WO2003103641A1 - 貼付剤 - Google Patents
貼付剤 Download PDFInfo
- Publication number
- WO2003103641A1 WO2003103641A1 PCT/JP2003/007173 JP0307173W WO03103641A1 WO 2003103641 A1 WO2003103641 A1 WO 2003103641A1 JP 0307173 W JP0307173 W JP 0307173W WO 03103641 A1 WO03103641 A1 WO 03103641A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- patch
- adhesive layer
- sensitive adhesive
- drug
- support
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- 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
- A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/28—Web or sheet containing structurally defined element or component and having an adhesive outermost layer
- Y10T428/2852—Adhesive compositions
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/28—Web or sheet containing structurally defined element or component and having an adhesive outermost layer
- Y10T428/2852—Adhesive compositions
- Y10T428/2878—Adhesive compositions including addition polymer from unsaturated monomer
- Y10T428/2883—Adhesive compositions including addition polymer from unsaturated monomer including addition polymer of diene monomer [e.g., SBR, SIS, etc.]
Definitions
- the present invention relates to a patch, and more particularly, to a patch having improved anchoring properties.
- Patches are generally formed by laminating a support and a pressure-sensitive adhesive layer containing a drug, in order to absorb the drug contained in the pressure-sensitive adhesive layer into the body through the skin. It is used. Such patches have good absorbency, do not transfer the drug to the support, and have strong adhesion between the support and the adhesive, so-called glue when peeled from the skin. It is required that there is no residue, that is, it has excellent anchoring properties.
- the drug when a stretchable film such as polyurethane or a polyvinyl chloride film is used as the support, the drug often migrates to the support when stored for a long period of time. Expected to affect. Also, when a drug has a strong diffusion permeability, the drug may also penetrate and diffuse into the support, causing the support to swell and deteriorate, or in some cases, impair the intended therapeutic effect. Furthermore, even when a woven or non-woven fabric is used for the support, it is often inevitable that some drug is adsorbed to the support. Also, since the thickness of the plaster increases, the number of drugs used is relatively large, but all the used drugs are absorbed transdermally. It was not wasteful and it was difficult to say that the drug was being used effectively.
- a polyester film such as polyethylene terephthalate, which does not show the transfer of the drug, is used for the support.
- a polyester film, particularly a polyethylene terephthalate film is preferably used from the viewpoint of preventing the transfer of the drug to the support, but when these are used in the form of a film, the film and the pressure-sensitive adhesive layer There was a problem that the anchoring property was poor. For this reason, even when the pressure-sensitive adhesive layer was laminated on the support, it was immediately separated without adhering well.
- the anchoring force between the support and the pressure-sensitive adhesive layer is weak, so that after application to the skin, when peeled from the skin, so-called glue residue may occur.
- the base sheet was delaminated during storage, resulting in a significant decrease in product value.
- a pressure-sensitive adhesive layer is laminated thereon via a single adhesive primer layer.
- the thickness of the support varies depending on the material and the like, when the above-mentioned patch is used for medical treatment, the patch is usually applied to the skin in many cases, so that the patch can follow the patch or the skin. It is necessary to impart properties such as skin non-irritancy. Also for these Patches used in certain applications may be applied over a relatively long period of time, and it is desirable that they do not cause discomfort or irritation to the skin after application to the skin.
- the thickness of the support is too thick, the user may feel uncomfortable when applying the skin, and the patch itself may damage the skin. In addition, the patch tends to peel off even with a slight movement of the skin, and the problem that the intended therapeutic effect cannot be obtained occurs. In order to solve such problems, it is conceivable to reduce the thickness of the support.However, if the thickness is too thin, the patch itself loses its stiffness, and the patch becomes entangled or squeezed. The handling during the sticking operation becomes extremely poor.
- Japanese Unexamined Patent Publication No. 6-98931 discloses a long side length L of an adhesive sheet, a stiffness X of a pressure-sensitive adhesive sheet from which a release liner has been removed (a cantilever method), and an adhesive sheet coated with a release liner.
- a technique has been disclosed in which an adhesive sheet having a relation of stiffness Y of 0.5 Y ⁇ 0.1 LX satisfies the condition of good handling when pasted.
