Iontophoretic drug delivery device and reservoir and method of making same
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.
1 - 23 . (canceled)
24 . An iontophoretic drug delivery device, comprising:
an electrode assembly, comprising:
a working reservoir situated in electrically conductive relation to the electrode assembly, wherein the working reservoir comprises an aqueous swollen cross-linked water soluble polymer, lidocaine and epinephrine.
25 . The iontophoretic drug delivery device of claim 24 , wherein the iontophoretic drug delivery device is prepackaged as a ready to use device.
26 . The iontophoretic drug delivery device of claim 24 , wherein, as measured by weight % of the total weight of the working reservoir, epinephrine is present up to 0.1 wt. %.
27 . The iontophoretic drug delivery device of claim 26 , wherein the lidocaine is present up to 10 wt. %.
28 . The iontophoretic drug delivery device of claim 27 , the working reservoir further comprises:
glycerin, sodium metabisulfite, and EDTA.
29 . The iontophoretic drug delivery device of claim 28 , wherein the concentration of glycerin is up to 10 wt. %, the concentration of sodium metabisulfite is up to 0.05 wt. %, and the concentration of EDTA is up to 0.01 wt. %.
30 . The iontophoretic drug delivery device of claim 27 , wherein the iontophoretic drug delivery device is prepackaged as a ready to use device.
31 . The iontophoretic drug delivery device of claim 24 , wherein the concentration of epinephrine, as measured in weight % of the total weight of the working reservoir, is about 0.1 wt. % and the concentration of lidocaine is about 10 wt. %.
32 . The iontophoretic drug delivery device of claim 31 , the working reservoir further comprises about 10 wt. % glycerin, about 0.05 wt. % sodium metabisulfite, and about 0.01 wt. % EDTA disodium.
33 . The iontophoretic drug delivery device of claim 24 , wherein the electrode assembly further comprises from one to three return electrodes and a working electrode.
34 . The iontophoretic drug delivery device of claim 33 , wherein the one to three return electrodes have a total surface area between 1 to 5 cm 2 and wherein the working electrode has a surface area between 2 to 10 cm 2 .
35 . The iontophoretic drug delivery device of claim 24 , wherein the working reservoir further comprises at least one stabilizer.
36 . The iontophoretic drug delivery device of claim 35 , wherein at least one stabilizer is at least one of sodium metabisulphite and EDTA.
37 . The iontophoretic drug delivery device of claim 35 , wherein the working reservoir further comprises at least one additive.
38 . The iontophoretic drug delivery device of claim 37 , wherein the additive is selected from glycerin, propylene glycol, polyethylene glycol, and conductive salts.
39 . The iontophoretic drug delivery device of claim 24 , wherein the aqueous swollen cross linked water soluble polymer acts as an adhesive.
40 . The iontophoretic drug delivery device of claim 39 , wherein the aqueous swollen cross linked water soluble polymer is selected from polyethylene oxide, polyvinyl pyrrolidone, polyvinyl alcohol, and polyacrylimide.
41 - 68 . (canceled)
69 . An iontophoretic drug delivery device, comprising:
an electrode assembly, comprising:
a working reservoir situated in electrically conductive relation to the electrode assembly, wherein the working reservoir comprises an aqueous swollen cross-linked water soluble polymer, lidocaine and epinephrine;
wherein the iontophoretic drug delivery device is prepackaged as a ready to use device.
70 . (canceled)