Pain-relieving anti-inflammatory patches

Abstract

To provide an analgesic anti-inflammatory patch that has excellent workability (ease of application) and can be applied without discomfort when applied.SOLUTION: An analgesic anti-inflammatory patch consists of: a support; a plaster layer containing a rubber elastomer as a main base ingredient and a non-steroidal analgesic anti-inflammatory drug as an active ingredient; and a release liner. The support consists of a polyester knitted fabric with a thickness of 600 to 800 μm and a tension [horizontal] at a 20% extension of 1.5 N or more and 3.5 N or less. The analgesic anti-inflammatory patch has excellent workability (ease of application) during application and can be applied without discomfort.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a non-aqueous analgesic and anti-inflammatory patch containing a non-steroidal analgesic and anti-inflammatory drug in a plaster layer containing a rubber elastomer as a main base component. The analgesic and anti-inflammatory patch of the present invention is capable of transdermally delivering a non-steroidal analgesic and anti-inflammatory drug, such as loxoprofen sodium, into local tissue with good skin permeability, is easy to apply, can be applied without discomfort, and causes little skin irritation. [Background technology]

[0002] For adhesive bases containing rubber-based elastomers as the main base component, calendaring and hot-melt methods, which do not use organic solvents, are widely used, and patches using adhesive bases that are less irritating to the skin and do not use organic solvents, are known (Patent Document 1). Also known are patches in which, to improve application (ease of application), two vertical slits are made in the release liner of the patch, and the portion of the release liner between the two slits is first peeled off and applied, and then the release liner on both sides is peeled off and applied (Patent Documents 2 and 3). However, even with this, when applying the patch to the shoulders or back, it is difficult to apply it neatly because it is not possible to visually check the application, and problems such as wrinkles or adhesion of the adhesive surfaces to each other can occur. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 5365964 [Patent Document 2] Japanese Utility Model Application Publication No. 63-014530 [Patent Document 3] Japanese Patent Application Laid-Open No. 2014-73210 Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention is intended to solve the above problems, and aims to provide an analgesic and anti-inflammatory patch containing a non-steroidal analgesic and anti-inflammatory drug in a plaster layer containing a rubber elastomer as a main base component, which has excellent workability (ease of application) when applied, can be applied without any discomfort, and causes little skin irritation. [Means for solving the problem]

[0005] As a result of intensive research conducted by the present inventors to solve the above-mentioned problems, they discovered that in an analgesic and anti-inflammatory patch comprising a backing, a plaster layer containing a rubber-based elastomer as the main base component and a non-steroidal analgesic and anti-inflammatory drug as the active ingredient, and a release liner, by setting the thickness of the backing and the tension when stretched within a certain range, excellent workability during application (ease of application) can be achieved and the patch can be applied without any discomfort when applied, and that by using a mixture containing a styrene-isoprene-styrene block copolymer and low molecular weight polyisobutylene as the rubber-based elastomer for the plaster layer, skin irritation can be reduced, thereby solving the above-mentioned problems, and thus completed the present invention.

[0006] Specifically, the present invention relates to an analgesic and anti-inflammatory patch comprising a backing, a plaster layer, and a release liner, the plaster layer containing a nonsteroidal analgesic and anti-inflammatory drug as an active ingredient, and the plaster layer containing a rubber elastomer as the main base component, wherein the backing is made of a polyester knitted fabric, the thickness of the backing is 600 to 800 μm, and the tension [lateral] at 20% elongation is 1.5 to 3.5 N. Here, the rubber elastomer preferably contains a styrene-isoprene-styrene block copolymer and a low-molecular-weight polyisobutylene having a viscosity-average molecular weight of 10,000 to 100,000.

