JP2688778B2 - Patch for disease treatment - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (a) Field of Industrial Application The present invention relates to a patch for transcutaneously administering a drug into a living body for treating a disease.

(B) Conventional Technology In recent years, transdermal preparations that are administered through the skin surface as a means of administering a drug into the living body have been actively developed from the standpoints of manifesting persistent pharmacological effects and reducing side effects. Among them, patches are attracting attention because of their ease of handling and strictness of dosage.

Further, in such patches, various devises have been made to the drug-containing layer, and studies have been conducted from various points of view such as percutaneous absorption, rapid-acting improvement, and sustainability improvement.

(C) Problems to be Solved by the Invention The above-mentioned patch is characterized in that it is intended to maintain its pharmacological effect over a long period of time, and the carrier which is the material of the patch is flexible in sticking to the skin and drug. Non-permeability, moisture permeability, and light stability have been studied.

By the way, for example, in the case of a drug having excellent transdermal absorbability, the drug-containing layer is plasticized and the adhesive strength with the carrier that can withstand use is extremely weak, so the drug-containing polymer layer peels off when peeled off after application It remains on the surface, and as a result, it does not hold as a product.

Therefore, recently, a patch comprising a pressure-sensitive adhesive layer provided on one surface of a substrate via a foam or an elastic sheet, wherein the adhesive layer contains a transdermal drug. It has been proposed that the substance is contained (JP-A-62-77315).

As the foam or elastic sheet, polyethylene,
Polyolefin such as polypropylene, ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane, polystyrene, silicon rubber, ethylene propylene terpolymer, chloroprene rubber, nitrile rubber, polybutadiene and other soft synthetic resin mainly composed of closed or open cells A foam or elastic sheet made of a flexible material is mentioned.

However, in the case of using a foam or elastic sheet made of a soft synthetic resin mainly composed of these closed cells or cells,
This type, the carrier has very small eye holes, and the surface portion of the drug-containing layer is difficult to be easily inserted into the eye hole of the carrier,
Therefore, the drawing power between the drug-containing layer and the carrier is weak, and especially in the plasticized drug-containing layer, the anchoring force with the carrier is weaker and the drug-containing layer peels off when peeled after application. The problem of remaining on the skin surface arises.

In addition, it is desirable for patients to have a patch with a size as small as possible from the viewpoint of discomfort and skin irritation, and the drug content is inevitably high due to the balance with the drug dose. Is more likely to peel off and remain on the applied skin surface.

Furthermore, the treatment with the patch may be continuous patching, and when the patch is applied to the skin surface, if the adhesiveness is too great, a great deal of pain at the time of peeling after application will cause rashes and skin irritation, etc. Control of low adhesion is also required, but detailed studies have not yet been made.

(D) Means for Solving the Problem As a result of repeated studies to solve the above-mentioned problems, the present inventor has selected a carrier formed by laminating a porous body on a base material as a carrier used for this type of patch. Used, and the porous body is formed of paper, woven fabric or non-woven fabric, and the porous body has a thickness of 20 to 500 μm and a basis weight of 5 to 30 g / m ² , When the drug content layer is laminated on the porous body side of this carrier, only the carrier does not fall off even after application for a long time, and the drug content layer remains on the skin surface even when peeled off after using this patch. We obtained the knowledge that it can be removed cleanly.

That is, the porous body is formed of paper, woven fabric or non-woven fabric, and the porous body has a thickness of 20 to 500 μm and a basis weight of 5 to 30 g / m ^2. The porous body has good flexibility and flexibility, and has a significantly higher porosity than that of a flexible synthetic resin foam or elastic sheet mainly composed of closed cells or open cells, and the surface portion of the drug content layer is Since it is easy to enter the gap of the porous body, the anchoring force is significantly improved, and after the patch for disease treatment of the present invention is applied to the skin, it is found that cohesive failure does not occur when peeling and removing. Obtained. Therefore, even if the drug-containing layer is plasticized by containing a plasticizer exhibiting a plasticizing action or a transdermal absorption enhancer (decreased cohesive force), the adhesiveness (anchoring force) with the carrier is improved. Even when applied for a long time, the carrier does not fall off, and after laminating the carrier and the drug-containing layer,
It has been found that the one formed by pressure bonding with a (heat) roll or the like has a further improved anchoring force, has a beautiful appearance, and has no adhesive residue on the skin surface.

