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WO1998014236A1 - Conceptions empechant une fuite de solution medicamenteuse et destinees a etre utilisees dans l'assemblage ou l'emballage d'un timbre iontophoretique - Google Patents

Conceptions empechant une fuite de solution medicamenteuse et destinees a etre utilisees dans l'assemblage ou l'emballage d'un timbre iontophoretique Download PDF

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Publication number
WO1998014236A1
WO1998014236A1 PCT/US1997/017447 US9717447W WO9814236A1 WO 1998014236 A1 WO1998014236 A1 WO 1998014236A1 US 9717447 W US9717447 W US 9717447W WO 9814236 A1 WO9814236 A1 WO 9814236A1
Authority
WO
WIPO (PCT)
Prior art keywords
patch according
iontophoretic patch
iontophoretic
reservoir
receiving means
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1997/017447
Other languages
English (en)
Inventor
Preston Keusch
Justin E. Mccarthy
Michael I. Bernhard
Vilambi Nrk Reddy
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to AU46560/97A priority Critical patent/AU4656097A/en
Publication of WO1998014236A1 publication Critical patent/WO1998014236A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A61N1/303—Constructional details

Definitions

  • the invention is in the field of iontophoresis.
  • 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 elect ⁇ cal components of the patch
  • Iontophoresis is the migration of ions when an elect ⁇ cal current is passed through a solution containing ionized species, usually the ionic form of a drug or other therapeutic agent
  • 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.
  • 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.
  • a positively charged drug is housed in the anode reservoir 50, and a negatively charged drug is housed in the cathode reservoir 70.
  • 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.
  • drug delivery 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.
  • 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.
  • 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.
  • an iontophoretic patch that includes a barrier, located substantially between the reservoirs and extending out from the lower surface of the backing layer.
  • At least one groove is provided in place of the barrier and positioned substantially between the reservoirs.
  • an iontophoretic patch in another aspect of the invention, includes a backing layer and a non-conducting layer having at least one groove located substantially between the reservoirs.
  • an iontophoretic patch is provided for that includes an absorption member located substantially between the reservoirs.
  • a release liner is provided for that interlocks with the backing layer of an iontophoretic patch.
  • the 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
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • iontophoretic patch 5 can be fastened to the user's skin by any known means for applying an iontophoretic patch to the body.
  • patch 5 may be adhered to the skin through the use of tacky reservoir matrix materials for the reservoirs 50 and 70.
  • a strap may be used to fasten patch 5 to skin 80.
  • 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.
  • 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.
  • 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
  • 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.
  • barrier 100 may also disrupt ionic conduction between electronic interconnectors 110 and 120, electrodes 40 and 60, and reservoirs 50 and 70.
  • barrier 100 may substantially or partially surround one or more reservoirs or electronic interconnectors.
  • barrier 100 provides means of disrupting conduction between all the components of the patch.
  • the second embodiment of the present invention 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.
  • conductive solution is lessened by evaporation helping to further eliminate the possibility of ionic conduction between components of the patch.
  • reservoirs 50 and 70 are housed with backing layer 90, thus extending up from lower surface 95.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • an abso ⁇ tion member 220 is provided on patch 5 that absorbs the conductive pathway between components in the patch.
  • Abso ⁇ tion 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.
  • Abso ⁇ tion member 220 extends from lower surface 95, and is positioned substantially between reservoirs 40 and 70. In that regard, abso ⁇ tion 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. Abso ⁇ tion member 220 absorbs the solution, thus eliminating the pathway of solution between the reservoirs.
  • Abso ⁇ tion 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
  • cross-sectional areas may be trapezoidal, rectangular, or spherical
  • 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
  • abso ⁇ tion member 220 may also disrupt ionic conduction between electronic interconnectors 110 and 120, electrodes 40 and 60, and reservoirs 50 and 70
  • abso ⁇ tion member 220 may substantially or partially surround one or more reservoirs or electronic interconnectors
  • 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
  • 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 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.
  • 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.
  • 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.
  • 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.
  • release liner 190 may be made of any number of known materials, including, but not limited to plastic or a silicone-surfaced paper