[0007] According to the present invention, the following embodiments are provided. [1] An analgesic and anti-inflammatory patch comprising a support, a plaster layer containing a rubber elastomer as a main base component and a non-steroidal analgesic and anti-inflammatory drug as an active ingredient, and a release liner, The analgesic and anti-inflammatory patch is characterized in that the support is made of a polyester knitted fabric, the thickness of the support is 600 to 800 μm, and the tension [horizontal] at 20% elongation is 1.5 N or more and 3.5 N or less. [2] The analgesic and anti-inflammatory patch according to [1], wherein the tension [vertical] of the support at 20% elongation is 3.0 N or more and 5.0 N or less. [3] The analgesic and anti-inflammatory patch according to [1] or [2], wherein the yarn thickness of the polyester knitted fabric is 60 denier or more and 80 denier or less. [4] The analgesic and anti-inflammatory patch according to any one of [1] to [3], wherein the bending resistance [width] of the polyester knitted fabric is 8 mm or more and 14 mm or less. [5] The analgesic and anti-inflammatory patch according to any one of [1] to [4], wherein the rubber-based elastomer comprises a styrene-isoprene-styrene block copolymer and a low-molecular-weight polyisobutylene having a viscosity-average molecular weight of 10,000 to 100,000. [6] The analgesic and anti-inflammatory patch according to any one of [1] to [5], wherein the paste layer is substantially free of water and contains an organic acid, a tackifying resin, and a plasticizer. [7] The analgesic and anti-inflammatory patch according to any one of [1] to [6], wherein the non-steroidal analgesic and anti-inflammatory drug is loxoprofen sodium. [8] The anti-inflammatory analgesic patch according to any one of [1] to [7], wherein the release liner has one or more slits in the vertical direction. [9] An analgesic and anti-inflammatory patch comprising a support, a plaster layer containing a rubber elastomer as a main base component and a non-steroidal analgesic and anti-inflammatory drug as an active ingredient, and a release liner, The analgesic and anti-inflammatory patch, wherein the rubber elastomer comprises a styrene-isoprene-styrene block copolymer and a low-molecular-weight polyisobutylene having a viscosity-average molecular weight of 10,000 to 100,000.

[10] The analgesic and anti-inflammatory patch according to [9], wherein the paste layer is substantially free of water and contains an organic acid, a tackifying resin, and a plasticizer.

[11] The analgesic and anti-inflammatory patch according to [9] or

[10] , wherein the nonsteroidal analgesic and anti-inflammatory drug is loxoprofen sodium. [Effects of the Invention]

[0008] According to the present invention, an analgesic and anti-inflammatory patch containing a non-steroidal analgesic and anti-inflammatory drug in a plaster layer containing a rubber-based elastomer as a main base component can be provided, which has excellent workability (ease of application) when applied, can be applied without any discomfort, and causes little skin irritation. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of an analgesic and anti-inflammatory patch according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0010] The analgesic and anti-inflammatory patch of the present invention comprises a backing, a paste layer containing a rubber elastomer as the main base component and a non-steroidal analgesic and anti-inflammatory drug as the active ingredient, and a release liner. For example, as shown in Figure 1, an analgesic and anti-inflammatory patch 1 of the present invention comprises a backing 4, a paste layer 3, and a release liner 2, and the release liner has slits 5 and 6 for ease of application. The analgesic and anti-inflammatory patch of the present invention will be described in detail below.

[0011] [Non-steroidal analgesic and anti-inflammatory drug] In the analgesic and anti-inflammatory patch of the present invention, the non-steroidal analgesic and anti-inflammatory drug contained as an active ingredient in the plaster layer may be any of a variety of drugs, but it is particularly preferred to use loxoprofen sodium. The content of loxoprofen sodium is not particularly limited, but is preferably 0.1 to 20% by mass, more preferably 0.5 to 10% by mass, based on the total components constituting the plaster layer.

[0012] In the present invention, the phrase "based on all components constituting the plaster layer" means a mass ratio calculated based on the total mass of the plaster layer, which includes the nonsteroidal analgesic and anti-inflammatory drug contained in the plaster layer of the analgesic and anti-inflammatory patch, the rubber-based elastomer constituting the base component, and further other additives such as organic acids, tackifying resins and plasticizers, as well as antioxidants and warming stimulating components.

