604 20- 21, 604/501
• US Class Current: 604/20
• CPC Class Codes: A61F 2013/0296 for making transdermal patches (chemical processes excluded)
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

A reservoir electrode assembly of the present invention for an iontophoretic drug delivery device includes an electrode and a hydrophilic reservoir situated in electrically conductive relation to the electrode. The hydrophilic reservoir is formed from a bibulous hydrophilic cross-linked polymeric material having a first surface and a second surface that is adhesively adherent to the electrode. The first surface of the polymeric material is releasably adhesively adherent when applied to an area of a patient'"'"'s skin. The polymeric material has a cohesive strength forms an adhesive bond with a bond strength between the second surface of the polymeric material to the electrode that is greater than the cohesive strength of the polymeric material. Additionally, 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 assembly of the invention from the applied area of the patient, substantially no polymeric material remains on the applied area and the hydrophilic reservoir remains substantially intact and adhesively adherent to the electrode.

Claims

1. An iontophoretic drug delivery device, comprising:

a single electrode assembly, comprising;

a working electrode connected to a working reservoir, the working reservoir comprising lidocaine and epinephrine; and

a return electrode connected to a return reservoir, the return reservoir comprising an electrolyte;

wherein the working reservoir and the return reservoir independently comprise at least one crosslinked water soluble polymer; and

wherein the electrode assembly is prepackaged as a ready to use device.

2. The iontophoretic drug delivery device of claim 1, wherein the working reservoir and the return reservoir comprise the same crosslinked water soluble polymer.

3. The iontophoretic drug delivery device of claim 1, wherein, as measured by weight % of the total weight of the working reservoir, epinephrine is about 0.1 wt. %.

4. The iontophoretic drug delivery device of claim 3 wherein the lidocaine is about 10 wt. % based on the total with of the reservoir.

5. The iontophoretic drug delivery device of claim 4, further comprising:

glycerin, sodium metabisulfite, and EDTA.

6. The iontophoretic drug delivery device of claim 5, wherein the concentration of glycerin is about 10 wt. %, the concentration of sodium metabisulfite is about 05 wt. %, and the concentration of EDTA is about 01 wt. %, all based on the total with of the working reservoir.

7. The iontophoretic drug delivery device of claim 1, wherein the concentration of epinephrine is about 0.1 wt % and the concentration of lidocaine is about 10 wt %, all based on the total weight of the working reservoir.

8. The iontophoretic drug delivery device of claim 7, further comprising about 10 wt. % glycerin, about 0.05 wt. % sodium metabisulfite, and about 0.01 wt. % EDTA disodium.

9. The iontophoretic drug delivery device of claim 1, further comprising from one to three return electrodes.

10. The iontophoretic drug delivery device of claim 1, wherein the return electrodes have a total surface area from 1 to 5 cm² and wherein the working electrode has a surface area from 2 to 10 cm².

11. The iontophoretic drug delivery device of claim 1, wherein the working reservoir further comprises at least one stabilizer.

12. The iontophoretic drug delivery device of claim 11, wherein at least one stabilizer is at least one of sodium metabisulphite and EDTA.

13. The iontophoretic drug delivery device of claim 11, wherein the working reservoir further comprises at least one additive.

14. The iontophoretic drug delivery device of claim 13, wherein the additive is selected from glycerin, propylene glycol, polyethylene glycol, and conductive salts.

15. The iontophoretic drug delivery device of claim 1, wherein the cross linked water soluble polymer acts as an adhesive.

16. The iontophoretic drug delivery device of claim 1, wherein the at least one crosslinked water soluble polymer is selected from polyethylene oxide, polyvinyl pyrrolidone, polyvinyl alcohol, and polyacrylamide.