WO2011136330A1 - Timbre adhésif et son utilisation - Google Patents

Timbre adhésif et son utilisation Download PDF

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Publication number
WO2011136330A1
WO2011136330A1 PCT/JP2011/060373 JP2011060373W WO2011136330A1 WO 2011136330 A1 WO2011136330 A1 WO 2011136330A1 JP 2011060373 W JP2011060373 W JP 2011060373W WO 2011136330 A1 WO2011136330 A1 WO 2011136330A1
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WO
WIPO (PCT)
Prior art keywords
patch
adhesive layer
sensitive adhesive
skin
pressure
Prior art date
Application number
PCT/JP2011/060373
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English (en)
Japanese (ja)
Inventor
川原康慈
石倉庸子
Original Assignee
ニチバン株式会社
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Publication date
Application filed by ニチバン株式会社 filed Critical ニチバン株式会社
Priority to JP2012512907A priority Critical patent/JPWO2011136330A1/ja
Publication of WO2011136330A1 publication Critical patent/WO2011136330A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/44—Medicaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/58—Adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/22—Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/428—Vitamins, e.g. tocopherol, riboflavin

Definitions

  • the present invention relates to a patch that can be used to cover and protect the affected skin area caused by various skin diseases such as atopic dermatitis, and to improve and treat various symptoms caused by the skin disease.
  • the patch of the present invention can reduce itch caused by inflammation and drying by covering the affected skin area where dermatitis or the like occurs, and also suppress the spread of itch caused by scratching the inflammatory site and the spread of inflammation. Can do.
  • the patch of the present invention can be applied to uses such as pharmaceuticals or quasi drugs by containing a pharmacologically active substance in the adhesive layer.
  • the patch of the present invention is suitable as a medical patch, but is not limited thereto and can be applied to other uses.
  • a layer structure in which a pressure-sensitive adhesive layer is provided on a support (base material layer), and a release liner is bonded to the pressure-sensitive adhesive layer.
  • a form of the patch a form wound in a roll shape is common, but there is also a sheet form. Since the patch is required to have various functions such as adhesion to the skin surface, peel resistance, and moisture permeability, for example, a patch using a thick material such as a nonwoven fabric as a support. There are many.
  • a thick patch has a defect that a sticking part is conspicuous. In order to relieve the sticking part from being noticeable, a patch is known in which the support is colored in a color close to the skin color, but it is difficult to sufficiently eliminate the difference in color tone from the actual skin.
  • Transparent products are also sold as patches used as medical dressings, but for the purpose of fixing infusion tubes, liquid injection needles, gauze, etc., the thickness of the support and adhesive layer is relatively large. The affixed part is easily noticeable. Moreover, since the adhesive has a strong adhesive force in the adhesive layer, the keratinocytes are easily detached when the adhesive is peeled from the skin surface. As a result, the patch may cause inflammation, rash, etc., or may increase inflammation due to skin irritation.
  • Patent Document 1 discloses a patch in which a drug-containing adhesive layer is provided on one side of a polyurethane film support, and the support has a 100% modulus of 60 to 110 kg /
  • a patch that is a non-self-adhesive polyurethane film having a thickness of 4 to 150 ⁇ m at cm 2 and having a moisture permeability of 300 to 500 g / m 2 ⁇ 24 hr has been proposed.
  • this patch has insufficient moisture permeability because its moisture permeability is kept as low as 300 to 500 g / m 2 ⁇ 24 hr.
  • Patent Document 2 describes an acrylic system in which a thermoplastic polyester polyurethane film having a thickness of 5 to 50 ⁇ m is used as a support and pyrrolidone having a thickness of 1 to 20 ⁇ m is copolymerized on one side of the support.
  • a patch with guide film having a layer structure provided with an adhesive layer has been proposed.
  • Patent Document 2 describes that the patch does not cause pain and does not cause redness of the skin due to sufficient moisture permeability and appropriate adhesive strength. The relaxation of keratinocyte detachment is not considered.
  • Patent Document 3 As a non-adhesive patch, an adhesive patch in which an adhesive layer having a thickness of 1 to 15 ⁇ m is provided on one side of a base material layer made of an elastomer film having a thickness of 1 to 10 ⁇ m is disclosed.
  • Patent Document 3 shows an experimental example using an acrylic pressure-sensitive adhesive as the pressure-sensitive adhesive layer.
  • a patch having an acrylic pressure-sensitive adhesive layer does not take into consideration the amount of keratinocyte peeling at the time of peeling.
  • Patent Document 4 discloses a patch comprising a base film having a thickness of 10 to 80 ⁇ m and a moisture-permeable base material, which is directly or indirectly formed with an adhesive layer for adhering to the skin.
  • a patch for treating dermatitis in which the moisture permeability as a patch is adjusted in the range of 300 to 1500 g / m 2 ⁇ 24 hr is disclosed.
  • the patch for dermatitis treatment is used for protecting the affected area of atopic dermatitis.
  • the patch for treating dermatitis moderately suppresses the transpiration of water from the skin of atopic dermatitis by selecting the base film and the pressure-sensitive adhesive so that the moisture permeability is in the above range.
  • Patent Document 4 describes that it is preferable to form the adhesive layer for skin application with an acrylic adhesive from the viewpoint of stability of quality, adhesive properties, and ease of adjustment of moisture permeability.
  • a patch having an acrylic pressure-sensitive adhesive layer has a defect that the amount of keratinocyte peeling attached to the pressure-sensitive adhesive layer is large when the patch is peeled off.
  • Patent Document 5 discloses a pressure-sensitive adhesive layer comprising a mutual condensation product of a mixture containing an organopolysiloxane resin and at least one alkylaryl polysiloxane raw rubber on the surface of an ultrathin polyurethane film.
  • An ultra-thin pressure-sensitive adhesive tape is disclosed.
  • the pressure-sensitive adhesive tape described in Patent Document 5 since the pressure-sensitive adhesive layer does not sufficiently adhere to the base material, the pressure-sensitive adhesive tends to remain on the skin surface when peeling from the skin surface.
  • Patent Document 6 discloses a body comprising a base material mainly composed of a polyester elastomer and an adhesive layer containing an addition reaction type silicone formed on at least one surface thereof. A surface patch is disclosed.
