WO2016125878A1 - 貼付剤 - Google Patents

貼付剤 Download PDF

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Publication number
WO2016125878A1
WO2016125878A1 PCT/JP2016/053456 JP2016053456W WO2016125878A1 WO 2016125878 A1 WO2016125878 A1 WO 2016125878A1 JP 2016053456 W JP2016053456 W JP 2016053456W WO 2016125878 A1 WO2016125878 A1 WO 2016125878A1
Authority
WO
WIPO (PCT)
Prior art keywords
patch
adhesive layer
mass
pressure
sensitive adhesive
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2016/053456
Other languages
English (en)
French (fr)
Inventor
中島　健太郎
佐藤　昌宏
靖久 古瀬
隆明 義永
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hisamitsu Pharmaceutical Co Inc
Original Assignee
Hisamitsu Pharmaceutical Co Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hisamitsu Pharmaceutical Co Inc filed Critical Hisamitsu Pharmaceutical Co Inc
Priority to HK18104665.6A priority Critical patent/HK1245121B/en
Priority to EP16746709.1A priority patent/EP3254677B1/en
Priority to US15/547,645 priority patent/US10292941B2/en
Priority to KR1020177024402A priority patent/KR101939932B1/ko
Priority to ES16746709T priority patent/ES2887200T3/es
Priority to BR112017015737-3A priority patent/BR112017015737B1/pt
Priority to CN201680008513.4A priority patent/CN107205957B/zh
Publication of WO2016125878A1 publication Critical patent/WO2016125878A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

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    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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    • 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
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    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • B32B2262/00—Composition or structural features of fibres which form a fibrous or filamentary layer or are present as additives
    • B32B2262/02—Synthetic macromolecular fibres
    • B32B2262/0253—Polyolefin fibres
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2262/00—Composition or structural features of fibres which form a fibrous or filamentary layer or are present as additives
    • B32B2262/02—Synthetic macromolecular fibres
    • B32B2262/0261—Polyamide fibres
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2262/00—Composition or structural features of fibres which form a fibrous or filamentary layer or are present as additives
    • B32B2262/02—Synthetic macromolecular fibres
    • B32B2262/0276—Polyester fibres
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2262/00—Composition or structural features of fibres which form a fibrous or filamentary layer or are present as additives
    • B32B2262/02—Synthetic macromolecular fibres
    • B32B2262/0292—Polyurethane fibres
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2262/00—Composition or structural features of fibres which form a fibrous or filamentary layer or are present as additives
    • B32B2262/04—Cellulosic plastic fibres, e.g. rayon
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2262/00—Composition or structural features of fibres which form a fibrous or filamentary layer or are present as additives
    • B32B2262/06—Vegetal fibres
    • B32B2262/062—Cellulose fibres, e.g. cotton
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2262/00—Composition or structural features of fibres which form a fibrous or filamentary layer or are present as additives
    • B32B2262/08—Animal fibres, e.g. hair, wool, silk
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/732—Dimensional properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/748—Releasability
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter

Definitions

  • the present invention relates to a patch.
  • a plaster patch in which an adhesive layer containing a drug such as an anti-inflammatory analgesic is laminated on a support is commercially available.
  • a patch using a woven fabric as a support is excellent in stretchability and easy to follow the stretch of the skin, and therefore has excellent adhesion.
  • a patch using a woven fabric as the support tends to have a weak so-called “firmness”. Therefore, when the patch is applied to the affected area, the adhesive surfaces may stick together due to unexpected bending, and it tends to be difficult to apply the patch.
  • a patch using a nonwoven fabric as a support has also been developed. Compared to the patch using a woven fabric as a support, the patch using a nonwoven fabric as a support tends to improve the “strain” problem, but the so-called cold flow occurs and the adhesive layer is formed from the support. The component tends to ooze out easily.
  • An object of the present invention is to provide a patch that is excellent in ease of sticking and that does not allow the components of the pressure-sensitive adhesive layer to exude from the support.
  • the present inventors conducted extensive studies. As a result, by combining a support made of spunlace nonwoven fabric with a pressure-sensitive adhesive layer containing styrene-isoprene-styrene block copolymer and liquid paraffin, and setting the bending resistance of the patch to 18-30 mm, The present inventors have found that the above problems can be solved.
  • the present invention relates to a patch comprising a support and an adhesive layer laminated on the support, the support comprising a spunlace nonwoven fabric, and the adhesive layer comprising a styrene-isoprene-styrene block copolymer.
  • a 45 ° cantilever defined in JIS L 1085: 1998 has a first direction which is a predetermined reference axis direction and a second direction perpendicular to the first direction.
  • a patch having a bending resistance in the first direction of 18-30 mm measured by the method is provided.
  • the mass ratio of the styrene-isoprene-styrene block copolymer to the liquid paraffin in the pressure-sensitive adhesive layer may be 1 to 1.65: 1.
  • the pressure-sensitive adhesive layer may contain methyl salicylate and menthol.
  • the pressure-sensitive adhesive layer may contain polyisobutylene.
  • the pressure-sensitive adhesive layer may contain a terpene resin.
  • the pressure-sensitive adhesive layer may contain 9 to 11% by mass of methyl salicylate and 2.5 to 6.5% by mass of menthol based on the total mass of the pressure-sensitive adhesive layer, and based on the total mass of the pressure-sensitive adhesive layer.
  • styrene-isoprene-styrene block copolymer 23.7-32.5% by weight styrene-isoprene-styrene block copolymer, 17.9-27.5% by weight liquid paraffin, 9-11% by weight methyl salicylate, 3-6% by weight menthol 3-12% by weight polyisobutylene and 17-25% by weight terpene resin may be included.
  • the basis weight of the nonwoven fabric may be 90 to 110 g / m 2 .
  • the nonwoven fabric may have a 20% modulus in the width direction of 3 to 5 N / 50 mm.
  • the 50% modulus in the width direction of the nonwoven fabric may be 8 to 15 N / 50 mm.
  • the nonwoven fabric may be made of polyester.
  • the bending resistance in the first direction of the patch measured by the 45 ° cantilever method defined in JIS L 1085: 1998 may be 18 to 27 mm.
  • the patch according to the present invention is easy to apply because there is “strain”. Moreover, the cold flow of the component of an adhesive layer does not arise easily.
  • the patch according to the present embodiment has a support and a pressure-sensitive adhesive layer laminated on the support.
  • the support is made of a spunlace nonwoven fabric, and the pressure-sensitive adhesive layer contains a styrene-isoprene-styrene block copolymer and liquid paraffin.
  • the patch has a first direction which is a predetermined reference axis direction and a second direction perpendicular to the first direction, and the bending resistance of the patch in the first direction is 18 to 30 mm.
  • the bending resistance means bending resistance measured by the 45 ° cantilever method defined in JIS L 1085: 1998. That is, the bending resistance means that a test piece (a patch or a support) having a width of 2 cm is placed on a smooth horizontal surface having a slope of 45 ° and having a scale on the upper surface, and its short side. The distance that the specimen moved until the central point of one short side of the specimen touched the slope when the specimen was slid gently in the direction of the slope. Means (mm).
  • the bending resistance in the first direction of the patch means bending resistance when the test piece is gently slid along the slope in the first direction.