[0013] [Organic acid] The paste layer of the analgesic and anti-inflammatory patch targeted by the present invention preferably contains an organic acid for the purpose of improving the skin permeability and stability of the non-steroidal analgesic and anti-inflammatory drug, which is the active ingredient. There are no particular restrictions on the organic acid, so long as it is substantially water-free and solid at room temperature (20°C). However, in terms of compatibility with the other ingredients used in the paste layer and effectiveness in inhibiting decomposition products of the non-steroidal analgesic and anti-inflammatory drug, one or a combination of two or more selected from the group consisting of adipic acid, succinic acid, and malic acid is used, with adipic acid being particularly preferred.

[0014] The content of the organic acid is preferably 0.1 to 10% by mass, more preferably 0.3 to 5% by mass, based on all the components constituting the paste layer of the analgesic and anti-inflammatory patch. If the content of the organic acid is less than 0.1% by mass, based on all the components constituting the paste layer of the analgesic and anti-inflammatory patch, there is a problem that the effect of improving the transdermal absorbability of the non-steroidal analgesic and anti-inflammatory drug is low, and if the content exceeds 10% by mass, there is a problem that skin irritation caused by the organic acid occurs, and this is not preferred. In the present invention, from the viewpoint of easily achieving a smooth coating surface free from defects such as scratches during the production of an analgesic and anti-inflammatory patch, it is preferred that the adipic acid be blended in the adipic acid-containing paste layer in an amount of 0.1 to 10% by mass, preferably 0.1 to 5% by mass, more preferably 0.3 to 5% by mass, and particularly preferably 1 to 3% by mass, based on all components constituting the paste layer. Here, "substantially free of water" means that water is not intentionally added, and does not apply to the case where a trace amount of water is inevitably mixed in due to the manufacturing conditions, environment, etc.

[0015] [Rubber elastomer] The paste layer of the analgesic and anti-inflammatory patch of the present invention uses as its main base component a rubber-based elastomer that can be produced by the calendaring method or hot melt method, taking into consideration ease of control of physical properties and quality, as well as environmental protection. As the rubber-based elastomer, a mixture containing a styrene-isoprene-styrene block copolymer, low-molecular-weight polyisobutylene, and liquid rubber can be used.

[0016] The styrene-isoprene-styrene block copolymer imparts adhesiveness to the paste layer, retains each component in the paste layer, and dissolves or disperses other components. The content of the styrene-isoprene-styrene block copolymer is not particularly limited, but is preferably 10 to 30% by mass, more preferably 15 to 25% by mass, based on all components constituting the paste layer. The styrene-isoprene-styrene block copolymer (SIS) used in the present invention can more efficiently retain, dissolve, or disperse multiple components by combining a low diblock copolymer having a styrene-isoprene diblock copolymer (SI) component content of 10 to 20% with a high diblock copolymer having a styrene-isoprene diblock content of 70 to 80%. In the styrene-isoprene-styrene block copolymer, the polymerization ratio of the low diblock copolymer to the high diblock copolymer is preferably 0 / 100 to 50 / 50, more preferably 10 / 90 to 50 / 50, and even more preferably 15 / 85 to 50 / 50. In the present invention, commercially available styrene-isoprene-styrene block copolymers can be used. For example, a specific example of a high diblock copolymer is Quintac 3520 (Zeon Corporation), and a specific example of a low diblock copolymer is JSR SIS 5002 (JSR Corporation).

[0017] In the present invention, it is particularly preferable to use a styrene-isoprene-styrene block copolymer and low molecular weight polyisobutylene as the rubber elastomer, since this reduces the skin irritation of the analgesic and anti-inflammatory patch. The low-molecular-weight polyisobutylene preferably has a viscosity-average molecular weight (Mv) of 10,000 to 100,000, more preferably 30,000 to 100,000, and even more preferably 50,000 to 100,000. The viscosity-average molecular weight used here is determined by the Flory method.

[0018] The content of the low-molecular-weight polyisobutylene is 1 to 8% by mass, more preferably 3 to 8% by mass, based on all components constituting the paste layer. If the amount of low molecular weight polyisobutylene blended is below the above numerical range, the adhesive strength will be too weak and there is a risk of the adhesive coming off during use, and if it exceeds the above numerical range, there is a risk of the adhesive strength being too strong and causing pain when peeling off, which is undesirable as it will cause significant skin irritation. In the present invention, commercially available polyisobutylenes can be used. For example, examples of low molecular weight polyisobutylenes include Oppanol B-10, B-12, B-15, and B-15SFN (all manufactured by BASF Japan Ltd.), Vistanex LM-MS, LM-MH, and LM-H (all manufactured by Exxon), Hymol 4H, 5H, 5.5H, and 6H, and Tetrax 3T, 4T, 5T, and 6T (manufactured by JX Nippon Oil & Energy Corporation).