Further, in the patch for treating diseases of the present invention, the porous body used is formed of paper, woven fabric or non-woven fabric, and the porous body has a thickness of 20 to 500 μm and a basis weight of Since it is 5 to 30 g / m ^2, the contained drug is adsorbed to the porous body to some extent and acts as a drug storage layer with respect to a drug which is lightly irritating to the skin and has good transdermal absorbability. However, it was also found that the skin irritation is alleviated by providing mild transdermal absorbability.

The present invention has been completed based on these findings, and the present invention will be described in detail below.

The carrier used in the present invention is obtained by laminating a porous body on a base material and laminating the porous body, or by interposing a hot-melt adhesive sheet / film between the base material and the porous body to heat-bond the laminated body. Alternatively, it may be formed by laminating an adhesive binder between the base material and the porous body, and the base material and the porous body may be easily separated.

Examples of the substrate include polyethylene, polypropylene, polyester, polyvinyl acetate, polyurethane, polyvinyl alcohol, polyvinylidene chloride, polyamide, and a film or sheet having no opening formed of a polyethylene-vinyl acetate laminate. .
The thickness of this base material is preferably 5 to 100 μm, and it is not preferable if the thickness is less than 5 μm because it is difficult to produce a homogeneous laminated film. On the other hand, if the thickness exceeds 100 μm, the laminated film becomes too thick and a strange feeling when applied Also, it is not preferable because it has poor skin adhesion.

Further, as the above-mentioned porous body, the adhesiveness (anchoring property) to the drug-containing layer described below is remarkably good, the required anchoring force can be obtained even in the plasticized drug-containing layer, and the pliability and flexibility are excellent. Therefore, in the present invention, in particular,
Examples include paper, woven fabric, and non-woven fabric. This porous body preferably has a thickness in the range of 20 to 500 μm and a thickness of 20 μm.
If it is less than m, the drug-containing layer is difficult to bite into the carrier and the required anchoring property cannot be obtained. On the other hand, if it exceeds 500 μm, the carrier is stiff when applied to the skin and the lack of flexibility results in poor skin adhesion. It is inferior and not preferable.

When preparing a thin patch such as a plaster type or adhesive tape-like preparation, it is preferable to use a porous body having a thickness of 20 to 200 μm.

The above-mentioned paper preferably has a thickness in the range of 20 to 200 μm, and when the thickness is 20 μm or less, the drug-containing layer is difficult to bite into the paper and the required anchoring property cannot be obtained.
When it is more than μm, it is not preferable because the carrier has a stiff feel when applied to the skin and lacks flexibility, resulting in poor skin adhesion and adhesion.

Further, as the above-mentioned woven or non-woven fabric, materials such as cotton, polyester, nylon, vinylon, rayon,
Examples include those made of acetate and the like. Of these, non-woven fabrics that can freely change the properties of the film or sheet are preferred.

Preferably has weight per unit area of 5 to 30 g / m ² in the above woven and nonwoven fabric, and most preferably those of 10 to 20 g / m ^2.

If the basis weight is less than 5 g / m ² , the desired anchoring effect cannot be obtained.On the other hand, if the basis weight exceeds 30 g / m ² , the thickness of the entire patch will be too large and a strange feeling will occur when applied to the skin. Alternatively, the drug-containing layer is press-fitted between fibers too much to reduce the adhesive force to the skin, which may cause the adhesive agent to float from the skin during application or cause the patch to fall off, which is not preferable.

Further, the above-mentioned woven fabric or non-woven fabric should have a gap between the fibers so that the drug-containing layer can enter into the eye. However, it is not preferable that the size is 2 mm × 2 mm or more like a net because the drug-containing layer may be destroyed on the skin surface and the carrier surface. Therefore, when seen through, a woven or non-woven fabric in which fibers having a continuous diameter of 2 mm or more and in which fibers are intertwined with each other uniformly and densely is most desirable.