  • the spunlace nonwoven fabric means a nonwoven fabric formed by a so-called hydroentanglement method in which a high-pressure water stream is jetted and entangled with fibers.
  • the raw material for spunlace nonwoven fabric is polyester such as polyethylene terephthalate (PET), ethylene-vinyl acetate copolymer (EVA), polyolefin such as vinyl chloride, polyethylene and polypropylene, butadiene-styrene-methyl methacrylate copolymer resin, nylon, Examples thereof include synthetic resins such as polyurethane, alkoxyalkyl (meth) acrylate copolymer, polyvinyl acetal, polyamide and rayon, and natural materials such as cotton, wool and silk.
  • the spunlace nonwoven fabric is preferably a spunlace nonwoven fabric made of polyester.
  • the diameter of the fiber is preferably 5 to 15 ⁇ m.
  • the basis weight of the spunlace nonwoven fabric is, for example, 50 g / m 2 or more, preferably 70 g / m 2 or more, and more preferably 90 g / m 2 or more.
  • the basis weight of the spunlace nonwoven fabric is, for example, 200 g / m 2 or less, preferably 150 g / m 2 or less, and more preferably 125 g / m 2 or less.
  • the basis weight of the spunlace nonwoven fabric is particularly preferably 90 to 110 g / m 2 or 100 to 110 g / m 2 .
  • the spunlace nonwoven fabric has a machine direction (flow direction or vertical direction) and a cross direction (width direction or horizontal direction).
  • the stretchability of the spunlace nonwoven fabric has, for example, a 50% modulus in the flow direction of 200 to 400 N / 50 mm and a 50% modulus in the width direction of 5 to 15 N / 50 mm.
  • the measurement of stretchability is based on the elongation force at constant elongation specified in JIS L 1096: 2010. When the stretchability of the spunlace nonwoven fabric is within the above range, it becomes easy to follow the stretch of the skin at the patch application site.
  • the stretchability of the spunlace nonwoven fabric is preferably 40 to 90 N / 50 mm, more preferably 55 to 75 N / 50 mm, and more preferably 55 to 75 N / 50 mm in the width direction.
  • the 20% modulus is preferably 3 to 5 N / 50 mm, more preferably 3.6 to 4.4 N / 50 mm, and the 50% modulus in the flow direction is preferably 150 to 350 N / 50 mm. More preferably, it is 220 to 300 N / 50 mm, and the 50% modulus in the width direction is preferably 8 to 15 N / 50 mm, and preferably 11.2 to 11.7 N / 50 mm. It is preferable that the width direction and the flow direction of the spunlace nonwoven fabric coincide with the first direction and the second direction of the patch, respectively.
  • the bending resistance in the width direction of the spunlace nonwoven fabric is preferably 18 to 30 mm.
  • the bending softness in the width direction of the spunlace nonwoven fabric is within the above range, when a patch in which an adhesive layer is laminated on a support made of the spunlace nonwoven fabric is produced, the bending resistance in the first direction of the patch is produced.
  • the degree can be easily set to a desired range.
  • the bending resistance in the first direction of the patch is 18 to 30 mm, and is preferably 18 to 27 mm or 21 to 27 mm from the viewpoint of easy sticking of the patch.
  • the support products marketed as spunlace nonwoven fabric can be used.
  • examples of such products include Unitika Co., Ltd., Kuraray Laflex Co., Ltd., Yuho Co., Ltd., Daiwabo Polytech Co., Ltd., and Japan Vilene Co., Ltd. It is sold by companies.
  • the pressure-sensitive adhesive layer contains styrene-isoprene-styrene block copolymer (hereinafter sometimes referred to as SIS or SIS block copolymer) and liquid paraffin.
  • Products commercially available as SIS block copolymers can be used, and such products include Califlex TR-1107, Califlex TR-1111, Califlex TR-1112, Califlex TR-1117 (above, Shell Chemical Co., Ltd.), JSR5000, JSR5002, JSR5100 (above, manufactured by JSR Corporation), and QUINTAC 3570C (manufactured by Zeon Corporation).
  • the content of the SIS block copolymer in the pressure-sensitive adhesive layer is, for example, 10% by mass or more, preferably 15% by mass or more, and more preferably 20% by mass or more with respect to the total mass of the pressure-sensitive adhesive layer.
  • the patch provided with the pressure-sensitive adhesive layer containing the SIS block copolymer having the lower limit value or more has a sufficient “strain” without causing the patch to peel off from the skin during the necessary application period.
  • the content of the SIS block copolymer in the pressure-sensitive adhesive layer is, for example, 50% by mass or less, preferably 40% by mass or less, more preferably 30% by mass or less, with respect to the total mass of the pressure-sensitive adhesive layer.
  • a patch provided with a pressure-sensitive adhesive layer containing a SIS block copolymer having an upper limit value of not more than the above upper limit is excellent in usability such as no pain when the patch is peeled off.
  • the content of the SIS block copolymer in the pressure-sensitive adhesive layer is particularly preferably 23.7 to 32.5% by mass.
  • the content of liquid paraffin in the pressure-sensitive adhesive layer is, for example, 5% by mass or more, preferably 10% by mass or more, and more preferably 15% by mass or more with respect to the total mass of the pressure-sensitive adhesive layer.
  • a patch provided with a pressure-sensitive adhesive layer containing liquid paraffin above the lower limit has sufficient adhesiveness.
  • the content of liquid paraffin in the pressure-sensitive adhesive layer is, for example, 50% by mass or less, preferably 40% by mass or less, more preferably 30% by mass or less, with respect to the total mass of the pressure-sensitive adhesive layer.
  • a patch comprising a pressure-sensitive adhesive layer containing a liquid paraffin having the upper limit value or less is moderately flexible and therefore easy to stick. From the viewpoint of easy application of the patch, the content of liquid paraffin in the adhesive layer is particularly preferably 17.9 to 27.5% by mass.
  • the mass ratio of the SIS block copolymer to the liquid paraffin in the pressure-sensitive adhesive layer is preferably 1 to 1.65: 1.
  • the “strain” of the patch can be strengthened, and the patch can be easily applied.
  • blended in this ratio an adhesive layer can be adjusted to moderate hardness, it becomes difficult to produce a bubble in an adhesive layer at the time of manufacture, and it is excellent in manufacture aptitude.
  • both are blended in such a ratio it becomes easy to prevent cold flow.
  • the pressure-sensitive adhesive layer may contain a pressure-sensitive adhesive other than the SIS block copolymer and a plasticizer other than liquid paraffin, if necessary, and a tackifier, an absorption accelerator, an antioxidant, a filler, a crosslinking agent, and an antiseptic.
  • An additive such as an agent, an ultraviolet absorber, a surfactant, a pH adjuster, a pigment and a fragrance may be included.
  • Examples of the adhesive other than the SIS block copolymer include natural rubber, synthetic isoprene rubber, polyisobutylene, polyvinyl ether, polyurethane, polyisoprene, polybutadiene, styrene-butadiene copolymer, and styrene-isoprene copolymer.
  • the pressure-sensitive adhesive layer preferably contains polyisobutylene. By using polyisobutylene, the adhesive force can be improved.
