WO2017061310A1 - Procédé de production de feuille d'absorption percutanée - Google Patents

Procédé de production de feuille d'absorption percutanée Download PDF

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Publication number
WO2017061310A1
WO2017061310A1 PCT/JP2016/078556 JP2016078556W WO2017061310A1 WO 2017061310 A1 WO2017061310 A1 WO 2017061310A1 JP 2016078556 W JP2016078556 W JP 2016078556W WO 2017061310 A1 WO2017061310 A1 WO 2017061310A1
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WO
WIPO (PCT)
Prior art keywords
mold
electroforming
pretreatment liquid
pattern
concave pattern
Prior art date
Application number
PCT/JP2016/078556
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English (en)
Japanese (ja)
Inventor
小川　正太郎
健一郎 玉木
Original Assignee
富士フイルム株式会社
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
Priority claimed from JP2016022835A external-priority patent/JP6499598B2/ja
Application filed by 富士フイルム株式会社 filed Critical 富士フイルム株式会社
Priority to CN201680058111.5A priority Critical patent/CN108138344B/zh
Priority to EP16853464.2A priority patent/EP3375909A4/fr
Priority to KR1020187007590A priority patent/KR102088197B1/ko
Publication of WO2017061310A1 publication Critical patent/WO2017061310A1/fr
Priority to US15/940,985 priority patent/US10814527B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/38—Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D1/00—Electroforming

Definitions

  • the present invention relates to a method for producing a transdermal absorption sheet.
  • micro-needle array has been known as a new dosage form that can administer drugs such as insulin, vaccine (Vaccines) and hGH (human Growth Hormone) into the skin without pain.
  • the microneedle array is an array of biodegradable microneedles (also referred to as microneedles or microneedles) containing a drug. By affixing this microneedle array to the skin, each microneedle pierces the skin, the microneedle is absorbed in the skin, and the drug contained in each microneedle can be administered into the skin.
  • the microneedle array is also called a transdermal absorption sheet.
  • a metal microneedle array produced by machining is used as an original plate.
  • a concave mold which is an inverted resin mold, is produced using the produced microneedle array master.
  • a medical or cosmetic microneedle array is produced from the produced mold.
  • many masters are required.
  • the work for preparing the original plate increases, so the manufacturing cost of the original plate increases.
  • Patent Document 1 discloses that an ultrasonic wave is applied to an electroforming solution to remove a gas attached to a cathode and attached to an original plate.
  • the present invention has been made in view of such circumstances, and an object thereof is to provide a method for producing a transdermal absorption sheet using an electroformed mold.
  • a method for producing a percutaneous absorption sheet includes a preparation step of preparing a matrix having a needle-like concave pattern, and a degassed pretreatment liquid held in a pretreatment liquid tank. Immerse the mold, apply the ultrasonic wave generated from the ultrasonic transducer to the concave pattern of the master mold, fill the concave part constituting the concave pattern with the pretreatment liquid, and remove the master mold from the pretreatment liquid tank A take-out step to be taken out, a forming step of forming a metal body on the surface of the concave pattern of the mother die by immersing the mother die in an electroforming liquid held in an electroforming tank and performing an electroforming process; and A peeling step of peeling from the mold to obtain an electroformed mold having a projecting pattern having a reverse shape of the concave pattern, a step of producing a mold having a concave pattern using the electroformed mold, and a drug to the concave pattern of the mold Fill the poly
  • the pretreatment liquid is water.
  • the ultrasonic transducer and the surface on which the concave pattern of the matrix is formed are arranged to face each other.
  • the matrix is made of a resin material.
  • the resin material is a thermoplastic resin or an ultraviolet curable resin.
  • the dissolved oxygen concentration of the degassed pretreatment liquid is 0.5 mg / L or less.
  • a vacuum deaeration device connected to the pretreatment liquid tank through a circulation channel is provided, and the degassed pretreatment liquid is passed between the pretreatment liquid tank and the vacuum deaeration device. Prepared by circulating.
  • the step of producing the mold includes producing a resin mold having a concave pattern which is a reverse shape of the projecting pattern of the electroforming mold.
  • it includes a peeling step of peeling the polymer sheet from the mold.
  • the polymer solution contains a water-soluble material.
  • a transdermal absorption sheet can be produced using an electroforming mold.
  • FIG. 2 is an appearance photograph of a protruding pattern of an electroforming mold according to Example 1.
  • FIG. 4 is an appearance photograph of a protruding pattern of an electroforming mold according to Comparative Example 1.
  • 6 is an appearance photograph of a protruding pattern of an electroformed mold according to Comparative Example 2.
  • FIG. 1A to 4C are process diagrams showing a procedure of a method for producing an electroforming mold.
  • FIG. 5 is a perspective view of a mold that is a matrix.
  • FIG. 1A shows a preparation process for preparing a mold 10 as a mother mold.
  • the mold 10 has a needle-like concave pattern 10 ⁇ / b> A (hereinafter also simply referred to as a concave pattern 10 ⁇ / b> A) formed on the surface 10 ⁇ / b> B (or one surface) side.
  • the concave pattern 10A has an inverted shape of the projection pattern of the electroforming mold desired to be produced (or the projection pattern of the percutaneous absorption sheet desired to be produced).
  • the needle-like concave pattern 10 ⁇ / b> A is a state in which the needle-like concave portion 12 extending from the surface 10 ⁇ / b> B of the mold 10 toward the other surface is formed, and the concave portion 12 is disposed on the surface 10 ⁇ / b> B side of the mold 10.
  • the number of the concave portions, the arrangement of the concave portions, the depth of the concave portions, etc. are not limited.