- the adhesive sheet from which the release liner has been removed has a stiffness X of 10 mm or less, which is insufficient for improving the actual handling properties in view of the size of a normal external patch.
- many attempts have been made to improve the handleability by easily attaching a holding material to the surface of the support opposite to the pressure-sensitive adhesive layer and peeling off the holding material after application. It is not practical due to difficulties in cost and cost.
- an object of the present invention is to solve the problems of the prior art as described above, Not only does it not migrate to the support, it also has good anchoring properties between the support and the pressure-sensitive adhesive layer, and the pressure-sensitive adhesive layer containing the drug is firmly adhered to the support, and after being applied to the skin, peeled from the skin
- An object of the present invention is to provide a patch which has no adhesive residue on the pressure-sensitive adhesive layer.
- the present inventors have conducted intensive studies to solve the above problems, and as a result, surprisingly, by using a polyester film having a specific value of surface roughness, The inventors have found that the use of the support improves the anchoring property between the support and the pressure-sensitive adhesive layer, and have completed the present invention.
- the present invention relates to a patch formed by laminating a support made of a polyester film and an adhesive layer containing a drug, wherein the surface roughness of the polyester film surface on the side in contact with the adhesive layer is reduced. 0.05 to 0.8 / mRa.
- the present invention relates to a patch comprising a support made of a polyester film and a pressure-sensitive adhesive layer containing a drug laminated thereon, wherein the surface of the polyester film on the side in contact with the pressure-sensitive adhesive layer has a
- the patch is characterized by being subjected to a plast treatment.
- the present invention also relates to the above patch, wherein the polyester film has a thickness of 5 to 40 m.
- the present invention relates to the patch, wherein the pressure-sensitive adhesive layer has a thickness of 50 to 12.
- the present invention also relates to the above patch, wherein the polyester film is polyethylene terephthalate.
- the present invention relates to the above patch, wherein the adhesive comprises a styrene-isoprene-styrene block copolymer.
- the present invention also relates to the above patch, wherein the adhesive comprises two components of polyisobutylene and styrene-isoprene-styrene block copolymer.
- the present invention relates to the above patch, wherein the adhesive comprises a tackifier and / or a plasticizer.
- the present invention also relates to the patch, wherein the patch has an area of 5 to 60 cm 2 .
- JP03 / 07173 Furthermore, the present invention relates to the above-mentioned patch, wherein the support has a stiffness of 10 to 80 mm.
- the present invention also relates to the above patch, wherein the drug is a narcotic analgesic.
- the present invention relates to the above-mentioned patch, wherein the narcotic analgesic is fenuinil or a salt thereof.
- the use of the polyester film not only prevents the transfer of the drug to the support, but also causes the film on the side in contact with the pressure-sensitive adhesive layer to have a specific value of surface roughness.
- This makes it possible to provide a patch having good anchoring properties. That is, there is no so-called glue residue when peeling from the skin after being applied to the skin, and there is no significant decrease in product value due to delamination of the base sheet during storage. It is.
- since there is no need to provide a single primer layer or use an anchor coating agent it is possible to improve anchoring properties without causing a problem such as discoloration without causing interaction with a drug.
- the patch of the present invention can be made extremely thin as compared with a conventional patch by forming the support into a film shape. Therefore, a patch that is light, not bulky, has less discomfort when applied to the skin than a thick patch, and is less likely to damage the skin surface, and further reduces skin irritation and has a good usability. Can be provided. Furthermore, according to the patch of the present invention, the transfer to the support can be suppressed, and the effect of the drug can be obtained more efficiently in a smaller area than in the conventional patch. Is also reduced, and skin irritation can be further reduced.
- the support of the patch of the present invention has a rigidity of 10 to 80 mm, it does not become entangled or clogged at the time of sticking, and has a good handleability. Can be provided.