In the present invention, the drug-containing layer is laminated on the porous body side of the above-mentioned carrier, and the drug-containing layer contains an adhesive having an adhesive property at room temperature and a transdermal drug as essential components.

In this case, in order to percutaneously absorb and reduce irritation, and to balance the carrier and the drug-containing layer, the concentration of the drug in the drug-containing layer and the selection of the type of the porous body to be used are adjusted.

A typical example of the pressure-sensitive adhesive is an acrylic pressure-sensitive adhesive.

As the acrylic pressure-sensitive adhesive, for example, a homopolymer of a (meth) acrylic acid alkyl ester having an alkyl group having 4 or more carbon atoms, or a copolymer having a (meth) acrylic acid alkyl ester as a main component monomer is used. Can be mentioned.

As the alkyl (meth) acrylate,
For example, n-butyl acrylate, n-butyl methacrylate, hexyl acrylate, 2-ethylbutyl acrylate, isooctyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate,
Examples thereof include undecyl acrylate, dodecyl acrylate, tridecyl acrylate and tridecyl methacrylate.

Further, as the other monomer copolymerized with the (meth) acrylic acid alkyl ester, for example, (meth) acrylic acid, itaconic acid, maleic acid, maleic anhydride, a carbosyl group-containing monomer such as fumaric acid, Styrene sulfonic acid, allyl sulfonic acid, sulfopropyl acrylate,
Sulfoxyl group-containing monomers such as (meth) acryloyloxynaphthalene sulfonic acid, acrylamidomethylpropanesulphonic acid, acryloyloxybenzene sulfonic acid, and hydroxyl such as (meth) acrylic acid hydroxyethyl ester and (meth) acrylic acid hydroxypropyl ester Group-containing monomer, (meth) acrylamide, dimethyl (meth) acrylamide, N-butylacrylamide, tetramethylbutylacrylamide, N-
Amido group-containing acrylic monomers such as methylol (meth) acrylamide, (meth) acrylic acid aminoethyl ester, (meth) acrylic acid dimethylaminoethyl ester, (meth) acrylic acid diethylaminoethyl ester, (meth) acrylic acid tert. An alkylaminoalkyl group-containing acrylic monomer such as butylaminoethyl ester, (meth) acrylic acid methoxyethyl ester,
(Meth) acrylic acid ethoxyethyl ester, (meth)
(Meth) acrylic acid alkoxyalkyl esters such as acrylic acid butoxyethyl ester, (meth) acrylic acid tetrahydrofurfuryl ester, (meth) acrylic acid methoxyethylene glycol ester, (meth) acrylic acid methoxydiethylene glycol ester, (meth)
Acrylic acid methoxy polyethylene glycol ester,
Alkoxy group-containing (or ether bond in the side chain) -containing monomer such as (meth) acrylic acid methoxy polypropylene glycol ester, vinyl-based monomer such as N- (meth) acryloyl amino acid, urethane of acrylic acid, urea, isocyanate ester Functional monomers such as acrylic monomers such as, and (meth) acrylonitrile, vinyl acetate, vinyl propionate, vinylpyrrolidone, vinylpyridine, vinylpyrazine, vinylpiperazine, vinylpiperidone, vinylpyrimidine, vinylpyrrole, vinylimidazole , Vinylcaprolactam, vinyloxazole, vinyl aerosol, vinylmorpholine, styrene, α-methylstyrene, and bis (N, N′-dimethylaminoethyl) maleate.

These monomers have a function of imparting cohesive force by copolymerization with the main component monomer or improving drug solubility, and unless the solubility of the drug is extremely lowered, The polymerization ratio can be arbitrarily selected and used.