  • the needle shape means a tapered shape in the depth direction from the surface 10B to the other surface. Examples thereof include a cone shape, a combination of a column shape and a cone shape, and a combination of a frustum shape and a cone shape.
  • the ratio of the depth to the opening length of the recess is 1.2 to 8.0.
  • the concave pattern 10A is an inverted shape of the projection pattern of the electroformed mold to be produced, the size, number, and arrangement of the concave portions of the concave pattern 10A are basically the same as the size of the projection pattern of the electroformed mold. It will be the same. As shown in FIGS. 1A and 5, the mold 10 has a 4 ⁇ 4 concave pattern 10A formed on the surface 10B side.
  • FIG. 1B is a diagram showing a state in which the mold 10 is attached to the cathode 20 used in the electroforming process.
  • the cathode 20 includes at least a shaft 22 and a cathode plate 24.
  • the mold 10 is detachably attached to the cathode plate 24 by a fixing member 26 at a position where the concave pattern 10 ⁇ / b> A faces away from the cathode plate 24.
  • the shaft 22 and the cathode plate 24 are made of a conductive member.
  • electroforming treatment refers to a treatment method in which metal is deposited on the surface of a mold by electroplating.
  • FIG. 1C shows a filling step of filling the degassed pretreatment liquid 32 into the concave portions of the concave pattern 10A of the mold 10.
  • a pretreatment liquid tank 30 that holds the pretreatment liquid 32 is installed.
  • a vacuum deaerator 36 is connected to the pretreatment liquid tank 30 via the circulation channel 34.
  • An ultrasonic transducer 38 is installed in the pretreatment liquid tank 30.
  • a dissolved oxygen meter 40 is installed in the pretreatment liquid tank 30 in order to measure the dissolved oxygen concentration of the pretreatment liquid 32.
  • the vacuum degassing device 36 is a device that removes the dissolved gas dissolved in the pretreatment liquid 32 using a vacuum degassing method.
  • the mold 10 as a mother die is immersed in the pretreatment liquid 32 held in the pretreatment liquid tank 30 while being attached to the cathode 20.
  • the surface 10B of the mold 10 on which the concave pattern 10A is formed and the ultrasonic transducer 38 are aligned.
  • the surface 10B on which the concave pattern 10A of the mold 10 is formed and the ultrasonic transducer 38 are arranged to face each other. Since the ultrasonic transducer 38 and the surface 10B face each other, ultrasonic waves can be applied efficiently.
  • the pretreatment liquid 32 in the pretreatment liquid tank 30 is circulated through the pretreatment liquid tank 30 and the vacuum deaeration device 36 by the circulation flow path 34, and the pretreatment liquid 32 is degassed when passing through the vacuum deaeration device 36.
  • the degassed pretreatment liquid means a dissolved oxygen concentration of 8.0 mg / L or less (20 ° C., 1 atm (101.325 kPa). In normal pure water, the dissolved oxygen concentration is 8.84 mg / L. L (20 ° C., 1 atm (101.325 kPa)).
  • the pretreatment liquid 32 It is preferable to deaerate the pretreatment liquid 32 until the dissolved oxygen concentration of the pretreatment liquid 32 is 0.5 mg / L or less.
  • the dissolved oxygen concentration of the pretreatment liquid 32 can be measured by the dissolved oxygen meter 40.
  • the pretreatment liquid 32 is circulated between the pretreatment liquid tank 30 and the vacuum degassing device 36 for about 1 hour, so that dissolved oxygen in the pretreatment liquid 32 is obtained.
  • the concentration can be 0.5 mg / L or less, and the degassed pretreatment liquid 32 can be prepared.
  • the dissolved oxygen concentration of the pretreatment liquid 32 0.5 mg / L or less, it is possible to more effectively prevent the gas from remaining in the recess 12 of the mold 10.
  • the ultrasonic wave generated from the ultrasonic vibrator 38 is applied to the concave pattern 10A of the mold 10.
  • the degassed pretreatment liquid 32 is also immersed in the mold 10 and an ultrasonic wave is applied to the concave pattern 10A, whereby the gas present in the concave portion 12 constituting the concave pattern 10A is removed, and the pretreatment liquid 32 becomes the concave portion 12. Filled.
  • the degassed pretreatment liquid 32 since the degassed pretreatment liquid 32 is used, the amount of gas dissolved in the pretreatment liquid 32 is small. Furthermore, by applying ultrasonic waves to the pretreatment liquid 32, positive and negative pressures are instantaneously applied to the pretreatment liquid 32, and so-called cavitation is generated in which minute bubbles are generated and disappeared instantaneously under negative pressure. Thereby, the gas in the pretreatment liquid 32 is removed.
  • the gas present in the concave portion 12 of the concave pattern 10A can be removed. Further, since the gas is removed, the pretreatment liquid 32 can be filled in the recess 12. In particular, the pretreatment liquid 32 can be pushed into the tapered tip of the recess 12 by ultrasonic waves.
  • the ultrasonic wave means a frequency of 20 kHz or higher.
  • the pretreatment liquid 32 held in the pretreatment liquid tank 30 pure water or an aqueous solution in which an electroforming liquid component is dissolved in pure water can be used.
  • FIG. 2A shows a removal step of taking out the mold 10 as a mother mold from the pretreatment liquid tank 30.
  • the mother mold 10 attached to the cathode 20 is taken out from the pretreatment liquid tank 30 (not shown).
  • the concave portion 12 constituting the concave pattern 10 ⁇ / b> A of the mold 10 is filled with a sufficiently degassed pretreatment liquid 32.
  • FIG. 2B is a diagram showing a state when the mold 10 which is a mother die attached to the cathode 20 is immersed in the electroforming liquid 62.