- drugs such as fenninyl, which are known as drugs with a high analgesic effect, are used at the time of intraoperative and postoperative constant-rate infusions. Absent. Therefore, relatively long-term pain such as cancer pain is treated with a patch that has good skin permeability and excellent stability over time. Is effective. Furthermore, in the United States, long-acting patch preparations containing fenninyl base are already on the market, but these preparations have the disadvantage that they tend to cause irritation such as itching and redness at the site of administration. I have. However, when the patch of the present invention is used, as described above, the skin irritation is low, the drug does not migrate to the support, the transdermal absorbability is good, and the stability over time is excellent.
- the present invention can provide a patch provided with an adhesive layer containing nil or a salt thereof, morphine sulfate, and other narcotic analgesics.
- the patch used in the present invention is a patch provided with a support and a pressure-sensitive adhesive layer, wherein the support is made of a polyester film, and the side of the support in contact with the pressure-sensitive adhesive layer has a specific shape. It is characterized by having surface roughness, or having surface roughness by being subjected to sandblasting.
- the support is made of a polyester film and supports the pressure-sensitive adhesive layer.
- the patch of the present invention is characterized in that a polyester-based film as a support has a surface roughness.
- a polyester-based film as a support has a surface roughness.
- the anchoring property between the support and the pressure-sensitive adhesive layer is improved, so that when the patch is applied to the skin and peeled off from the skin, so-called adhesive residue is not generated, and the feeling of use is reduced.
- An excellent patch can be obtained. Therefore, if such an effect can be obtained, any method can be used as the method for roughening the surface, but for example, sandplast treatment can be suitably used.
- the surface is treated so as to have a surface roughness of 0.05 to 0.8 zmRa, preferably 0.3 to 0.7.
- sand plast treatment means that sand (silica sand) is applied at high speed to the surface of the film. This is a method of physically roughening the film surface by irradiation.
- the surface roughness in the present invention is based on JIS-B0601, and Ra indicates the center line average roughness (cutoff value 0.25 mm).
- the material constituting the support in the patch of the present invention is preferably a polyester film, particularly preferably polyethylene terephthalate, from the viewpoint of preventing the transfer of the drug to the support. If a stretch film such as polyurethane is used, there is a high possibility that the transfer of the drug to the support will be recognized. If a polyester film such as polyethylene terephthalate is used, the transfer of the drug to the support will be high. No drug is found, and the drug can be used efficiently and effectively, especially when expensive drugs are used.
- the thickness of the polyester film is not particularly limited, but is preferably 2 to 50 m, more preferably 5 to 40 m, and particularly preferably 20 to 30 zm.
- the smaller the thickness the more likely it will be to break during the manufacturing process and the application of the product, and the more difficult it will be to handle such as pinholes during the sand plasting process and wrinkles when the product is applied. There is.
- the patch becomes harder, which causes a sense of incongruity when applied to the skin and tends to deteriorate the feeling of use.
- the polyester-based film may be used as a single layer or may be used by laminating. In some cases, a woven or non-woven fabric may be laminated.
- the pressure-sensitive adhesive layer of the present invention preferably has a thickness of 50 to 125 ⁇ m. If the thickness is too small, the pressure-sensitive adhesive layer cannot be applied uniformly on the support, which causes inconvenience during the production process and tends to decrease the drug permeation rate. On the other hand, if the thickness is too large, voids are generated in the pressure-sensitive adhesive layer to make the pressure-sensitive adhesive layer non-uniform, causing inconvenience in the production process, and using a drug more than necessary, which tends to cause waste. It is.
- the rigidity of the support of the present invention is preferably from 10 to 80 mm, more preferably from 12 to 60 mm.
- the patch tends to become entangled or become stiff, making it difficult to handle.On the other hand, if it is too large, the patch is hard and the finger is cut near the end face of the patch. Or it may be difficult to apply it in conformity with the irregularities on the application site of the human body. This is because they also tend to peel off, and there is a possibility that sufficient drug effects may not be obtained due to a change in the application area.