In the present invention, the alkyl (meth) acrylate and the copolymerizable monomer include various isomers in which the alkyl portion is linear and branched, and various isomers and derivatives in which the position of the substituent is different. Includes

Other adhesives used in the present invention include, for example, silicone rubber, polyisoprene rubber, polyisobutylene rubber, polybutadiene, styrene-butadiene (or isoprene) -styrene block copolymer rubber, acrylic rubber, arabic rubber, etc. Examples thereof include rubber-based substances such as natural rubber, synthetic resins such as polyurethane, polyester, polyamide, and ethylene-vinyl acetate copolymer, and examples of tackifying components thereof include rosin and modified rosin, petroleum-based resin, and polyterpene. Examples thereof include resins, polystyrene resins, polybutene, and liquid polyisobutylene, and examples of plasticizers include machine oils, trans oils, rosin oils, and various liquid paraffins.

Gels are mentioned as those having other adhesive properties. For example, water-soluble polymers such as polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid and its salts, synthetic synthetic systems such as mechanical acid anhydride copolymers, natural systems such as dextran, pullulan, gelatin, methyl cellulose, ethyl cellulose, carboxymethyl cell. The gel base can be prepared by using a semi-synthetic compound such as a roll with a plasticizer such as glycerin, propylene glycol, or polyethylene glycol, and if necessary, a known crosslinking agent.

The adhesive contains a drug, but the reagent is not particularly limited as long as it is transdermally absorbable, and specific examples include the following.

A) CCa ²⁺ antagonists: dihydropyridine Ca ²⁺ antagonists such as nifedipine, nizoldipine, nimodipine, nildipine, nicardipine and nitredipine, b) corticosteroids: eg hydrocortisone, prednisolone, beclomethasone propionate,
Flumethasone, triamcinolone, triamcinolone acetonide, fluocinolone, fluocinolone acetonide, fluocinolone acetonide acetate, clobetasol propionate, etc. c) Analgesic and anti-inflammatory agents: For example, acetaminophen, mefenamic acid, flufenamic acid, indomethacin, diclofenac, diclofenac. Sodium, alclofenac, oxyphenbutazone, phenylbutazone, ibuprofen, flurbiprofen, salicylic acid, methyl salicylate, l-menthol, camphor, sulindac, tolmetin sodium, naproxen, fenbufen, etc. Barbital, amobarbital, cyclobarbital, triazolam, nitrazepam, lorazepam, etc. : For example, fluphenazine, Teoritajin, diazepam, full diazepam, flunitrazepam,
Haloperidol, chlorpromazine, etc. f) Antihypertensive agents: For example, clonidine, clonidine hydrochloride,
Pindolol, propranolol, propranolol hydrochloride, bupranolol, indenolol, lofezixin, nitrendipine, nipradilol, pukumolol,
Timolol, metoprolol, etc. g) antihypertensive diuretics: eg hydrothiazide, pendroflunathiazide, cyclopenthiazide etc. ti) antibiotics: eg penicillin, tetracycline,
Oxytetracycline, fradiomycin, erythromycin, chloramphenicol, etc.) anesthetics: eg lidocaine, dibucaine hydrochloride, benzocaine, ethyl aminobenzoate, etc.) antibacterial substances: eg benzalkonium hydrochloride, nitrofurazone, nystatin, Acetosulfamine, clotrimazole, etc.) antifungal substances: eg pentamycin, amphotericin B, pyrrolenitrin, clotrimazole etc. w) vitamins: eg vitamin A, ergocalciferol, cholecalciferol, octothiacin, riboflavin Butyric acid esters, etc. w) Antiepileptic agents: eg, Nitrazepam, mepropamate, clonazepam, etc.) Coronary vasodilators: eg, nitroglycerin, nitroglycol, isosorbidodina Trait, erythritol tetranitrate, pentaerythritol tetranitrate, prop chill nitrate, nifedipine, etc., Yo) antihistamines: such as acetic acid, diphenhydramine,
Chlorpheniramine, diphenylimidazole, etc. Ta) antitussives: For example, dextromethorphan hydrobromide, terbutason sulfate, ephedrine, ephedrine acetate, salbutamol acetate, isoproterenolol hydrochloride, isoproterenolol sulfate, etc.) Reproductive hormones: eg progesterone, Estradiol, etc. No) Antidepressants: For example, doxepin T) Cerebral circulation improvers: For example, Videlkin, ergot alkaloids, ifenprodil, Ne) Antiemetics, antitumor agents: For example, metoclopramide, clevopride, domperidone, scopramine, odor Scopolamine hydrochloride, 5-fluorouracil, mercaptopurine, etc. Na) Biopharmaceuticals: For example, polypeptides (derivatives of TRH, LHRH), prostaglandins, etc. La) Others: For example, fenta Lumpur, digoxin, desmopressin, dihydroergotamine methanesulfonate,
Examples include dihydroergotamine tartaric acid.