  • the content of polyisobutylene in the pressure-sensitive adhesive layer is, for example, 1 to 20% by mass, preferably 2 to 15% by mass. From the viewpoint of easy application of the patch, the content of polyisobutylene in the pressure-sensitive adhesive layer is particularly preferably 3 to 12% by mass.
  • plasticizers other than liquid paraffin include polybutene, liquid polyisobutylene, and animal and vegetable oils.
  • tackifiers alicyclic saturated hydrocarbon resins (manufactured by Arakawa Chemical Industry Co., Ltd., trade name: Alcon P-100, etc.), hydrogenated rosin esters (manufactured by Arakawa Chemical Industries, trade names: KE-311, KE-100) Manufactured by Hercules Co., Ltd., trade names: Foral 105, Foral 85, etc.), hydrogenated alicyclic hydrocarbons (produced by Exxon Chemical Co., Ltd., trade name: Escollets 5300, etc.), terpene resins, petroleum resins, and phenol resins.
  • terpene resins composed of ⁇ -pinene, ⁇ -pinene, and the like are preferable because they have an excellent effect of increasing the adhesive strength.
  • the SIS block copolymer and the liquid paraffin are blended in the pressure-sensitive adhesive layer at a ratio of 1 to 1.65: 1, the pressure-sensitive adhesive strength of the pressure-sensitive adhesive layer tends to decrease.
  • the adhesive force can be improved by using a terpene resin.
  • the content of the terpene resin in the pressure-sensitive adhesive layer is particularly preferably 17 to 25% by mass.
  • Absorption enhancers include isopropyl myristate, diethyl sebacate, sorbitan monolaurate, sodium oleyl phosphate, sodium lauryl sulfate, octylphenyl ether, lauryl ether, sorbitan monolaurate, lauroyl diethanolamide, lauroyl sarcosine, oleoyl sarcosine sugar ester , Lecithin, glycyrrhetinic acid, urea, salicylic acid, calcium thioglycolate, lactic acid, lactic acid ester, olive oil, squalene, lanolin and glycerin.
  • antioxidants include tocopherol and its ester derivatives, ascorbic acid, ascorbic acid stearate, nordihydroguaiaretic acid, dibutylhydroxytoluene and butylhydroxyasonyl.
  • filler examples include calcium carbonate, magnesium carbonate, silicate (eg, aluminum silicate, magnesium silicate, etc.), silicic acid, barium sulfate, calcium sulfate, calcium zincate, zinc oxide, titanium oxide, and zinc stearate. It is done.
  • silicate eg, aluminum silicate, magnesium silicate, etc.
  • silicic acid barium sulfate, calcium sulfate, calcium zincate, zinc oxide, titanium oxide, and zinc stearate. It is done.
  • thermosetting resins such as amino resins, phenol resins, epoxy resins, alkyd resins, and unsaturated polyesters
  • organic crosslinking agents such as isocyanate compounds and blocked isocyanate compounds
  • inorganic crosslinking agents such as metals and metal compounds.
  • Preservatives include ethyl paraoxybenzoate, propyl paraoxybenzoate and butyl paraoxybenzoate.
  • ultraviolet absorbers examples include p-aminobenzoic acid derivatives, anthranilic acid derivatives, salicylic acid derivatives, coumarin derivatives, amine acid compounds, imidazoline derivatives, pyridine derivatives and dioxane derivatives.
  • the drug contained in the adhesive layer is not particularly limited.
  • Anti-inflammatory analgesics such as flurbiprofen, ketoprofen, ampenac sodium, mepyrazole, indomethacin, piroxicam and felbinac
  • steroidal anti-inflammatory agents such as hydrocortisone, triamcinolone, dexamethasone and prednisolone; diltiazem hydrochloride, pentaerythritol tetranitrate, isosorbide nitrate, Taradipil, nicorandil, nitroglycerin, prenylamine lactate, molsidomine, aluminum nit
  • the adhesive layer When high concentrations of methyl salicylate and menthol (for example, 1-menthol) are contained in the adhesive layer, the action of these drugs increases the tendency of the adhesive layer to be easily plasticized. It becomes weak and it becomes difficult to apply the patch. However, since the patch according to the present embodiment has a strong “strain” as described above, the patch can be easily applied even if these drugs are contained in a high concentration in the adhesive layer. In particular, when the adhesive layer contains 9 to 11% by mass of methyl salicylate and 2.5 to 6.5% by mass or 3 to 6% by mass of menthol based on the total mass of the adhesive layer, Application of such a patch is suitable.
  • the thickness of the pressure-sensitive adhesive layer is preferably 50 to 3000 ⁇ m. When the thickness of the pressure-sensitive adhesive layer is 3000 ⁇ m or less, the release of the drug contained in the pressure-sensitive adhesive layer is good, and when it is 50 ⁇ m or more, the skin adhesiveness is good and the patch is difficult to peel off.
  • the thickness of the support is, for example, 300 ⁇ m or more, and preferably 400 ⁇ m or more. When the thickness of the support is not less than the above lower limit value, it is difficult for the components of the pressure-sensitive adhesive layer to ooze out. Moreover, the thickness of a support body is 1200 micrometers or less, for example, and it is preferable that it is 700 micrometers or less. When the thickness of the support is not more than the above upper limit value, the patch is difficult to peel off.
  • the total thickness of the support and the pressure-sensitive adhesive layer that is, the thickness of the patch is preferably 300 to 5000 ⁇ m.
  • the thickness of the patch is 5000 ⁇ m or less, the end of the patch is hardly caught by clothes or the like, and the patch is difficult to peel off.
  • the thickness of the patch is 300 ⁇ m or more, the support of the patch is sufficient, the patch can be reliably attached, and wrinkles are not easily generated in the patch after application.
  • the patch according to this embodiment may have a rectangular or rounded rectangular shape with a short side of 4 to 10 cm and a long side of 6 to 15 cm.
  • the shape of the patch according to this embodiment is a rectangle or a rounded rectangle
  • the long side direction and the short side direction respectively match the width direction and the flow direction of the spunlace nonwoven fabric
  • the first patch It is preferable to correspond to the direction and the second direction.
  • the patch according to this embodiment may further include a release film for covering and protecting the adhesive layer.
  • the material of the release film is unstretched polypropylene (CPP), stretched polypropylene (OPP), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene, polyester, polyurethane, polyvinyl chloride, polystyrene, and other plastic films, synthetic resin And silicon processed paper processed with silicon such as synthetic paper and synthetic fiber, aluminum foil, and laminated paper obtained by laminating kraft paper with polyethylene or the like. Among these, PET and processed paper are preferably used.
  • the bending resistance of the patch means the bending resistance measured with the patch with the release film peeled off.
  • the thickness of the release film is, for example, 10 to 100 ⁇ m, preferably 30 to 90 ⁇ m, more preferably 40 to 85 ⁇ m.
  • the thickness of the release film is equal to or more than the above lower limit value, the release film is easily grasped, and when the release film is peeled off, the adhesive layer is hardly entangled.
  • the thickness of the release sheet is not more than the above upper limit, cutting during production becomes easy and production suitability is improved.