- the fat-soluble polymer blended in the pressure-sensitive adhesive layer of the present invention is not particularly limited, but preferred examples include polyisobutylene (PIB), styrene-isoprene-styrene block copolymer (SIS), isoprene rubber, Styrene-butadiene-styrene copolymer (SBS), acrylic polymer (at least 2 'copolymer of 2-ethylhexyl acrylate, vinyl acetate, methacrylate, methoxyethyl acrylate, and acrylic acid) These can be used alone or in combination of two or more. Among these,? It is preferable to use two components of 18 and 3 IS. In that case, the weight ratio of PIB to SIS is preferably 1: 1 to 1: 4.
- the fat-soluble polymer is 0.1 to 98% by weight, preferably 0.1 to 98% by weight, based on the total weight of the adhesive layer of the patch of the present invention, taking into account the physical properties of the preparation itself and good adhesiveness to human skin. 0.1 to 70% by weight, more preferably 0.1 to 50% by weight.
- the drug to be contained in the pressure-sensitive adhesive layer of the present invention is not particularly limited as long as it is a drug that can be absorbed transdermally.
- hypnotic sedatives flurazepam hydrochloride, rilmazahon hydrochloride, penobarbi, and amobarbi
- Antipyretic and antiphlogistic analgesics butorphanol tartrate, perisoxal quenate, acetaminophen, mefenamic acid, diclofenac sodium, aspirin, alclofenac, ketoprofen, flurbiprofen, naproxen, piroxicam, pennix
- steroid anti-inflammatory drugs hydrocortisone, prednisolone, dexamezosone, betamethasone, etc.
- excitement stimulants methamphetamine hydrochloride, methyl hydrochloride
- Psychotropic nerve agents imibramine hydrochloride, diazepam, sertraline hydrochlor
- the patch of the present invention can be preferably used for fenubinil or a salt thereof, particularly, because these drugs are expensive and want to obtain a medicinal effect efficiently.
- the phenyiunyl salt is not particularly limited, and may be an inorganic salt or an organic salt, and examples thereof include phenate, phenate, and the like. it can. Of these, phenynyl citrate is particularly preferred. Although fentanyl or a salt thereof can be used alone, a mixture of two or more kinds may be used. May be.
- phenynil or a salt thereof is 0.1% based on the total weight of the adhesive layer of the patch of the present invention. It is preferable to mix in an amount of 0.5 to 20% by weight.
- the skin permeability of fenadenyl or a salt thereof becomes extremely high.
- Sodium acetate is preferably incorporated in an amount of 0.01 to 15% by weight, more preferably 0.01 to 10% by weight, and particularly preferably 0.01 to 5% by weight, based on the weight of the whole adhesive layer. If the amount of sodium acetate is too small, the effect of remarkably improving skin permeability cannot be sufficiently obtained, and if it is too large, irritation to the skin tends to increase.
- the compounding weight ratio of phenylphenate to sodium acetate may be any ratio as long as it is effective in terms of physical properties and skin permeability. Generally, the maximum effect is obtained when the ratio is 2: 1. If the blending ratio of sodium acetate is small, the drug skin permeability will decrease rapidly. Conversely, if the blending ratio of sodium acetate is large, the formulation will be non-uniform and the physical properties such as adhesion will tend to be poor.
- the phenynil salt is phenynil acetate
- the same effect as in the case of combining sodium acetate can be obtained, and therefore, the combination of sodium acetate is not essential.
- a tackifier can be added to the pressure-sensitive adhesive layer of the formulation in order to impart tackiness to the formulation.
- Preferred examples of the tackifier include polyterpene resin-based, petroleum resin-based, rosin-based, rosin ester-based, and oil-soluble phenol resin-based tackifiers.
- the tackifier is incorporated in an amount of 0.1 to 70% by weight, more preferably 5 to 50% by weight, especially 10 to 35% by weight, based on the weight of the whole adhesive layer of the preparation of the present invention. Is preferred.
- fats and oils can be added to the adhesive layer as a plasticizer.
- examples of fats and oils include liquid paraffin, squalane, olive oil, persimmon oil, basic oil, laccase oil, etc. Are preferred, and liquid paraffin is particularly preferred.
- the fats and oils are blended in an amount of 1.0 to 70% by weight, more preferably 10 to 60% by weight, especially 20 to 50% by weight, based on the weight of the whole adhesive layer of the preparation of the present invention. Is preferred.