  • an electroforming apparatus 60 that performs electroforming on the mold 10 includes an electroforming tank 64 that holds an electroforming liquid 62 and a drain that receives an electroforming liquid 62 ⁇ / b> A that overflows the electroforming tank 64.
  • a tank 66 and a titanium case 70 filled with Ni pellets 68 are provided.
  • the cathode 20 with the mold 10 attached is functioned as an electroforming apparatus 60 by immersing it in the electroforming liquid 62.
  • a drain pipe 72 is connected to the drain tank 66, and a supply pipe 74 is connected to the electroforming tank 64.
  • the electroforming liquid 62 overflowed from the electroforming tank 64 to the drain tank 66 is recovered by the drain pipe 72, and the recovered electroforming liquid 62 is supplied from the supply pipe 74 to the electroforming tank 64.
  • the concave portion 12 of the mold 10 is filled with the degassed pretreatment liquid 32. There is no gas in the concave portion 12 of the mold 10.
  • FIG. 2B when the mold 10 is immersed in the electroforming liquid 62 with the pretreatment liquid 32 filled in the recess 12, the pretreatment liquid 32 filled in the recess 12 is replaced with the electroforming liquid 62. By replacing the pretreatment liquid 32 with the electroforming liquid 62, the electroforming liquid 62 is filled in the recess 12 of the mold 10. As a result, gas is suppressed from being brought into the recess 12 of the mold 10.
  • 3A and 3B show that the metal body 80 is placed on the surface of the concave pattern 10A of the mold 10 by immersing the mold 10 as a mother mold in the electroforming liquid 62 held in the electroforming tank 64 and performing electroforming. The formation process to form is shown.
  • the mold 10 attached to the cathode 20 is completely immersed in the electroforming liquid 62.
  • the recess 12 of the mold 10 is filled with the electroforming liquid 62 without any gas.
  • the mold 10 held by the cathode 20 is aligned at a position where the surface on which the concave pattern 10A is formed is opposed to the titanium case 70 serving as the anode.
  • the cathode 20 is connected to the negative electrode, and the positive electrode is connected to the titanium case 70 serving as the anode.
  • a DC voltage is applied between the cathode 20 and the titanium case 70 while rotating the mold 10 held by the cathode plate 24 around the shaft 22 at a rotation speed of 50 to 150 rpm.
  • the Ni pellet 68 is melted, and a metal body 80 (electroformed film) is formed on the surface of the mold 10 attached to the cathode 20 on which the concave pattern 10A is formed.
  • the metal body 80 along the shape of the recess 12 can be formed. In particular, it is possible to obtain a metal body 80 having no protrusions and / or voids.
  • the electroforming liquid 62 for example, a liquid in which 400 to 800 g / L nickel sulfamate, 20 to 50 g / L boric acid, and necessary additives such as a surfactant (for example, sodium lauryl sulfate) are mixed. Can be used.
  • the temperature of the electroforming liquid 62 is preferably 40 to 60 ° C.
  • the mold 10 is made of a resin material, it is preferable to first conduct the conductive treatment on the mold 10.
  • a metal for example, nickel
  • sputtered on the mold 10 to adhere the metal to the surface of the mold 10 and the concave pattern 10A.
  • the cathode 20 to which the mold 10 is attached is taken out from the electroforming tank 64 (not shown).
  • the mold 10 on which the metal body 80 is formed is removed from the cathode 20.
  • FIG. 4C shows a peeling process for obtaining the electroforming mold 82.
  • the metal body 80 is peeled off from the mold 10 which is a mother mold to obtain an electroformed mold 82 having a protruding pattern 82A.
  • the protruding pattern 82 ⁇ / b> A has an inverted shape of the concave pattern 10 ⁇ / b> A of the mold 10.
  • the electroforming mold 82 is a metal body 80 peeled from the mold 10.
  • the metal body 80 having no voids and / or chips in the protrusions can be obtained, as a result, the electroforming mold 82 having the protruding pattern 82A having no voids and / or chips is obtained. it can.
  • FIGS. 6A to 7C are process diagrams showing the procedure of the method for producing the mold 10 which is the mother die.
  • the mold 10 which is a matrix is made of a resin material. This is because the mold 10 can be easily manufactured.
  • FIG. 6A shows a state in which the original 100 is prepared.
  • the original plate 100 having the protruding pattern 100A is produced, for example, by machining a metal substrate to be the original plate 100 using a cutting tool such as a diamond tool.
  • a cutting tool such as a diamond tool.
  • the metal substrate stainless steel, aluminum alloy, Ni or the like can be used.
  • an original plate 100 having a plurality of protruding patterns 100A is produced.
  • the protruding pattern 100A refers to a state in which protruding portions protruding in a direction away from the flat surface 100B of the original 100 are arranged on the flat surface 100B of the original 100.
  • the number of protrusions, the positions of the protrusions, etc. are not limited.
  • the protruding portion constituting the protruding pattern 100A is configured with a needle portion tapering in a direction away from the plane 100B, it is configured with a frustum portion and a tapered needle portion in a direction away from the plane 100B. Moreover, you may comprise from the frustum part, the columnar part, and the needle part which tapers in the direction away from the plane 100B.
  • the protrusion has a height of, for example, 100 to 2000 ⁇ m from the flat surface 100B of the original 100, and preferably has a tip diameter of ⁇ 50 ⁇ m or less.
  • the interval between adjacent protrusions is preferably 300 to 2000 ⁇ m.
  • the aspect ratio of the protrusion (height of the protrusion / width of the bottom surface of the protrusion) is preferably 1.2 to 8.0.