  • the patch according to this embodiment can be produced by a method known to those skilled in the art. For example, using a mixer such as a kneader or mixer, while heating to 120-160 ° C, mix each component of the adhesive layer other than the drug, then add and mix the drug at a temperature that does not thermally decompose to form the adhesive layer Prepare a mixture for use. This mixture is directly spread on the support to form a pressure-sensitive adhesive layer, or is spread on the release film to form a pressure-sensitive adhesive layer, and the support is placed on the pressure-sensitive adhesive layer. May be pressure-transferred onto a support.
  • a mixer such as a kneader or mixer
  • 1 The state where the patch is not peeled off and is in close contact with the skin 2
  • the state where only the end of the surface of the patch is peeled 3 The state where more than 1/4 of the surface of the patch is peeled off (4)
  • the penetration of the adhesive into the support (Exudation) Visually observe the presence or absence of oozing (bleeding) of the pressure-sensitive adhesive on the support.
  • the evaluation when there is no problem in the use of ⁇ was ⁇ , and the evaluation when the bleeding (bleeding) was recognized and it was not suitable for use as a patch was evaluated as x.
  • Formulation suitability The presence or absence of bubbles on the surface of the pressure-sensitive adhesive layer was visually observed.
  • the patches of Examples 1 and 2 in which the bending resistance of the patch is 18 or more are easy to stick, have excellent adhesion, and the adhesive spreads onto the support. It was an excellent patch.
  • the patch of Comparative Example 1 in which the bending resistance of the patch was less than 18 was inferior in terms of ease of sticking.
  • Evaluation experiment of patch (2) The components shown in Table 5 were heated and kneaded to obtain adhesives 2 to 6. Adhesives 2 to 6 were applied to the nonwoven fabrics 1 (made of polyester) and 3 shown in Table 2 so that the coating amount was 210 g / m 2, and the patches of Examples 3 to 7 and Comparative Examples 2 to 6 were applied. Obtained. About the obtained patch, the same evaluation as evaluation experiment (1) was performed. The results are shown in Table 7.
  • the patches of Comparative Examples 2 to 6 using the nonwoven fabric 1 produced by the needle punch method as a support were inferior in terms of ease of sticking.
  • the patches of Examples 3 to 7 using the nonwoven fabric 3 produced by the spunlace method as a support were excellent in ease of sticking and adhesion.
  • the patches of Examples 4 to 6 in which the mass ratio of SIS to liquid paraffin is in the range of 1 to 1.65: 1 are excellent in terms of difficulty in the penetration of the adhesive into the support and production suitability. It was.

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Abstract

　支持体と、支持体上に積層された粘着剤層とを有する貼付剤であって、支持体はスパンレース不織布からなり、粘着剤層はＳＩＳブロック共重合体及び流動パラフィンを含み、貼付剤は所定の基準軸方向である第１の方向と、第１の方向に直角な第２の方向を有し、貼付剤の第１の方向の剛軟度は１８～３０ｍｍである、貼付剤を開示する。

Description

貼付剤
　本発明は、貼付剤に関する。