- the adhesion layer of the preparation of the present invention may optionally contain an absorption promoter.
- the absorption enhancer may be any compound that has been shown to have an absorption promoting effect on the skin, such as fatty acids having 6 to 20 carbon chains, aliphatic alcohols, fatty acid esters or ethers, and aromatics. Organic acid, aromatic alcohol, aromatic organic acid ester or ether.
- Such an absorption enhancer is preferably used in an amount of 0.01 to 20% by weight, more preferably 0.1 to 10% by weight, especially 0.5 to 5% by weight, based on the weight of the whole adhesive layer of the preparation of the present invention. Is preferably performed. If the amount of the absorption enhancer is too large, irritation to the skin such as redness and edema is observed, and if the amount is too small, the effect of the absorption enhancer tends not to be obtained.
- a hydrophilic polymer can be blended as necessary to absorb aqueous components such as sweat generated from the skin.
- the hydrophilic polymer include light caustic anhydride, cellulose derivatives (carboxymethylcellulose (CMC), sodium carboxymethylcellulose (CMCNa), methylcellulose (MC), hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose ( HPC), Hydroxyethyl Cell mouth (HEC) ⁇ Starch derivative (Pullulan), Polyvinyl alcohol (PVA), Polyvinylpyrrolidone (PVP), Vinyl acetate (VA), Carboxyvinyl polymer (CVP), Ethyl Vinyl acetate (EVA), Eudragit (trade name), gelatin, polyacrylic acid, polyacrylic acid soda, polyisobutylene maleic anhydride copolymer, alginic acid, sodium alginate, carrageenan, arabia gum, tragacanth , Karaya gum, polyvinyl
- the hydrophilic polymer is preferably incorporated in an amount of 0.1 to 20% by weight, particularly 0.5 to 10% by weight based on the weight of the entire adhesive layer of the patch of the present invention.
- the adhesive layer of the patch of the present invention may contain other components such as a crosslinking agent, a preservative, and an antioxidant.
- crosslinking agent examples include thermosetting resins such as amino resin, phenol resin, epoxy resin, alkyd resin, and unsaturated polyester, isocyanate compounds, block isocyanate compounds, organic crosslinking agents, and inorganic crosslinking agents such as metal or metal compounds. Is preferred. Preferred preservatives are ethyl para-hydroxybenzoate, propyl para-oxybenzoate, and butyl para-oxybenzoate.
- Antioxidants include tocopherol and its ester derivatives, ascorbic acid, and stearic acid. 173 Steroid, nordihydroxyglycoleic acid, dibutylhydroxytoluene (BHT), butylhydroxydissol (BHA) and the like are preferred.
- the pressure-sensitive adhesive layer of the patch of the present invention is preferably composed of a non-aqueous base material.
- a non-aqueous base By using a non-aqueous base, the effects of the present invention can be effectively obtained.
- the adhesive layer having the above composition can be produced by any method.
- the present formulation can be obtained by adding another component to an organic solvent solution of a polymer to be blended, stirring, spreading on a support, and drying.
- the polymer to be compounded can be applied by a hot melt method, after dissolving the polymer component at a high temperature, another component is added, and the mixture is agitated. Agent can be obtained.
- the area of the patch of the present invention is not particularly limited as long as a sufficient drug effect can be obtained, but is preferably 5 to 60 cm 2 . If the area is too small, the effect of the drug tends to be insufficient.On the other hand, if the area is too large, it will be difficult to follow the movement of the skin, and it will be difficult to handle. This is because irritation also tends to increase.
- the patch of the present invention is not particularly limited, and may be colored by kneading a pigment into a support.
- a white support can be obtained by adding titanium oxide.
- characters and the like can be easily printed on the surface of the support, and even when a drug requiring careful handling is used, the notes for handling can be printed easily.
- the patch of the present invention has no problem in solvent resistance and has good stability even when colored using titanium oxide.
- the patch of the present invention can be composed of a pressure-sensitive adhesive layer, a support layer supporting the pressure-sensitive adhesive layer, a release paper provided on the pressure-sensitive adhesive layer, and the like.