[0019] The liquid rubber improves the compatibility between the styrene-isoprene-styrene block copolymer and low-molecular-weight polyisobutylene in the base component. Examples of liquid rubbers include polybutene, high-cis polyisoprene rubber, and liquid polyisoprene rubber. Among these liquid rubbers, high-cis polyisoprene rubber or liquid polyisoprene rubber is preferred. These liquid rubbers may be used alone or in combination of two or more. When added, the content of these liquid rubbers is 0.1 to 5% by mass, more preferably 0.3 to 3% by mass, based on the total components constituting the paste layer.

[0020] [Other base ingredients] The analgesic and anti-inflammatory patch of the present invention may further contain a tackifying resin and a plasticizer as base components. The tackifying resin is not particularly limited, but examples thereof include rosin-based resins, terpene-based resins, coumarone-indene resins, petroleum-based resins, and phenol-based resins. Among these tackifying resins, rosin-based resins, terpene-based resins, and petroleum-based resins are preferred, with rosin-based resins being particularly preferred. These tackifying resins may be used alone or in combination of two or more. The content of these tackifying resins is not particularly limited, but is preferably 5 to 35% by mass, more preferably 10 to 25% by mass, based on all components constituting the paste layer. If the content of the tackifying resin is too low, sufficient adhesive strength to enable long-term application will not be obtained, while if the content of the tackifying resin is too high, pain will occur when the patch is removed and skin rashes will be more likely to occur.

[0021] The plasticizer does not function as a drug absorption enhancer, but rather serves to soften the plaster layer. The plasticizer is not particularly limited, and examples include petroleum-based oils (paraffinic process oil, naphthenic process oil, aromatic process oil, etc.), squalane, squalene, vegetable oils, silicone oil, and liquid fatty acid esters. Among these plasticizers, liquid paraffin is preferred. These plasticizers may be used alone or in combination of two or more. The content of these plasticizers is not particularly limited, but is preferably 10 to 60% by mass, more preferably 30 to 50% by mass, based on the total components constituting the plaster layer.

[0022] The analgesic and anti-inflammatory patch of the present invention may further contain an antioxidant as a base component. Examples of the antioxidant include tocopherol and its ester derivatives, ascorbic acid, dibutylhydroxytoluene, dibutylhydroxyanisole, sodium sulfite, 1,2,3-benzotriazole, n-propyl gallate, and 2-mercaptoimidazole. When these antioxidants are used, their content is not particularly limited, but is preferably 0.1 to 5% by mass, more preferably 0.3 to 3% by mass, based on the total components constituting the plaster layer.

[0023] Furthermore, the analgesic and anti-inflammatory patch of the present invention may contain a warming sensation stimulating component as a base component. Examples of the warming sensation stimulating component include nonylic acid vanillylamide and capsaicin. When such a warming sensation stimulating component is used, its content is not particularly limited, but is preferably 0.001 to 0.05% by mass based on the total components constituting the paste layer.

[0024] In addition to the above ingredients, fillers, stabilizers, absorption promoters, etc. may be appropriately blended as needed. Preferred fillers include calcium carbonate, magnesium carbonate, silicates (such as aluminum silicate and magnesium silicate), silicic acid, barium sulfate, calcium sulfate, calcium zincate, zinc oxide, and titanium oxide. Examples of absorption enhancers include terpene oils such as d-limonene, fatty acid esters such as glycerin monolaurate, glycerin monooleate, and diethyl sebacate, azone, pyrothiodecane, fatty acids such as oleic acid, lauric acid, and myristic acid, or derivatives thereof.