　肩、肘、膝及び腰の痛みを緩和するために、消炎鎮痛剤などの薬物を配合した粘着剤層が支持体に積層された硬膏貼付剤（プラスター剤）が市販されている。このような貼付剤のうち支持体に織布を用いた貼付剤は、伸縮性に優れ、皮膚の伸縮に追従しやすいため、付着性に優れる。しかし、支持体に織布を用いた貼付剤は、いわゆる「こし」（firmness）が弱い傾向がある。したがって、貼付剤を患部に貼付する際に不意に折れ曲がることで粘着面同士がくっつくことがあり、貼付剤を貼り難い傾向がある。
　一方、支持体に不織布を用いた貼付剤も開発されている。支持体に織布を用いた貼付剤と比べ、支持体に不織布を用いた貼付剤は、「こし」の問題が改善される傾向にあるものの、いわゆるコールドフローが生じて支持体から粘着剤層の成分が滲み出し易くなる傾向がある。
特開２００１－３２８９３５号公報
　本発明は、貼り易さに優れ、かつ、粘着剤層の成分が支持体から滲み出さない、貼付剤を提供することを目的とする。
　本発明者らは、上記事情に鑑み、鋭意検討を行った。その結果、スパンレース不織布からなる支持体と、スチレン－イソプレン－スチレンブロック共重合体及び流動パラフィンを含む粘着剤層とを組み合わせ、かつ、貼付剤の剛軟度を１８～３０ｍｍとすることで、上記課題が解決することを本発明者らは見出した。
　すなわち、本発明は、支持体と、支持体上に積層された粘着剤層とを有する貼付剤であって、支持体はスパンレース不織布からなり、粘着剤層はスチレン－イソプレン－スチレンブロック共重合体及び流動パラフィンを含み、貼付剤は所定の基準軸方向である第１の方向と、第１の方向に直角な第２の方向を有し、ＪＩＳ　Ｌ　１０８５：１９９８に規定される４５゜カンチレバー法で測定した貼付剤の第１の方向の剛軟度は１８～３０ｍｍである貼付剤を提供する。
　上記粘着剤層におけるスチレン－イソプレン－スチレンブロック共重合体と流動パラフィンとの質量比が１～１．６５：１であってよい。上記粘着剤層は、サリチル酸メチル及びメントールを含んでよい。上記粘着剤層は、ポリイソブチレンを含んでよい。上記粘着剤層は、テルペン樹脂を含んでよい。上記粘着剤層は、粘着剤層の全質量基準で、９～１１質量％のサリチル酸メチル及び２．５～６．５質量％のメントールを含んでよく、また、粘着剤層の全質量基準で、２３．７～３２．５質量％のスチレン－イソプレン－スチレンブロック共重合体、１７．９～２７．５質量％の流動パラフィン、９～１１質量％のサリチル酸メチル、３～６質量％のメントール、３～１２質量％のポリイソブチレン及び１７～２５質量％のテルペン樹脂を含んでよい。
　また、上記不織布の目付けは９０～１１０ｇ／ｍ２であってよい。上記不織布の幅方向の２０％モジュラスが３～５Ｎ／５０ｍｍであってよい。上記不織布の幅方向の５０％モジュラスが８～１５Ｎ／５０ｍｍであってよい。上記不織布はポリエステルからなってよい。ＪＩＳ　Ｌ　１０８５：１９９８に規定される４５゜カンチレバー法で測定した貼付剤の第１の方向の剛軟度は１８～２７ｍｍであってよい。
　本発明に係る貼付剤は「こし」があるため貼り易い。また、粘着剤層の成分のコールドフローが生じ難い。
　本実施形態に係る貼付剤は、支持体と、支持体上に積層された粘着剤層とを有する。支持体は、スパンレース不織布からなり、粘着剤層は、スチレン－イソプレン－スチレンブロック共重合体及び流動パラフィンを含む。貼付剤は所定の基準軸方向である第１の方向と、第１の方向に直角な第２の方向を有し、貼付剤の第１の方向の剛軟度は、１８～３０ｍｍである。
　本明細書において、剛軟度とは、ＪＩＳ　Ｌ　１０８５：１９９８に規定される４５゜カンチレバー法で測定した剛軟度を意味する。すなわち、剛軟度とは、４５゜の斜面を有しかつ上面にスケールを備える、表面の滑らかな水平台の上に、幅２ｃｍの試験片（貼付剤又は支持体）を、その短辺とスケールの基線とが一致するように配置し、試験片を前記斜面の方向にゆるやかに滑らせたとき、試験片の一方の短辺の中央点が前記斜面と接するまでに試験片が移動した距離（ｍｍ）を意味する。貼付剤の第１の方向の剛軟度は、試験片を第１の方向に沿って斜面をゆるやかに滑らせたときの剛軟度を意味する。
　スパンレース不織布とは、繊維に高圧の水流を噴射して絡ませる、いわゆる水流絡合法で形成された不織布を意味する。スパンレース不織布の原料は、ポリエチレンテレフタレート（ＰＥＴ）などのポリエステル、エチレン－酢酸ビニル共重合体（ＥＶＡ）、塩化ビニル、ポリエチレン及びポリプロピレンなどのポリオレフィン、ブタジエン－スチレン－メタクリル酸メチル共重合樹脂、ナイロン、ポリウレタン、アルコキシアルキル（メタ）アクリレート共重合体、ポリビニルアセタール、ポリアミド及びレイヨンなどの合成樹脂、木綿、ウール、シルクなどの天然素材が挙げられる。貼付剤の貼り易さの観点から、スパンレース不織布は、ポリエステルからなるスパンレース不織布が好ましい。繊維の直径は５～１５μｍであることが好ましい。
　スパンレース不織布の目付けは、例えば５０ｇ／ｍ２以上であり、７０ｇ／ｍ２以上であることが好ましく、９０ｇ／ｍ２以上であることがより好ましい。スパンレース不織布の目付けが上記下限値以上であると、粘着剤層の成分の滲み出しが生じ難くなる。スパンレース不織布の目付けは、例えば２００ｇ／ｍ２以下であり、１５０ｇ／ｍ２以下であることが好ましく、１２５ｇ／ｍ２以下であることがより好ましい。上記上限値以下であると、貼付剤の貼付時に違和感が生じ難くなる。貼付剤の貼り易さの観点から、スパンレース不織布の目付けは、９０～１１０ｇ／ｍ２又は１００～１１０ｇ／ｍ２であることが特に好ましい。
　スパンレース不織布は、ｍａｃｈｉｎｅ　ｄｉｒｅｃｔｉｏｎ（流れ方向又は縦方向）及びｃｒｏｓｓ　ｄｉｒｅｃｔｉｏｎ（幅方向又は横方向）を有する。スパンレース不織布の伸縮性は、例えば、流れ方向の５０％モジュラスが２００～４００Ｎ／５０ｍｍであり、幅方向の５０％モジュラスが５～１５Ｎ／５０ｍｍである。伸縮性の測定は、ＪＩＳ　Ｌ　１０９６：２０１０に規定される定伸長時伸長力に基づく。スパンレース不織布の伸縮性が上記範囲内であると、貼付剤の貼付部位の皮膚の伸縮に追従し易くなる。貼付剤の貼り易さの観点から、スパンレース不織布の伸縮性は、流れ方向の２０％モジュラスが４０～９０Ｎ／５０ｍｍであることが好ましく、５５～７５Ｎ／５０ｍｍであることがより好ましく、幅方向の２０％モジュラスが３～５Ｎ／５０ｍｍであることが好ましく、３．６～４．４Ｎ／５０ｍｍであることがより好ましく、流れ方向の５０％モジュラスが１５０～３５０Ｎ／５０ｍｍであることが好ましく、２２０～３００Ｎ／５０ｍｍであることがより好ましく、幅方向の５０％モジュラスが８～１５Ｎ／５０ｍｍであることが好ましく、１１．２～１１．７Ｎ／５０ｍｍであることが好ましい。スパンレース不織布の幅方向及び流れ方向は、それぞれ貼付剤の第１の方向及び第２の方向に一致することが好ましい。
　スパンレース不織布の幅方向の剛軟度は、１８～３０ｍｍであることが好ましい。スパンレース不織布の幅方向の剛軟度が上記範囲内であると、スパンレース不織布からなる支持体に粘着剤層を積層した貼付剤を作製した場合に、貼付剤の第１の方向の剛軟度を容易に所望の範囲とすることができる。貼付剤の第１の方向の剛軟度は１８～３０ｍｍであり、貼付剤の貼り易さの観点から１８～２７ｍｍ又は２１～２７ｍｍであることが好ましい。
　支持体は、スパンレース不織布として市販されている製品を使用することができ、そのような製品は、例えば、ユニチカ株式会社、クラレクラフレックス株式会社、株式会社ユウホウ、ダイワボウポリテック株式会社及び日本バイリーン株式会社などから販売されている。
