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WO2025205761A1 - Dispositif d'administration de médicament et procédé de production d'un dispositif d'administration de médicament - Google Patents

Dispositif d'administration de médicament et procédé de production d'un dispositif d'administration de médicament

Info

Publication number
WO2025205761A1
WO2025205761A1 PCT/JP2025/011722 JP2025011722W WO2025205761A1 WO 2025205761 A1 WO2025205761 A1 WO 2025205761A1 JP 2025011722 W JP2025011722 W JP 2025011722W WO 2025205761 A1 WO2025205761 A1 WO 2025205761A1
Authority
WO
WIPO (PCT)
Prior art keywords
conductive layer
delivery device
drug
drug delivery
opening
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.)
Pending
Application number
PCT/JP2025/011722
Other languages
English (en)
Japanese (ja)
Inventor
未來 田中
正興 後藤
弘幸 荻野
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.)
Kaneka Corp
Original Assignee
Kaneka Corp
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 Kaneka Corp filed Critical Kaneka Corp
Publication of WO2025205761A1 publication Critical patent/WO2025205761A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • 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

Definitions

  • the first disclosure relates to a drug delivery device and a method for manufacturing a drug delivery device.
  • the second and third disclosures each relate to a drug delivery device, and more specifically, to a drug delivery device that can deliver drugs into the body transdermally through electrical action.
  • Iontophoresis is a known technique for applying a voltage to the skin using electrodes, thereby delivering a drug placed between the electrode and the skin into the body through the skin.
  • Patent Document 1 discloses an iontophoresis device for transdermal or transmucosal drug delivery that combines pulse depolarized current with at least one of direct current and pulsed current.
  • the first disclosure was made in response to the above-mentioned problems, and its purpose is to provide a method for efficiently manufacturing drug delivery devices. Another purpose is to provide a drug delivery device with excellent manufacturing efficiency.
  • a method for manufacturing a drug delivery device comprising: a step of printing a first conductive layer including a first electrode portion and a first wiring portion on a base sheet;
  • a method for manufacturing a drug delivery device comprising: a step of forming a first through hole in at least a portion of the base sheet that contacts the first electrode portion; and a step of forming a drug-containing portion in the first through hole.
  • [2] A method for manufacturing a drug delivery device described in [1], in which the first through hole is formed in the base sheet by laser trimming.
  • [3] A method for manufacturing a drug delivery device described in [1] or [2], comprising a step of heating at least the first electrode portion after forming the first through hole.
  • [4] A method for manufacturing a drug delivery device described in any one of [1] to [3], wherein the drug-containing portion contains a drug, a moisture-retaining substance, and water.
  • the base sheet has a second through hole
  • the drug delivery device further includes an electrolyte-containing portion disposed in the second through-hole; a second conductive layer disposed on the base sheet and including a second electrode portion and a second wiring portion;
  • the drug delivery device according to [9] or [10], wherein the second electrode portion is in contact with the electrolyte-containing portion.
  • a power supply unit electrically connected to the first wiring unit;
  • the drug delivery device according to any one of [9] to [12], further comprising a control unit that controls the flow of electricity from the power supply unit.
  • a drug delivery device comprising: an insulating layer having a first opening and a second opening; a first conductive layer disposed on the insulating layer and given a first potential; and a second conductive layer disposed on the insulating layer and given a second potential different from the first potential; the first conductive layer is disposed so as to overlap the first opening; the second conductive layer is disposed so as to overlap the second opening; and a drug composition is disposed in at least one of the first opening and the second opening.
  • a drug delivery device comprising: a first conductive layer to which a first potential is applied, a first insulating layer, a second conductive layer to which a second potential different from the first potential is applied, and a second insulating layer, stacked in this order; an opening is provided in each of the first insulating layer, the second conductive layer, and the second insulating layer, and the openings are arranged to overlap each other and covered with the first conductive layer to form a first reservoir; an opening is provided in the second insulating layer, and the opening is covered with the second conductive layer to form a second reservoir; and a drug composition is disposed in at least one of the first reservoir and the second reservoir.
  • the first disclosure provides a method for efficiently manufacturing a drug delivery device. It also provides a drug delivery device with excellent manufacturing efficiency.
  • the drug delivery device of the second disclosure is configured such that a conductive layer overlaid on an opening in an insulating layer functions as an electrode, and a drug composition is disposed on the electrode, so the arrangement pattern and shape of the electrode can be determined by the arrangement pattern and shape of the opening in the insulating layer. Because insulating layers are easier to process and handle than conductive layers, according to the second disclosure, drug delivery devices equipped with electrodes in a variety of arrangement patterns and shapes can be easily manufactured.
  • the first conductive layer including the first electrode portion and first wiring portion on the base sheet, manufacturing efficiency is improved compared to forming the electrode and wiring separately and connecting them. Furthermore, by forming a first through-hole in at least the portion of the base sheet that contacts the first electrode portion and forming a drug-containing portion in the first through-hole, it becomes easier to align the first electrode portion and drug-containing portion.
  • Figure 1 is a plan view of a base sheet on which a first conductive layer and a second conductive layer are printed.
  • Figure 2 is a cross-sectional view taken along II-II in Figure 1.
  • Figure 3 is a plan view of the base sheet of Figure 1 when first through-holes and second through-holes are formed.
  • Figure 4 is a cross-sectional view taken along IV-IV in Figure 3.
  • Figure 5 is a plan view of Figure 3 when a drug-containing portion is formed in the first through-hole and an electrolyte-containing portion is formed in the second through-hole.
  • Figure 6 is a cross-sectional view taken along VI-VI in Figure 5.
  • Figure 7 is a plan view of the base sheet of Figure 5 when a power supply unit and a control unit are arranged.
  • Figure 8 is a plan view of the base sheet of Figure 7 when a cover sheet is arranged.
  • Figure 9 is a cross-sectional view taken along IX-IX in Figure 8.
  • the manufacturing method for the drug delivery device includes a step of printing a first conductive layer 1 including a first electrode portion 1C and a first wiring portion 1D on a base sheet 40.
  • a step of printing a first conductive layer 1 including a first electrode portion 1C and a first wiring portion 1D on a base sheet 40 By printing the first conductive layer 1 including the first electrode portion 1C and the first wiring portion 1D on the base sheet 40, manufacturing efficiency is improved compared to when the electrodes and wiring are formed separately and then connected.
  • the manufacturing method according to the embodiment preferably includes a step of printing a second conductive layer 2 including a second electrode portion 2C and a second wiring portion 2D onto a base sheet 40.
  • a step of printing a second conductive layer 2 including a second electrode portion 2C and a second wiring portion 2D onto a base sheet 40 By printing the second conductive layer 2 including the second electrode portion 2C and the second wiring portion 2D onto the base sheet 40, manufacturing efficiency is improved compared to when the electrodes and wiring are formed separately and then connected.
  • the second conductive layer 2 may be printed onto the base sheet 40 before or after the first conductive layer 1 is printed onto the base sheet 40, or the first conductive layer 1 and the second conductive layer 2 may be printed onto the base sheet 40 simultaneously.
  • the first conductive layer 1 and the second conductive layer 2 are preferably printed by inkjet printing, screen printing, flexographic printing, gravure printing, or offset printing, or a combination of these, with inkjet printing or screen printing being more preferred. This allows for efficient printing. It is preferable that the first conductive layer 1 and the second conductive layer 2 are printed by the same type of printing.
  • Conductive ink is preferably used in the printing process. Using conductive ink makes it easier to print on the base sheet 40.
  • the conductive ink preferably contains a conductive substance and a binder resin.
  • the first conductive layer 1 and the second conductive layer 2 may be printed using conductive inks with the same components, or conductive inks with different components.
  • the conductive material preferably contains a metal, carbon, or a mixture thereof, and more preferably contains a metal.
  • the metal preferably contains gold, silver, silver halide, copper, platinum, zinc, lead, tin, titanium, aluminum, nickel, or a combination thereof, and more preferably contains silver, silver halide, zinc, or a combination thereof.
  • the metal is preferably in particulate form. Examples of particulate forms include spheres, ellipsoids, polyhedrons, rods, plates, scales, and irregular shapes. If particulate, the average particle diameter is preferably 0.1 nm or more and 1000 nm or less, and more preferably 1 nm or more and 500 nm or less.
  • the average particle diameter can be measured as the median diameter (d50) using laser diffraction/scattering methods.
