WO1998014236A1

WO1998014236A1 - Designs to prevent transport of drug solution for use in assembly or packaging of an iontophoretic patch

Info

Publication number: WO1998014236A1
Application number: PCT/US1997/017447
Authority: WO
Inventors: Preston Keusch; Justin E. Mccarthy; Michael I. Bernhard; Vilambi Nrk Reddy
Original assignee: Becton Dickinson And Company
Priority date: 1996-09-30
Filing date: 1997-09-29
Publication date: 1998-04-09
Also published as: AU4656097A

Abstract

An iontophoretic patch (5) for delivering a therapeutic agent into the skin of a user comprising a backing, having a lower surface (95) for housing a plurality of electrodes mutually spaced apart and a plurality of electrical conductors. Also included are reservoirs (50, 70) integral to the backing for containing a therapeutic agent and return solution. A barrier (100), integral to the backing, is substantially located between the reservoir and provides a point to break a conductive path of solution or perspiration between the reservoirs or components of the system.

Description

DESIGNS TO PREVENT TRANSPORT OF DRUG SOLUTION FOR USE IN ASSEMBLY OR PACKAGING OF AN TONTOPHORETTC PATCH

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION The invention is in the field of iontophoresis. In particular, the invention relates to a lontophoretic drug delivery patch having a barrier to prevent leakage of the drug and electrolyte solution from the device and to prevent short-circuiting between electπcal components of the patch

DESCRIPTION OF RELATED ART

Iontophoresis is the migration of ions when an electπcal current is passed through a solution containing ionized species, usually the ionic form of a drug or other therapeutic agent One particularly advantageous application of iontophoresis is the noninvasive transdermal delivery of ionized drugs into a patient This is done by applying low levels of current to an lontophoretic patch placed on skin of a patient, which forces the ionized drugs contained in the patch through the skin and into the bloodstream

lontophoretic delivery offers an alternative and effective method of drug delivery over other drug delivery methods such as passive transdermal patches, needle injection, or oral ingestion. and is a especially useful method for children, the bedridden and the elderly

An iontophoretic drug delivery device typically includes a controller, containing a current source (I e , battery) and a patch The patch generally includes active and return reservoirs usually containing the drug and electrolyte respectively The patch also contains electrodes, arranged in contact with the active and return reservoirs to be in contact with the drug or electrolyte and electronic interconnectors The interconnectors or conductors carry current to each of the electrodes from the batterv/controller current source If the drug to be delivered has a positive ionic charge, then the active electrode will be the anode and the return electrode will be the cathode. Accordingly, if the ionic charge of the drug is negative, then the active electrode will be the cathode and the return electrode will be the anode.

In an iontophoretic patch with a positively charged drug, current flows to the active electrode, whereby the drug ions migrate from the active reservoir through the skin of a patient and into the bloodstream.

When an iontophoretic delivery device is in operation, a circuit is created, as illustrated in Figure 1, and is described as follows. A controller / battery 10 is connected with an anode 40 and cathode 60 in the patch 5 via the electronic interconnectors 120 and 110, respectively. Depending upon the charge of the drug to be delivered, a positively charged drug is housed in the anode reservoir 50, and a negatively charged drug is housed in the cathode reservoir 70. When the patch is placed on skin 80, the body completes the circuit (reservoirs being ionically connected) and the drug is delivered into blood vessel 85.

In general drug delivery (drug flux) in an iontophoretic delivery device is directly proportional to the current applied. Accordingly, if another conductive path is created between components of the patch aside from the intended current path through the body, the current delivered into the body will be altered, thus altering the dosage of the drug. Therefore, it is essential to keep the anode, cathode and electronic interconnectors separated both electronically and ionically to prevent leakage and short-circuiting of the intended current path.

In that regard, there is the problem of solution on the surface of the patient's skin creating a conductive path between the active and return reservoirs and electronic interconnectors of the patch. This alternate conductive path can be created by many factors including perspiration, solution leaked from either or both reservoirs, or any external source that can place solution on the skin of the user between the components. Examples of external sources include rain water, shower and bath water, and beverages.

Another problem of existing iontophoretic patches is leakage of solution out of the reservoirs during storage. This can cause a reduction in the proper concentration of solution within the affected reservoir, and lead to drying of the reservoirs and short- circuiting and corrosion of the electrodes. This is especially problematic if the patch is required to have a long shelf life prior to actual use.