  • Patent Document 6 describes that the thickness of the base material composed mainly of a polyester elastomer is preferably 15 to 150 ⁇ m, and the thickness of the pressure-sensitive adhesive layer is preferably 10 to 2000 ⁇ m. Comparative Examples 1 and 2 of Patent Document 6 show that a patch using a polyurethane film as a base material instead of a polyester elastomer film tends to peel off the adhesive layer from the base material. It is described that the water vapor transmission rate is as small as 641 to 678 g / m 2 ⁇ 24 hr.
  • the patch not only prevents the invasion of various external factors such as pathogenic bacteria by covering the damaged skin such as inflammation and damage, but also supports the moisture retention function of the stratum corneum on the skin surface. Fulfill. For this reason, the patch acts as a substitute for the stratum corneum for skin with impaired original skin function, such as atopic dermatitis, and prevents the affected area from deteriorating by directly scratching strong itching. It is expected to play a role in promoting the natural recovery of the affected area.
  • the patch has an appropriate moisture retention function, it has a defect that sweat tends to accumulate between the skin surface and the adhesive layer. For this reason, it is desirable for the patch to be able to exhibit an appropriate moisture retention function while preventing sweat from accumulating between the skin surface and the pressure-sensitive adhesive layer by being excellent in moisture permeability.
  • the applied area may be unnoticeable because the applied area becomes larger or the applied area increases and the applied area is often exposed from clothing. desirable.
  • the patch contains a pharmacologically active substance in the adhesive layer, it is desirable that the pharmacologically active substance can be efficiently released even with a small content.
  • An object of the present invention is to provide a patch that is excellent in moisture permeability, in which the applied part is not conspicuous and the amount of keratinocyte peeling is suppressed.
  • Another subject of the present invention is excellent in the above-mentioned various characteristics, and when a pharmacologically active substance is contained in the pressure-sensitive adhesive layer, the release efficiency of the pharmacologically active substance is high even when the content is small, and the skin inflammation site It is to provide an effective patch for the treatment of cerebral palsy.
  • the present inventor has conducted intensive research in order to achieve the above problems. As a result, it is a patch having a layer structure in which a pressure-sensitive adhesive layer is provided on one side of a support, and a polyurethane film having a specific range of thickness is used as the support, and a specific range of thickness is used as the pressure-sensitive adhesive layer.
  • the release efficiency is high and a small amount of pharmacologically active substance is contained. It is possible to obtain a patch that can exhibit excellent medicinal effects even in an amount.
  • the present invention has been completed based on these findings.
  • the support is a polyurethane film having a thickness in the range of 1 to 10 ⁇ m
  • the adhesive layer is an addition reaction type silicone pressure-sensitive adhesive layer made of polyorganosiloxane having a thickness in the range of 5 to 50 ⁇ m and having no vinyl group in the side chain, and the moisture permeability of the patch is 1500 g.
  • a patch is provided that is more than / m 2 ⁇ 24 hr.
  • the adhesive patch wherein the adhesive layer contains a pharmacologically active substance in a proportion of 0.01 to 7% by weight based on the total amount of the adhesive.
  • the pharmacologically active substance contains at least one pharmacologically active substance selected from lipids or derivatives thereof present in the skin stratum corneum.
  • the pharmacologically active substance contains at least one pharmacologically active substance selected from the group consisting of fat-soluble vitamins, water-soluble vitamins and derivatives thereof.
  • the patch of the present invention is excellent in moisture permeability, it is difficult to cause rash and peeling due to the retention of sweat at the applied site.
  • the patch of the present invention is a polyurethane film with a very thin support, the entire layer thickness is relatively thin and excellent in transparency, so that it adheres to fine wrinkles and irregularities on the skin surface, and the application site is conspicuous Absent.
  • the addition reaction type silicone pressure-sensitive adhesive made of polyorganosiloxane having no vinyl group in the side chain used in the present invention is not excessively cured and becomes a gel because the crosslinking reaction is carried out only at the end of the molecule.
  • the silicone-based pressure-sensitive adhesive does not need to contain additives such as a silicone resin, a plasticizer (for example, an oily component), and a filler. For this reason, the patch of the present invention provided with the silicone-based pressure-sensitive adhesive layer has no adverse effect on the physical properties of the support and skin irritation caused by the additive component, and it is difficult to exfoliate keratinocytes on the skin surface at the time of exfoliation.
  • additives such as a silicone resin, a plasticizer (for example, an oily component), and a filler.
  • the patch of the present invention can contain a pharmacologically active substance suitable for improving various skin symptoms in the silicone pressure-sensitive adhesive layer.
  • the pharmacologically active substance exhibits a high release property with a small content.
  • the patch of the present invention covers and protects skin affected areas caused by various skin diseases such as atopic dermatitis, and is suitable for use in improving and treating various symptoms caused by skin diseases.
  • the patch of the present invention is a patch having a layer structure in which an adhesive layer is provided on one side of a support.
  • the entire shape is usually wound in a roll shape, but may be a sheet shape.
  • the support is a polyurethane film having a thickness in the range of 1 to 10 ⁇ m.
  • the pressure-sensitive adhesive layer is an addition reaction type silicone pressure-sensitive adhesive layer made of polyorganosiloxane having a thickness in the range of 5 to 50 ⁇ m and having no vinyl group in the side chain.
  • the moisture permeability of the patch is over 1500 g / m 2 ⁇ 24 hr.
  • the patch of the present invention may have a carrier film and / or a release liner in addition to the support and the pressure-sensitive adhesive layer.
  • the patch of the present invention preferably includes a carrier film, a support, and an adhesive layer in this order, and more preferably includes a carrier film, a support, an adhesive layer, and a release liner in this order.
  • the patch of the present invention has a layer configuration in which an adhesive layer is provided on one side of a support.
  • the patch of the present invention can be provided with additional layers such as a carrier film and a release liner.
  • the additional layer is peeled off when the patch is applied to the skin surface.
  • the characteristic of the patch such as moisture permeability means a characteristic relating to a multilayer structure composed of two layers of a support and an adhesive layer.
  • a release liner can be disposed to protect the surface of the pressure-sensitive adhesive layer.
  • a method of forming a pressure-sensitive adhesive layer on the release liner Since the polyurethane film of the support is extremely thin, it is preferable to use a multilayer film in which the polyurethane film is disposed on the carrier film.
  • the patch of the present invention usually preferably has a multilayer structure of “carrier film / support / adhesive layer / release liner” including a release liner and a carrier film.
  • the release liner is peeled and removed from the pressure-sensitive adhesive layer, and then applied to the skin surface, and then the carrier film on the support is peeled and removed.
  • the patch of the present invention has a layer structure of “support / adhesive layer” at the time of sticking to the skin surface.