  • the carbon preferably contains carbon fiber, graphite, ketjen black, fullerene, carbon nanotubes, carbon nanohorns, furnace black, or a mixture thereof.
  • the carbon is preferably in particulate form.
  • the binder resin preferably contains a thermoplastic resin, a thermosetting resin, or a mixture of these, and preferably contains a thermosetting resin. This improves the adhesion of the conductive ink to the base sheet 40.
  • the binder resin is preferably one that can be burned away by heating or can be released from the conductive material by heating. This makes it easier for the conductive materials to come into contact with or bond with each other, reducing the resistance of the conductive layer.
  • the conductive ink may further include a curing accelerator, a solvent, an additive, or a combination thereof.
  • the curing accelerator may include a crosslinking agent, a thermal polymerization initiator, a photopolymerization initiator, or a mixture thereof.
  • the solvent may include an aqueous solvent, an organic solvent, or a mixture thereof.
  • the organic solvent may include ethanol, methanol, 2-propanol, N-methyl-2-pyrrolidone, isophorone, terpineol, triethylene glycol monobutyl ether, butyl cellosolve acetate, or a mixture thereof.
  • the additive may include a dispersant, an antifoaming agent, a leveling agent, or a mixture thereof.
  • the first layer is located in the electrode section, and the second layer is located in the electrode section and the wiring section.
  • the shapes of the first conductive layer 1 and the second conductive layer 2 when printed please refer to the description of the planar shapes of the first conductive layer 1 and the second conductive layer 2 of the drug delivery device 91 described below.
  • the base sheet 40 preferably includes a resin sheet, a paper sheet, fabric, or a laminate of these, and more preferably includes a resin sheet. This makes it easier to form through holes.
  • the method for forming the first through holes 40H and the second through holes 40I in the base sheet 40 it is preferable to form the through holes by laser trimming.
  • Laser trimming makes it easy to form through holes in the base sheet 40.
  • through holes are formed by laser trimming in the areas of the base sheet 40 that contact the electrode portions, the electrode portions and their vicinity are heated, thereby shortening the heating time in the heating step described below.
  • the method is not limited to lasers; for example, a blade may be used to form the through holes in the base sheet 40.
  • Laser trimming can be performed, for example, by irradiating a laser onto the surface of the base sheet 40 closest to the epithelial tissue and then moving the irradiation position sequentially to form through-holes. Specifically, it is preferable to fix the position of the base sheet 40 and move the laser emitted from the laser oscillator, but it is also possible to fix the position of the laser and move the base sheet 40, or to move both the laser and the base sheet 40. Laser trimming is preferably a so-called hole-punching process.
  • the laser is preferably a solid-state laser in which the laser medium is a solid, or a gas laser in which the laser medium is a gas, and more preferably a gas laser.
  • the output of the laser light is preferably 1 W or more and 50 W or less, and more preferably 10 W or more and 40 W or less. An output of 1 W or more can improve the trimming speed. An output of 50 W or less can reduce damage to the base sheet 40.
  • the shape of the first through hole 40H and the second through hole 40I in a plan view is preferably a convex polygon, a concave polygon, a circle, an ellipse, an arcuate shape, or a combination of these, and is more preferably a convex polygon.
  • convex polygons include a square and a rectangle.
  • concave polygons include an L-shape.
  • the convex corners of a convex polygon may be rounded.
  • the convex corners, concave corners, or both of the convex corners of a concave polygon may be rounded.
  • the manufacturing method according to the embodiment preferably includes a step of heating at least the first electrode portion 1C after forming the first through-hole 40H. It is more preferable to heat at least the first electrode portion 1C and the first wiring portion 1D in this heating step. For example, if the conductive ink contains a solvent, this heating can evaporate the solvent. Furthermore, by heating at a high temperature, at least the first electrode portion 1C can be baked, thereby reducing resistance.
  • the heating temperature in the heating step is preferably 50°C or higher and 150°C or lower, more preferably 70°C or higher and 130°C or lower, and even more preferably 80°C or higher and 110°C or lower.
  • a heating temperature of 50°C or higher makes it easier to evaporate the solvent.
  • a heating temperature of 70°C or higher makes it easier to bake the electrode portions and wiring portions.
  • a heating temperature of 150°C or lower makes it easier to prevent denaturation of the base sheet 40.
  • the heating temperature does not need to be constant and can be varied. For example, if the conductive ink contains a solvent, heating can be performed to dry the solvent after printing, and then the temperature can be raised and heating can be performed for baking. This heating can also be performed multiple times.
  • the heating time in the heating step is preferably 30 minutes or more and 5 hours or less, and more preferably 1 hour or more and 3 hours or less. A heating time of 30 minutes or more makes drying and firing easier. A heating time of 5 hours or less further improves manufacturing efficiency.
  • an electric heating oven it is preferable to use an electric heating oven, an infrared oven, a far-infrared oven (IR), or a near-infrared oven (NIR).
  • IR far-infrared oven
  • NIR near-infrared oven
  • a laser irradiation device may also be used.
  • the drug-containing portion 20 When forming the drug-containing portion 20 in the first through-hole 40H, it is preferable to form the drug-containing portion 20 in the first through-hole 40H by placing a moisture-retaining substance containing at least a drug and moisture in the first through-hole 40H.
  • the drug-containing portion 20 may also be formed in the first through-hole 40H by placing a moisture-retaining substance in the first through-hole 40H and then adding at least a drug and moisture to the moisture-retaining substance.
  • the drug-containing portion 20 may be formed in the first through-hole 40H by placing a moisture-retaining substance containing at least an electrolyte in the first through-hole 40H and then adding a drug and moisture to the moisture-retaining substance.
  • the drug-containing portion 20 may be formed in the first through-hole 40H by placing a moisture-retaining substance containing at least an electrolyte and a drug in the first through-hole 40H and then adding moisture to the moisture-retaining substance.
  • the moisture-retaining substance may also be fixed to the first conductive layer 1, the base sheet 40, or both, with an adhesive. In this case, a conductive adhesive may be used.
  • the drug-containing portion 20 is preferably formed after the heating step. Furthermore, when forming the drug-containing section 20, it is preferable to orient the first through-hole 40H vertically upward and place the drug or the like into the first through-hole 40H from above in the vertical direction.
  • the drug-containing portion 20 preferably contains a drug, a moisture-retaining substance, and water. This makes it easier to deliver the drug from the drug-containing portion 20 into the epithelial tissue when a voltage is applied to the first electrode portion 1C.
  • the moisture-retaining substance preferably contains fabric, a paper sheet, a porous membrane, a hydrogel, or a combination thereof, more preferably contains fabric, a hydrogel, or a combination thereof, and even more preferably contains hydrogel.
  • the manufacturing method according to the embodiment preferably includes a step of forming an electrolyte-containing portion 30 in the second through-hole 40I.
  • a step of forming an electrolyte-containing portion 30 in the second through-hole 40I By forming the second through-hole 40I in at least the portion of the base sheet 40 that contacts the second electrode portion 2C, and further forming the electrolyte-containing portion 30 in the second through-hole 40I, it becomes easier to align the second electrode portion 2C with the electrolyte-containing portion 30.
  • the electrolyte-containing portion 30 When forming the electrolyte-containing portion 30 in the second through-hole 40I, it is preferable to form the electrolyte-containing portion 30 in the second through-hole 40I by placing a water-retaining substance containing at least an electrolyte and moisture in the second through-hole 40I.
  • the electrolyte-containing portion 30 may also be formed in the second through-hole 40I by placing at least a water-retaining substance in the second through-hole 40I and then adding an electrolyte and moisture to the water-retaining substance, or by placing a water-retaining substance containing at least an electrolyte in the second through-hole 40I and then adding moisture to the water-retaining substance.
  • the water-retaining substance may also be fixed to the second conductive layer 2, the base sheet 40, or both with an adhesive.
  • a conductive adhesive may be used.
  • the electrolyte-containing portion 30 preferably contains an electrolyte, a moisture-retaining substance, and water.
  • the moisture and electrolyte in the electrolyte-containing portion 30 can reduce skin resistance and power consumption.
  • the moisture-retaining substance preferably includes fabric, a paper sheet, a porous membrane, a hydrogel, or a combination thereof, more preferably fabric, hydrogel, or a combination thereof, and even more preferably includes hydrogel.