Yet another problem with current iontophoretic patches is corrosion of the electronic interconnectors during storage and use. This is especially problematic during storage of the patch prior to use. Solution leaked from a reservoir can lead to galvanic corrosion of the electronic interconnectors on the patch. Corrosion of the electronic interconnectors can eventually lead to electrical disconnection (i.e., a break in the interconnector) and failure of the patch.

Still another problem associated with existing iontophoretic patches pertains to flexibility. An iontophoretic patch needs to be as flexible as possible in order to adjust to the changing positions of a users skin from daily activities. An inflexible patch can lead to one or both of the reservoirs becoming loosely affixed or detached, resulting in a weakly connected or incomplete circuit and improper drug delivery.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an improved iontophoretic patch for delivering a drug to a patient.

It is another object of the invention to provide an improved iontophoretic patch having a drug reservoir adapted to be placed on the skin of a user and a return reservoir also to be placed on the skin of the user. It is another object of the present invention to provide an improved iontophoretic patch that prevents short-circuiting of components of the patch.

It is yet another object of the present invention to provide an improved iontophoretic patch that prevents leakage or evaporation of solution from a reservoir.

It is still another object of the present invention to provide an improved iontophoretic patch that prevents electronic interconnectors from corrosion.

In one aspect of the invention, an iontophoretic patch is provided that includes a barrier, located substantially between the reservoirs and extending out from the lower surface of the backing layer.

In another aspect of the invention, at least one groove is provided in place of the barrier and positioned substantially between the reservoirs.

In another aspect of the invention, an iontophoretic patch is provided for that includes a backing layer and a non-conducting layer having at least one groove located substantially between the reservoirs.

In yet another aspect of the invention, an iontophoretic patch is provided for that includes an absorption member located substantially between the reservoirs.

In still another aspect of the present invention, a release liner is provided for that interlocks with the backing layer of an iontophoretic patch.

By surrounding certain areas of the patch such as the electronic interconnectors, electrodes and reservoirs with a barrier or an absorption material or both, ionic conduction between the components can be eliminated and thus the drug delivery profile of the device will not be altered. The result is an integrated patch that isolates electrical components and prevents performance failures in an iontophoretic device. Indeed, any solution is either directed away, blocked, or absorbed from strategic areas of the patch

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features and advantages of the present invention can best be understood by reference to the detailed description of the preferred embodiments set forth below taken with the drawings, in which

Figure 1 illustrates a iontophoretic delivery system

Figure 2 is a bottom view of an iontophoretic patch according to a first embodiment of the present invention

Figure 3 is a sectional view of the first embodiment

Figure 4 is an alternate bottom view of an iontophoretic patch according to the first embodiment of the present invention

Figure 5 is an alternate sectional view of the first embodiment

Figure 6 is a bottom view of an iontophoretic patch according to a second embodiment of the present invention

Figure 7 is a sectional view of the second embodiment

Figure 8 is a bottom view of an iontophoretic patch according to a third embodiment of the present invention

Figure 9 is a sectional view of the third embodiment Figure 10 is a bottom view of an iontophoretic patch according to a fourth embodiment of the present invention.

Figure 11 is a sectional view of the fourth embodiment.

Figure 12 is a bottom view of an iontophoretic patch according to a fifth embodiment of the present invention.

Figure 13 is a sectional view of the fifth embodiment.

Figures 14-16 are side views of alternate configurations according to a sixth embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The embodiments of the present invention relate to an iontophoretic patch 5 including a backing layer 90 with lower surface 95 as shown in Figure 2. Iontophoretic patches can be of any size, but generally are under 50 square inches. Electrodes 40 and 60, mutually spaced apart from one another, are connected to electronic interconnectors. As shown in Figure 4, electronic interconnectors 110 and 120 can be disposed on lower surface 95. Alternatively, interconnectors 110 and 120, and electrodes 40 and 60 may be positioned on top of and within backing layer 90.

Backing layer 90 is typically made from a dielectric material comprising a plastic or other sturdy but flexible material.

Since electrodes and interconnectors pass current supplied from a current source, they are made of a conducting material, and may be of the printed / mesh type.