Among these drugs having transdermal absorbability, those having a melting point of 100 ° C. or less are preferable because they plasticize the drug-containing layer with a particularly small drug content.

The compounding ratio of the drug (A) and the pressure-sensitive adhesive (B) is preferably such that (A) is contained in the range of 3 to 40% by weight of the whole (A + B), and the content of (A) is 3%. If it is less than wt%, the dose of the drug in the body may be small and the therapeutic effect may be poor. On the other hand, if it exceeds 40 wt%, the therapeutic effect may be limited and it is uneconomical.

In the patch for treating diseases of the present invention, it is desirable to add a substance acting as a plasticizer as an additive to the drug-containing layer to relieve pain at the time of peeling after application to the skin surface. As such an additive, one having a relatively high melting point in the drug group to be used is preferable. This additive acts not only as a plasticizer but also as a percutaneous absorption enhancer.

In the present invention, an additive which does not act as a plasticizer but has only a transdermal absorption promoting effect may be added.

Examples of such additives include lower alcohols such as methanol and ethanol, glycols such as diethylene glycol, propylene glycol, polyethylene glycol, polypropylene glycol and polyethylene glycol, oils and fats such as olive oil, squalene and lanolin, dimethyldecyl phosoxide and methyl. Octyl sulfoxide, dimethyl sulfoxide, dimethylformamide, dimethylacetamide, dimethyllaurylamide,
Polar solvents such as dodecylpyrrolidone and isosorbitol, salicylic acid, amino acids, nicotinic acid, benzyl ester, diisopropyl adipate, phthalic acid ester,
Diethyl sebacate, N-methylpyrrolidone, glycerin ester, 1-dodecylazacycloheptan-2-one, isopropyl myristate, ethyl laurate, silicone oil, various surfactants, high molecular polyester plasticizers, etc. You can Two or more of these may be added as required.

The amount of the above-mentioned additive is determined in consideration of the balance with the skin adhesiveness and cohesive force and further the drawing power, but it is preferably in the range of 0.1 to 40% by weight based on the whole drug-containing layer. If the amount is less than 0.1% by weight, the effect is poor, and if it exceeds 40% by weight, the skin adhesiveness may be extremely lowered, or the cohesive force and the anchoring property may be deteriorated, which is not preferable.

(E) Action The patch for disease treatment of the present invention has the above-mentioned constitution, and the porous body is formed of paper, woven fabric or non-woven fabric,
This porous body has a thickness of 20 to 500 μm and a basis weight of 5 to 30 g / m ² , and has a remarkably high porosity, and the surface portion of the drug-containing layer is in the gap of the porous body. Since it is easy to enter, the anchoring force is remarkably improved. Therefore, the drug-containing layer is plasticized by adding an additive such as a plasticizer or a percutaneous absorption enhancer. The adhesive property (anchoring property) of the product is improved, and the carrier does not fall off even when it is applied for a long time. Moreover, when the drug-containing layer containing the additive is used to reduce the skin adhesive force, The skin irritation is reduced even when the patch is repeatedly applied and peeled off, and there is no adhesive residue on the skin surface.