[0025] The support used in the analgesic and anti-inflammatory patch of the present invention is a polyester knitted fabric, and the polyester knitted fabric may be a flexible support such as a laminated composite with a film. The polyester knitted fabric support is preferably made of a material that can adhere to the skin and is flexible enough to follow the movement of the skin. Examples of materials for the polyester knitted fabric support include those containing polyester as an essential component, such as polyethylene terephthalate, polybutylene terephthalate, and polyethylene naphthalate. The support is preferably a polyethylene terephthalate knitted fabric, and particularly preferably a circularly knitted polyethylene terephthalate knitted fabric.

[0026] The thickness of the backing in the analgesic and anti-inflammatory patch of the present invention is 600 to 800 μm, preferably 600 to 750 μm, and more preferably 600 to 700 μm. When the thickness of the backing is within this range, the analgesic and anti-inflammatory patch of the present invention is easy to apply (ease of application) and does not feel uncomfortable when applied.

[0027] The tension [horizontal] of the backing at 20% extension in the analgesic and anti-inflammatory patch of the present invention is 1.5 N or more and 3.5 N or less, preferably 2.0 N or more and 3.0 N or less. When the tension [horizontal] of the backing at 20% extension is within this range, the analgesic and anti-inflammatory patch of the present invention is easy to apply (ease of application) and does not feel uncomfortable when applied. Here, "horizontal" refers to the long side direction, and "longitudinal" in the tension [longitudinal] at extension described below refers to the short side direction. However, if the release liner has slits, the direction of the slits is considered to be the longitudinal direction.

[0028] The tension [longitudinal] of the support at 20% extension in the analgesic and anti-inflammatory patch of the present invention is preferably 3.0 N to 5.0 N, more preferably 3.0 N to 4.0 N. The tension [lateral] of the support at 50% extension is preferably 4.0 N to 9.0 N, more preferably 5.0 N to 8.0 N, and even more preferably 5.5 N to 7.5 N. The tension [longitudinal] of the support at 50% extension is preferably 10.0 N to 20.0 N, more preferably 12.0 N to 19.0 N, and even more preferably 14.0 N to 18.0 N. When the tension [longitudinal] at 20% extension, the tension [lateral] at 50% extension, and the tension [longitudinal] at 50% extension of the support are within these ranges, the analgesic and anti-inflammatory patch of the present invention exhibits excellent workability (ease of application) when applied, and no discomfort is felt when applied.

[0029] Here, the tension during stretching is a value measured using a tensile tester specified in JIS B7721.

[0030] The bending resistance [horizontal] of the support in the analgesic and anti-inflammatory patch of the present invention is preferably 8 mm to 14 mm, more preferably 10 mm to 14 mm, and even more preferably 11 mm to 13 mm. The bending resistance [vertical] of the support is preferably 15 mm to 32 mm, and even more preferably 20 mm to 32 mm. Having the bending resistance of the support within this range improves the ease of application (ease of application) of the analgesic and anti-inflammatory patch of the present invention, and reduces the discomfort felt when applied. As with the tension during extension, the "horizontal" in "bending resistance [horizontal]" refers to the long side direction, and the "vertical" in "bending resistance [vertical]" refers to the short side direction. However, if the release liner has a slit, the direction of the slit is considered to be the vertical direction. The bending resistance is a value measured in accordance with JIS L1096 8.21.4 Method D (heart loop method).

[0031] The yarn thickness of the polyester knitted fabric, which is the backing of the analgesic and anti-inflammatory patch of the present invention, is preferably 60 denier or more and 80 denier or less, more preferably 70 denier or more and 80 denier or less. 2 More than 210g / m2 Preferably less than 140 g / m 2 More than 160g / m 2 The following is even more preferable: Within such ranges, the analgesic and anti-inflammatory patch of the present invention will have better workability (ease of application) when applied, and will also have less discomfort when applied.

[0032] Furthermore, the release liner used in the analgesic and anti-inflammatory patch of the present invention is preferably made of a material that is difficult for drugs to absorb or adsorb, such as silicone-treated polyester film, silicone-treated polyethylene-laminated wood-free paper, silicone-treated glassine paper, etc. The release liner preferably has one or more longitudinal slits, more preferably two slits. For example, as shown in Figure 1, it is preferable that the release liner of the analgesic and anti-inflammatory patch of the present invention has two vertical slits in the center. In this case, the release liner between the two slits is first peeled off and applied, and then the release liner on both sides is peeled off and applied, allowing for efficient application. The shape of the slits is not limited to straight lines, but may also be curved, or may be wavy as shown in Figure 1. The spacing between the slits is not particularly limited, but is preferably 10 mm to 30 mm, and more preferably 20 mm to 25 mm.