Although not limited to a finite number of reservoirs, patch 5 generally includes for a positively charged drug to be delivered an active reservoir 50, the reservoir housing the agent to be delivered into the body, and a return reservoir 70, housing the return agent. Both reservoir 50 and 70 are integral to backing layer 90, extending from lower surface 95. The distance each reservoir extends may be substantially equal. The reservoirs are placed in contact to skin 80 of a user during operation. Alternatively, for a negatively charged drug, reservoir 70 may house the active agent and reservoir 50 may house the return agent.

Within each respective reservoir, an electrode is placed adjacent in contact with the solution housed within, but spaced apart from skin. For the purpose of this discussion, active reservoir 50 will house active electrode 40 and return reservoir 70 will house return reservoir electrode 60. Electrodes 40 and 60 provide a surface area for conducting electrical current into solution and housed in each respective reservoir and support the required electro-chemistry.

An ionically charged agent or drug for iontophoretic delivery is placed within active reservoir 50, and must have sufficient ionic mobility to carry the system current. The charged agent may be in liquid solution, gel, or solid form. Accordingly, an electrolyte, such as sodium chloride, is placed within return reservoir 70. It may also be in liquid solution, gel or solid form.

A non-conducting adhesive may be used on lower surface 95 of backing layer 90, to fasten the patch to a user. However, iontophoretic patch 5 can be fastened to the user's skin by any known means for applying an iontophoretic patch to the body.

Alternatively, patch 5 may be adhered to the skin through the use of tacky reservoir matrix materials for the reservoirs 50 and 70. As an alternative, or in conjunction with any of the above, a strap may be used to fasten patch 5 to skin 80. As shown in the figures, the perimeter of the patch is fastened to the skin of the patient by the above means. If an adhesive is used, it may also serve to removably fasten non-conductive release liner 190 (Figures 14-16) to lower surface 95. Release liner 190 ensures that lower surface 95 and reservoirs 50 and 70 remain free from contaminants before use.

F ST EMBODIMENT

In the first embodiment of the present invention, illustrated in Figures 2-5, the problem of ionic conduction between components of patch 5 is addressed.

A barrier 100, extending from lower surface 95, is positioned substantially between reservoirs 50 and 70 Alternatively, barrier 100 may also substantially or partially surround one or both reservoirs 50 and 70 When a conductive solution such as perspiration, leaked electrolyte / drug, and external water gets between components of the patch, it can create a conductive path between the components resulting in short-circuiting of the patch Barrier 100 disrupts or breaks the pathway by physically dividing conductive solution on the skin

Barrier 100 may be a protruding member, having a cross-sectional area terminating to an edge or point The cross-sectional area may be in any geometric shape, so long as it terminates on the skin of the user during operation. For example, cross-sectional areas may be substantially triangular, trapezoidal, rectangular, or spherical in shape. Barrier 100 also extends a distance from lower surface 95, that may be substantially equal to the distances the reservoirs extend from lower surface 95

Additionally, a plurality of protruding members may be used. Barrier 100 may comprise a plurality of hips and a plurality of valleys (hip and valley) When using a plurality of protruding members as a barrier, each individual protruding member may extend from lower surface 95 a substantially equal distance, that distance being substantially equal to the reservoir distances. Barrier 100 may be formed in a number of ways. Depending upon the construction of the patch, the barriers may be produced by mechanical means including stamping, extrusion, and molding of the backing layer. Alternatively, barrier 100 may be an additional member fastened to lower surface 95 by an adhesive or physical means. Barrier materials may also include hydrophobic materials such as Teflon.

Accordingly, depending upon the arrangement of components in the patch, barrier 100 may also disrupt ionic conduction between electronic interconnectors 110 and 120, electrodes 40 and 60, and reservoirs 50 and 70. Thus, barrier 100 may substantially or partially surround one or more reservoirs or electronic interconnectors. As shown in Figure 4, barrier 100 provides means of disrupting conduction between all the components of the patch.

SECOND EMBODIMENT

To lessen the chances of ionic solution emanating from outside of patch 5, the second embodiment of the present invention, as illustrated in Figures 6 and 7, provides a second barrier 140, substantially surrounding the perimeter of patch 5. Barrier 140 extends from lower surface 95 and provides an outer seal to keep conductive solution from flowing into the patch from an external source (i.e., bathing water, rain). The distance barrier 140 extends may be substantially equal to the distances the reservoirs extend from lower surface 95.