  • the manufacturing method according to the embodiment preferably includes a step of placing a power supply unit 50 on a base sheet 40.
  • the power supply unit 50 preferably has a primary battery or a secondary battery.
  • the primary battery or secondary battery is preferably housed in a package, and the package may be fixed to the base sheet 40, for example, via an adhesive.
  • the manufacturing method preferably includes a step of placing the control unit 60 on the base sheet 40.
  • an electric or electronic circuit housed in a package may be prepared, and the package may be fixed to the base sheet 40 with an adhesive.
  • a portion of the electric or electronic circuit may be formed on the base sheet 40 by printing, and passive components, active components, or both may be placed on top. This printing may be performed before the heating step.
  • the manufacturing method according to the embodiment may include a step of printing a third conductive layer 3 including a third wiring portion 3D on a base sheet 40.
  • the third conductive layer 3 can electrically connect the power supply unit 50 and the control unit 60.
  • the third conductive layer 3 preferably includes the third wiring portion 3D, and more preferably consists of the third wiring portion 3D.
  • the third conductive layer 3 may be printed on the base sheet 40 before or after the first conductive layer 1 and the second conductive layer 2 are printed on the base sheet 40, or may be printed on the base sheet 40 simultaneously with the first conductive layer 1 and the second conductive layer 2.
  • the third conductive layer 3 is preferably printed on the base sheet 40 before the heating step.
  • the power supply unit 50 and the control unit 60 may be connected by a cable.
  • the printing of the third conductive layer 3 is preferably inkjet printing, screen printing, flexographic printing, gravure printing, offset printing, or a combination of these, and more preferably inkjet printing or screen printing.
  • the printing of the third conductive layer 3 is preferably the same type as the printing of the first conductive layer 1 and the second conductive layer 2, but may be a different type of printing.
  • a conductive ink is preferably used when printing the third conductive layer 3.
  • the conductive ink preferably contains a conductive material and a binder resin.
  • drug delivery device 91 includes a drug-containing portion 20 containing a drug, and a first conductive layer 1 including a first electrode portion 1C and a first wiring portion 1D. As shown in FIG. 10, drug delivery device 91 preferably further includes a second conductive layer 2 including a second electrode portion 2C and a second wiring portion 2D, a power supply portion 50, and a control unit 60 that controls the flow of electricity from power supply portion 50.
  • the drug delivery device 91 includes a base sheet 40 having a first through-hole 40H, a drug-containing portion 20 disposed in the first through-hole 40H, and a first conductive layer 1 disposed on the base sheet 40.
  • the first conductive layer 1 includes a first electrode portion 1C and a first wiring portion 1D.
  • the first electrode portion 1C is in contact with the drug-containing portion 20.
  • the drug-containing portion 20 is disposed in the first through-hole 40H, which makes it easier to maintain the external shape of the drug-containing portion 20.
  • the first electrode portion 1C being in contact with the drug-containing portion 20 makes it easier to deliver the drug from the drug-containing portion 20 when a voltage is applied. Specifically, it is preferable that a surface 1E of the first electrode portion 1C that is closer to the epithelial tissue 90 is in contact with the drug-containing portion 20.
  • the base sheet 40 preferably further has a second conductive layer 2 disposed on the base sheet 40.
  • the second conductive layer 2 preferably includes a second electrode portion 2C and a second wiring portion 2D.
  • the first electrode portion 1C preferably has a first linear portion.
  • the second electrode portion 2C preferably has a second linear portion.
  • the first linear portion and the second linear portion preferably face each other in the width direction.
  • the first linear portion and the second linear portion each preferably have a straight portion, and more preferably consist of a straight portion. This improves manufacturing efficiency.
  • the first electrode portion 1C and the second electrode portion 2C may have a wavy or zigzag portion. This allows the opposing length of adjacent electrodes to be further increased.
  • the outer edges of the first electrode portion 1C and the second electrode portion 2C each have multiple corners, but at least one corner may be rounded.
  • the first electrode portion 1C and the second electrode portion 2C may each be a convex polygon, a concave polygon, a circle, an ellipse, an arcuate shape, or a combination of these shapes, and may be a convex polygon or a concave polygon.
  • convex polygons include a square and a rectangle.
  • concave polygons include an L-shape.
  • the convex corners of a convex polygon may be rounded.
  • the convex corners, concave corners, or both of the convex corners of a concave polygon may be rounded.
  • the width of the gap between the first electrode portion 1C and the second electrode portion 2C is preferably larger than the width of the first electrode portion 1C and larger than the width of the second electrode portion 2C. This reduces the effect of fluctuations in the width of the gap even when the drug delivery device 91 is extended.
  • the width of the gap between the first electrode portion 1C and the second electrode portion 2C may be smaller than the width of the first electrode portion 1C and smaller than the width of the second electrode portion 2C. This makes it easier to deliver drugs between the electrodes.
  • the first conductive layer 1 may be a single layer or a multi-layer structure.
  • the first electrode portion 1C and the first wiring portion 1D share at least one conductive layer. This improves manufacturing efficiency and also improves conductivity.
  • the first conductive layer 1 may have, for example, a conductive first layer located in the first electrode portion 1C, and a conductive second layer located in the first electrode portion 1C and the first wiring portion 1D. In this case, it is preferable that a portion of the conductive second layer is located on the conductive first layer. It is also preferable that the conductive first layer contains a component different from that of the conductive second layer.
  • the first wiring portion 1D is continuous with the first electrode portion 1C and is narrower than the first electrode portion 1C.
  • the second wiring portion 2D is continuous with the second electrode portion 2C and is narrower than the second electrode portion 2C.
  • the shapes of the first wiring portion 1D and the second wiring portion 2D are not particularly limited, but it is preferable that each be linear.
  • the first wiring portion 1D and the second wiring portion 2D may each have a branch portion.
  • the molecular weight of the drug is preferably 100 or more and 1,000,000 or less, more preferably 500 or more and 50,000 or less, even more preferably 700 or more and 15,000 or less, and particularly preferably 1,000 or more and 8,000 or less.
  • a drug with a molecular weight of 8,000 or less allows the drug to easily permeate the epithelial tissue 90.
  • the first electrode portion 1C is the anode and the second electrode portion 2C is the cathode, but the first electrode portion 1C may be the cathode and the second electrode portion 2C may be the anode.
  • the anode and cathode may be switched by changing the direction of current at predetermined intervals. For example, if the drug delivery device 91 has multiple drug-containing portions 20, the anode and cathode may be switched by changing the direction of current at predetermined intervals as described above.
  • the moisture-retaining material preferably includes a fabric, a paper sheet, a porous membrane, a hydrogel, or a combination thereof, more preferably includes a fabric, a hydrogel, or a combination thereof, and even more preferably includes a hydrogel.
  • the fabric preferably includes nonwoven fabric, woven fabric, knitted fabric, or a laminate thereof, and more preferably includes knitted fabric.
  • the fabric preferably includes cotton, linen, silk, cellulose, cellulose derivatives, synthetic fibers, or combinations thereof.
  • the synthetic fibers preferably include polyester resin, polyolefin resin, urethane resin, fluororesin, silicone resin, or combinations thereof.
  • the paper sheet preferably includes pulp.
  • the porous membrane has air bubbles, and preferably has interconnected, open cells.
  • the porous membrane preferably contains a fluororesin, polyolefin resin, polyester resin, silicone resin, cellulose, a cellulose derivative, or a mixture thereof.
  • methods for forming air bubbles include dissolving a gas in a resin under high pressure and then reducing the pressure to form air bubbles; mixing a foaming agent into the resin and causing thermal decomposition or a chemical reaction to form air bubbles; mixing a filler into the resin and stretching the resin to form air bubbles at the interface between the resin and the filler; and mixing a bubble-forming agent into the resin and then eluting the bubble-forming agent with warm water or the like to form air bubbles.
  • the fluororesin preferably contains polytetrafluoroethylene.
  • the polyolefin resin preferably contains polyethylene, polypropylene, or a mixture thereof.
  • the polyester resin preferably contains polyethylene terephthalate.
  • the silicone resin preferably contains polydimethylsiloxane.
  • the cellulose derivative preferably contains hydroxyethyl cellulose, hydroxypropyl cellulose, or a mixture thereof.
  • the hydrogel preferably contains a water-soluble polymer.