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un timbre (5) iontophorétique destiné à l'administration d'un agent thérapeutique dans la peau d'un patient. Le timbre iontophorétique comprend un support, présentant une surface inférieure (95) destinée à loger plusieurs électrodes espacées et plusieurs conducteurs électriques, ainsi que des réservoirs (50, 70) intégrés au support et destinés à contenir un agent thérapeutique et une solution récupérée. Une barrière (100) intégrée au support est située essentiellement entre les réservoirs et constitue un point de rupture d'un chemin de conduction de solution ou de transpiration entre les réservoirs ou des éléments du système.
PCT/US1997/017447 1996-09-30 1997-09-29 Conceptions empechant une fuite de solution medicamenteuse et destinees a etre utilisees dans l'assemblage ou l'emballage d'un timbre iontophoretique Ceased WO1998014236A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU46560/97A AU4656097A (en) 1996-09-30 1997-09-29 Designs to prevent transport of drug solution for use in assembly or packaging of an iontophoretic patch

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US72410796A 1996-09-30 1996-09-30
US08/724,107 1996-09-30

Publications (1)

Publication Number Publication Date
WO1998014236A1 true WO1998014236A1 (fr) 1998-04-09

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PCT/US1997/017447 Ceased WO1998014236A1 (fr) 1996-09-30 1997-09-29 Conceptions empechant une fuite de solution medicamenteuse et destinees a etre utilisees dans l'assemblage ou l'emballage d'un timbre iontophoretique

Country Status (2)

Country Link
AU (1) AU4656097A (fr)
WO (1) WO1998014236A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU750912B2 (en) * 1999-05-25 2002-08-01 Iomed, Inc Methods and apparatus for ocular iontophoresis
EP2578267A3 (fr) * 2001-09-21 2015-08-19 Empi Corp. Procédé et dispositif pour l'administration iontophorétique d'un médicament

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4028125A1 (de) * 1990-01-17 1991-07-18 Klimke Markus Applikationsvorrichtung fuer die geregelte dosierung verschiedener pharmakons mittels elektrischem strom zum perkutanen transport zur lokalen und systemischen therapie
EP0483883A1 (fr) * 1990-11-01 1992-05-06 Robert Tapper Système de traitement par iontophorèse
WO1992007618A1 (fr) * 1990-10-29 1992-05-14 Alza Corporation Electrode iontophoretique d'apport de medicament et procede pour son hydratation
US5310404A (en) * 1992-06-01 1994-05-10 Alza Corporation Iontophoretic delivery device and method of hydrating same
US5387189A (en) * 1993-12-02 1995-02-07 Alza Corporation Electrotransport delivery device and method of making same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4028125A1 (de) * 1990-01-17 1991-07-18 Klimke Markus Applikationsvorrichtung fuer die geregelte dosierung verschiedener pharmakons mittels elektrischem strom zum perkutanen transport zur lokalen und systemischen therapie
WO1992007618A1 (fr) * 1990-10-29 1992-05-14 Alza Corporation Electrode iontophoretique d'apport de medicament et procede pour son hydratation
EP0483883A1 (fr) * 1990-11-01 1992-05-06 Robert Tapper Système de traitement par iontophorèse
US5310404A (en) * 1992-06-01 1994-05-10 Alza Corporation Iontophoretic delivery device and method of hydrating same
US5387189A (en) * 1993-12-02 1995-02-07 Alza Corporation Electrotransport delivery device and method of making same

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU750912B2 (en) * 1999-05-25 2002-08-01 Iomed, Inc Methods and apparatus for ocular iontophoresis
EP2578267A3 (fr) * 2001-09-21 2015-08-19 Empi Corp. Procédé et dispositif pour l'administration iontophorétique d'un médicament

Also Published As

Publication number Publication date
AU4656097A (en) 1998-04-24

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