Barrier 140 may also be a protruding member, having a cross-sectional area that terminates to an edge or point. The cross-sectional area may be in any geometric shape, so long as it terminates on the skin of the user. A plurality of protruding members may also be used for barrier 140 and may be in the form of a hip and valley layout.

Barrier 140 can be formed in a number of ways. Depending upon the construction of the patch, the barriers may be produced by mechanical means including stamping, extrusion and molding of the backing layer. Alternatively, barrier 140 may be an additional member fastened to lower surface 95 by adhesive and physical means. Barrier materials may also include hydrophobic materials such as Teflon.

Barrier 140 may be provided with a non-conductive adhesive at its termination end to provide a comprehensive seal against the skin, and may be used alone or in addition to first barrier 100.

Backing layer 90 may also contain a plurality of perforations 130 extending up from lower surface 95. The perforations allow for air to circulate around the vicinity of the perforation near the skin of the patient. Thus, conductive solution is lessened by evaporation helping to further eliminate the possibility of ionic conduction between components of the patch.

THIRD EMBODIMENT

In the third embodiment of the present invention, as illustrated in Figures 8-9, reservoirs 50 and 70 are housed with backing layer 90, thus extending up from lower surface 95. In this case, a groove 150 is provided for to disrupt conduction between components of patch 5

Reservoirs 70 and 50 may be contained in reservoir housings 65 and 45 respectively. Reservoirs 70 and 50 have bottom surfaces 75 and 55 that are substantially flush with lower surface 95 of backing layer 90.

In order to disrupt ionic conduction of a solution located on the surface of the skin, patch 5 is provided with groove 150. Located substantially between reservoirs 70 and 50, and extending substantially from one side of patch 5 to the other side, groove 150 disrupts ionic conduction between reservoirs 70 and 50. Groove 150 allows conductive solution to channel out from between reservoirs 70 and 50, and also allows an airway for evaporation. A further advantage of groove 150 is that it adds flexibility to patch 5. Added flexibility is advantageous since patch 5 can now better accommodate the daily rhythms of the user (e.g., movement of the skin). Accordingly, a plurality of grooves 150 may be provided for on lower surface

95 for added security of disrupting ionic conduction and increased flexibility.

Groove 150 can also be substantially located between other components of the patch apart from or in addition to between reservoirs 70 and 50. In that regard, groove 150 can isolate interconnectors 110 and 120 from one another, reservoirs 50 and 70, and electrodes 60 and 40. In this way, groove 150 can eliminate conduction between all components.

FOURTH EMBODIMENT

In the fourth embodiment of the present invention, as illustrated in Figures 10- 11, patch 5 further comprises a non-conducting layer 160 attached to lower surface 95 of backing layer 90, containing groove 150 for disruption of ionic conduction between components of patch 5.

Similar in aspects to groove 150 of the second embodiment, groove 150 of the present embodiment is located substantially between reservoirs 70 and 50, and extends substantially from one side of patch 5 to the other side. Groove 150 allows conductive solution to channel out from between reservoirs 70 and 50, and also allows an airway for evaporation.

Non-conducting layer 160 can be made of a variety of materials including, but not limited to, non-conducting plastic foam or rubber, and other materials hydrophobic in nature. It is fastened to backing layer 90 in any way previously disclosed including an adhesive. A further advantage of groove 150 is that it adds flexibility to patch 5. Added flexibility is advantageous because patch 5 can now better accommodate the daily rhythms of the user (e.g., movement of the skin). Additionally, a plurality of grooves 150 may be provided for on lower surface 95 for added security of disrupting ionic conduction and increased flexibility.

Groove 150 can also be substantially located between other components of the patch apart from or in addition to between reservoirs 70 and 50. In that regard, groove 150 can isolate interconnectors 110 and 120 from one another, reservoirs 50 and 70, and electrodes 60 and 40. In this way, groove 150 can eliminate conduction between the components.

FIFTH EMBODIMENT

In the fifth embodiment for the present invention, as illustrated in Figures 12 and 13, an absoφtion member 220 is provided on patch 5 that absorbs the conductive pathway between components in the patch.

Absoφtion member 220 is made from any absorbent hydrophilic material, including a non-conductive dry hydrogel material, cellulosic fibrous absorbent material, or absorbent foam and a non-conductive hydrophilic adhesive.