  • the water-soluble polymer preferably has a crosslinked structure, a hydrophobic group, a crystalline structure, or a combination of these, and more preferably has a crosslinked structure. This makes the water-soluble polymer more likely to function as a gel. In particular, the crosslinked structure improves the shape retention of the hydrogel.
  • the crosslinked structure of the water-soluble polymer may be formed using, for example, a polyvalent metal compound, a sequestering agent, a pH adjuster, or a combination of these.
  • the water-soluble polymer preferably includes a polysaccharide, a synthetic resin, or a mixture thereof, and more preferably includes a polysaccharide.
  • the polysaccharide preferably includes gelatin, agar, agarose, dextran, carboxy starch, dextrin, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, chitosan, alginic acid, hyaluronic acid, a salt thereof, or a mixture thereof.
  • the salt may be either a partially neutralized salt or a fully neutralized salt.
  • the synthetic resin preferably includes polyvinyl alcohol, polyethylene oxide, polyvinyl methyl ether, polyvinyl ether-maleic anhydride copolymer, methoxyethylene-maleic anhydride copolymer, isobutylene-maleic anhydride copolymer, a silicone-containing copolymer, polyvinylpyrrolidone, polyacrylamide, a carboxyvinyl polymer, polyacrylic acid, a salt thereof, or a mixture thereof.
  • the salt may be either a partially neutralized salt or a fully neutralized salt.
  • the silicone-containing copolymer preferably has a siloxane structure, an ether structure, an ester structure, or both.
  • the drug-containing portion 20 may contain additives other than the drug, water, and moisture-retaining substance.
  • the additives may include crosslinking agents, electrolytes, pH adjusters, fillers, adhesives, preservatives, moisturizers, antioxidants, colorants, fragrances, oils, UV absorbers, cooling agents, warming agents, transdermal absorption enhancers, conductive substances, or mixtures thereof.
  • the electrolyte preferably includes a salt.
  • the salt preferably includes a halide.
  • the halide preferably includes calcium chloride, potassium chloride, sodium chloride, calcium bromide, potassium bromide, sodium bromide, or a mixture thereof.
  • the pH adjuster preferably includes acetic acid, phosphoric acid, citric acid, carbonic acid, or a salt thereof, or a mixture thereof.
  • the drug-containing portion 20 contains an adhesive, allowing it to be directly attached to the epithelial tissue 90.
  • the drug-containing portion 20 contains a transdermal absorption enhancer, making it easier to deliver the drug into the epithelial tissue 90.
  • the transdermal absorption enhancer preferably includes hydrophilic polyethers such as polyethylene glycol and polypropylene glycol; organic acid esters such as isopropyl myristate and isopropyl palmitate; fatty acids having 6 to 20 carbon atoms such as oleic acid, stearic acid, and palmitic acid; squalane; castor oil; anionic surfactants; cationic surfactants; amphoteric surfactants; or mixtures thereof.
  • the conductive material preferably includes conductive fibers, conductive fillers, or a combination thereof.
  • the conductive filler preferably includes conductive particles.
  • the base sheet 40 preferably further has a second through-hole 40I.
  • the drug delivery device 91 preferably further has an electrolyte-containing portion 30 disposed in the second through-hole 40I.
  • the second electrode portion 2C of the second conductive layer 2 preferably contacts the electrolyte-containing portion 30.
  • the electrolyte-containing portion 30 preferably contains an electrolyte, a moisture-retaining substance, and water.
  • the water and electrolyte in the electrolyte-containing portion 30 can reduce skin resistance and power consumption.
  • the electrolyte-containing portion 30 preferably does not contain any drugs.
  • the moisture-retaining substance preferably includes a fabric, a paper sheet, a porous membrane, a hydrogel, or a combination thereof, more preferably a fabric, a hydrogel, or a combination thereof, and even more preferably a hydrogel.
  • the moisture-retaining substance of the drug-containing portion 20 preferably includes the same moisture-retaining substance as the drug-containing portion 20, but does not have to include the same moisture-retaining substance.
  • the electrolyte preferably includes a salt.
  • the salt preferably includes a halide.
  • the halide preferably includes calcium chloride, potassium chloride, sodium chloride, calcium bromide, potassium bromide, sodium bromide, or a mixture thereof.
  • the electrolyte-containing portion 30 may contain additives other than water, a moisture-retaining substance, and electrolytes.
  • the additives may include pH adjusters, fillers, adhesives, preservatives, moisturizers, antioxidants, colorants, fragrances, oils, UV absorbers, cooling agents, warming agents, conductive substances, or mixtures thereof.
  • an adhesive in the electrolyte-containing portion 30, the electrolyte-containing portion 30 can be directly attached to the epithelial tissue 90.
  • the conductive substance preferably includes conductive fibers, a conductive filler, or a combination thereof.
  • the conductive filler preferably includes conductive particles.
  • the electrolyte-containing portion 30 is preferably in contact with the surface 2E of the second electrode portion 2C that is closer to the epithelial tissue 90.
  • the drug is more easily delivered into the epithelial tissue 90.
  • the drug delivery device 91 is preferably attached to the epithelial tissue 90 by sticking, wrapping, adhering, or placement on the epithelial tissue 90, and more preferably attached to the epithelial tissue 90 by sticking.
  • attachment include sticking with an adhesive, which will be described later.
  • wrapping include wrapping with an elastic band, which will be described later.
  • adhering include adhering with a porous sheet, which will be described later.
  • placement include placement with a medical clip.
  • the drug delivery device 91 is preferably placed on the epithelial tissue 90 of humans, but may also be placed on the epithelial tissue of animals other than humans, such as dogs, cats, horses, and cows.
  • the control unit 60 preferably has a DC output, a pulse output, a pulse depolarized output, or a circuit for executing these outputs, and more preferably has a circuit for executing pulse output.
  • the control unit 60 may further have a processor and memory.
  • the control unit 60 may be configured so that the processor switches between DC output, pulse output, and pulse depolarized output in accordance with a program recorded in the memory. Examples of memory include an SSD, HDD, and ROM.
  • the control unit 60 may also have a circuit capable of changing the direction of current.
  • the control unit 60 may be configured so that the processor changes the direction of current using the circuit in accordance with a program recorded in the memory. This allows for alternating switching between anode and cathode.
  • control unit 60 may switch from a mode in which a voltage is applied so that the first electrode unit 1C is the anode and the second electrode unit 2C is the cathode to a mode in which a voltage is applied so that the first electrode unit 1C is the cathode and the second electrode unit 2C is the anode. If the first electrode portion 1C, the second electrode portion 2C, or both are active electrodes, switching the electrodes in this manner can regenerate consumed electrodes.
  • the pulse frequency of the pulse voltage is preferably 0.5 Hz or more and 50 Hz or less. This allows the drug delivery device 91 to increase the skin permeability of the drug while reducing irritation of the epithelial tissue 90 caused by the application of voltage.
  • the pulse frequency of the pulse voltage is not limited to the above range and may be, for example, 0.5 Hz or more and 5,000 kHz or less, 0.5 Hz or more and 50 kHz or less, or 0.5 Hz or more and 5 kHz or less.
  • the pulse width is preferably between 10 ms and 1000 ms.
  • the pulse width corresponds to the time during one cycle that the output is on.
  • the pulse width is preferably between 40% and 60% of one cycle, and more preferably between 45% and 55%.
  • the waveform of the pulse voltage is preferably a square wave, triangular wave, sawtooth wave, or sine wave, and more preferably a square wave.
  • Each function in the control unit 60 may be implemented by, for example, a processor, an ASIC (Application Specific Integrated Circuit), a DSP (Digital Signal Processor), an FPGA (Field Programmable Gate Array), or a combination of these.
  • the control unit 60 may also have a constant voltage diode or a constant current diode.
  • the drug delivery device 91 preferably further includes a third conductive layer 3 including a third wiring portion 3D on the base sheet 40.
  • the third conductive layer 3 electrically connects the power supply unit 50 and the control unit 60.
  • the third conductive layer 3 preferably includes the third wiring portion 3D, and more preferably consists of the third wiring portion 3D.
  • the third conductive layer 3 is preferably fixed to the base sheet 40.
  • the third conductive layer 3 is preferably formed and fixed on the base sheet 40 by printing. If the drug delivery device 91 does not include the third conductive layer 3, the power supply unit 50 and the control unit 60 may be connected by a cable. Examples of the cable include a metal wire coated with an insulating film.