　粘着剤層は、スチレン－イソプレン－スチレンブロック共重合体（以下、ＳＩＳ又はＳＩＳブロック共重合体と言うことがある）及び流動パラフィンを含む。これらの成分を含む粘着剤層をスパンレース不織布と組み合わせることで、貼付剤の「こし」を強くすることが可能となり、貼付剤が貼り易くなる。
　ＳＩＳブロック共重合体として市販されている製品を使用することができ、そのような製品として、カリフレックスＴＲ－１１０７、カリフレックスＴＲ－１１１１、カリフレックスＴＲ－１１１２、カリフレックスＴＲ－１１１７（以上、シェル化学株式会社製）、ＪＳＲ５０００、ＪＳＲ５００２、ＪＳＲ５１００（以上、ＪＳＲ株式会社製）及びクインタック３５７０Ｃ（日本ゼオン株式会社製）が挙げられる。
　粘着剤層におけるＳＩＳブロック共重合体の含有量は、粘着剤層全質量に対し、例えば、１０質量％以上、好ましくは１５質量％以上、より好ましくは２０質量％以上である。上記下限値以上のＳＩＳブロック共重合体を含む粘着剤層を備える貼付剤は、必要な貼付期間中に皮膚から貼付剤が剥離することなく、かつ十分な「こし」を有する。粘着剤層におけるＳＩＳブロック共重合体の含有量は、粘着剤層全質量に対し、例えば、５０質量％以下、好ましくは４０質量％以下、より好ましくは３０質量％以下である。上記上限値以下のＳＩＳブロック共重合体を含む粘着剤層を備える貼付剤は、貼付剤を剥離する際に痛みを伴わないなどの使用性に優れる。貼付剤の貼り易さの観点から、粘着剤層におけるＳＩＳブロック共重合体の含有量は、２３．７～３２．５質量％であることが特に好ましい。
　粘着剤層における流動パラフィンの含有量は、粘着剤層全質量に対し、例えば、５質量％以上、好ましくは１０質量％以上、より好ましくは１５質量％以上である。上記下限値以上の流動パラフィンを含む粘着剤層を備える貼付剤は、十分な粘着性を有する。粘着剤層における流動パラフィンの含有量は、粘着剤層全質量に対し、例えば、５０質量％以下、好ましくは４０質量％以下、より好ましくは３０質量％以下である。上記上限値以下の流動パラフィンを含む粘着剤層を備える貼付剤は、適度な柔軟性を備えるため、貼り易くなる。貼付剤の貼り易さの観点から、粘着剤層における流動パラフィンの含有量は、１７．９～２７．５質量％であることが特に好ましい。
　また、粘着剤層におけるＳＩＳブロック共重合体と流動パラフィンとの質量比は、１～１．６５：１が好ましい。かかる比率で両者を配合すると、貼付剤の「こし」を強くすることが可能となり、貼付剤が貼り易くなる。また、かかる比率で両者を配合すると、粘着剤層を適度な硬さに調整することができ、製造時に、粘着剤層に気泡が生じ難くなり、製造適性に優れる。さらに、かかる比率で両者を配合すると、コールドフローも防ぎ易くなる。
　粘着剤層は、必要に応じて、ＳＩＳブロック共重合体以外の粘着剤、流動パラフィン以外の可塑剤を含んでもよく、粘着付与剤、吸収促進剤、抗酸化剤、充填剤、架橋剤、防腐剤、紫外線吸収剤、界面活性剤、ｐＨ調整剤、色素及び香料などの添加剤を含んでもよい。
　ＳＩＳブロック共重合体以外の粘着剤として、天然ゴム、合成イソプレンゴム、ポリイソブチレン、ポリビニルエーテル、ポリウレタン、ポリイソプレン、ポリブタジエン、スチレン－ブタジエン共重合体及びスチレン－イソプレン共重合体が挙げられる。粘着剤層は、好ましくはポリイソブチレンを含む。ポリイソブチレンの使用により、粘着力を向上させることが可能となる。粘着剤層におけるポリイソブチレンの含有量は、例えば１～２０質量％であり、好ましくは２～１５質量％である。貼付剤の貼り易さの観点から、粘着剤層におけるポリイソブチレンの含有量は、３～１２質量％であることが特に好ましい。
　流動パラフィン以外の可塑剤として、ポリブテン、液状ポリイソブチレン及び動植物油が挙げられる。
　粘着付与剤として、脂環族飽和炭化水素樹脂（荒川化学工業社製、商品名：アルコンＰ－１００など）、水素添加ロジンエステル（荒川化学工業社製、商品名：ＫＥ－３１１、ＫＥ－１００；ハーキュレス社製、商品名：フォーラル１０５、フォーラル８５など）、水素化脂環族系炭化水素（エクソン化学社製、商品名：エスコレッツ５３００など）、テルペン樹脂、石油樹脂及びフェノール樹脂が挙げられる。粘着付与剤のうち、α－ピネン及びβ－ピネンなどからなるテルペン樹脂は、粘着力を高める作用に優れるため、好ましい。ＳＩＳブロック共重合体及び流動パラフィンを１～１．６５：１の比率で粘着剤層に配合する場合、粘着剤層の粘着力が低下する傾向がある。このような場合には、テルペン樹脂の使用により、粘着力を向上させることができる。粘着力向上の観点から、粘着剤層におけるテルペン樹脂の含有量は、１７～２５質量％であることが特に好ましい。
　吸収促進剤として、ミリスチン酸イソプロピル、セバシン酸ジエチル、ソルビタンモノラウレート、オレイルリン酸ナトリウム、ラウリル硫酸ナトリウム、オクチルフェニルエーテル、ラウリルエーテル、ソルビタンモノラウレート、ラウロイルジエタノールアミド、ラウロイルサルコシン、オレオイルサルコシンシュガーエステル、レシチン、グリチルレチン酸、尿素、サリチル酸、チオグリコール酸カルシウム、乳酸、乳酸エステル、オリーブ油、スクワレン、ラノリン及びグリセリンが挙げられる。
　抗酸化剤として、トコフェロール及びそのエステル誘導体、アスコルビン酸、アスコルビン酸ステアリン酸エステル、ノルジヒドログアヤレチン酸、ジブチルヒドロキシトルエン及びブチルヒドロキシアソニールが挙げられる。
　充填剤として、炭酸カルシウム、炭酸マグネシウム、ケイ酸塩（例えば、ケイ酸アルミニウム、ケイ酸マグネシウム等）、ケイ酸、硫酸バリウム、硫酸カルシウム、亜鉛酸カルシウム、酸化亜鉛、酸化チタン及びステアリン酸亜鉛が挙げられる。
　架橋剤として、熱硬化性樹脂（アミノ樹脂、フェノール樹脂、エポキシ樹脂、アルキド樹脂及び不飽和ポリエステルなど）、イソシアネート化合物及びブロックイソシアネート化合物などの有機系架橋剤、金属及び金属化合物などの無機系架橋剤が挙げられる。
　防腐剤として、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル及びパラオキシ安息香酸ブチルが挙げられる。
　紫外線吸収剤として、ｐ－アミノ安息香酸誘導体、アントラニル酸誘導体、サリチル酸誘導体、クマリン誘導体、アミン酸系化合物、イミダゾリン誘導体、ピリジン誘導体及びジオキサン誘導体が挙げられる。