- a release paper a film of silicone-treated polyester, polyvinyl chloride, polyvinylidene chloride, or the like, or a high-quality paper treated with silicone can be used.
- compositions components other than sodium acetate and phenycyl quinate were dissolved and mixed at 180 ° C, and the remaining components were added and dispersed until uniform, then adhered to PET film 25 m
- the layer was spread so as to have a thickness of 50 ⁇ m, and a patch of the present invention was obtained by a conventional method.
- one side of the PET film was previously subjected to a sand blast treatment so as to have a surface roughness of 0.1 zmRa.
- Example 11 In the same composition as in Example 11, the PSA film was spread on 10 zm so that the pressure-sensitive adhesive layer had a thickness of 50 ⁇ m, and a patch of the present invention was obtained by an ordinary method.
- the PET film was preliminarily sand-plasted on one side to a surface roughness of 0.1 l ⁇ mRa.
- the PSA of the present invention was obtained by a conventional method by extending the PET film to 3.5 ⁇ m so that the pressure-sensitive adhesive layer became 50 zm.
- PET fill TJP03 / 07173 was previously sand-plasted on one side to a surface roughness of 0.1 mRa.
- Example 11 In the same composition as in Example 11, the adhesive layer was spread on a PET film of 25 ⁇ m so as to have a thickness of 50 ⁇ m, and a patch of the present invention was obtained by an ordinary method.
- the PET film was previously sandblasted on one side to a surface roughness of 0.3 mRa.
- Example 11 In the same composition as in Example 11, the PSA film was spread on 10 ⁇ m of the PET film so that the pressure-sensitive adhesive layer became 50 m, and a patch of the present invention was obtained by an ordinary method.
- the PET film was previously sand-plasted on one side to a surface roughness of 0.3 mRa.
- the PSA layer was stretched to a thickness of 5 m using a PET film 40 ⁇ m, and a patch of the present invention was obtained by a conventional method. Note that one side of the PET film was previously subjected to sand blasting so as to have a surface roughness of 0.3 mRa.
- a PSA of the present invention was obtained in the same manner as in Example 1-1 by using a 25 m PET film so as to extend the pressure-sensitive adhesive layer to 50 im.
- the PET film was previously subjected to sandblasting on one side so that the surface roughness was 0.6 mRa.
- Example 11 In the same composition as in Example 11, the PSA film of 10 ⁇ m was stretched so that the pressure-sensitive adhesive layer became 50 ⁇ m, and a patch of the present invention was obtained by a conventional method.
- the PET film was previously sandblasted on one side to a surface roughness of 0.6 Z mRa.
- Example 2 The same composition as that of Example 1 one 1, the pressure-sensitive adhesive layer by using a PET film 50 ⁇ m is The patch was extended to 5 m, and the patch of the present invention was obtained by an ordinary method. Note that one side of the PET film was previously subjected to sand blast treatment so as to have a surface roughness of 0.6 ZmRa.
- Example 11 An adhesive layer was stretched to the same composition as in Example 11 using a PET film of 25 zm so that the pressure-sensitive adhesive layer became 50 m, and a patch was obtained by an ordinary method. One side of the PET film was previously sand-plasted to have a surface roughness of 0.01 mRa.
- the pressure-sensitive adhesive layer was extended to 50 m in the same composition as in Example 1-1, and a patch was obtained by an ordinary method.
- the PET film was previously sandblasted on one side to a surface roughness of 0.01 mRa.
- a PSA was obtained in the same manner as in Example 1-1 by using a PET film (25 m) so that the pressure-sensitive adhesive layer was stretched to 50 / m.
- the PET film was preliminarily sand-plasted on one side to a surface roughness of 1.0 mRa.
- a PSA was obtained by a conventional method, using the same composition as in Example 1-1, and extending the adhesive layer to a thickness of 50 / m using 10% of syrup 7 film.
- the PET film was preliminarily sand-plasted on one side to a surface roughness of 1.0 z mRa.
- Example 1-1 Using the same composition as in Example 1-1, using a PET film 25 / m 2, the pressure-sensitive adhesive layer was stretched to a thickness of 5 ⁇ m, and a patch was obtained by an ordinary method.