Absoφtion member 220 extends from lower surface 95, and is positioned substantially between reservoirs 40 and 70. In that regard, absoφtion member 220 may also substantially or partially surround one or both of reservoirs 50 and 70. When an ionic conductive solutions such as perspiration, leaked electrolyte or drug, and external water gets between components of the patch, it can create a conductive path between the components resulting in short-circuiting of the patch. Absoφtion member 220 absorbs the solution, thus eliminating the pathway of solution between the reservoirs. Absoφtion member 220 has a cross-sectional area that terminates to an edge The cross-sectional area may be in the form of a number of geometric shapes, so long as it terminates on the skin of the user For example, cross-sectional areas may be trapezoidal, rectangular, or spherical Additionally, a plurality of absorption members may be used.

Barrier 100 extends a distance from lower surface 95, that may be substantially equal to the distances that first and second reservoirs extend from lower surface 95 When using a plurality of protruding members as a barrier, each individual protruding member may extend from lower surface 95 substantially equally

Accordingly, depending upon the arrangement of components in the patch, absoφtion member 220 may also disrupt ionic conduction between electronic interconnectors 110 and 120, electrodes 40 and 60, and reservoirs 50 and 70 Thus, absoφtion member 220 may substantially or partially surround one or more reservoirs or electronic interconnectors

Applying to all of the above embodiments, perforations 130 may be randomly or specifically located depending upon the design of patch 5 Perforations 130 allow air to circulate at or above the skin surface to allow for evaporation of conductive solution and perspiration As shown in Figure 4, perforations 130 are situated near barrier 100 in order to dissipate conductive solution located between components of the patch

In addition to the above feature a non-conducting release liner may be used with any of the above embodiments to ensure that the body facing surfaces remain free of debris and solution remains intact in reservoirs 50 and 70 prior to use STXTH EMBODIMENT

The sixth embodiment of the present invention, as illustrated in Figures 14-16, provides a release liner 190 interlocked with patch 5 to seal a reservoir. The interlock may be a receiving groove or channel, or the like, and a corresponding protruding member 180 on release liner 190, or vice-versa. The receiving groove or channel substantially surrounds at least one of reservoirs 70 and 50. Likewise, protruding member 180 substantially surrounds the area of release liner 190 that corresponds to the area of the receiving groove or channel surrounding the reservoir. As shown in Figure 15, the receiving groove or channel and protruding member may be in the form of a hip 180 and valley 170 A plurality of hips 180 and valleys 170 may be used to ensure adequate sealing.

Similarly, the receiving groove or channel and protruding member may be in the form of a tongue 210 and groove 200 as illustrated in Figure 16 Tongue 210 and groove 200 may be formed in a number of different cross-sectional areas, including spherical (Figure 15) or rectangular. A plurality of tongues 210 and grooves 200 may also be used to ensure adequate sealing.

It will be appreciated that release liner 190 may be made of any number of known materials, including, but not limited to plastic or a silicone-surfaced paper

Of course, it will be appreciated that the invention may take forms other than those specifically described, and the scope of the invention is to be determined solely by the following claims.

While the present invention has been described in connection with iontophoresis, it should be appreciated that it may be used in connection with other principles of active introduction, i.e., motive forces, such as electrophoresis which includes the movement of particles in an electric field toward one or other electric pole, anode, or cathode and electro-osmosis which includes the transport of uncharged compounds due to the bulk flow of water induced by an electric field. Also, it should be appreciated that the patient may include humans as well as animals.

Claims

WHAT IS CLAIMED IS:

1. An iontophoretic patch comprising: a backing layer having a lower surface and a perimeter, said backing layer for housing a plurality of electrodes mutually spaced apart and a plurality of electronic interconnectors, each said interconnector respectively electrically connected to each said electrode; at least one active reservoir for containing a therapeutic agent to be placed against the skin of a user, said active reservoir extending out a first distance from said lower surface, one of said plurality of electrodes positioned in said active reservoir to be in contact with the therapeutic agent and apart from the skin; at least one return reservoir for containing a return agent to be placed against the skin of a user, said return reservoir extending out a second distance from said lower surface, another of said plurality of electrodes positioned in said return reservoir to be in contact with the return agent and apart from the skin; and a first barrier extending from said lower surface a third distance, said barrier being integral to said backing and located substantially between said reservoirs.