  • FIGS. 6B and 6C are process diagrams showing a process of producing a resin mold 10 having a concave pattern 10A by using an original plate 100 having a protruding pattern 100A.
  • the concave pattern 10 ⁇ / b> A refers to a state in which a concave portion extending from one surface of the mold 10 toward the other surface is disposed on one surface of the mold 10.
  • the number of recesses, the position where the recesses are arranged, etc. are not limited.
  • the mold 10 serving as a mother mold having the concave pattern 10A can be manufactured by the first to third methods described below.
  • An ultraviolet curable resin that cures when irradiated with ultraviolet rays is prepared.
  • the protruding pattern 100A of the original 100 is pressed against the ultraviolet curable resin.
  • the ultraviolet curable resin is irradiated with ultraviolet rays to cure the ultraviolet curable resin.
  • the original 100 is peeled from the cured ultraviolet curable resin.
  • a resin mold 10 having a concave pattern 10 ⁇ / b> A that is an inverted shape of the protruding pattern 100 ⁇ / b> A of the original 100 is produced.
  • ultraviolet curable resin refers to a resin that is cured through a crosslinking reaction and a polymerization reaction when irradiated with ultraviolet rays.
  • examples of the ultraviolet polymerizable functional group include unsaturated polymerizable functional groups such as a (meth) acryloyl group, a vinyl group, a styryl group, and an allyl group.
  • thermoplastic resin as a material for the mold 10 is prepared.
  • the master 100 having the protruding pattern 100A is heated.
  • the protruding pattern 100A of the heated original plate 100 is pressed against the surface of the thermoplastic resin. Since the surface of the thermoplastic resin is softened, the surface of the thermoplastic resin is deformed into the shape of the protruding pattern 100A.
  • the original plate 100 While the original plate 100 is pressed against the thermoplastic resin, the original plate 100 is cooled. The original resin 100 is cooled to cure the thermoplastic resin. Thereafter, the original 100 is peeled from the thermoplastic resin to which the protruding pattern 100A is transferred. A resin mold 10 having a concave pattern 10 ⁇ / b> A that is an inverted shape of the protruding pattern 100 ⁇ / b> A of the original 100 is produced.
  • thermoplastic resin 14 examples include LDPE (Low Density Polyethylene), HDPE (High Density Polyethylene), PP (polypropylene), and PC (polycarbonate).
  • LDPE Low Density Polyethylene
  • HDPE High Density Polyethylene
  • PP polypropylene
  • PC polycarbonate
  • a silicone resin in which a curing agent is added to PDMS (polydimethylsiloxane, for example, Sylgard 184, Sylgard: registered trademark manufactured by Dow Corning) is prepared.
  • the protruding pattern 100A of the original 100 is pressed against the silicone resin.
  • the silicone resin is heated and cured at 100 ° C.
  • the original plate 100 is peeled from the cured silicone resin.
  • a mold 10 serving as a resin mother mold having a concave pattern 10A that is an inverted shape of the protruding pattern 100A of the original 100 is produced.
  • the method for producing the mold 10 is not limited to the first to third methods.
  • FIG. 7A shows a state in which the original 100 is prepared.
  • the original plate 100 having the protruding pattern 100A is produced, for example, by machining a metal substrate to be the original plate 100 using a cutting tool such as a diamond tool.
  • a cutting tool such as a diamond tool.
  • the metal substrate stainless steel, aluminum alloy, Ni or the like can be used.
  • an original plate 100 having one protruding pattern 100A is manufactured.
  • protruding pattern 100A The meaning of the protruding pattern 100A, the shape and dimensions of the protruding portion, and the like are the same as those in FIGS.
  • FIGS. 7B and 7C are process diagrams showing a process of producing a resin mold 10 having a concave pattern 10A by using an original plate 100 having a protruding pattern 100A.
  • a sheet-like thermoplastic resin 14 to be the mold 10 is prepared.
  • the original plate 100 and the sheet-like thermoplastic resin 14 are relatively moved to determine the position at which the original plate 100 is pressed against the thermoplastic resin 14.
  • the original plate 100 is heated to a temperature higher than the softening temperature of the thermoplastic resin 14.
  • the original plate 100 is pressed against the surface 10B side of the thermoplastic resin 14.
  • the protruding pattern 100 ⁇ / b> A of the original 100 is pressed against the thermoplastic resin 14.
  • the original plate 100 is cooled, so that the thermoplastic resin 14 is cooled to a softening temperature or lower.
  • the original plate 100 and the thermoplastic resin 14 are separated from each other, and a concave pattern 10A having an inverted shape of the protruding pattern 100A is formed on the surface 10B side of the thermoplastic resin 14.
  • the original plate 100 and the thermoplastic resin 14 are positioned in another region of the thermoplastic resin 14.
  • the heated original plate 100 is pressed against the surface 10 ⁇ / b> B side of the thermoplastic resin 14.
  • the original resin 100 is cooled to cool the thermoplastic resin 14 to a softening temperature or lower.
  • the positioning of the original plate 100 and the thermoplastic resin 14 and the formation of the concave pattern 10A on the surface 10B side of the thermoplastic resin 14 are repeated as many times as necessary.
  • the mold 10 serving as a mother mold is manufactured.
  • FIG. 8A to 8C are process diagrams showing the procedure of the method for producing the mold 50 using the electroforming mold 82.
  • FIG. 8A to 8C are process diagrams showing the procedure of the method for producing the mold 50 using the electroforming mold 82.
  • FIG. 8A shows a state in which an electroforming mold 82 is prepared.
  • the electroforming mold 82 is manufactured by the above-described electroforming mold manufacturing method.
  • the electroforming mold 82 includes a protruding pattern 82A on one surface.