  • the polyurethane film as a support of the patch of the present invention can be formed by any molding method such as a solution casting method or an extrusion molding method. Since the support of the patch of the present invention is an extremely thin polyurethane film having a thickness in the range of 1 to 10 ⁇ m, solution casting is required for stable and continuous production while suppressing the occurrence of tearing.
  • the method (solution coating method) or the extrusion lamination method is preferably employed, and the solution casting method is more preferably employed.
  • a method of applying an organic solvent solution of polyurethane onto a carrier film and drying is preferably employed.
  • a polyurethane solution is coated on the carrier film and dried, whereby a polyurethane film can be continuously formed.
  • the thickness of the polyurethane film can be accurately controlled, and the anisotropy of physical properties depending on the direction of the film can be reduced.
  • the pressure-sensitive adhesive layer is formed by (1) a method of directly forming a pressure-sensitive adhesive layer on a polyurethane film as a support; and (2) a pressure-sensitive adhesive layer on a release liner. After forming, the method of bonding so that the surface of this adhesive layer and the surface of a support body closely_contact
  • the silicone pressure-sensitive adhesive layer can be formed by applying a material for forming the addition reaction type silicone pressure-sensitive adhesive layer on one side of the support.
  • an organic solvent such as hexane or heptane may be used in the case of blending another solvent-based silicone pressure-sensitive adhesive obtained by a condensation reaction or the like with an addition-reactive silicone-based pressure-sensitive adhesive layer.
  • a bar coater such as a comma coater, a reverse coater, a comma reverse coater, a lip coater, a knife coater, and a Mayer bar can be employed.
  • the method (2) as a method for forming the pressure-sensitive adhesive layer on the release liner, a method of applying the material for forming the pressure-sensitive adhesive layer on the release liner and drying it while running the release liner in one direction.
  • the silicone-based pressure-sensitive adhesive may be applied on the release liner as a melt or a solution.
  • the patch of the present invention is non-aqueous, and water is not intentionally contained intentionally in the adhesive layer of the finally obtained patch.
  • the support of the patch of the present invention is a polyurethane film having a thickness in the range of 1 to 10 ⁇ m.
  • the polyurethane is not particularly limited as long as it is a polyurethane produced by polyaddition reaction of a polyisocyanate component and a polyol component. However, since a pharmacologically active substance can be added in a small amount, a polyether is used as a polyol component. The polyether-based polyurethane used is preferable.
  • Polyethers that are polyol components include polyethylene glycol, modified polyethylene glycol, polypropylene glycol, polytrimethylene ether glycol, polytetramethylene ether glycol, tetrahydrofuran, and modified polytetramethylene ether glycol that is a copolymer of 3-methyl-tetrahydrofuran. Etc. These polyol components can be used alone or in combination of two or more.
  • polyisocyanate components include diphenylmethane diisocyanate, tolylene diisocyanate, 1,4-diisocyanate benzene, xylylene diisocyanate, 2,6-naphthalene diisocyanate, methylenebiscyclohexyl isocyanate, isophorone diisocyanate, cyclohexane-1,4-diisocyanate, hexahydroxylylene. And diisocyanates such as diisocyanate and hexahydrotolylene diisocyanate. These diisocyanate components can be used alone or in combination of two or more.
  • polyester polyurethane using polyester as a polyol component in addition to polyether polyurethane, polyester polyurethane using polyester as a polyol component can be used.
  • the polyisocyanate component the diisocyanates listed above can be used.
  • the polyol component a polyester obtained from a dibasic acid such as adipic acid or phthalic acid and a diol such as ethylene glycol or propylene glycol is used.
  • the amount of the pharmacologically active substance contained in the silicone pressure-sensitive adhesive layer transferred to the support is relatively large, so that a sufficient pharmacological effect can be obtained. Needs to be added in relatively large amounts.
  • the pharmacologically active substance transferred to the support may impair properties such as strength and stretchability of the support. For this reason, polyether polyurethane is more preferable as polyurethane.
  • the thickness of the support is in the range of 1 to 10 ⁇ m, preferably 3 to 7 ⁇ m, particularly preferably 4 to 6 ⁇ m, from the viewpoint of being well adapted to the skin and not noticeable. If the thickness of the support is too thin, it is difficult to form a film, and the strength as a support is insufficient, so that the patch is applied to the adherend or the adhesive is peeled off from the adherend. In some cases, the support may be cut off. If the thickness of the support is too large, even if the thickness of the entire patch is reduced, the patch is less likely to adhere to the skin surface with fine irregularities such as skin grooves, making the applied state conspicuous and uncomfortable. It tends to grow.
  • the patch of the present invention can be used for the purpose of preventing skin scratching in humans and the like having dermatitis such as atopic dermatitis (hereinafter sometimes simply referred to as “atopy use”).
  • atopy use When the patch of the present invention is applied to atopy, the patch on the skin functions as a barrier to prevent direct scratching of the skin even when the skin is scratched, and the film does not easily break. It is preferable to have only strength.
  • the 10% tensile load in the longitudinal direction and the transverse direction of the polyurethane film measured according to JIS Z0237 of Japanese Industrial Standard is usually 0.01 to 1.2 N / 10 mm, preferably 0.05 to 1. It is desirable to be within the range of 0N / 10mm.
  • the 10% tensile load value of the polyurethane film is too small, the strength is so weak that the film-forming property and the handleability are lowered.
  • the 10% tensile load value of the polyurethane film is too large, the rigidity becomes strong and the stretchability and flexibility are insufficient. Therefore, the patch using the polyurethane film as a support is used for skin with fine irregularities such as skin grooves. It becomes difficult to adhere along the surface, and the attached state is easily noticeable.
  • the polyurethane film used for the support may contain a colorant such as a pigment or a dye, if desired. If necessary, the polyurethane film may further contain various additives such as a stabilizer, an ultraviolet absorber, and a lubricant.
  • the surface of the polyurethane film used for the support is subjected to surface treatment or primer treatment on the surface in contact with the pressure-sensitive adhesive layer of the support. It can be performed.
  • the surface treatment of the support include embossing, corona treatment, and alkali treatment.
  • a silane primer for example, FS XA-2869 manufactured by Dow Corning
  • the primer treatment agent can be applied directly to the surface of the support.
  • the thickness of the primer layer is preferably 0.05 to 3 ⁇ m, more preferably 0.05 to 1 ⁇ m.