  • the power supply unit 50, control unit 60, and each electrode are connected in sequence by wires.
  • the first conductive layer 1 and the second conductive layer 2 are fixed to the surface of the base sheet 40 farther from the epithelial tissue 90 (hereinafter sometimes referred to as the "upper surface"), and it is more preferable that at least the first conductive layer 1, the second conductive layer 2, the power supply unit 50, and the control unit 60 are fixed. At least some of these may be fixed with an adhesive or bonding agent.
  • the drug delivery device of the second disclosure is configured by an insulating layer having an opening and a conductive layer disposed over the opening, with a drug composition disposed in the opening of the insulating layer.
  • the insulating layer has a first opening and a second opening, with a first conductive layer disposed over the first opening and a second conductive layer disposed over the second opening and a second conductive layer disposed over the second opening and a second conductive layer disposed over the first opening and a second potential different from the first potential.
  • the conductive layer disposed over the opening of the insulating layer functions as an electrode, with one of the portion of the first conductive layer overlapping the first opening and the portion of the second conductive layer overlapping the second opening acting as an anode and the other as a cathode.
  • Iontophoresis is known as a technique for transdermally supplying drugs into the body using electrical action. Iontophoresis is a technique in which a voltage is applied from electrodes to the skin, generating a potential gradient across the skin, and this potential gradient is used to transdermally supply drugs into the body. Using the potential gradient across the skin as a driving force, the drug can be permeated into the skin by the electrical repulsion between the drug and the electrode, or the potential gradient across the skin can generate an electroosmotic flow within the skin, and the drug can be delivered from the epithelial tissue into the subcutaneous tissue or blood vessels by riding on the electroosmotic flow.
  • the drug delivery device of the second disclosure can be used as such an iontophoresis device.
  • FIGS. 11 to 13 show exemplary configurations of a drug delivery device according to the first embodiment of the second disclosure.
  • FIG. 11 shows an exemplary cross-sectional configuration of the drug delivery device according to the second disclosure, illustrating the state in which the drug delivery device is placed on the skin.
  • FIG. 12 shows a cross-sectional view of the drug delivery device according to the first embodiment
  • FIG. 13 shows a plan view of the drug delivery device shown in FIG. 12, viewed from the bottom. Note that while the drug composition and electrolyte composition are hatched in FIG. 13, this hatching does not represent a cross section, but is provided to clearly distinguish between the drug composition and the electrolyte composition.
  • the drug delivery device 101 is a device placed on the skin 191 for use, and can transdermally supply drugs into the body.
  • the drug delivery device 101 of the first embodiment comprises a base sheet 121, a first conductive layer 131 placed on the base sheet 121 and given a first potential, a second conductive layer 132 placed on the base sheet 121 and given a second potential different from the first potential, a first insulating layer 141 placed on the first conductive layer 131 and having a first opening 151, and a second insulating layer 142 placed on the second conductive layer 132 and having a second opening 152, the first conductive layer 131 being positioned so as to overlap the first opening 151, and the second conductive layer 132 being positioned so as to overlap the second opening 152, and a drug composition 106 being placed in at least one of the first opening 151 and the second opening 152.
  • first conductive layer 131 and the second conductive layer 132 on the base sheet 121 means that the first conductive layer 131 and the second conductive layer 132 are arranged on the surface (main surface) of the base sheet 121, and does not refer to the vertical positional relationship between the base sheet 121 and the first conductive layer 131 or the second conductive layer 132. The same applies to expressions such as "on the first conductive layer 131" and "on the second conductive layer 132.”
  • the portion of the first conductive layer 131 that overlaps the first opening 151 and the portion of the second conductive layer 132 that overlaps the second opening 152 function as electrodes.
  • Each electrode is preferably electrically connected to a power supply unit 181.
  • Drug delivery device 101 has a planar direction and a thickness direction.
  • the planar direction refers to the direction in which each layer constituting drug delivery device 101 extends
  • the thickness direction refers to the direction in which each layer constituting drug delivery device 101 is stacked.
  • An upper side and a lower side are defined in the thickness direction, with the lower side referring to the side facing the skin (epithelial tissue) when drug delivery device 101 is placed on the skin for use, and the upper side referring to the opposite side.
  • the base sheet 121 is a sheet on which the first conductive layer 131 and the second conductive layer 132 are arranged.
  • the base sheet 121 preferably constitutes the main part of the drug delivery device 101, and it is preferable that each layer be laminated on the base sheet 121 and that components such as the power supply unit 181 be installed on the base sheet 121.
  • the area of the base sheet 121 preferably accounts for 50% or more of the area of the drug delivery device 101, more preferably 60% or more, and even more preferably 70% or more.
  • the first conductive layer 131 and the second conductive layer 132 are arranged on the underside of the base sheet 121, i.e., on the surface of the base sheet 121 closest to the epithelial tissue.
  • the base sheet 121 can be made of an insulator, and is preferably electrically insulated from the first conductive layer 131 and second conductive layer 132 arranged on the base sheet 121. At least the areas of the base sheet 121 where the first conductive layer 131 and second conductive layer 132 are arranged need to be made of an insulator, but it is preferable that the entire base sheet 121 be made of an insulator.
  • the base sheet 121 can be made of, for example, a resin sheet, a cloth material such as nonwoven fabric, woven fabric, or knitted fabric, or paper.
  • the base sheet 121 may also be an elastic body, and may be made of, for example, a rubber sheet, which is a type of resin sheet.
  • the first conductive layer 131 and the second conductive layer 132 are electrically connected to the power supply unit 181.
  • the first potential applied to the first conductive layer 131 and the second potential applied to the second conductive layer 132 are different potentials. This allows a potential gradient to be generated between the first conductive layer 131 and the second conductive layer 132 through the skin when the drug delivery device 101 is placed against the skin.
  • the fact that the first potential and the second potential are different can be determined by the fact that one of the first conductive layer 131 and the second conductive layer 132 is connected to the positive electrode of the power supply unit 181 and the other is connected to the negative electrode of the power supply unit 181.
  • the first conductive layer 131 and the second conductive layer 132 may be connected to either the positive electrode or the negative electrode of the power supply unit 181.
  • the conductive layer connected to the positive electrode can function as an anode
  • the conductive layer connected to the negative electrode can function as a cathode.
  • the first conductive layer 131 and the second conductive layer 132 can function as anode or cathode electrodes and also serve as the wiring unit 183.
  • the first conductive layer 131 and the second conductive layer 132 are composed of a conductor.
  • conductors that make up the first conductive layer 131 or the second conductive layer 132 include metals such as gold, silver, copper, platinum, zinc, lead, tin, titanium, aluminum, nickel, and alloys thereof, as well as silver halides and carbon.
  • the first conductive layer 131 or the second conductive layer 132 may be made of silver/silver halide, i.e., silver coated with silver halide. Preferred metals are silver, zinc, gold, platinum, and titanium, with silver and zinc being more preferred.
  • silver halides include silver fluoride, silver chloride, silver bromide, and silver iodide, with silver chloride being preferred.
  • carbon include carbon fiber, graphite, ketjen black, fullerene, carbon nanotubes, carbon nanohorns, and furnace black.
  • the first conductive layer 131 and the second conductive layer 132 are preferably made of a thin-film conductor. This allows the drug delivery device 101 to be made thinner.
  • the thin-film conductive layer can be formed, for example, by printing ink containing a conductive substance on the base sheet 121, by placing a thin metal film on the base sheet 121, or by etching.
  • the drug delivery device 101 may have a base sheet 121 disposed above the first conductive layer 131 and the second conductive layer 132.
  • FIG. 16 shows a cross-sectional view of the drug delivery device
  • FIG. 17 shows a plan view of the drug delivery device shown in FIG. 15 viewed from the bottom.
  • the base sheet 121 be disposed above the insulating layer 104, the first conductive layer 131, and the second conductive layer 132.
  • the first conductive layer 131 and the second conductive layer 132 be disposed between the base sheet 121 and the insulating layer 104.
  • a drug delivery device has a laminate in which a first conductive layer, a first insulating layer, a second conductive layer, and a second insulating layer are stacked in this order.
  • This laminate includes a first reservoir section that penetrates the second insulating layer, the second conductive layer, and the first insulating layer, with the first conductive layer forming its bottom surface, and a second reservoir section that penetrates the second insulating layer, with the second conductive layer forming its bottom surface.
  • a drug composition is disposed in at least one of the first reservoir section and the second reservoir section.