  • the concave pattern 50 ⁇ / b> A refers to a state in which a concave portion extending from one surface of the mold 50 toward the other surface is disposed on one surface of the mold 50.
  • the number of recesses, the position of the recesses, etc. are not limited.
  • the mold 50 having the concave pattern 50A can be manufactured by the following first to third methods. Basically, it is possible to apply a method for producing the mother mold 10 from the original 100 shown in FIGS. 6A to 6C.
  • An ultraviolet curable resin that cures when irradiated with ultraviolet rays is prepared.
  • the protruding pattern 82A of the electroforming mold 82 is pressed against the ultraviolet curable resin.
  • the ultraviolet curable resin is irradiated with ultraviolet rays to cure the ultraviolet curable resin.
  • the electroforming mold 82 is peeled from the cured ultraviolet curable resin.
  • a resin mold 50 having a concave pattern 50A, which is an inverted shape of the protruding pattern 82A of the electroforming mold 82, can be produced.
  • a sheet-like thermoplastic resin used as a material for the mold 50 is prepared.
  • the electroforming mold 82 having the protruding pattern 82A is heated.
  • the protruding pattern 82A of the heated electroforming mold 82 is pressed against the surface of the thermoplastic resin. Since the surface of the thermoplastic resin is softened, the protruding pattern 82A is transferred to the thermoplastic resin.
  • thermoplastic resin and the electroformed mold 82 are cooled.
  • the thermoplastic resin is cured by cooling the electroforming mold 82.
  • the electroformed mold 82 is peeled from the thermoplastic resin to which the protruding pattern 82A is transferred.
  • a resin mold 50 having a concave pattern 50A, which is an inverted shape of the protruding pattern 82A of the electroforming mold 82, can be produced.
  • a silicone resin in which a curing agent is added to PDMS (polydimethylsiloxane, for example, Sylgard 184 manufactured by Dow Corning) is prepared.
  • the protruding pattern 82A of the electroforming mold 82 is pressed against the silicone resin.
  • the silicone resin is heated at 100 ° C. to be cured.
  • the electroformed mold 82 is peeled off from the cured silicone resin.
  • a resin mold 50 having a concave pattern 50A, which is an inverted shape of the protruding pattern 82A of the electroforming mold 82, can be produced.
  • the size of each concave portion of the concave pattern 50A is substantially the same as the size of the protruding portion of the protruding pattern 82A.
  • the method for producing the mold 50 is not limited to the first to third methods.
  • FIG. 9A to 9G are process diagrams showing the procedure of the method for manufacturing the transdermal absorption sheet using the mold 50.
  • FIG. 9A shows a state where the mold 50 is prepared.
  • the mold 50 is manufactured by the mold manufacturing method shown in FIGS. 8A to 8C.
  • a concave pattern 50 ⁇ / b> A is formed on the surface 50 ⁇ / b> B of the mold 50.
  • FIG. 9B shows a supply process of supplying the polymer solution to the concave pattern 50A of the mold 50.
  • a polymer solution 200 is prepared.
  • a material of the resin polymer used for the polymer solution 200 it is preferable to use a biocompatible resin.
  • resins include glucose, maltose, pullulan, sodium chondroitin sulfate, sodium hyaluronate, saccharides such as hydroxyethyl starch and hydroxypropylcellulose, biodegradable proteins such as gelatin, polylactic acid and lactic acid glycolic acid copolymer.
  • a conductive polymer is preferable to use.
  • the gelatin-based material has adhesiveness with many base materials, and has a strong gel strength as a material to be gelled. Therefore, it can be brought into close contact with the base material in the peeling step described later. Since a polymer sheet can be peeled off using a base material, it can be suitably used.
  • the transdermal absorption sheet 220 As a material for forming the transdermal absorption sheet 220, it is preferable to use a water-soluble material. By making the material of the percutaneous absorption sheet 220 into a water-soluble material, when the protruding pattern 220A formed on the percutaneous absorption sheet 220 is inserted into the skin, it can dissolve and easily inject chemicals. . Therefore, the polymer solution 200 preferably contains a water-soluble material.
  • the water-soluble material means a material that is soluble in water.
  • medical agent can be included in the polymer solution 200.
  • medical agent contained in the polymer solution 200 should just be a substance which has physiological activity, and is not specifically limited.
  • the drug is preferably selected from peptides, proteins, nucleic acids, polysaccharides, vaccines, pharmaceutical compounds, or cosmetic ingredients.
  • a pharmaceutical compound belongs to a water-soluble low molecular weight compound.
  • the low molecular compound is a compound having a molecular weight in the range of several hundred to several thousand.
  • the concentration varies depending on the material, it is preferable that the concentration is such that 10 to 50% by mass of the resin polymer is contained in the polymer solution 200 containing no drug.
  • the solvent used for dissolution may be volatile even if it is other than warm water, and methyl ethyl ketone, alcohol, or the like can be used.
  • the solution of polymer resin it is possible to dissolve together the medicine for supplying into the body according to the use.
  • the polymer concentration of the polymer solution 200 containing the drug is preferably in the range of 0 to 40% by mass.
  • a water-soluble powder may be dissolved in water, and a drug may be added after dissolution, or a liquid in which a drug is dissolved.
  • a water-soluble polymer powder may be put in and dissolved. If it is difficult to dissolve in water, it may be dissolved by heating.
  • the temperature can be appropriately selected depending on the type of the polymer material, but it is preferable to heat at a temperature of about 60 ° C. or lower.
  • the viscosity of the polymer resin solution is preferably 100 Pa ⁇ s or less, more preferably 10 Pa ⁇ s or less, in the case of a solution containing a drug.