  • the surface of the support opposite to the pressure-sensitive adhesive layer side ("support of the support"
  • a minute unevenness may be formed on the back surface.
  • the minute irregularities are particularly useful for suppressing the reflection of light on the back surface (support surface) of the support and making the application site inconspicuous, when the patch is difficult to notice. If minute irregularities are formed on the surface of the carrier film by embossing and a polyurethane film is formed on the minute irregularities, the minute irregularities can be transferred to the back surface of the support made of polyurethane film. .
  • the pressure sensitive adhesive layer of the patch of the present invention has an addition reaction type silicone pressure sensitive adhesive having a thickness in the range of 5 to 50 ⁇ m and comprising a polyorganosiloxane having no vinyl group in the side chain. Is a layer.
  • Acrylic adhesives that have been widely used as adhesives for patches have polar groups such as esters in the molecule, so the solubility of pharmacologically active substances is high, and when the amount of pharmacologically active substances added is small, There is a problem that the amount of release is reduced.
  • Rubber adhesives are composed of hydrocarbons, so the solubility of pharmacologically active substances is low, but they are poorly permeable to moisture, so sweat tends to accumulate on the application site and may be easily peeled off by external forces such as skin movements. There is a drawback.
  • Peroxide reaction type, condensation reaction type, and addition reaction type silicone pressure sensitive adhesives are known as general-purpose silicone pressure sensitive adhesives.
  • a peroxide-reactive silicone-based pressure-sensitive adhesive is benzoyl peroxide (BPO), which is a typical peroxide
  • BPO benzoyl peroxide
  • benzoic acid remains in the pressure-sensitive adhesive as a decomposition product, and is pressurized and sealed.
  • a large reactor is required.
  • the condensation reaction type silicone pressure-sensitive adhesive proceeds at room temperature, alcohols and carboxylic acids are generated as by-products, which is not preferable as a medical pressure-sensitive adhesive from the viewpoint of skin irritation.
  • Silicone pressure-sensitive adhesives generally used as medical pressure-sensitive adhesives are those in which one or more organometallic compounds are used to form a three-dimensional structure by cross-linking vinyl groups in the side chain in dimethylsiloxane.
  • a silicone resin having a three-dimensional structure is added to adjust the characteristics as an adhesive, moisture permeability, and the like.
  • the silicone-based pressure-sensitive adhesive having a general-purpose three-dimensional structure has a large number of functional groups involved in the crosslinking reaction in the molecule, so that the pressure-sensitive adhesive layer becomes hard. As a result, it was found that the amount of exfoliated keratinocytes is large and is not suitable particularly when used for atopic use.
  • the addition reaction type silicone pressure-sensitive adhesive used in the patch of the present invention is composed of a polyorganosiloxane having no vinyl group in the side chain as a main component, and the molecule has a linear structure due to the addition reaction using a catalyst. , Itself exhibits gel-like physical properties.
  • an addition reaction type silicone pressure-sensitive adhesive made of polyorganosiloxane having no vinyl group in the side chain is characterized by a lower cohesive force than a general pressure-sensitive adhesive, and as a result, is well adapted to the skin crevice. For this reason, it is useful as a pressure-sensitive adhesive for a patch where the patch site is less noticeable.
  • the patch using this addition reaction type silicone adhesive has a small amount of keratinocyte peeling when it is peeled off after being applied to the skin, and can efficiently release the added pharmacologically active substance. Therefore, an excellent function can be exhibited when combined with the polyurethane film support.
  • the addition reaction type silicone pressure-sensitive adhesive used in the patch of the present invention is prepared by adjusting the composition of a terminal vinyldimethylsiloxane, dimethylsiloxane, and dimethylsiloxane having a hydroxyl group at the terminal or side chain as a basic component within a suitable range. Further, it can be produced by a crosslinking reaction of a vinylsilyl group and a hydrosilyl group (Si—H) by adding a platinum catalyst or the like. Since the addition reaction can be cured at room temperature without using a solvent, it is friendly to the working environment, and no by-product is generated after the reaction. Therefore, the addition reaction is particularly useful as a medical adhesive.
  • the addition reaction type silicone pressure-sensitive adhesive layer of the present invention usually does not contain a silicone resin, a plasticizer, a filler or the like.
  • a silicone resin having a three-dimensional structure called MQ resin is a component that is usually blended in the silicone-based pressure-sensitive adhesive layer in order to increase skin adhesive force, but causes a large amount of keratinocyte peeling.
  • Silicone oils such as low molecular weight dimethylpolysiloxane that may be blended as a plasticizer (oil component) in the silicone pressure-sensitive adhesive layer may shift to the support and change its properties, or the silicone oil may remain on the skin after application. May feel uncomfortable.
  • the silicone-based pressure-sensitive adhesive layer contains a filler such as silica or aluminum silicate, the cohesive force is lowered and the skin adhesive ability is lowered.
  • the addition reaction type silicone pressure-sensitive adhesive layer of the present invention usually does not contain surfactants, powders, water-absorbing polymers, pH adjusters, preservatives, etc., but there are unavoidable circumstances due to the characteristic design of the pressure-sensitive adhesive. Sometimes, these additives can be blended to the extent that the object of the present invention is not impaired.
  • addition reaction type silicone pressure sensitive adhesive of the patch of the present invention it is possible to adjust the adhesive force by mixing other commonly used silicone pressure sensitive adhesives within the range of addition reaction type silicone as a main component. Can do. In particular, when pharmacologically active substances are added for the purpose of improving various skin symptoms, the adhesive properties generally decrease in many cases. For this reason, mixing with other silicone adhesives is useful. is there.
  • the content of the addition reaction type silicone in the pressure-sensitive adhesive is preferably in the range of 70 to 100% by weight, more preferably 80 to 100% by weight, and particularly preferably 90 to 100% by weight.
  • the pressure-sensitive adhesive component other than the silicone-based pressure-sensitive adhesive such as acrylic pressure-sensitive adhesive and rubber-based pressure-sensitive adhesive is usually in the range of 0 to 25% by weight, preferably 0 to 15% by weight, more preferably 0 to 10% by weight. You may contain in.
  • Additives such as fillers, pigments, and curing inhibitors can be added in the range of usually 0 to 30% by weight, preferably 0 to 20% by weight, more preferably 0 to 10% by weight.
  • the thickness of the addition reaction type silicone pressure-sensitive adhesive layer in the patch of the present invention is in the range of 5 to 50 ⁇ m, preferably 8 to 45 ⁇ m, more preferably 16 to 40 ⁇ m, and particularly preferably 20 to 35 ⁇ m.