  • the drug delivery device 201 is a device that is placed on the skin 241 and can transdermally supply drugs into the body.
  • the drug delivery device 201 comprises a first conductive layer 202 to which a first potential is applied, a first insulating layer 203, a second conductive layer 204 to which a second potential different from the first potential is applied, and a second insulating layer 205, stacked in this order. Openings 211, 212, and 213 are provided in the first insulating layer 203, the second conductive layer 204, and the second insulating layer 205, respectively.
  • the openings 211, 212, and 213 are arranged overlapping each other and covered with the first conductive layer 202 to form a first reservoir 207.
  • the second insulating layer 205 has an opening 213, which is covered with the second conductive layer 204 to form a second reservoir 208.
  • a drug composition 221 is disposed in at least one of the first reservoir 207 and the second reservoir 208.
  • Drug delivery device 201 has a planar direction and a thickness direction.
  • the planar direction refers to the direction in which each layer constituting drug delivery device 201 extends
  • the thickness direction refers to the direction in which each layer constituting drug delivery device 201 is stacked.
  • An upper side and a lower side are defined in the thickness direction, with the lower side referring to the side facing the skin (epithelial tissue) when drug delivery device 201 is placed on the skin for use, and the upper side referring to the opposite side.
  • the first conductive layer 202 and the second conductive layer 204 are composed of a conductor.
  • conductors that make up the first conductive layer 202 or the second conductive layer 204 include metals such as gold, silver, copper, platinum, zinc, lead, tin, titanium, aluminum, nickel, and alloys thereof, as well as silver halides and carbon.
  • the first conductive layer 202 or the second conductive layer 204 may be made of silver/silver halide, i.e., silver coated with silver halide. Preferred metals are silver, zinc, gold, platinum, and titanium, with silver and zinc being more preferred.
  • silver halides include silver fluoride, silver chloride, silver bromide, and silver iodide, with silver chloride being preferred.
  • carbon include carbon fiber, graphite, ketjen black, fullerene, carbon nanotubes, carbon nanohorns, and furnace black.
  • the first conductive layer 202 and the second conductive layer 204 may be connected to either the positive electrode or the negative electrode of the power supply unit 231.
  • the conductive layer connected to the positive electrode can function as an anode
  • the conductive layer connected to the negative electrode can function as a cathode.
  • the first conductive layer 202 and the second conductive layer 204 can function as anode or cathode electrodes and can also serve as wiring units.
  • First conductive layer 202 and second conductive layer 204 are preferably made of thin-film conductors. This allows the drug delivery device 201 to be made thinner. Thin-film conductive layers can be formed, for example, by printing with ink containing a conductive substance, by arranging a thin metal film, or by etching.
  • the thickness of the first conductive layer 202 and the second conductive layer 204 is preferably less than 0.3 mm, more preferably 0.2 mm or less, and even more preferably 0.1 mm or less.
  • the lower limit of the thickness of the first conductive layer 202 and the second conductive layer 204 may be, for example, 1 ⁇ m or more, 3 ⁇ m or more, 5 ⁇ m or more, or 10 ⁇ m or more, which makes the first conductive layer 202 and the second conductive layer 204 less likely to break unintentionally.
  • the first insulating layer 203 and the second insulating layer 205 are made of an insulator.
  • the first insulating layer 203 electrically insulates the first conductive layer 202 and the second conductive layer 204.
  • the second insulating layer 205 prevents the second conductive layer 204 from coming into direct contact with the skin.
  • the first insulating layer 203 and the second insulating layer 205 can be made of, for example, a resin sheet, a cloth material such as nonwoven fabric, woven fabric, or knitted fabric, or paper.
  • the first insulating layer 203 and the second insulating layer 205 may also be made of an elastic material, and may be made of, for example, a rubber sheet, which is a type of resin sheet.
  • the opening 211 in the first insulating layer 203, the opening 212 in the second conductive layer 204, and the opening 213 in the second insulating layer 205 are disposed overlapping each other, and the first conductive layer 202 is disposed above them, and by being covered with the first conductive layer 202, a first storage portion 207 is formed. Furthermore, the second conductive layer 204 is disposed above the opening 213 in the second insulating layer 205, and by being covered with the second conductive layer 204, a second storage portion 208 is formed.
  • the first conductive layer 202 is preferably arranged to overlap the first insulating layer 203 in a portion other than the first storage portion 207.
  • the portion of the first conductive layer 202 other than the first storage portion 207 can function as a wiring portion.
  • the first conductive layer 202 may be arranged only in a portion overlapping with the first insulating layer 203 to form a wiring portion.
  • the first conductive layer 202 is preferably entirely covered by the first insulating layer 203 in a portion other than the first storage portion 207.
  • the opening 212 in the second conductive layer 204 is preferably larger than the opening 211 in the first insulating layer 203 and the opening 213 in the second insulating layer 205. Specifically, it is preferable that the second conductive layer 204 is not exposed in the first storage section 207, and it is preferable that the entire edge of the opening 212 in the second conductive layer 204 is sandwiched between the first insulating layer 203 and the second insulating layer 205. This prevents short circuits in the first storage section 207. More preferably, although not shown in the drawings, the first insulating layer 203 and the second insulating layer 205 are bonded to each other at the opening 212 in the second conductive layer 204.
  • planar shape of the laminate in which the first conductive layer 202, the first insulating layer 203, the second conductive layer 204, and the second insulating layer 205 are stacked, or, if a base sheet 206 is provided, the laminate in which the base sheet 206, the first conductive layer 202, the first insulating layer 203, the second conductive layer 204, and the second insulating layer 205 are stacked, is not particularly limited.
  • planar shapes include polygons such as squares, hexagons, and octagons, rounded polygons, circles, ellipses, dumbbell shapes, and irregular shapes.
  • the outer shapes of the first insulating layer 203, the second insulating layer 205, and the base sheet 206 are substantially identical.
  • the first conductive layer 202 can be formed on the base sheet 206.
  • the second conductive layer 204 by printing ink containing a conductive substance on the first insulating layer 203 or by placing a thin metal film on the first insulating layer 203, the thin-film second conductive layer 204 can be easily formed.
  • Drug composition 221 is disposed in at least one of first storage section 207 and second storage section 208.
  • drug composition 221 may be disposed in at least a portion of the interior of first storage section 207 in contact with first conductive layer 202
  • drug composition 221 may be disposed in at least a portion of the interior of second storage section 208 in contact with second conductive layer 204.
  • the drug is preferably a pharmaceutical.
  • Pharmaceuticals are drugs used for the diagnosis, treatment, or prevention of disease.
  • Examples of pharmaceuticals include anti-inflammatory agents, antipyretic and anti-inflammatory analgesics, antibiotics, local anesthetics, anti-allergy agents, anti-Alzheimer's agents, anti-Parkinson's disease agents, psychotropic agents, anti-rheumatic agents, smoking cessation aids, and circulatory system agents.
  • the molecular weight of the drug is preferably 100 or more and 1,000,000 or less, more preferably 500 or more and 50,000 or less, even more preferably 700 or more and 15,000 or less, and even more preferably 1,000 or more and 8,000 or less. In particular, if the molecular weight of the drug is 8,000 or less, the drug's permeability into the skin can be increased.
  • Cloth materials include nonwoven fabrics, woven fabrics, knitted fabrics, etc., with knitted fabrics being preferred.
  • Fibers constituting cloth materials include natural fibers such as cotton, linen, and silk; recycled fibers such as rayon; semi-synthetic fibers such as acetate; and synthetic fibers made from polyester (e.g., PET), polyolefin (e.g., polypropylene, polyethylene), polyurethane, and polyamide (e.g., nylon).
  • Paper materials preferably contain pulp, and examples include tissue paper.
  • resins that make up the porous body include fluororesins such as PTFE, PFA, and ETFE; polyolefin resins such as polyethylene and polypropylene; polyester resins such as polyethylene terephthalate and polybutylene terephthalate; silicone resins such as polydimethylsiloxane; polyamide resins such as nylon; and cellulose derivatives such as hydroxyethyl cellulose and hydroxypropyl cellulose.
  • the porous body may also be a porous membrane.
  • transdermal absorption enhancers examples include hydrophilic polyethers such as polyethylene glycol and polypropylene glycol, organic acid esters such as isopropyl myristate and isopropyl palmitate, fatty acids having 6 to 20 carbon atoms such as oleic acid, stearic acid, and palmitic acid, squalane, castor oil, anionic surfactants, cationic surfactants, and amphoteric surfactants.