  • a solution that does not contain a drug it is preferably 2000 Pa ⁇ s or less, more preferably 1000 Pa ⁇ s or less.
  • the viscosity of the polymer resin solution can be measured with a capillary tube viscometer, falling ball viscometer, rotary viscometer, or vibration viscometer.
  • the polymer solution 200 is supplied to the mold 50, and the polymer solution 200 is filled in the concave pattern 50A. That is, the polymer solution 200 is filled in the concave portions constituting the concave pattern 50A.
  • a method of filling the polymer solution 200 into the concave pattern 50A As a method of filling the polymer solution 200 into the concave pattern 50A, a method of filling using a spin coater, a method of filling by moving a squeegee, a method of filling while moving a slit nozzle, and filling a concave portion of the concave pattern 50A with a dispenser And the like.
  • the polymer solution 200 can be supplied to the concave pattern 50A while moving the slit nozzle and the mold relative to each other while the slit nozzle is in contact with the surface of the mold 50.
  • the surface of the mold 50 has flatness.
  • the polymer solution 200 is difficult to enter into the recess of the concave pattern 50A of the mold 50 due to the presence of air. Therefore, it is desirable to perform the supply process under a reduced pressure environment.
  • Under reduced pressure environment means a state below atmospheric pressure.
  • the mold 50 is set in a decompression device (not shown), and the polymer solution 200 is supplied to the mold 50, whereby the polymer solution is drawn to the tip of the concave pattern 50A while drawing out the air in the recesses in a reduced pressure environment. 200 can be filled.
  • the mold 50 is made of a gas permeable material, it is particularly effective to perform the supply process in a reduced pressure environment.
  • the mold 50 supplied with the polymer solution 200 is placed in a pressure vessel. After the inside of the pressure vessel is heated to 40 ° C. by the heating jacket, compressed air is injected into the pressure vessel from the compressor. By holding the pressure container at a pressure of 0.5 MPa for 5 minutes and applying pressure, it is possible to remove the air in the recess and fill the polymer solution 200 up to the tip of the concave pattern 50A of the mold 50. .
  • FIG. 9C shows a drying process in which the polymer solution 200 is dried to form the polymer sheet 210.
  • the polymer solution 200 supplied to the mold 50 can be dried by blowing air.
  • the drying is divided into four zones: (1) set drying at 15 ° C. (low humidity, wind speed 4 m / sec), (2) weak wind drying at 35 ° C. (low humidity, wind speed 8 m / sec), (3 It can be efficiently dried by setting conditions such as high wind drying at 50 ° C. (wind speed 12 m / sec) and (4) high wind drying at 30 ° C. (wind speed 20 m / sec).
  • the applied polymer solution 200 is dried, or the polymer solution 200 is gelled and then dried to form a polymer sheet 210.
  • the polymer solution 200 can be gelled by flowing low-humidity cold air.
  • cool air 10 to 15 [° C.] is blown for a longer time than in the above case, and thereafter, wind is blown in the same manner as described above.
  • when flowing hot air for drying after this if the temperature of the hot air is too high, gelation in the polymer solution 200 may return, or depending on the chemical, heating may occur. Careful attention must be paid to the temperature of the wind to be blown, as the efficacy changes due to decomposition.
  • the polymer sheet 210 By using the polymer sheet 210, the polymer sheet is reduced more than the state when the polymer solution 200 is injected, and particularly when gelation is performed, the polymer sheet is significantly reduced. Thereby, peeling of the polymer sheet 210 from the mold 50 described later becomes easy.
  • the polymer sheet 210 means a state after the polymer solution 200 is subjected to a desired drying process.
  • the water content of the polymer sheet 210 is set as appropriate.
  • FIG. 9D and 9E show a polymer sheet peeling process for peeling the polymer sheet 210 from the mold 50.
  • a sheet-like base material 300 on which an adhesive layer is formed is attached to the opposite surface of the mold 50 to the polymer sheet 210.
  • the surface of the substrate 300 may be bonded by performing a surface activation treatment.
  • the base material 300 may be embedded by applying a polymer solution from above the base material 300.
  • PET polyethylene terephthalate
  • PP polypropylene: polypropylene
  • PC polycarbonate
  • PE Polyethylene: polyethylene
  • the base material 300 and the polymer sheet 210 are peeled simultaneously.
  • a suction cup (not shown) is installed on the surface of the base material 300 opposite to the surface to be bonded to the polymer sheet 210, and the base material 300 is pulled up vertically while being sucked with air.
  • the polymer sheet 210 is peeled from the mold 50 to form a transdermal absorption sheet 220 having a protruding pattern 220A.
  • the material which comprises the mold 50 with the material which peels very easily.
  • the stress applied to the protruding pattern 220A of the percutaneous absorption sheet 220 at the time of peeling can be relaxed by making the material constituting the mold 50 a soft material having high elasticity.
  • the protruding pattern 220A of the percutaneous absorption sheet 220 has an inverted shape of the concave pattern 50A of the mold 50.
  • the percutaneous absorption sheet 220 is basically the same as the polymer sheet 210 peeled from the mold 50.
  • 9F and 9G show a cutting process in which the transdermal absorption sheet 220 is cut into individual transdermal absorption sheets 220.
  • the percutaneous absorption sheet 220 having the protruding pattern 220A and the base material 300 peeled from the mold 50 are set in a cutting device (not shown).
  • the position for cutting the transdermal absorption sheet 220 is determined. Basically, the cutting position is determined for each protruding pattern 220A.
  • the transdermal absorption sheet 220 is cut into a plurality of individual transdermal absorption sheets 220.