[0033] The analgesic and anti-inflammatory patch of the present invention can be produced by a general method for producing analgesic and anti-inflammatory patches, such as a calendar method or a hot melt method, but the production method is not limited to these. [Example]

[0034] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0035] [Example 1] First, a paste was prepared having the following composition: In the specific composition shown below, styrene-isoprene-styrene block copolymer, polyisobutylene, liquid paraffin, and hydrogenated rosin ester resin were mixed by heating and stirring, and then adipic acid, L-menthol, and loxoprofen sodium were added, and the mixture was heated and mixed to obtain a uniform melt (adhesive composition), which was then used to prepare a paste. Next, this melt was spread to a thickness of 10 μm on a silicone-treated release liner (polyester film, thickness 75 μm) to form a paste layer. A polyester knitted fabric substrate having the following properties was laminated onto the adhesive layer as a support, which was then cut into a 7 cm x 10 cm piece, and two slits were made in the release liner lengthwise as shown in Figure 1 to prepare a sample of the analgesic and anti-inflammatory patch of the present invention.

[0036] <Composition of the plaster> Loxoprofen sodium 8.1% by mass Styrene-isoprene-styrene block copolymer 4.3% by mass Product name: SIS 5002 (Ziblock ratio: 15%, JSR Corporation) Styrene-isoprene-styrene block copolymer 17.1% by mass Product name: Quintac 3520 (Ziblock ratio: 78%, Zeon Corporation) Polyisobutylene 6.0% by mass Product name: Oppanol B15SFN (BASF Japan Ltd.) (Viscosity average molecular weight: 85,000) Hydrogenated rosin ester resin 17.0% by mass Product name: Pine Crystal KE-311 (Arakawa Chemical Industries, Ltd.) Dibutylhydroxytoluene 1.0% by mass Product name: BHT (Seiko Chemical Co., Ltd.) Liquid paraffin 43.5% by mass Product name: Hicall M-352 (Kaneda Co., Ltd.) ·Adipic acid 1.4% by mass Product name: Adipic acid (Wako Pure Chemical Industries, Ltd.) L-menthol 3.0% by mass [Product name: L-Menthol, Ogi Pharmaceutical Co., Ltd.] (All of the above mass percentages are based on the mass of all components that make up the plaster layer.)

[0037] <Characteristics of the substrate> Base material: Polyethylene terephthalate (PET) knitted fabric (circular knit) Thread thickness: 75 denier Substrate thickness: 600 μm Base material weight: 140g / m 2 Tension at 20% elongation [vertical]: 3.4N Tension at 20% extension [horizontal]: 2.2N Tension at 50% elongation [vertical]: 14.4N Tension at 50% extension [horizontal]: 5.7N Bending resistance [vertical]: 21.3mm Bending resistance [horizontal]: 10.7mm

[0038] [Example 2] A sample of the analgesic and anti-inflammatory patch of the present invention was prepared in the same manner as in Example 1, except that a support having the substrate properties shown below was used.

[0039] <Support substrate characteristics> Base material: Polyethylene terephthalate (PET) knitted fabric (circular knit) Thread thickness: 75 denier Substrate thickness: 650 μm Base material weight: 150g / m 2 Tension at 20% elongation [vertical]: 3.7N Tension at 20% extension [horizontal]: 2.6N Tension at 50% elongation [vertical]: 15.8N Tension at 50% extension [horizontal]: 6.6N Bending resistance [vertical]: 26.5 mm Bending resistance [horizontal]: 12.0mm

[0040] [Example 3] A sample of the analgesic and anti-inflammatory patch of the present invention was prepared in the same manner as in Example 1, except that a support having the substrate properties shown below was used.