  • Drug composition 221 containing a conductive substance can enhance the conductivity of drug composition 221.
  • conductive substances include conductive fibers and conductive fillers.
  • the conductive filler preferably contains conductive particles.
  • Drugs can be placed on either the anode electrode or the cathode electrode, i.e., on either the first reservoir 207 in which the first conductive layer 202 is disposed or the second reservoir 208 in which the second conductive layer 204 is disposed, depending on whether the ionized substance that functions as the medicinal ingredient becomes a cation or anion upon ionization. If the ionized substance that functions as the medicinal ingredient is a cation, it is preferably placed on the anode electrode. If the ionized substance that functions as the medicinal ingredient is an anion, it is preferably placed on the cathode electrode.
  • drug composition 221 can be placed on either the anode electrode or the cathode electrode, depending on whether the ionized substance is positively or negatively charged overall.
  • the ionization state of the drug is determined based on the pH conditions of drug composition 221.
  • drug composition 221 is placed in first storage section 207, and first conductive layer 202 placed in first storage section 207 is connected to the positive electrode of power supply section 231, so first conductive layer 202 placed in first storage section 207 serves as the anode. Therefore, it is preferable that the drug contained in drug composition 221 has its active ingredient become a cation when ionized, or become an ionized substance that is positively charged overall.
  • drug composition 221 is placed in second storage section 208, and second conductive layer 204 placed in second storage section 208 is connected to the positive electrode of power supply section 231, so second conductive layer 204 placed in second storage section 208 serves as the anode. Therefore, it is preferable that the drug contained in drug composition 221, when ionized, has its active ingredient become a cation, or becomes an ionized substance that is positively charged overall.
  • drug composition 221 When drug composition 221 is placed in first storage section 207, as shown in FIG. 22, it is preferable that drug composition 221 is placed inside first storage section 207 and protrudes from first storage section 207 on the side opposite first conductive layer 202.
  • drug composition 221 When drug composition 221 is placed in second storage section 208, as shown in FIG. 24, it is preferable that drug composition 221 is placed inside second storage section 208 and protrudes from second storage section 208 on the side opposite second conductive layer 204.
  • the thickness (length in the thickness direction) of drug composition 221 protruding from first reservoir 207 to the side opposite first conductive layer 202, and the thickness (length in the thickness direction) of drug composition 221 protruding from second reservoir 208 to the side opposite second conductive layer 204 are preferably 0.1 mm or more, more preferably 0.3 mm or more, even more preferably 0.5 mm or more, and preferably 10 mm or less, more preferably 5 mm or less, and even more preferably 3 mm or less.
  • the drug composition 221 may be disposed in both the first reservoir 207 and the second reservoir 208. However, if the drug composition 221 is disposed in only one of the first reservoir 207 and the second reservoir 208, it is preferable that the electrolyte composition 222 be disposed in the other of the first reservoir 207 and the second reservoir 208. In Figures 22 and 23, the drug composition 221 is disposed in the first reservoir 207 and the electrolyte composition 222 is disposed in the second reservoir 208, while in Figures 24 and 25, the drug composition 221 is disposed in the second reservoir 208 and the electrolyte composition 222 is disposed in the first reservoir 207.
  • electrolyte composition 222 may further contain a pH adjuster, and may also contain additives such as crosslinkers, fillers, adhesives, preservatives, humectants, antioxidants, colorants, fragrances, oils, UV absorbers, cooling agents, warming agents, transdermal absorption enhancers, and conductive substances.
  • electrolyte composition 222 is a drug-free composition.
  • the electrolyte composition 222 When the electrolyte composition 222 is placed in the second storage section 208, as shown in FIG. 22, the electrolyte composition 222 may be placed in at least a portion of the interior of the second storage section 208 in contact with the second conductive layer 204, and preferably placed inside the second storage section 208 while protruding from the second storage section 208 on the side opposite the second conductive layer 204.
  • the electrolyte composition 222 is placed in the first storage section 207, as shown in FIG.
  • the drug composition 221 or the electrolyte composition 222 may be arranged so as to protrude from the first storage section 207 on the side opposite the first conductive layer 202, and in the second storage section 208, the drug composition 221 or the electrolyte composition 222 may be arranged so as not to protrude from the second storage section 208.
  • the drug composition 221 or the electrolyte composition 222 may be arranged so as not to protrude from the first storage section 207, and in the second storage section 208, the drug composition 221 or the electrolyte composition 222 may be arranged so as to protrude from the second storage section 208 on the side opposite the second conductive layer 204.
  • the drug composition 221 or the electrolyte composition 222 is arranged to protrude from the first reservoir 207 on the side opposite the first conductive layer 202, and in the second reservoir 208, the drug composition 221 or the electrolyte composition 222 is arranged to protrude from the second reservoir 208 on the side opposite the second conductive layer 204.
  • the drug composition 221 is disposed in one of the first storage section 207 and the second storage section 208, and the electrolyte composition 222 is disposed in the other. More preferably, the drug composition 221 is disposed in the first storage section 207 and protrudes from the first storage section 207 on the side opposite the first conductive layer 202, and the electrolyte composition 222 is disposed in the second storage section 208 and protrudes from the second storage section 208 on the side opposite the second conductive layer 204; alternatively, the drug composition 221 is disposed in the second storage section 208 and protrudes from the second storage section 208 on the side opposite the second conductive layer 204, and the electrolyte composition 222 is disposed in the first storage section 207 and protrudes from the first storage section 207 on the side opposite the first conductive layer 202. Furthermore, since it becomes possible to place a larger amount of drug composition 221, it is preferable that drug composition 221 be placed in first reservoir 207 and electro
  • the drug delivery device 201 By configuring the drug delivery device 201 as described above, it becomes easy to arbitrarily set the arrangement pattern and shape of the first storage section 207 and the second storage section 208 when manufacturing the drug delivery device 201. By appropriately setting the arrangement pattern and shape when forming the opening 211 in the first insulating layer 203, the opening 212 in the second conductive layer 204, and the opening 213 in the second insulating layer 205, it becomes possible to set a variety of arrangement patterns and shapes for the first storage section 207 and the second storage section 208.
  • Figures 23 and 25 the area where the first reservoir 207 is provided and the area where the second reservoir 208 is provided are separated in a plan view of the drug delivery device 201, but as shown in Figure 26, the first reservoir 207 and the second reservoir 208 may be interleaved.
  • Figure 26 shows a plan view of the drug delivery device 201 as seen from the bottom side, with the power supply unit, control unit, and wiring unit omitted.
  • the entire first storage section 207 and the entire second storage section 208 can each be surrounded by a convex polygon, and the area formed by the convex polygon surrounding the entire first storage section 207 and the area formed by the convex polygon surrounding the entire second storage section 208 are arranged so that they do not overlap.
  • a convex polygon is a polygon in which the interior angles of all vertices are less than 180°, and is formed so that all vertices protrude toward the outside of the polygon when viewed from the inside.
  • the convex rectangle surrounding the entire first storage section 207 and the convex rectangle surrounding the entire second storage section 208 can be set so that they do not overlap.
  • the number of vertices of a convex polygon is not particularly limited as long as it is three or more, and the number of vertices may be infinite.
  • the convex polygon may be a triangle, a rectangle, or a substantially circle.
  • the positive electrode be connected to the conductive layer that provides the electrode on which drug composition 221 is provided. If, upon ionization of the drug, anions or ionized substances with a negative charge overall become the active ingredient, it is preferable that the negative electrode be connected to the conductive layer that provides the electrode on which drug composition 221 is provided.
  • the battery used in the power supply unit 231 may be a primary battery or a secondary battery.
  • the primary battery is preferably a lithium battery, and more preferably a coin-type lithium battery. This reduces costs and is particularly suitable when the drug delivery device 201 is disposable.
  • the power supply unit 231 may have multiple batteries, for example, two coin-type lithium batteries connected directly.
  • the applied voltage of the power supply unit 231 is preferably 0.1 V or more and 6 V or less.
  • the current density is preferably 0.01 mA/ cm2 or more and 0.4 mA/ cm2 or less.
  • the drug delivery device 201 preferably has a control unit 232 that controls the current flow from the power supply unit 231.