  • the percutaneous absorption sheet 220 and the substrate 300 are cut at the same time, but the present invention is not limited to this.
  • the percutaneous absorption sheet 220 and the base material 300 peeled from the mold 50 can be separated into individual transdermal absorption sheets 220 by peeling the base material 300 and cutting the percutaneous absorption sheet 220.
  • the present invention is not limited to this.
  • the polymer solution 200 containing the drug can be filled in the concave pattern 50A and dried, and then the polymer solution 200 not containing the drug can be filled in the concave pattern 50A and dried to form a polymer sheet.
  • the number of times the polymer solution 200 is supplied and the presence or absence of the drug in the polymer solution 200 can be changed as appropriate.
  • FIG. 10 is a perspective view of an individual transdermal absorption sheet 220.
  • the individual transdermal absorption sheet 220 has a protruding pattern 220A on one surface.
  • the percutaneous absorption sheet 220 has a substrate 300 on the surface opposite to the surface on which the protruding pattern 220A is formed.
  • air bubbles can be removed from the mold attached to the cathode, and an electroformed mold free from voids and / or chips can be produced.
  • a mold can be produced using the produced electroformed mold.
  • a transdermal absorption sheet can be manufactured using the produced mold.
  • LLDPE Linear Low Density Polyethylene
  • An LDPE matrix having a needle-like concave pattern was prepared by forming conical concave portions at a pitch of 1 mm.
  • a pretreatment for the mother die a 0.2 ⁇ m thick Ni film was formed on the mother die having a concave pattern by sputtering.
  • the pre-processed master mold is immersed in an electroforming liquid held in an electroforming tank and temperature-controlled at 45 ° C. After the master mold is immersed, an electroforming mold having a thickness of 0.15 mm is obtained. Casting was performed.
  • As the electroforming liquid a nickel sulfamate electroforming liquid (manufactured by Showa Chemical Co., Ltd., NS160) was used.
  • Example 1 Before being immersed in the electroforming solution, defoaming treatment was performed under the following conditions.
  • the pre-treated matrix was immersed in a pre-treatment liquid temperature controlled at 25 ° C. held in a pre-treatment liquid tank. Pure water was used as a pretreatment liquid.
  • a vacuum degassing device Choda Electric Co., Ltd., water-based vacuum degassing device TKH-11
  • degassing pure water at a treatment water volume of 5 L / min. Sound waves were applied to the concave pattern of the matrix for 3 minutes.
  • the dissolved oxygen concentration of pure water was 1.0 mg / L or less.
  • the matrix after the defoaming treatment was taken out from the pretreatment bath and immersed in the electroforming solution, and electroforming was performed according to the basic conditions.
  • Example 1 Before being immersed in the electroforming solution, defoaming treatment was performed under the following conditions.
  • the pretreated matrix was immersed in pure water temperature controlled at 25 ° C. held in a pretreatment liquid tank.
  • An ultrasonic wave having a fundamental frequency of 35 kHz and an output of 600 W was applied to the concave pattern of the matrix for 3 minutes.
  • the deaeration process by a vacuum deaerator was not performed.
  • the matrix after the defoaming treatment was taken out from the pretreatment bath and immersed in the electroforming solution, and electroforming was performed according to the basic conditions.
  • FIG. 11 is an appearance photograph of the protruding pattern of the electroformed mold according to Example 1
  • FIG. 12 is an appearance photograph of the electroformed mold according to Comparative Example 1
  • FIG. 13 is an electroformed mold according to Comparative Example 2. It is the external appearance photograph of a type
  • the matrix having a needle-like concave pattern is immersed in the degassed pretreatment liquid, and ultrasonic waves are applied toward the concave pattern to remove the mold.
  • the pretreatment liquid that has been noticed can be sufficiently filled in the recess.
  • transdermal absorption sheet was manufactured using the electroforming mold obtained in Example 1.
  • Example 2 On the electroformed mold obtained in Example 1, a 0.6 mm thick silicone rubber film (SILASTIC-MDX4-4210 manufactured by Dow Corning) was formed. The silicone rubber film was thermoset with the tip of the electroforming mold protruding from the film surface by 50 ⁇ m. Next, the cured silicone rubber film was peeled off from the electroforming mold. A reversal mold of silicone rubber having a through-hole having a diameter of about 30 ⁇ m was produced. A concave pattern in a two-dimensional array of 10 columns ⁇ 10 rows was formed in the center of the mold. The wider opening of the concave pattern was used as the mold surface, and the surface having through holes (air vent holes) with a diameter of 30 ⁇ m was used as the back surface of the mold.
  • SILASTIC-MDX4-4210 manufactured by Dow Corning
  • the chemical filling apparatus includes an X-axis drive unit that controls the relative position coordinates of the mold and the nozzle, a drive unit having a Z-axis drive unit, and a liquid supply device that can be attached with a nozzle (Ultra-low-quantity dispenser SMP- manufactured by Musashi Engineering Co., Ltd.) III), a suction table for fixing the mold, a laser displacement meter for measuring the mold surface shape (HL-C201A manufactured by Panasonic), and a load cell for measuring the nozzle indentation pressure (LCX-A-500N manufactured by Kyowa Denki Co., Ltd.) , A control system for controlling the Z axis based on the measurement data of the surface shape and the pressing pressure, and a stainless steel nozzle attached to the liquid supply device.
  • a nozzle Ultra-low-quantity dispenser SMP- manufactured by Musashi Engineering Co., Ltd.
  • a gas-permeable film with a side of 15 mm (Pureflon FP-010, Poflon: registered trademark) manufactured by Sumitomo Electric Industries, Ltd. was placed on a horizontal suction table, and a mold was placed thereon so that the surface was on top.