  • the thickness of the pressure-sensitive adhesive layer is extremely thin, since the polyorganosiloxane having no vinyl group in the side chain has few functional groups, the crosslinking reaction does not proceed sufficiently.
  • crosslinking is easily inhibited, and it is important to ensure a certain thickness of the pressure-sensitive adhesive layer.
  • the total thickness of the support and the addition reaction type silicone pressure-sensitive adhesive layer is preferably 11 to 52 ⁇ m, in order to produce an effect that the followability to the skin surface is not impaired and the sticking site is not noticeable.
  • a range of 20 to 46 ⁇ m is more preferable, and a range of 25 to 40 ⁇ m is particularly preferable.
  • the patch of the present invention preferably exhibits an adhesive strength of 0.5 N / 10 mm or less, more preferably 0.2 N / 10 mm or less, particularly in a 90-degree peel test for a bakelite plate specified in JIS Z0237. Preferably, it is within the range of 0.01 to 0.1 N / 10 mm. If the adhesive strength of the pressure-sensitive adhesive layer is too large, the amount of keratinocyte peeling will increase. If the adhesive strength is too small, it may generally be easily peeled off by an external force such as skin movement. However, in the patch of the present invention, a combination of a thin and flexible support and a gel adhesive Thus, even if the adhesive force is small, it can follow the movement of the skin well.
  • the patch of the present invention preferably exhibits a holding force by which the weight falls within 30 minutes in a holding force test in which a load is applied with a weight of 200 g, and particularly preferably within a range of 5 to 25 minutes. That is, in the holding force test, a carton tape (manufactured by Nichiban Co., Ltd.) is attached to the support surface of the patch, backing, and cut into 12 mm ⁇ 50 mm, and this is pasted on a glass plate to be 12 mm ⁇ 20 mm. For a patch that was cut and applied with a weight of 200 g so that the patch hangs vertically, and the weight dropped within 30 minutes, the drop time is measured and the result of the holding force test is obtained.
  • a carton tape manufactured by Nichiban Co., Ltd.
  • the displacement distance after 30 minutes was measured with a microscope with a scale.
  • a patch in which the weight does not fall within 30 minutes has too much holding power for the pressure-sensitive adhesive layer and increases the amount of keratinocyte peeling. If the holding force is too small, it may be easily peeled off by an external force such as skin movement, but in the patch of the present invention, a combination of a thin and flexible support and a gel adhesive Thus, even if the holding force is small, the movement of the skin can be followed well.
  • the addition reaction type silicone pressure-sensitive adhesive layer preferably covers the entire surface of the support, but may be coated in a pattern if necessary.
  • a pattern for example, an arbitrary shape such as a wave shape, a lattice shape, a dot shape, a circular shape, or an arabesque pattern can be selected.
  • the patch of the present invention protects the skin surface while having appropriate moisture permeability without adding a pharmacologically active substance to the addition reaction type silicone pressure-sensitive adhesive layer. Since it is possible to prevent intrusion of an exogenous substance and prevent unintentional scratching, it is possible to prevent the affected part of dermatitis such as atopic dermatitis from getting worse.
  • the patch having the addition reaction type silicone pressure-sensitive adhesive layer of the present invention has a very small amount of exfoliated keratinocytes, and can suppress the exfoliation of the keratinocytes in the affected area to the minimum when exfoliating.
  • the patch of the present invention can enhance the function as a medical patch by containing a pharmacologically active substance in the addition reaction type silicone pressure-sensitive adhesive layer.
  • the skin of patients with atopic dermatitis is known to have glucosylceramide metabolism abnormality, and the amount of ceramide produced is small. Therefore, since the skin barrier function and moisturizing ability are lowered, it is effective to contain lipids or derivatives thereof existing in the skin stratum corneum such as ceramide in order to supplement the reduced production amount of ceramide.
  • ceramide and its precursor include ceramide 1, 2, 3, 4, 5, and 6, and keratinocyte lipids such as phytosphingosine.
  • vitamins that are effective against skin moisturizing and itching and blemishes; glycyrrhetin, glycyrrhizinate and menthol, which suppress skin inflammation; crotamiton, which suppresses skin itchiness; The drug lidocaine; and the like can be used.
  • the vitamins at least one selected from the group consisting of vitamin E, which is a fat-soluble vitamin, and esters thereof, vitamin B6, which is a water-soluble vitamin, vitamin C, esters thereof, and derivatives thereof is effective.
  • vitamin C derivative ascorbyl tetrahexyldecanoate (NIKKOL (registered trademark) VC-IP, Nikko Chemicals Co., Ltd.) has high permeability to the skin, relieves oxidative stress, and suppresses pigmentation.
  • pyridoxine tri-2-hexyldecanoate (NIKKOL (registered trademark) VB6-IP, Nikko Chemicals Co., Ltd.), which is a vitamin B6 derivative having a high moisturizing effect.
  • ceramide 1 which is considered to be remarkably reduced in affected areas of atopic dermatitis, phytosphingosine having ceramide synthesis promotion and bacteriostatic action is useful.
  • a humectant such as glycerin, propylene glycol, sorbitol, 1,3-butylene glycol, polyethylene glycol, urea, sodium lactate, peptide, heparin, and hyaluronic acid for maintaining the moisture retention can be appropriately added.
  • Ceramide or precursors of keratinocyte lipids lost in affected areas of dermatitis such as atopic dermatitis, and vitamins useful for alleviating skin symptoms are compatible with addition-reactive silicone adhesives. Since the solubility is moderately good, when it is added to an addition reaction type silicone pressure-sensitive adhesive, it exhibits a high release property with a small addition amount compared to the case of adding them to an acrylic pressure-sensitive adhesive. Therefore, the patch of the present invention containing a pharmacologically active substance in the pressure-sensitive adhesive layer is effective for treating and alleviating various symptoms of dermatitis.
  • Pharmacologically active substances can be used alone or in combination of two or more. These pharmacologically active substances are usually in the range of 0.01 to 7% by weight, preferably 0.05 to 6% by weight, more preferably 0.1 to 5% by weight in the addition reaction type silicone pressure-sensitive adhesive layer. It can be made to contain.
  • the thickness of the polyurethane film as the support in the patch of the present invention is 1 to 10 ⁇ m, more preferably 3 to 7 ⁇ m.