2. An iontophoretic patch according to claim 1, said backing layer further comprising a second barrier substantially surrounding said perimeter and extending from said lower surface a fourth distance.

3. An iontophoretic patch according to claim 1, wherein said first, second and third distances are substantially equal.

4. An iontophoretic patch according to claim 1, wherein said first barrier comprises a hip and valley.

5. An iontophoretic patch according to claim 2, wherein said second barrier comprises a hip and valley.

6 An iontophoretic patch according to claim 1, said backing layer further comprising a plurality of perforations

7 An iontophoretic patch according to claim 1 , wherein said first barrier substantially surrounds at least one of said reservoirs

8. An iontophoretic patch according to claim 1, wherein said first barrier comprises a hydrophobic material.

9 An iontophoretic patch according to claim 2, wherein said second barrier comprises a hydrophobic material

10 An iontophoretic patch according to claim 1, said patch further comprising a non-conductive liner removably connected to said lower surface

1 1 An iontophoretic patch according to claim 1, said patch further comprising a non-conductive adhesive on said lower surface

12. An iontophoretic patch according to claim 10, said patch further comprising a non-conductive adhesive on said lower surface, said adhesive located between said liner and said lower surface

13 An iontophoretic patch according to claim 10, said patch further comprising a receiving means substantially surrounding at least one of said reservoirs, and said liner further comprising a protruding member integral to said liner for connection to said receiving means

14 An iontophoretic patch according to claim 13, wherein said protruding member and said receiving means interlock

15. An iontophoretic patch according to claim 14, wherein said protruding member and said receiving means interlock using a hip and valley.

16. An iontophoretic patch according to claim 14, wherein said protruding member and said receiving means interlock using a tongue and groove.

17. An iontophoretic patch according to claim 10, said patch further comprising a protruding member substantially surrounding at least one of said reservoirs, and said liner further comprising a receiving means integral to said liner for connection to said protruding member.

18. An iontophoretic patch according to claim 17, wherein said protruding member and said receiving means interlock.

19. An iontophoretic patch according to claim 17, wherein said protruding member and said receiving means interlock using a hip and valley.

20. An iontophoretic patch according to claim 17, wherein said protruding member and said receiving means interlock using a tongue and groove.

21. An iontophoretic patch comprising: a backing layer having a lower surface, said backing layer for housing a plurality of electrodes mutually spaced apart and a plurality of electronic interconnectors, each said interconnectors respectively electrically connected to each said electrode; at least one active reservoir for containing a therapeutic agent to be placed against the skin of a user, said active reservoir having a bottom surface and housed in a first depression in said lower surface, wherein one of said plurality of electrodes is positioned in said active reservoir to be in contact with the therapeutic agent and apart from the skin, and wherein said bottom surface of said active reservoir is substantially flush with said lower surface; at least one return reservoir for containing a return agent to be placed against the skin of a user, said return reservoir having a bottom surface and housed in a second depression in said lower surface, wherein another of said plurality of electrodes is positioned in said active reservoir to be in contact with said return solution and apart from the skin, and wherein said bottom surface of said return reservoir is substantially flush with said lower surface; and at least one groove within said lower surface, said groove located substantially between said reservoirs.

22. An iontophoretic patch according to claim 21, said backing layer further comprising a plurality of perforations

23 An iontophoretic patch according to claim 21, wherein said plurality of perforations are located substantially within said groove

24 An iontophoretic patch according to claim 21, wherein said groove substantially surrounds at least one of said reservoirs

25 An iontophoretic patch according to claim 21, wherein said backing layer is non-conductive

26. An iontophoretic patch according to claim 21, said patch further comprising a non-conductive liner removably connected to said lower surface

27. An iontophoretic patch according to claim 21, said patch further comprising a non-conductive adhesive on said lower surface

28 An iontophoretic patch according to claim 26, said patch further comprising a non-conductive adhesive on said lower surface and between said liner and said lower surface

29. An iontophoretic patch according to claim 26, said patch further comprising a receiving means surrounding at least one of said reservoirs, and said liner further comprising a protruding member integral to said liner for connection to said receiving means.

30. An iontophoretic patch according to claim 29, wherein said protruding member and said receiving means interlock.

31. An iontophoretic patch according to claim 30, wherein said protruding member and said receiving means interlock using a hip and valley.