  • the control unit 232 can set the form of current flow between the electrodes.
  • the control unit 232 can be arranged, for example, in a laminate including the first conductive layer 202, the first insulating layer 203, the second conductive layer 204, and the second insulating layer 205.
  • Current flow forms include DC current, pulse current, and pulse depolarized current.
  • DC current is a form in which a predetermined direct current is applied between the electrodes.
  • Pulse current is a form in which a predetermined repetitive pulse is applied between the electrodes.
  • the pulse frequency is preferably 0.5 Hz or more and 50 Hz or less. This ensures skin permeability of the drug while reducing irritation to epithelial tissue caused by the application of voltage.
  • the pulse frequency of the pulse voltage is not limited to the above range, and may be, for example, 0.5 Hz or more and 5,000 kHz or less, 0.5 Hz or more and 50 kHz or less, or 0.5 Hz or more and 5 kHz or less. Pulse frequency refers to the frequency of the pulse voltage applied between the electrodes.
  • the waveform of the pulse voltage is not particularly limited, and examples include a square wave, a triangular wave, a sawtooth wave, a sine wave, and any combination thereof. Of these, it is preferable that the waveform of the pulse voltage is a square wave.
  • the control unit 232 preferably performs pulse output by controlling the voltage, but may also perform pulse output by controlling the current.
  • the control unit 232 may have a circuit capable of changing the direction of the current.
  • the control unit 232 may be configured so that a processor changes the direction of the current using the circuit in accordance with a program recorded in memory. This allows for alternating switching between the anode and the cathode.
  • the drug delivery device 201 may be configured so that the control unit 232 can switch from a mode in which a voltage is applied so that the first conductive layer 202 is the anode and the second conductive layer 204 is the cathode to a mode in which a voltage is applied so that the first conductive layer 202 is the cathode and the second conductive layer 204 is the anode. If the first conductive layer 202, the second conductive layer 204, or both, are active electrodes, switching the electrodes in this manner can regenerate consumed electrodes.
  • Each function in the control unit 232 may be realized by, for example, a processor, an ASIC (Application Specific Integrated Circuit), a DSP (Digital Signal Processor), an FPGA (Field Programmable Gate Array), or a combination of these.
  • the control unit 232 may also have a constant voltage diode or a constant current diode.
  • the drug delivery device 201 preferably has a wiring section 233 that electrically connects each electrode to the power supply section 231.
  • the wiring section 233 preferably electrically connects the power supply section 231 to the control section 232, and also electrically connects the control section 232 to the electrodes. This allows the control section 232 to control the flow of electricity from the power supply section 231 to the electrodes.
  • the control section 232 may be provided so as to be electrically connected to at least one of the electrode that functions as an anode and the electrode that functions as a cathode.
  • the first conductive layer 202 and/or the second conductive layer 204 may constitute at least a part of the wiring section 233.
  • the wiring portion 233 may be in the form of a thin film, a plate, or a cable.
  • Examples of thin-film wiring include printed wiring created by printing, etching, or the like. Examples of printing include screen printing, offset printing, and inkjet printing, and the wiring portion 233 can be formed by printing using ink containing a conductive substance. Examples of cable-shaped wiring include metal wire coated with an insulating film.
  • the wiring portion 233 is preferably made of a conductor, and for details of the conductor that makes up the wiring portion 233, see the explanation of the conductor that makes up the first conductive layer 202 and the second conductive layer 204 above.
  • the drug delivery device 201 may have a cover sheet 209.
  • Figures 27 and 28 show an example configuration in which a cover sheet 209 is further provided to the drug delivery device 201 shown in Figures 22 and 23, with Figure 27 showing a cross-sectional view of the drug delivery device 201 and Figure 28 showing a plan view of the drug delivery device 201 shown in Figure 27 viewed from the bottom.
  • the cover sheet 209 is preferably placed on top of the laminate including the first conductive layer 202, the first insulating layer 203, the second conductive layer 204, and the second insulating layer 205, and is provided to cover the entire laminate and be larger than the laminate.
  • the cover sheet 209 preferably extends outward beyond the outer edge of the laminate.
  • the drug delivery device 201 preferably has an adhesive portion on its underside. This allows the drug delivery device 201 to be attached to the skin, and the drug delivery device 201 to be stably attached to the skin.
  • the adhesive portion is the portion exposed on the underside of the drug delivery device 201, and can be provided on the underside of the second insulating layer 205 or the underside of the cover sheet 209.
  • Drug delivery device 201 can be placed in epithelial tissue for use.
  • the epithelial tissue on which drug delivery device 201 is placed may be epithelial tissue of the skin or epithelial tissue of the mucosa, but is preferably epithelial tissue of the skin.
  • Drug delivery device 201 is preferably attached to epithelial tissue of the arm, hand, leg, foot, back, abdomen, chest, face, head, or oral cavity, and more preferably attached to epithelial tissue of or near joints such as elbows, shoulders, and wrists.
  • drug delivery device 201 is preferably configured to allow the drug to pass through at least the tight junctions of the epithelial tissue. The degree of penetration of the drug into the epithelial tissue can be adjusted, for example, by controlling the voltage.
  • the drug delivery device 201 is preferably attached to the epithelial tissue by sticking, wrapping, adsorption, or placement, and more preferably attached to the epithelial tissue by sticking. Attachment can be by sticking using an adhesive portion. Wrapping can be by wrapping using a band. Adsorption can be by adsorption using a porous body, for example. Placement can be by placement using a medical clip, for example.
  • the drug delivery device 201 is preferably placed in the epithelial tissue of humans, but may also be placed in the epithelial tissue of animals other than humans, such as dogs, cats, horses, and cows.
  • each configuration of the drug delivery device described above can be implemented by arbitrarily combining or substituting multiple embodiments.
  • the configuration in which a cover sheet is provided, as shown in Figures 27 and 28, can be applied to any of the embodiments described above.
  • drug delivery devices equipped with electrodes of various arrangement patterns and shapes can be easily manufactured.
  • a configuration in which multiple first storage sections and/or multiple second storage sections are provided is preferable in that the effects of the third disclosure are more effectively achieved.

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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)

Abstract

La présente invention concerne un procédé permettant de produire efficacement un dispositif d'administration de médicament, et un dispositif d'administration de médicament présentant une efficacité de production exceptionnelle. Ce procédé de production d'un dispositif d'administration de médicament comprend : une étape d'impression, sur une feuille de matériau de base, d'une première couche électroconductrice comprenant une première partie électrode et une première partie de câblage ; une étape de formation d'un premier trou traversant dans au moins une partie de la feuille de matériau de base qui est en contact avec la première partie électrode ; et une étape de formation d'une partie contenant un médicament dans le premier trou traversant.
PCT/JP2025/011722 2024-03-27 2025-03-25 Dispositif d'administration de médicament et procédé de production d'un dispositif d'administration de médicament Pending WO2025205761A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
JP2024051373 2024-03-27
JP2024-051374 2024-03-27
JP2024-051373 2024-03-27
JP2024-051375 2024-03-27
JP2024051374 2024-03-27
JP2024051375 2024-03-27

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WO2025205761A1 true WO2025205761A1 (fr) 2025-10-02

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009034117A (ja) * 2006-03-10 2009-02-19 Transcutaneous Technologies Inc イオントフォレーシス装置
JP2010531202A (ja) * 2007-06-26 2010-09-24 アルザ・コーポレーシヨン ロフェンタニルおよびカルフェンタニルの経皮的電気輸送送達の方法および装置
JP2012529353A (ja) * 2009-06-09 2012-11-22 Ｔｔｉ・エルビュー株式会社 長寿命高容量電極、装置および製造方法
JP2023073133A (ja) * 2021-11-15 2023-05-25 アイソン株式会社 微弱電流発生ヒト適用部品

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009034117A (ja) * 2006-03-10 2009-02-19 Transcutaneous Technologies Inc イオントフォレーシス装置
JP2010531202A (ja) * 2007-06-26 2010-09-24 アルザ・コーポレーシヨン ロフェンタニルおよびカルフェンタニルの経皮的電気輸送送達の方法および装置
JP2012529353A (ja) * 2009-06-09 2012-11-22 Ｔｔｉ・エルビュー株式会社 長寿命高容量電極、装置および製造方法
JP2023073133A (ja) * 2021-11-15 2023-05-25 アイソン株式会社 微弱電流発生ヒト適用部品

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