  • a carrier film is disposed on the surface (back surface) opposite to the addition-reactive silicone pressure-sensitive adhesive layer of the support for the purpose of improving handleability and usability at the time of application to the skin. It is desirable to have a layer structure.
  • the carrier film may cover the entire surface of the support, may cover only the edge of the patch, or may be covered with a pattern such as a lattice, but it covers the entire surface of the support. Preferably there is.
  • glassine paper using high-quality paper usually used for patches glassine paper using high-quality paper usually used for patches, polylaminated paper in which a plastic film is laminated on high-quality paper, or a film that has been subjected to a release treatment by applying a silicone resin to the surface of the plastic film, etc. Can be used.
  • plastic film used as the carrier film examples include various thermoplastic resins such as polyester, polyurethane, polyethylene, polypropylene, ionomer, polyamide, polyvinyl chloride, polyvinylidene chloride, ethylene vinyl acetate copolymer, and polytetrafluoroethylene. Can be used.
  • carrier film for example, polyhydroxybutyrate resin, polyhydroxyalkanoate, maltotriose, polylactic acid resin, polyethylene succinate resin, polybutylene succinate resin, polycaprolactone resin, polybutylene adipate Films formed from terephthalate, polytetramethylene adipate terephthalate, polyethylene terephthalate, polyvinyl alcohol, polyglycolic acid, starch fatty acid ester, starch processing resin, starch polyester, cellulose acetate, chitosan and the like can be used. Among these, a biodegradable plastic film is preferable. These various films may be laminated on paper.
  • the surface of the surface coated with silicone or the like can be removed.
  • a non-drug-adsorbing carrier film such as a polyester film is suitable because the pharmacologically active substance may migrate through the support polyurethane film. ing.
  • the patch having a low adhesive strength as in the present invention it is desirable that the patch is peeled off so that the carrier film can be easily peeled after being applied to the skin.
  • a polyester film that has been subjected to release treatment on both sides can be used for the carrier film.
  • the carrier film is desirably thicker or firmer than the support polyurethane film.
  • the thickness of the carrier film can be appropriately set, but is usually 10 ⁇ m or more, preferably 20 ⁇ m or more, and the upper limit is usually 500 ⁇ m, preferably 300 ⁇ m, more preferably 200 ⁇ m.
  • release liner In the patch of the present invention, a release liner (hereinafter sometimes referred to as “release film”) is provided on the surface of the addition reaction type silicone pressure-sensitive adhesive layer opposite to the side in contact with the support. Is preferred.
  • release liner polyolefin films such as untreated polyethylene film and polypropylene film; polyester film represented by polyethylene terephthalate; laminated paper of plastic film and paper (polylaminated paper); A release liner that is widely used in the above can be used.
  • the surface of the release liner (the surface on the pressure-sensitive adhesive layer side) can be subjected to a surface treatment (release treatment) with a fluororesin, a fluorosilicone resin, a silicone resin, or the like.
  • a surface treatment (release treatment) with a fluororesin, a fluorosilicone resin, a silicone resin, or the like is suitable.
  • the pharmacologically active substance may migrate to the release liner as in the case of the carrier film, it is preferable to perform a surface treatment (mold release treatment) on a non-drug adsorbing film such as a polyester film.
  • the thickness of the release liner can be appropriately set, but is usually 10 ⁇ m or more, preferably 20 ⁇ m or more, and the upper limit is usually 500 ⁇ m, preferably 300 ⁇ m, more preferably 200 ⁇ m.
  • the release liner may be formed by applying an addition reaction type silicone pressure-sensitive adhesive layer on a support and then pressing the release liner with the release liner, or the addition reaction type silicone pressure-sensitive adhesive layer on the release liner. After the coating, the addition reaction type silicone pressure-sensitive adhesive layer may be formed by a method of pressure-bonding to a support.
  • a patch comprising a carrier film, a support, a pressure-sensitive adhesive layer, and a release liner in this order is used to separate the support from the carrier film because of the peeling force required to peel the release liner from the pressure-sensitive adhesive layer. It is preferable to set so as to be larger than the required peeling force. By doing so, the surface of the addition reaction type silicone pressure-sensitive adhesive layer that appears after the release liner is peeled off can be applied to the skin, and then the carrier film can be peeled off, so that workability is improved.
  • the patch of the present invention is a patch having a layer structure in which an adhesive layer is provided on one side of a support, and the support is a polyurethane film having a thickness in the range of 1 to 10 ⁇ m.
  • the layer is an addition reaction type silicone pressure-sensitive adhesive layer made of polyorganosiloxane having a thickness in the range of 5 to 50 ⁇ m and having no vinyl group in the side chain, and the moisture permeability exceeds 1500 g / m 2 ⁇ 24 hr.
  • covering damaged skin not only prevents the invasion of various external factors, but also serves to help the moisture retention ability of the stratum corneum on the skin surface.
  • the patch of the present invention has a moisture permeability of more than 1500 g / m 2 ⁇ 24 hr, thereby preventing the skin that causes skin irritation from accumulating at the applied site, and causing the patch to peel from the skin by sweating. Therefore, the skin surface can be protected with appropriate moisture permeability.
  • the patch of the present invention can prevent the entry of exogenous substances, and can also serve as a substitute for the stratum corneum for skin in which the function of healthy skin such as atopic dermatitis is impaired. .
  • the moisture permeability is a value measured according to JIS Z0208.
  • the patch of the present invention covers the affected area of the skin, thereby avoiding deterioration of the affected area due to scratching and promoting natural recovery of the affected area of dermatitis such as atopic dermatitis.
  • the patch of the present invention prevents the entry of exogenous substances by protecting the skin surface while having an appropriate moisture permeability, even without adding a pharmacologically active substance to the addition reaction type silicone pressure-sensitive adhesive layer. Since it is possible to prevent a human having symptoms of dermatitis such as dermatitis from unintentionally scratching the skin, the affected area can be prevented from deteriorating.
  • the patch of the present invention functions as a barrier that prevents the skin patch from directly scratching even when a person with atopic skin inflammation or the like takes a skin scratching action. Therefore, the patch of the present invention can be suitably used as a patch for preventing skin scratches on humans with atopic skin inflammation.
  • the addition reaction type silicone pressure-sensitive adhesive layer may contain a pharmacologically active substance.
  • the patch of the present invention When the patch of the present invention is peeled off after being applied to the skin surface, the amount of exfoliated keratinocytes on the skin is extremely small.
  • the patch of the present invention When the patch of the present invention is affixed to the skin surface inside the human forearm for 6 hours and then peeled off, the keratinocyte peeling area relative to the sticking area can be 20% or less.