  • the gas permeable film and the mold were fixed to a suction table by reducing the pressure from the back side of the mold with a suction pressure of a gauge pressure of 90 kPa.
  • the concave pattern was filled with the chemical solution from the nozzle.
  • the chemical solution was dried by leaving the mold after filling with the chemical solution in an environment of a temperature of 5 ° C. and a relative humidity of 50% RH for 30 minutes.
  • the chemical solution was localized at the tip of the concave pattern by drying.
  • a stainless steel thin plate having an opening was prepared as a mold.
  • the mold filled with the chemical solution was fixed by suction to a suction device.
  • the concave pattern of the mold was aligned so as to enter the opening of the stainless steel thin plate.
  • a stainless steel thin plate was superimposed on the surface of the mold.
  • the substrate solution was poured into the opening of the stainless steel thin plate, and the excess substrate solution was scraped off with a squeegee or a round bar.
  • the substrate solution was filled into the concave pattern.
  • the mold In a temperature 23 ° C., relative humidity 45% RH and wind speed 0.4 m / s environment, the mold was placed on a 35 ° C. hot plate and allowed to stand for 6 hours for drying. The water content of the substrate solution reached 5% or less.
  • the polymer sheet was peeled from the mold by a method of pulling up the polymer sheet while sucking with air.
  • a percutaneous absorption sheet having a three-dimensional arrayed protrusion-like pattern composed of a drug-containing layer and a drug-free layer at the tip was manufactured.

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Abstract

La présente invention concerne un procédé de production de feuille d'absorption percutanée au moyen d'un moule électroformé. Dans un procédé de fabrication de moule électroformé, un moule qui est une matrice ayant un motif évidé est préparé, le moule est immergé dans un liquide de prétraitement dégazé qui est maintenu dans une cuve de liquide de prétraitement et ensuite, des ondes ultrasonores qui sont générées depuis un vibrateur ultrasonore sont appliquées au motif évidé dans le moule de telle manière que le liquide de prétraitement remplisse dans une section évidée constituant le motif évidé. Le moule est immergé dans une cuve d'électroformage pour un traitement d'électroformage pour produire un moule électroformé. Un moule comportant le motif évidé est fabriqué à partir du moule électroformé, et une feuille d'absorption percutanée est produite au moyen du moule.
PCT/JP2016/078556 2015-10-06 2016-09-28 Procédé de production de feuille d'absorption percutanée WO2017061310A1 (fr)

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CN201680058111.5A CN108138344B (zh) 2015-10-06 2016-09-28 经皮吸收片材的制造方法
EP16853464.2A EP3375909A4 (fr) 2015-10-06 2016-09-28 Procédé de production de feuille d'absorption percutanée
KR1020187007590A KR102088197B1 (ko) 2015-10-06 2016-09-28 경피 흡수 시트의 제조 방법
US15/940,985 US10814527B2 (en) 2015-10-06 2018-03-30 Method of producing transdermal absorption sheet

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JP2015198402 2015-10-06
JP2015-198402 2015-10-06
JP2016022835A JP6499598B2 (ja) 2015-10-06 2016-02-09 経皮吸収シートの製造方法
JP2016-022835 2016-02-09

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Publication number Priority date Publication date Assignee Title
CN113766943A (zh) * 2019-04-25 2021-12-07 考司美德制药株式会社 水溶性片状制剂的敷料器2

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JPH04238129A (ja) * 1991-01-22 1992-08-26 Canon Inc 光記録媒体製造用スタンパーの電鋳方法
JPH08129782A (ja) * 1994-11-02 1996-05-21 Mitsubishi Chem Corp スタンパ複製用電鋳装置
JPH08180475A (ja) * 1994-12-22 1996-07-12 Canon Inc 光記録媒体用スタンパーの製造方法
JPH0935337A (ja) * 1995-07-13 1997-02-07 Mitsubishi Chem Corp 光ディスク用スタンパの製造方法
JP2004288266A (ja) * 2003-03-20 2004-10-14 Tdk Corp スタンパー製造方法およびスタンパー製造装置
WO2014077242A1 (fr) * 2012-11-13 2014-05-22 富士フイルム株式会社 Procédé de fabrication d'une structure stratiforme d'absorption transdermique
WO2014196522A1 (fr) * 2013-06-03 2014-12-11 凸版印刷株式会社 Procédé de fabrication et dispositif de fabrication de corps d'aiguille

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Publication number Priority date Publication date Assignee Title
JPH04238129A (ja) * 1991-01-22 1992-08-26 Canon Inc 光記録媒体製造用スタンパーの電鋳方法
JPH08129782A (ja) * 1994-11-02 1996-05-21 Mitsubishi Chem Corp スタンパ複製用電鋳装置
JPH08180475A (ja) * 1994-12-22 1996-07-12 Canon Inc 光記録媒体用スタンパーの製造方法
JPH0935337A (ja) * 1995-07-13 1997-02-07 Mitsubishi Chem Corp 光ディスク用スタンパの製造方法
JP2004288266A (ja) * 2003-03-20 2004-10-14 Tdk Corp スタンパー製造方法およびスタンパー製造装置
WO2014077242A1 (fr) * 2012-11-13 2014-05-22 富士フイルム株式会社 Procédé de fabrication d'une structure stratiforme d'absorption transdermique
WO2014196522A1 (fr) * 2013-06-03 2014-12-11 凸版印刷株式会社 Procédé de fabrication et dispositif de fabrication de corps d'aiguille

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Title
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113766943A (zh) * 2019-04-25 2021-12-07 考司美德制药株式会社 水溶性片状制剂的敷料器2

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