　粘着剤層に含有される薬物は特に限定されず、例えば、アセトアミノフェノン、フェナセチン、メフェナム酸、ジクロフェナクナトリウム、フルフェナム酸、アスピリン、サリチル酸ナトリウム、サリチル酸メチル、サリチル酸グリコール、アミノピリン、アルクロフェナク、イブプロフェン、ナプロキセン、フルルビプロフェン、ケトプロフェン、アンフェナクナトリウム、メピリゾール、インドメタシン、ピロキシカム及びフェルビナクなどの消炎鎮痛剤；ヒドロコルチゾン、トリアムシノロン、デキサメタゾン及びプレドニゾロンなどのステロイド系抗炎症剤；塩酸ジルチアゼム、四硝酸ペンタエリスリトール、硝酸イソソルビド、タラジピル、ニコランジル、ニトログリセリン、乳酸プレニラミン、モルシドミン、亜硝酸アルミ、塩酸トラゾリン及びニフェジピンなどの血管拡張剤；塩酸プロカインアミド、塩酸リドカイン、塩酸プロプラノロール、塩酸アルプレノロール、アテノロール、ナドロール、酒石酸メトプロロール、アジマリン、ジソピラミド及び塩酸メキシレチンなどの不整脈用剤；塩酸エカラジン、インダパミド、塩酸クロニジン、塩酸ブニトロロール、塩酸ラベタロール、カプトプリル、酢酸グアナベンズ、メブタメート及び硫酸ベタニジンなどの血圧降下剤；クエン酸カルベタペンタン、クロペラスチン、タンニン酸オキセラジン、塩酸クロプチノール、塩酸クロフェダノール、塩酸ノスカピン、塩酸エフェドリン、塩酸イソプロテレノール、塩酸クロリプレナリン、塩酸メトキシフェナミン、塩酸プロカテロール、塩酸ツロブテロール、塩酸クレンプテロール及びフマル酸ケトチフェンなどの鎮咳去痰剤；シクロフォスファミド、フルオロウラシル、デガフール、マイトマイシンＣ、塩酸プロカルバジン、ドキシフルリジン及びラニムスチンなどの抗悪性腫瘍剤；アミノ安息香酸エチル、塩酸テトラカイン、塩酸ブロカイン、塩酸ジブカイン、塩酸オキシブプロカイン及び塩酸プロピトカインなどの局所麻酔剤；プロピルチオウラシル、チアマゾール、酢酸メテロノン、エストラジオール、エストリオール及びプロゲステロンなどのホルモン剤；塩酸ジフェンヒドラミン、マレイン酸クロルフェニラミン、プロメタジン、塩酸ジプロヘプタジン及び塩酸ジフェニルピラリンなどの抗ヒスタミン剤；ワルファリンカリウム及び塩酸チクロピジンなどの血液凝固阻止剤；臭化メチルアトロピン及びスコポラミンなどの鎮痙剤；チオペンタールナトリウム及びペントバルビタールナトリウムなどの全身麻酔剤；ブロムワレニル尿素、アモバルビタール及びフェノバルビタールなどの催眠・鎮痛剤；フェニトインナトリウムなどの抗癲癇剤；塩酸メタンフェタミンなどの興奮剤・覚醒剤；塩酸ジフェンドール及びメシル酸ベタヒスチンなどの鎮暈剤；塩酸クロルプロマジン、チオリダジン、メプロバメート、塩酸イミプラミン、クロルジアゼポキシド及びジアゼパムなどの精神神経用剤；塩酸スキサメトニウム及び塩酸エペリゾンなどの骨格筋弛緩剤；臭化ネオスチグミン及び塩化ベタネコールなどの自律神経用剤；塩酸アマンタジンなどの抗パーキンソン剤；ヒドロフルメチアジド、イソソルビド及びフロセミドなどの利尿剤；塩酸フェニレフリンなどの血管収縮剤；臭化ロベリン、ジモルホラミン及び塩酸ナロキソンなどの呼吸促進剤；臭化グリコピロニウム、プログルミド、塩酸セトラキサート、シメチジン及びスピゾフロンなどの消化性潰瘍治療剤；ウルソデスオキシコール酸及びオサルミドなどの利胆剤；ヘキサミン、スパルティン、ジノプロスト及び塩酸リトドリンなどの泌尿生殖器及び肛門用剤；サリチル酸、シクロピロクスオラミン及び塩酸コロコナゾールなどの寄生性皮膚疾患用剤；尿素などの皮膚軟化剤；カルシトリオール、塩酸チアミン、リン酸リボフラピンナトリウム、塩酸ピリドキシン、ニコチン酸アミド、パンテノール及びアスコルビン酸などのビタミン剤；塩化カルシウム、ヨウ化カリウム及びヨウ化ナトリウムなどの無機質製剤；エタンシラートなどの止血剤；チオプロニンなどの肝臓疾患用剤；シアナミドなどの習慣性中毒用剤；コルヒチン、プロベネシド及びスルフィンピラゾンなどの通風治療剤；トルブタミド、クロルプロパミド、グリミジンナトリウム、グリプゾール、塩酸プホルミン及びインスリンなどの糖尿病用剤；ベンジルペニシリンカリウム、プロピシリンカリウム、クロキサシリンナトリウム、アンピシリンナトリウム、塩酸バカンピリシン、カルベニシリンナトリウム、セファロリジン、セフォキシチンナトリウム、エリスロマイシン、クロラムフェニコール、テトラサイクリン、硫酸カナマイシン及びサイクロセリンなどの抗生物質；イソシアニド、ピラジナミド及びエチオナミドなどの化学療法剤；塩酸モルヒネ、リン酸コデイン、塩酸コカイン、塩酸ペチジン及びクエン酸フェンタニルなどの麻薬、が挙げられる。
　高濃度のサリチル酸メチル及びメントール（例えば、ｌ－メントール）を粘着剤層に含有させると、これらの薬物の作用によって、粘着剤層が可塑化されやすくなる傾向が強まり、貼付剤の「こし」が弱くなり、貼付剤が貼り難くなる。しかしながら、本実施形態に係る貼付剤は、上述の通り「こし」が強いため、粘着剤層にこれらの薬物が高濃度に含まれていても、貼付剤が貼り易くなる。特に、粘着剤層の全質量基準で、９～１１質量％のサリチル酸メチル及び２．５～６．５質量％又は３～６質量％のメントールを粘着剤層が含む場合に、本実施形態に係る貼付剤の適用が適している。
　粘着剤層の厚みは５０～３０００μｍであることが好ましい。粘着剤層の厚みが３０００μｍ以下であると粘着剤層に含まれる薬剤の放出性が良好となり、５０μｍ以上であると、皮膚接着性が良好となり、貼付剤が剥がれ難くなる。
　支持体の厚みは、例えば３００μｍ以上であり、４００μｍ以上であることが好ましい。支持体の厚みが上記下限値以上であると、粘着剤層の成分の滲み出しが生じ難くなる。また、支持体の厚みは、例えば１２００μｍ以下であり、７００μｍ以下であることが好ましい。支持体の厚みが上記上限値以下であると、貼付剤が剥がれ難くなる。
　支持体の厚み及び粘着剤層の厚みの合計、すなわち貼付剤の厚みは、３００～５０００μｍであることが好ましい。貼付剤の厚みが５０００μｍ以下であると、貼付剤の端が衣類などに引っかかり難くなり、貼付剤が剥がれ難くなる。貼付剤の厚みが３００μｍ以上であると貼付剤の支持性が十分となり、貼付剤を確実に貼り付けられるようになり、また、貼付後の貼付剤にシワが発生し難くなる。
　本実施形態に係る貼付剤は、短辺が４～１０ｃｍであり長辺が６～１５ｃｍである長方形又は角丸長方形の形状であってよい。本実施形態に係る貼付剤の形状が長方形又は角丸長方形である場合、長辺方向及び短辺方向がそれぞれ、スパンレース不織布の幅方向及び流れ方向に一致し、かつ、貼付剤の第１の方向及び第２の方向に一致することが好ましい。
　本実施形態に係る貼付剤は、粘着剤層を被覆して保護するための剥離フィルムをさらに備えていてもよい。剥離フィルムの材質は、無延伸ポリプロピレン（ＣＰＰ）、延伸ポリプロピレン（ＯＰＰ）、ポリエチレンテレフタレート（ＰＥＴ）、ポリブチレンテレフタレート（ＰＢＴ）、ポリエチレン、ポリエステル、ポリウレタン、ポリ塩化ビニル及びポリスチレンなどのプラスチックフィルム、合成樹脂、合成紙及び合成繊維などのシリコン加工したシリコン加工紙、アルミ箔、クラフト紙にポリエチレンなどをラミネートしたラミネート加工紙などが挙げられる。これらの中でもＰＥＴ及び加工紙が好ましく用いられる。貼付剤が剥離フィルムを備える場合、貼付剤の剛軟度は剥離フィルムを剥がした状態の貼付剤で測定した剛軟度を意味する。
　剥離フィルムの厚みは、例えば１０～１００μｍ、好ましくは３０～９０μｍ、より好ましくは４０～８５μｍである。剥離フィルムの厚みが上記下限値以上であると剥離フィルムを掴み易くなり、また、剥離フィルムを剥がす際に粘着剤層に絡み付き難くなる。他方、剥離シートの厚みが上記上限値以下であると製造時の切断が容易となり、製造適性が良好となる。
　本実施形態に係る貼付剤は、当業者に公知の方法により製造することができる。例えば、ニーダー及びミキサーなどの混合機を用い、１２０～１６０℃に加熱しながら、薬物以外の粘着剤層の各成分を混合し、次いで、薬物を熱分解しない温度で添加混合し粘着剤層形成用の混合物を調製する。この混合物を、支持体の上に直接展延して粘着剤層を形成するか、あるいは剥離フィルム上に展延して粘着剤層を形成し、その上に支持体を載せて、粘着剤層を支持体上に圧着転写させてもよい。
貼付剤の評価実験（１）