- the PET film was previously sandblasted on one side to a surface roughness of 1.3 Z mRa.
- Comparative Example 3-2 Using the same composition as in Example 1-1, the PSA layer was stretched to 50 // m using a PET film of 10 zm, and a patch was obtained by an ordinary method. One side of the PET film was previously sand-plasted to a surface roughness of 1.3 Z mRa.
- Examples 1-1, 2-1 and 3-1 and Comparative Examples 1-1, 2-1 and 3-1 the following anchoring test was carried out.
- the respective patches were applied to 10 persons for 8 hours, and after peeling for 8 hours, peeling was performed, and the presence or absence of anchorage destruction (peeling of the support and the adhesive layer) was evaluated. If any part of the anchor is destroyed, it is assumed that the anchor was destroyed.
- Example 1 and Example 4 were subjected to a usability test of the patch for each thickness.
- the test method was applied to 10 people for 24 hours, and the usability was evaluated.
- the results are shown in Table 3.
- the adhesive tapes according to the surface roughness of Examples 1 to 3 show no so-called glue residue upon peeling after application to the skin, indicating that the anchoring property is good.
- the surface roughness is too small, the anchoring property is deteriorated, and as can be seen from Table 2, if the surface roughness is too large, the anchoring property is good, but a pinhole is formed on the support. Therefore, in order to improve the anchoring property and to prevent the formation of a binhole in the support, the surface roughness, which is a condition under which both are compatible, is preferably 0.05 to 0.8 mRa.
- Examples 1 to 3 are excellent patches that do not have pinholes in the support and have good anchoring properties as compared with Comparative Examples 1 to 3.
- Example 3 in the case of Examples 2-3 and 3-13 where the film thickness is large, the surface roughness is the same as that of Examples 2-1 and 3-1. Although there is no problem with anchoring properties, it tends to cause discomfort during sticking. On the other hand, in the case of Example 1-3 where the film thickness is small, the surface roughness is the same as that of Example 1-1, so there is no problem in anchoring property and there is no problem in usability. However, the patch tends to become entangled with the skin, making it difficult to apply to the skin.
- a polyester-based single-layer film having a thickness of about 2 to 50 ⁇ m can be suitably used, but from the viewpoint of improving both the usability and the ease of application, the thickness is preferably 5 to 4 ⁇ m. A value of 0 zm is more preferred.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE60327447T DE60327447D1 (de) | 2002-06-07 | 2003-06-06 | Pflaster |
EP03733301A EP1552822B1 (en) | 2002-06-07 | 2003-06-06 | Patch |
KR1020047019910A KR101065000B1 (ko) | 2002-06-07 | 2003-06-06 | 첩부제 |
AU2003242218A AU2003242218A1 (en) | 2002-06-07 | 2003-06-06 | Patch |
US10/517,468 US7754236B2 (en) | 2002-06-07 | 2003-06-06 | Patch with improved anchoring properties between a substrate and an adhesive |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2002167514A JP4199485B2 (ja) | 2002-06-07 | 2002-06-07 | 貼付剤 |
JP2002-167514 | 2002-06-07 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003103641A1 true WO2003103641A1 (ja) | 2003-12-18 |
Family
ID=29727665
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2003/007173 WO2003103641A1 (ja) | 2002-06-07 | 2003-06-06 | 貼付剤 |