[0041] <Characteristics of the substrate> Base material: Polyethylene terephthalate (PET) knitted fabric (circular knit) Thread thickness: 75 denier Substrate thickness: 700 μm Base material weight: 160g / m 2 Tension at 20% elongation [vertical]: 4.0N Tension at 20% extension [horizontal]: 3.0N Tension at 50% elongation [vertical]: 17.2N Tension at 50% extension [horizontal]: 7.5N Bending resistance [vertical]: 31.7 mm Bending resistance [horizontal]: 13.3mm

[0042] [Comparative Example 1] Analgesic and anti-inflammatory patch samples were prepared in the same manner as in Example 1, except that a support having the substrate properties shown below was used.

[0043] <Characteristics of the substrate> Base material: Polyethylene terephthalate (PET) knitted fabric (circular knit) Thread thickness: 50 denier Substrate thickness: 550 μm Base material weight: 107g / m 2 Tension at 20% elongation [vertical]: 3.7N Tension at 20% elongation [horizontal]: 1.4N Tension at 50% elongation [vertical]: 11.9N Tension at 50% extension [horizontal]: 3.2N Bending resistance [vertical]: 25.0 mm Bending resistance [horizontal]: 15.0mm

[0044] Comparative Example 2 Analgesic and anti-inflammatory patch samples were prepared in the same manner as in Example 1, except that a support having the substrate properties shown below was used.

[0045] <Characteristics of the substrate> Base material: Polyethylene terephthalate (PET) knitted fabric (circular knit) Thread thickness: 75 denier Substrate thickness: 840 μm Base material weight: 210g / m 2 Tension at 20% elongation [vertical]: 3.0N Tension at 20% extension [horizontal]: 6.5N Tension at 50% elongation [vertical]: 15.0N Tension at 50% extension [horizontal]: 20.0N Bending resistance [vertical]: 31.0 mm Bending resistance [horizontal]: 28.0mm

[0046] Comparative Example 3 Analgesic and anti-inflammatory patch samples were prepared in the same manner as in Example 1, except that a support having the substrate properties shown below was used.

[0047] <Characteristics of the substrate> Base material: Polyethylene terephthalate (PET) knitted fabric (circular knit) Thread thickness: 30 denier Substrate thickness: 460 μm Base material weight: 90g / m 2 Tension at 20% elongation [vertical]: 2.7N Tension at 20% elongation [horizontal]: 1.9N Tension at 50% elongation [vertical]: 15.8N Tension at 50% extension [horizontal]: 6.6N Bending resistance [vertical]: 8.5 mm Bending resistance [horizontal]: 7.1mm

[0048] 1.Measuring method of substrate characteristics The properties of the substrates described in Examples 1 to 3 and Comparative Examples 1 to 3 were measured by the following methods. <Method for measuring tension during stretching> Using a tensile tester specified in JIS B7721, the tension at 20% elongation and the tension at 50% elongation were measured under the following conditions. Test piece width: 50 mm Grip spacing: 200 mm Tensile speed: 300 mm / min Number of tests: 5 (average value of 5 tests)

[0049] <Method for measuring stiffness> Measurement was carried out in accordance with JIS L1096 8.21.4 D method (heart loop method) under the following conditions. Number of tests: 5 (average value of 5 tests)

[0050] 2. Performance evaluation of analgesic and anti-inflammatory patches The practical performance (ease of application, discomfort during application, skin irritation) of the analgesic and anti-inflammatory patch samples obtained in Examples 1 to 3 and Comparative Examples 1 to 3 was evaluated. Specifically, each analgesic and anti-inflammatory patch sample, prepared to a size of 7 cm x 10 cm, was applied to the shoulders of 24 subjects for approximately 6 hours, and the ease of application, discomfort during application, and skin irritation were evaluated using the following criteria (4 levels).

[0051] (Easy to apply) A: Over 75% of the test subjects were able to apply the mask neatly without any wrinkles. B: Less than 75% and more than 50% of the subjects were able to apply the tape neatly without wrinkles. C: Less than 50% and more than 30% of the subjects were able to apply the tape neatly without wrinkles. D: Less than 30% of the subjects were able to apply the mask neatly without wrinkles.