32. An iontophoretic patch according to claim 30, wherein said protruding member and said receiving means interlock using a tongue and groove.

33. An iontophoretic patch comprising: a backing layer having a lower surface, said backing for housing a plurality of electrodes mutually spaced apart and a plurality of electronic interconnectors, each said interconnectors respectively electrically connected to each said electrode; at least one active reservoir for containing a therapeutic agent to be placed against the skin of a user, said active reservoir extending out a first distance from said lower surface, one of said plurality of electrodes positioned in said active reservoir to be in contact with the therapeutic agent and apart from the skin; at least one return reservoir for containing a return agent to be placed against the skin of a user, said second reservoir extending out a second distance from said lower surface and spaced apart from said first reservoir, another of said plurality of electrodes positioned in said return reservoir to be in contact with the return agent and apart from the skin; a non-conductive layer having a bottom surface, said non-conductive layer integral to said backing and extending from said lower surface a third distance; and at least one groove within said bottom surface, said groove located substantially between said reservoirs.

34. An iontophoretic patch according to claim 33, wherein said first, second and third distances are substantially equal.

35. An iontophoretic patch according to claim 33, said patch further comprising a plurality of perforations extending from said backing layer through said non-conductive layer.

36. An iontophoretic patch according to claim 33, wherein said plurality of perforations are located substantially within said groove.

37. An iontophoretic patch according to claim 33, wherein said backing layer is non-conductive.

38. An iontophoretic patch according to claim 33, said patch further comprising a non-conductive liner removably connected to said lower surface

39. An iontophoretic patch according to claim 33, said patch further comprising a non-conductive adhesive on said lower surface.

40. An iontophoretic patch according to claim 38, said patch further comprising a non-conductive adhesive on said lower surface, said adhesive located between said liner and said lower surface.

41. An iontophoretic patch according to claim 38, said patch further comprising a receiving means surrounding at least one of said reservoirs, and said liner further comprising a protruding member integral to said liner for connection to said receiving means.

42. An iontophoretic patch according to claim 41, wherein said protruding member and said receiving means interlock.

43. An iontophoretic patch according to claim 42, wherein said protruding member and said receiving means interlock using a hip and valley.

44. An iontophoretic patch according to claim 42, wherein said protruding member and said receiving means interlock using a tongue and groove.

45. An iontophoretic patch comprising: a backing layer having a lower surface, said backing for housing a plurality of electrodes mutually spaced apart and a plurality of electronic interconnectors, each said interconnectors respectively electrically connected to each said electrode; at least one active reservoir for containing a therapeutic agent to be placed against the skin of a user, said active reservoir extending out a first distance from said lower surface, one of said plurality of electrodes positioned in said active reservoir to be in contact with the therapeutic agent and apart from the skin; at least one return reservoir for containing a return agent to be placed against the skin of a user, said second reservoir extending out a second distance from said lower surface and spaced apart from said first reservoir, another of said plurality of electrodes positioned in said return reservoir to be in contact with the return agent and apart from the skin; and an absoφtion member extending a third distance from said lower surface and integral to said backing, said absoφtion member located substantially between said reservoirs.

46. An iontophoretic patch according to claim 45, said backing layer further comprising a plurality of perforations.

47. An iontophoretic patch according to claim 45, wherein said first, second and third distances are substantially equal.

48. An iontophoretic patch according to claim 45, wherein said backing layer is non-conductive.

49. An iontophoretic patch according to claim 45, wherein said absoφtion member comprises a hydrophilic material.

50. An iontophoretic patch according to claim 45, said patch further comprising a non-conductive liner removably connected to said lower surface

51. An iontophoretic patch according to claim 45, said patch further comprising a non-conductive adhesive on said lower surface

52. An iontophoretic patch according to claim 50, said patch further comprising a non-conductive adhesive on said lower surface, said adhesive located between said liner and said lower surface

53 An iontophoretic patch according to claim 50, said patch further comprising a receiving means surrounding at least one of said reservoirs, and said liner fiirther comprising a protruding member integral to said liner for connection to said receiving means.

54. An iontophoretic patch according to claim 53, wherein said protruding member and said receiving means interlock.

55. An iontophoretic patch according to claim 54, wherein said protruding member and said receiving means interlock using a hip and valley

56. An iontophoretic patch according to claim 54, wherein said protruding member and said receiving means interlock using a tongue and groove.