  • the keratinocyte peeling area is 20% or less, generation of skin irritation is suppressed, and the affected area is not deteriorated. Therefore, since the patch of the present invention has a particularly reduced keratin intercellular binding force, it does not exacerbate the human symptoms of atopic skin inflammation in which the keratinocytes are more easily detached.
  • a patch of a predetermined shape was applied to the inner side of the forearm of a healthy subject (subject with a healthy skin) for a predetermined time (6 hours). Thereafter, the patch was peeled off, and the keratinocytes peeled from the skin and transferred to the surface of the pressure-sensitive adhesive layer were observed using a staining solution, and the area stained with the peeled keratinocytes with respect to the entire area of the patch It means that the area ratio is 20% or less. If the keratinocyte peeling area after 6 hours of application is preferably 15% or less, more preferably 10% or less, still more preferably 5% or less, and particularly preferably 2% or less, the damage to the skin is minimized. be able to.
  • ⁇ Amount of exfoliated corneocytes> The amount of exfoliated keratinocytes is applied to the inside of the forearm of 6 healthy adult men and women in their 20s and 40s for 6 hours, and the patch cut into a size of 15mm x 50mm is applied for 6 hours.
  • the attached keratinocytes are stained by immersing them in a cationic dye solution (gentian violet B: 1%, brilliant green: 0.5%, distilled water: 98.5%) for 3 hours, and the keratinocytes are detached using an image processing apparatus. The area ratio (%) was measured, and an average value and a standard deviation were obtained.
  • ⁇ Moisture permeability> The moisture permeability was measured at a temperature of 40 ° C. and a relative humidity of 90% in accordance with the B condition of JIS Z0208. That is, one side of the sample is adjusted to a temperature of 40 ° C. and a relative humidity of 90%, and about 16 g of a hygroscopic agent (calcium chloride) is placed on the other side to absorb the moisture that has passed through the sample. The amount of change was converted to 1 m 2 per 24 hours, and the average value of the three patches was taken as moisture permeability.
  • a hygroscopic agent calcium chloride
  • the adhesive strength was measured according to the 90 degree peel test defined in JIS Z0237. Specifically, after the washed bakelite plate (phenol resin plate, manufactured by Sumitomo Bakelite Co., Ltd., PL-1102) is dried, a patch cut to a width of 10 mm is applied, and after pressing with a 2 kg load roll, 20 ⁇ Measure the stress (N) when peeling off at a pulling rate of 100 mm / min in the 90-degree direction with an Instron type tensile tester within 10 minutes to determine the adhesive strength and the average value and standard deviation of the three patches. Asked.
  • N stress
  • ⁇ Pharmacologically active substance release test> The amount of the pharmacologically active substance released was determined by mounting the patch on a horizontal diffusion cell having a substantial permeation area of 1.766 cm 2 (circular with a diameter of 1.5 cm) so that the adhesive layer surface was inside, and receiving the receiver liquid (PBS; pH 7 .4) A 20% PEG aqueous solution was added, and a release test was performed at 32 ° C. for measurement. Sampling the effluent of 1 hour after the start, by HPLC (Shimadzu high performance liquid chromatograph LC-2010), to quantify the concentration of the pharmacologically active substances of three patches, as emission amount per 1 cm 2 Average values and standard deviations were determined.
  • HPLC Shiadzu high performance liquid chromatograph LC-2010
  • Example 1 A polyether-based polyurethane elastomer solution (Lack Skin (registered trademark) US2268 manufactured by Seiko Kasei Co., Ltd.) is applied to the surface of a 75 ⁇ m-thick polyester (PET) film treated with silicone on one side so that the thickness after drying is 5 ⁇ m and dried. And it was set as the support body which consists of a polyurethane film. Next, an appropriate amount of a silane primer (FS XA-2869 manufactured by Dow Corning) was applied to the surface of the polyurethane film with a Mayer bar.
  • a silane primer FS XA-2869 manufactured by Dow Corning
  • the film was coated to a thickness of 30 ⁇ m, placed in a constant temperature bath at 170 ° C. for 1 minute, and cured.
  • the treated surface of a polyester (PET) film having a thickness of 75 ⁇ m treated with single-sided fluorosilicone is bonded to the addition reaction type silicone pressure-sensitive adhesive and cut to form a laminated structure of carrier film / support / adhesive layer / release liner.
  • a patch with the following was obtained.
  • Example 2 Polyester polyurethane elastomer solution (Nipporan (registered trademark) 5111 manufactured by Nippon Polyurethane Co., Ltd.) was applied to a 75 ⁇ m thick PET film surface treated with one side of silicone so that the thickness after drying was 5 ⁇ m, dried, and then a polyurethane film It was set as the support body which consists of.
  • the film was coated to a thickness of 30 ⁇ m, placed in a constant temperature bath at 170 ° C. for 1 minute, and cured.
  • the treated surface of a PET film having a thickness of 75 ⁇ m treated with single-sided fluorosilicone was bonded to the addition reaction type silicone pressure-sensitive adhesive and cut to obtain a patch.
  • Example 3 The polyurethane film produced in Example 1 was coated with the addition-reactive silicone pressure-sensitive adhesive used in Example 1 so that the thickness was 10 ⁇ m, and was similarly bonded with a single-sided fluorosilicone-treated PET film and cut. A patch was obtained.
  • Example 1 The polyurethane film produced in Example 1 was coated with the addition reaction type silicone pressure-sensitive adhesive used in Example 1 so as to have a thickness of 60 ⁇ m. A patch was obtained.
  • Example 2 instead of the addition reaction type silicone adhesive used in Example 1, a silicone adhesive (BIO-PSA (registered trademark) 4501 manufactured by Dow Corning) was dried on the polyurethane film produced in Example 1 after drying. was coated with a PET film treated with single-sided fluorosilicone and cut to obtain a patch.
  • BIO-PSA 4501 is a general-purpose three-dimensional crosslinking type condensation-type silicone adhesive.
  • Comparative Example 2-2 A patch was obtained in the same manner as in Comparative Example 2, except that a silicone adhesive (BIO-PSA (registered trademark) 4501 manufactured by Dow Corning) was applied so that the thickness after drying was 10 ⁇ m.