Country Status (8)
Country | Link |
---|---|
US (1) | US7754236B2 (ja) |
EP (1) | EP1552822B1 (ja) |
JP (1) | JP4199485B2 (ja) |
KR (1) | KR101065000B1 (ja) |
CN (1) | CN1303986C (ja) |
AU (1) | AU2003242218A1 (ja) |
DE (1) | DE60327447D1 (ja) |
WO (1) | WO2003103641A1 (ja) |
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WO2006093139A1 (ja) * | 2005-02-28 | 2006-09-08 | Hisamitsu Pharmaceutical Co., Inc. | 経皮吸収製剤 |
ITMI20061933A1 (it) * | 2006-10-09 | 2008-04-10 | Biofarmitalia Spa | Composizioni solide cosmetiche e terapeutiche applicabili sulla pelle umana e gelificabili a contatto con acqua |
JP2008102271A (ja) * | 2006-10-18 | 2008-05-01 | Nitto Denko Corp | 表面保護フィルムおよび表面保護フィルム付き光学フィルム |
US20100003313A1 (en) * | 2006-10-27 | 2010-01-07 | Hisamitsu Pharmaceutical Co.,Inc. | Adhesive skin patch |
JP5196828B2 (ja) * | 2007-04-03 | 2013-05-15 | バンドー化学株式会社 | 皮膚貼付薬シート |
JP5192722B2 (ja) * | 2007-04-27 | 2013-05-08 | 祐徳薬品工業株式会社 | 外用貼付剤 |
WO2008146795A1 (ja) * | 2007-05-31 | 2008-12-04 | Hisamitsu Pharmaceutical Co., Inc. | 経皮吸収型製剤 |
JP5535640B2 (ja) * | 2007-10-17 | 2014-07-02 | 久光製薬株式会社 | フェンタニル含有経皮吸収製剤 |
EP2286814B1 (en) * | 2008-05-15 | 2013-10-16 | Hisamitsu Pharmaceutical Co., Inc. | Transdermal preparation containing palonosetron |
JP2010163367A (ja) * | 2009-01-13 | 2010-07-29 | Nitto Denko Corp | 貼付剤および貼付製剤 |
US20100178307A1 (en) * | 2010-01-13 | 2010-07-15 | Jianye Wen | Transdermal anti-dementia active agent formulations and methods for using the same |
US8952038B2 (en) | 2010-03-26 | 2015-02-10 | Philip Morris Usa Inc. | Inhibition of undesired sensory effects by the compound camphor |
BR112012024356A2 (pt) | 2010-03-26 | 2016-05-24 | Philip Morris Products Sa | inibição de irritação sensorial durante o consumo de tabaco não fumável |
EP2599478A1 (de) * | 2011-11-30 | 2013-06-05 | Acino AG | Transdermales therapeutisches System zur Verabreichung von Fentanyl oder einem Analogstoff davon |
EP2712612B1 (en) * | 2012-09-28 | 2020-03-25 | Nitto Denko Corporation | Patch preparation containing amine oxide and isopropyl myristate |
CN102871956B (zh) * | 2012-10-29 | 2014-03-05 | 中南大学湘雅医院 | 一种治疗婴幼儿浅表血管瘤的盐酸普萘洛尔凝胶 |
US20140271792A1 (en) * | 2013-03-14 | 2014-09-18 | Noven Pharmaceuticals, Inc. | Methylphenidate transdermal compositions with rubber-based adhesives |
ES2945331T3 (es) * | 2018-05-30 | 2023-06-30 | Moelnlycke Health Care Ab | Revestimiento de liberación multifuncional para apósitos |
CN114350291B (zh) * | 2022-01-07 | 2022-12-23 | 广州鹿山新材料股份有限公司 | 耐水耐汗热熔压敏胶及其制备方法和应用 |
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- 2003-06-06 CN CNB038132427A patent/CN1303986C/zh not_active Expired - Lifetime
- 2003-06-06 US US10/517,468 patent/US7754236B2/en active Active
- 2003-06-06 DE DE60327447T patent/DE60327447D1/de not_active Expired - Lifetime
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Also Published As
Publication number | Publication date |
---|---|
CN1303986C (zh) | 2007-03-14 |
AU2003242218A1 (en) | 2003-12-22 |
KR20050005551A (ko) | 2005-01-13 |
US7754236B2 (en) | 2010-07-13 |
KR101065000B1 (ko) | 2011-09-16 |
DE60327447D1 (de) | 2009-06-10 |
US20050175676A1 (en) | 2005-08-11 |
JP2004010552A (ja) | 2004-01-15 |
EP1552822A4 (en) | 2007-05-09 |
CN1658846A (zh) | 2005-08-24 |
JP4199485B2 (ja) | 2008-12-17 |
EP1552822B1 (en) | 2009-04-29 |
EP1552822A1 (en) | 2005-07-13 |
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