[0052] (Discomfort when applying) A: Over 50% of the subjects answered not at all. B: Less than 50% and more than 40% of the subjects answered "never." C: Less than 40% and more than 30% of the subjects answered "never." D: Less than 30% of subjects answered never.

[0053] (skin irritation) A: Over 95% of subjects showed no redness one hour after peeling. B: Less than 95% but more than 80% of the subjects showed no redness at all one hour after peeling. C: Less than 80% and more than 50% of the subjects showed no redness at all one hour after peeling. D: Less than 50% of subjects had no redness at all 1 hour after peeling.

[0054] 3. Results of practical performance evaluation The results of the practical performance evaluation are shown in Table 1. Table 1 also shows the base material properties of the support used in each analgesic and anti-inflammatory patch sample.

[0055] [Table 1]

[0056] As is clear from the results shown in Table 1, the analgesic and anti-inflammatory patch samples of Examples 1 to 3, in which the support is made of polyethylene terephthalate (PET) knitted fabric (circular knit), the support is 600 to 800 μm thick, and the tension [horizontal] at 20% elongation is 1.5 N or more and 3.5 N or less, obtained good results, rated A, in all items, and were found to have excellent workability (ease of application) when applied, no discomfort when applied, and no skin irritation.

[0057] In contrast, Comparative Example 1, in which the thickness of the support was 550 μm and the tension [horizontal] at 20% extension was 1.4 N, was rated C for ease of application. Comparative Example 2, in which the thickness of the support was 840 μm and the tension [horizontal] at 20% extension was 6.5 N, was rated C for discomfort when applied. Comparative Example 3, in which the thickness of the support was 460 μm and the tension [horizontal] at 20% extension was 1.9 N, was rated C for ease of application.

[0058] As for skin irritation, Examples 1 to 3 and Comparative Examples 1 to 3 were all rated A, which indicates that analgesic and anti-inflammatory patches in which the rubber elastomer used as the base component of the plaster layer contains a styrene-isoprene-styrene block copolymer and a low molecular weight polyisobutylene having a viscosity average molecular weight of 10,000 to 100,000 have good results in suppressing skin irritation regardless of the support. [Industrial Applicability]

[0059] As explained in detail above, according to the present invention, in an analgesic and anti-inflammatory patch comprising a support, a plaster layer containing a rubber-based elastomer as the main base component and a non-steroidal analgesic and anti-inflammatory drug as the active ingredient, and a release liner, by controlling the thickness of the support and the tension when stretched within a certain range, an analgesic and anti-inflammatory patch that is excellent in workability (ease of application) and can be applied without any discomfort when applied can be obtained. Furthermore, by using a mixture containing a styrene-isoprene-styrene block copolymer and low-molecular-weight polyisobutylene as the rubber-based elastomer for the plaster layer, an excellent analgesic and anti-inflammatory patch that is even less irritating to the skin can be obtained. [Explanation of symbols]

[0060] 1. Pain-relieving anti-inflammatory patches 2 release liners 3 Plasma layer 4 Support 5 Slits 6 Slit

Claims

1. An analgesic and anti-inflammatory patch comprising a support, a plaster layer containing a rubber elastomer as a main base component and a non-steroidal analgesic and anti-inflammatory drug as an active ingredient, and a release liner, The support is made of a polyester knitted fabric, the thickness of the support is 600 to 800 μm, and the tension [horizontal] at 20% elongation is 1.5 N or more and 3.5 N or less, An analgesic and anti-inflammatory patch, wherein the rubber elastomer comprises a styrene-isoprene-styrene block copolymer and a low molecular weight polyisobutylene having a viscosity average molecular weight of 10,000 to 100,000 (excluding those containing a medium molecular weight polyisobutylene having a viscosity average molecular weight of 200,000 to 800,000 as the rubber elastomer).

2. 2. The analgesic and anti-inflammatory patch according to claim 1, wherein the paste layer is substantially free of water and contains an organic acid, a tackifying resin, and a plasticizer.

3. 3. The analgesic and anti-inflammatory patch according to claim 1, wherein the nonsteroidal analgesic and anti-inflammatory drug is loxoprofen sodium.

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