Further, in the patch for treating diseases of the present invention, the porous body used is formed of paper, woven fabric or non-woven fabric, and the porous body has a thickness of 20 to 500 μm and a basis weight of Since it is 5 to 30 g / m ^2, the contained drug is adsorbed to the porous body to some extent and acts as a drug storage layer with respect to a drug which is lightly irritating to the skin and has good transdermal absorbability. In other words, it has a function of alleviating skin irritation by giving a mild transdermal absorbability.

(F) Examples Next, the present invention will be described in detail based on examples, but the present invention is not limited thereto.

Hereinafter, parts or% means parts by weight or% by weight.

Example 1 70 parts of acrylic acid octyl ester, 30 parts of vinyl acetate and 100 parts of ethyl acetate were charged into a 4-neck flask under a nitrogen gas atmosphere, and 0.2 part of azobisisobutyronitrile (AIBN) was added as a polymerization initiator. , Bath temperature 59 ~ 65
After maintaining the temperature at ℃ and stirring and gradually dropping 133.3 parts of ethyl acetate to carry out the polymerization reaction for 8 hours while controlling the reaction, the temperature of the inner bath is further raised to 70 to 75 ℃ and aged for 3 hours. Thus, a copolymer solution was obtained.

The polymerization rate of this copolymer is 91.2%, and the solid content concentration is 30%.
% Copolymer solution had a viscosity of 52 poise at a temperature of 30.degree.

The resulting copolymer solution was added and mixed so that the content of timolol when formed into a timolol sheet would be 1200 μg / cm ^2, and this was coated with 50 μm paper (porous material) on a polyethylene-vinyl acetate (EVA) film. The paste thickness after drying is 40 μm on the paper (porous body) side of the carrier formed by laminating
And a drug content layer were laminated by drying for 5 minutes at a temperature of 90 ° C. to obtain a patch for treating diseases of the present invention.

Comparative Example 1 A patch was obtained in the same manner as in Example 1 except that the same EVA film as that used in Example 1 was used as the carrier (therefore, no paper was used).

Example 2 As in Example 1, 1-ethylhexyl acrylate
90 parts and 10 parts of acrylic acid were copolymerized to obtain a copolymer solution having a polymerization rate of 98% and a solid content concentration of 30%. The viscosity of this copolymer solution was 73 poise at a temperature of 30 ° C.

The content of nifedipine in the obtained copolymer was 300 μg.
/ cm ² , 2-octyldecanol content is 400 μg / cm ²
The mixture is mixed to give a polyethylene terephthalate (EVA (PET / EVA) film and a cotton non-woven fabric (weight per unit area 18 g) laminated on the non-woven fabric (porous body) side of the carrier. And a drug-containing layer were laminated by drying at a temperature of 100 ° C. for 5 minutes to obtain a patch for treating diseases of the present invention.

Comparative Example 2 The same PET / EVA film as that used in Example 2 (therefore, no nonwoven fabric is used) is used as a carrier,
A patch was obtained in the same manner as in Example 2.

Example 3 85 parts isononyl acrylate, 10 butyl acrylate
Part, acrylic acid 5 parts by copolymerization to obtain a polymerization rate of 99%, solid content
A 30% copolymer solution was obtained. The viscosity of this copolymer solution was 98 poise at a temperature of 30 ° C.

The content of indomethacin in the obtained copolymer was 300
μg / cm ² , polyester plasticizer (trade name Polycizer W10
00EL) was added and mixed so that the content would be 1200 μg / cm ^2, and polyester nonwoven fabric (weight per unit area 20 g) was added to the EVA film.
The non-woven fabric (porous body) side of the carrier formed by laminating the above is applied so that the paste thickness after drying becomes 50 μm, and dried at a temperature of 100 ° C. for 5 minutes to laminate a drug-containing layer, and the present invention A patch for treating the disease was obtained.

Comparative Example 3a A patch was obtained in the same manner as in Example 3, except that the same EVA film as that used in Example 3 was used as the carrier.

Comparative Example 3b A patch containing no additive in Example 3a was obtained.

Using the above Examples and Comparative Examples, the results of investigating the anchorage breakage rate at the time of measuring the adhesive strength to the Bakelite plate, the anchorage breakage at the time of peeling after the skin adhesion test, and the adhesive residue are shown below.
It is shown in the table.