　表１の各成分を加熱及び練合して粘着剤１を得た。表２に記載のポリエステル製不織布２～４に、塗布量が２１０ｇ／ｍ２となるように粘着剤１を塗布し、実施例１～２及び比較例１の貼付剤を得た。貼付剤は、短辺の長さが約５ｃｍ、長辺の長さが約７ｃｍの長方形の形状である。また、不織布の幅方向と貼付剤の長辺方向は一致する。得られた貼付剤について、下記の評価を行った。結果を表４に示す。
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000003
貼付剤の評価項目
（１）貼付剤の剛軟度
　ＪＩＳ　Ｌ　１０８５：１９９８に規定される４５゜カンチレバー法に従い、貼付剤の長辺方向の剛軟度を測定した。
（２）貼付剤の貼り易さ
　健常成人３０名の肩部に貼付剤を貼付し、貼り易さを下記の３段階の基準でスコア化し、その平均値を求めた。平均値が２未満である場合の評価を○とし、２以上である場合の評価を×とした。
　　　１          貼り易い
　　　２          普通
　　　３          貼り難い
（３）貼付剤の付着性
　健常成人３０名の肩部に貼付剤を貼付し、８時間後の貼付剤の付着状態を下記の３段階の基準でスコア化し、その平均値を求めた。平均値が２未満である場合の評価を○とし、２以上である場合の評価を×とした。
　　　１          貼付剤が全く剥がれず、皮膚に密着した状態
　　　２          貼付剤面の端部のみが剥離した状態
　　　３          貼付剤面の１／４以上が剥離した状態
（４）粘着剤の支持体への滲み込み（滲み出し）
　粘着剤の支持体への滲み込み（滲み出し）の有無を目視観察し、滲み込み（滲み出し）が認められない場合の評価を○、滲み込み（滲み出し）が若干認められるものの貼付剤としての使用に問題がない場合の評価を△、滲み込み（滲み出し）が認められて貼付剤として使用に適さない場合の評価を×とした。
（５）製剤適性
　粘着剤層の表面の気泡の有無を目視観察し、気泡がない場合の評価を○とし、気泡がある場合の評価を×とした。
Figure JPOXMLDOC01-appb-T000004
　表４に示した結果から明らかなように、貼付剤の剛軟度が１８以上である実施例１及び２の貼付剤は、貼り易く、付着性に優れ、しかも支持体への粘着剤の滲み込みが認められず、優れた貼付剤であった。一方、貼付剤の剛軟度が１８未満である比較例１の貼付剤は、貼り易さの点で劣っていた。
貼付剤の評価実験（２）
　表５の各成分を加熱及び練合して粘着剤２～６を得た。表２に記載の不織布１（ポリエステル製）及び３に、塗布量が２１０ｇ／ｍ２となるように粘着剤２～６を塗布し、実施例３～７及び比較例２～６の貼付剤を得た。得られた貼付剤について、評価実験（１）と同様の評価を行った。結果を表７に示す。
Figure JPOXMLDOC01-appb-T000005
Figure JPOXMLDOC01-appb-T000006
Figure JPOXMLDOC01-appb-T000007
　表７に示した結果から明らかなように、ニードルパンチ法によって製造した不織布１を支持体として用いた比較例２～６の貼付剤は、貼り易さの点で劣っていた。一方、スパンレース法によって製造した不織布３を支持体として用いた実施例３～７の貼付剤は、貼り易さ及び付着性に優れていた。しかも、ＳＩＳと流動パラフィンとの質量比が１～１．６５：１の範囲である実施例４～６の貼付剤は、支持体への粘着剤の滲み込み難さ及び製造適性の点でも優れていた。

Claims (12)

  1. 　支持体と、支持体上に積層された粘着剤層とを有する貼付剤であって、
    　支持体は、スパンレース不織布からなり、
    　粘着剤層は、スチレン－イソプレン－スチレンブロック共重合体及び流動パラフィンを含み、
    　貼付剤は所定の基準軸方向である第１の方向と、第１の方向に直角な第２の方向を有し、
    　ＪＩＳ　Ｌ　１０８５：１９９８に規定される４５゜カンチレバー法で測定した貼付剤の第１の方向の剛軟度は１８～３０ｍｍである、貼付剤。
  2. 　粘着剤層におけるスチレン－イソプレン－スチレンブロック共重合体と流動パラフィンとの質量比が１～１．６５：１である、請求項１に記載の貼付剤。
  3. 　粘着剤層は、サリチル酸メチル及びメントールを含む、請求項２に記載の貼付剤。
  4. 　粘着剤層は、ポリイソブチレンを含む、請求項３に記載の貼付剤。
  5. 　粘着剤層は、テルペン樹脂を含む、請求項４に記載の貼付剤。
  6. 　粘着剤層は、粘着剤層の全質量基準で、９～１１質量％のサリチル酸メチル及び２．５～６．５質量％のメントールを含む、請求項５に記載の貼付剤。
  7. 　粘着剤層は、粘着剤層の全質量基準で、２３．７～３２．５質量％のスチレン－イソプレン－スチレンブロック共重合体、１７．９～２７．５質量％の流動パラフィン、９～１１質量％のサリチル酸メチル、３～６質量％のメントール、３～１２質量％のポリイソブチレン及び１７～２５質量％のテルペン樹脂を含む、請求項５記載の貼付剤。
  8. 　不織布の目付けは９０～１１０ｇ／ｍ２である、請求項１～７のいずれか一項に記載の貼付剤。
  9. 　不織布の幅方向の２０％モジュラスが３～５Ｎ／５０ｍｍである、請求項１～８のいずれか一項に記載の貼付剤。
  10. 　不織布の幅方向の５０％モジュラスが８～１５Ｎ／５０ｍｍである、請求項１～９のいずれか一項に記載の貼付剤。
  11. 　不織布はポリエステルからなる、請求項１～１０のいずれか一項に記載の貼付剤。
  12. 　ＪＩＳ　Ｌ　１０８５：１９９８に規定される４５゜カンチレバー法で測定した貼付剤の第１の方向の剛軟度は１８～２７ｍｍである、請求項１～１１のいずれか一項に記載の貼付剤。
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JP2021083934A (ja) * 2019-11-29 2021-06-03 リバテープ製薬株式会社 両伸縮パッド及び該両伸縮パッドを用いた創傷保護材

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ES2887200T3 (es) 2021-12-22
TWI674115B (zh) 2019-10-11
HK1245121A1 (en) 2018-08-24
US20180015049A1 (en) 2018-01-18
BR112017015737A2 (ja) 2018-03-13
EP3254677A1 (en) 2017-12-13
EP3254677A4 (en) 2018-09-19
KR20170109039A (ko) 2017-09-27
KR101939932B1 (ko) 2019-01-17
JP2016141675A (ja) 2016-08-08
JP5767417B1 (ja) 2015-08-19
EP3254677B1 (en) 2021-08-04
BR112017015737B1 (pt) 2023-01-17
US10292941B2 (en) 2019-05-21
CN107205957B (zh) 2020-12-01
CN107205957A (zh) 2017-09-26
TW201636009A (zh) 2016-10-16

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