  • a silicone adhesive BIO-PSA (registered trademark) 4501 manufactured by Dow Corning
  • SIS styrene-isoprene-styrene block copolymer
  • Comparative Example 5 In the acrylic adhesive used in Comparative Example 3, 20% by weight of oily component isopropyl myristate (IPM manufactured by Nikko Chemicals Co., Ltd.) was mixed, and after stirring, a patch was prepared in the same manner as in Comparative Example 1. .
  • oily component isopropyl myristate IPM manufactured by Nikko Chemicals Co., Ltd.
  • Example 6 A patch was obtained in the same manner as in Example 1 except that the polyether-based polyurethane elastomer solution used in Example 1 was applied so that the thickness after drying was 20 ⁇ m.
  • Table 1 shows the measurement results for the patches of Examples 1 to 3 and Comparative Examples 1 to 6.
  • FIG. 1 shows an external appearance photograph when the patches of Example 1 and Comparative Examples 2, 3 and 5 were applied to the inner portion of the forearm for 20 minutes, and the gloss values of the respective gloss checkers.
  • the black numbers are the values of the affixed sites by the gloss checker
  • the white numbers are the values of the non-applied sites by the gloss checker.
  • FIG. 2 shows an enlarged photograph (100 times) of the skin at the site of application when the patches of Example 3, Comparative Example 1 and Comparative Example 3 were applied to the inner part of the forearm.
  • (1) in FIG. 2 is the skin surface at the site where the patch is not applied
  • (2) is the skin surface at the site where the patch of Example 3 is applied
  • (3) is the site where the patch of Comparative Example 1 is applied
  • (4) is the skin surface of the patch application site of Comparative Example 3.
  • the patch of Example 3 is in close contact with the skin groove.
  • the patch of Comparative Example 1 is in close contact with the skin groove, but since the adhesive layer is thick, the skin groove is hidden, and conversely, the appearance is conspicuous.
  • the patch of Comparative Example 3 has a high cohesive strength of the acrylic adhesive, and thus the adhesive patch does not adhere to the skin groove even though the thickness of the entire patch is thin (part that looks white). Therefore, the appearance is conspicuous in pasting for a short time (about 20 minutes).
  • the polyurethane film of the support has a thickness of 10 ⁇ m or less and the addition reaction type silicone pressure-sensitive adhesive layer has a thickness in the range of 5 to 50 ⁇ m.
  • a patch comprising an adhesive layer that falls within 30 minutes in a retention test and has an adhesive strength of 0.1 N / 10 mm or less is a patch with a less noticeable site and a small amount of exfoliated keratinocytes. It can be seen that it is.
  • Comparative Example 7 In the acrylic adhesive used in Comparative Example 3, 4% by weight of pyridoxine tri-2-hexyldecanoate (“NIKKOL (registered trademark) VB6-IP” manufactured by Nikko Chemicals Co., Ltd.) was mixed, and after stirring, the adhesive layer A patch was prepared in the same manner as in Comparative Example 3, except that the thickness was 10 ⁇ m.
  • NIKKOL registered trademark
  • VB6-IP pyridoxine tri-2-hexyldecanoate
  • Example 4 For each patch of Example 4 and Comparative Example 7, a release test of pyridoxine tri-2-hexyldecanoate, which is a pharmacologically active substance, was performed. The results are shown in FIG. Error bars in the figure indicate standard deviation.
  • FIG. 4 shows that the patch of Example 4 of the present invention shows sufficient release properties even when a pharmacologically active substance is contained at a low concentration.
  • the pharmacologically active substance concentration (4% by weight) in the adhesive layer was twice the concentration (2% by weight) in the patch of Example 4, It can be seen that there is only about half the amount of the patch of Example 4.
  • a patch was prepared in the same manner as in Example 1 except that the coating was applied so that the thickness of the agent layer was 30 ⁇ m. This patch was inconspicuous even when applied to the skin (hardness of conspicuity: AAA), the adhesive strength (N / 10 mm) was 0.13 (0.011), and the amount of keratinocyte detachment was small.
  • the patch of the present invention covers and protects skin affected areas caused by various skin diseases such as atopic dermatitis, and can be used for improvement and treatment of various symptoms caused by skin diseases.
  • the patch of the present invention can be applied to uses such as pharmaceuticals or quasi drugs by including a pharmacologically active substance in the adhesive layer.
  • the patch of the present invention is suitable as a medical patch, but is not limited thereto, and can be used for other purposes such as application to the skin surface requiring protection.

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Abstract

Timbre adhésif présentant une configuration en couches comprenant une couche adhésive sur une surface d'un corps de support. Le corps de support est constitué d'un film polyuréthanne ayant une épaisseur dans la plage de 1 à 10 µm. La couche adhésive est formée par une couche adhésive de type silicone durcissable par addition ayant une épaisseur dans la plage de 5 à 50 µm et qui est constituée d'un polyorganosiloxane ne contenant pas de groupe vinyle dans une chaîne latérale. La perméabilité à la vapeur d'eau du timbre adhésif est supérieure à 1 500 g/m2·24 h.
PCT/JP2011/060373 2010-04-30 2011-04-28 Timbre adhésif et son utilisation WO2011136330A1 (fr)

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WO2014001653A1 (fr) 2012-06-26 2014-01-03 Ab7 Innovation S.A.S.U. Matrice sequencee multifonctionnelle monopolymerique en polyurethanne coule et procede de fabrication
WO2014051040A1 (fr) * 2012-09-28 2014-04-03 ニチバン株式会社 Timbre de fixation de cathéter à fenêtre
JP2018083791A (ja) * 2016-11-25 2018-05-31 バンドー化学株式会社 医療用粘着フィルム
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EP2648668A1 (fr) * 2010-12-08 2013-10-16 ConvaTec Technologies Inc. Pansement auto-adhésif
EP2648668A4 (fr) * 2010-12-08 2015-01-14 Convatec Technologies Inc Pansement auto-adhésif
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JPWO2018124089A1 (ja) * 2016-12-28 2019-10-31 久光製薬株式会社 貼付剤
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US11020356B2 (en) 2016-12-28 2021-06-01 Hisamitsu Pharmaceutical Co., Inc. Drug-containing patch
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JP2022036194A (ja) * 2016-12-28 2022-03-04 久光製薬株式会社 貼付剤
JP7069042B2 (ja) 2016-12-28 2022-05-17 久光製薬株式会社 貼付剤
JP7366166B2 (ja) 2016-12-28 2023-10-20 久光製薬株式会社 貼付剤
US11872320B2 (en) 2021-02-25 2024-01-16 Hisamitsu Pharmaceutical Co., Inc. Method for treating osteoarthritis

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