In Example 1 and Comparative Example 1, the skin irritation when applied to the skin surface was shown, and in Example 3 and Comparative Example 3b, the presence or absence of pain during peeling after the skin adhesion test was shown.

1) The test sample has a size of 12 mm × 10 mm, and the temperature is 23 ±
Adhesion was measured by peeling at 180 ° C in a Shopper test by press-bonding to a Bakelite plate at 2 ° C with a load of 850g (however, in Comparative Example 1 and Comparative Example 3a, the carrier was lined with polyethylene terephthalate tape). The rate of anchorage destruction is shown as a percentage of the applied area.

2) Various samples of 30 mmφ were attached to the inside of the upper arm of a healthy person for 24 hours, and the state at the time of peeling the sample was visually evaluated for the anchorage failure rate and the presence or absence of adhesive residue.

3) The same method as 2) was performed, and the skin irritation was visually evaluated 8 hours and 24 hours after the peeling.

-: None ±: Light erythema +: Erythema ++: Floating species +++: Vesicle 4) The same method as 2) was performed to determine the presence or absence of pain during peeling.

According to the results shown in Table 1, the anchors of each of the examples had no anchorage damage, no anchorage damage and no adhesive residue at the time of peeling after adhesion to the skin, and no pain at the time of peeling.
On the other hand, in Comparative Example 1, Comparative Example 2 and Comparative Example 3a, anchorage failure occurred, while in Comparative Example 3b, there was no anchorage failure, but skin pain was observed during peeling after skin adhesion. .

(G) Effect of the Invention The patch for treating diseases according to the present invention has a normal temperature on the side of the porous body of a carrier formed by laminating a porous body made of paper, woven fabric or nonwoven fabric on a substrate having no opening. It is made by laminating a drug-containing layer having adhesiveness, and this porous body has a thickness of 20 to 500 μm and a basis weight of 5 to 30 g / m ² , and has a significantly high porosity. Since the surface portion of the drug-containing layer easily enters the gap of the porous body, the anchoring property is remarkably improved. Therefore, even in the low-adhesion drug-containing layer containing a plasticizer and a transdermal absorption enhancer. Adhesion with the carrier becomes good and the carrier does not fall off even when applied over a long period of time.There is no skin irritation even if this type of patch is repeatedly applied and peeled off, and there is no adhesive residue on the skin surface. It has an effect that does not occur.

Further, in the patch for treating diseases of the present invention, the porous body used is formed of paper, woven fabric or non-woven fabric, and the porous body has a thickness of 20 to 500 μm and a basis weight of Since it is 5 to 30 g / m ² , the porosity is remarkably high, and for the drug such as light temporary irritant to the skin and good transdermal absorbability, the contained drug is adsorbed to the porous body to some extent. It acts as a drug storage layer and has the effect of mitigating skin irritation by providing mild transdermal absorbability.

Furthermore, in the patch for treating diseases of the present invention, one obtained by laminating a carrier and a drug-containing layer and then crimping with a (heat) roll or the like further improves the anchoring property, and also has a beautiful appearance. Has the effect.

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Keisuke Shibata 1-2-1, Shimohozumi, Ibaraki City, Osaka Prefecture Nitto Denko Corporation (56) Reference JP-A-62-77315 (JP, A) JP 56-147713 (JP, A) JP-A-2-180817 (JP, A)

Claims (2)

(57) [Claims] 1. A patch for treating a disease, comprising a support containing a porous body laminated on a substrate and a drug-containing layer having an adhesive property at room temperature on the side of the porous body. Is formed of a film or sheet having no openings, and the porous body is formed of paper, woven cloth or non-woven cloth, and the porous body has a thickness of 20 to 500 μm and a basis weight. Is 5 to 30 g / m ² , and a patch for treating diseases. 2. The patch for treating a disease according to claim 1, wherein the drug-containing layer contains an additive that relieves pain during peeling after application to the skin surface.