JP2020152652A - Patch and manufacturing method thereof - Google Patents

Abstract

To provide patches with inconspicuous sticking states when applied to the affected area, have good fitting feel, and can maintain sticking state for a long period of time.SOLUTION: Provided is a patch comprising a plaster layer containing a medicinal ingredient, a support adhered to one surface of the plaster layer, and a peeling liner attached on the other side of the plaster layer, the support being a non-woven fabric with a fabric weight of 7 to 20 g/m2 as the weight per unit area.SELECTED DRAWING: Figure 1

Description

The present invention relates to a patch using an ultrathin non-woven fabric, and further relates to a method for producing the patch.

A patch is a drug in which a drug that is a mixture of a medicinal ingredient and a base is spread thinly on a support such as cloth or plastic. It is attached to the surface of the skin and the active ingredient penetrates through the skin. It is an external medicine aimed at improving local symptoms. This patch is roughly divided into two types: a poultice that has a high water content in the base and can be expected to have a continuous cooling effect, and a tape agent that has a low water content in the base and does not cool the affected area. To do.

The main components of these patches include a transdermally absorbable plaster layer and a support that spreads the plaster layer. As a support for such a patch, a non-woven fabric has become the mainstream due to problems such as breathability. As for this non-woven fabric, in order to give elasticity when it is attached to a range of motion portion such as a joint, a non-woven fabric using a fiber having crimpability has also been proposed (see, for example, Patent Document 1).

JP-A-2009-79324

When such a non-woven fabric is thinned in order to obtain good air permeability, the components of the plaster may seep through the non-woven fabric. In particular, this is remarkable when a thin non-woven fabric is used to improve the fit when attached.

According to the present invention, when affixed to an affected area, the affixed state is inconspicuous, the fit is good, the affixed state can be maintained for a long time, and the components of the plaster body are appropriately applied to the non-woven fabric. It is an object of the present invention to obtain a transparent patch by soaking and to obtain a patch in which the components of the plaster do not seep through the non-woven fabric.

The patch according to the invention according to claim 1 includes a plaster layer containing a medicinal ingredient, a support adhered to one surface of the plaster layer, and the other surface of the plaster layer. A patch with a release liner attached to the
The support is characterized in that it is a non-woven fabric having a weight as a weight per unit area of 7 to 20 g / m ² .

In the patch according to the invention according to claim 2, the support according to claim 1 is a single-layered non-woven fabric containing only a spunbonded non-woven fabric made of polypropylene, polyester, rayon and a composite material thereof, or spunbonded non-woven fabric-melt blow. The non-woven fabric is a laminated non-woven fabric of spunbonded non-woven fabric.

The patch according to the invention according to claim 3 is characterized in that the plaster layer according to claim 1 or 2 is a plaster layer for ointment.

The method for producing a patch according to the invention according to claim 4 is a patch having a plaster layer in which a medicinal ingredient is kneaded and a support adhered on the surface of the plaster layer, and the patch. A method for producing a patch having a release liner to be bonded to the plaster layer of the drug.
A laminate forming step of obtaining a laminate by laminating and applying a plaster layer obtained by kneading a medicinal ingredient with a hot melt adhesive onto a release liner and then adhering a support to the plaster layer.
A half-cut step of punching the central region of the plaster agent from the obtained laminate leaving the release liner.
A half-cut removal step that removes the central region of the punched plaster agent,
From the laminate after the half-cut removal step, a cutting step of cutting the plaster agent together with the release liner into a shape in which two substantially rectangular plaster agents face each other with a predetermined distance between each other's short sides. Prepare,
The support is characterized in that it is a non-woven fabric having a weight as a weight per unit area of 7 to 20 g / m ² .

In the method for producing a patch according to the invention according to claim 5, the support according to claim 4 is a monolayer or spunbond containing only a spunbonded non-woven fabric made of polypropylene, polyester, rayon and a composite material thereof. The non-woven fabric is a laminate of a non-woven fabric, a melt-blown non-woven fabric, and a spunbonded non-woven fabric.

The method for producing a patch according to an invention according to claim 6 is characterized in that the plaster layer according to claim 4 or 5 is a plaster layer for ointment.

According to the present invention, when affixed to an affected area, the affixed state is inconspicuous, the fit is good, the affixed state can be maintained for a long time, and the components of the plaster body are appropriately applied to the non-woven fabric. By soaking, it is possible to obtain a transparent patch and a patch in which the components of the plaster do not seep through the non-woven fabric.

It is explanatory drawing which shows the structure of one Example of the plaster preparation of this invention, a figure is a plan view, b figure is a side view, and c figure is a front view including a partially enlarged view. It is explanatory drawing which shows the production of the plaster preparation shown in FIG. 1, FIG. aa shows the process up to the laminate formation process, and FIG.

In the present invention, a plaster layer containing a medicinal ingredient, a support adhered on one surface of the plaster layer, and a release liner adhered on the other surface of the plaster layer are provided. The patch is a non-woven fabric having a weight as a weight per unit area of the support of 7 to 20 g / m ² . As a result, when affixed to the affected area, the affixed state is inconspicuous, the fit is good, and the affixed state can be maintained for a long time.

That is, since the support is an ultra-thin non-woven fabric having a coating amount of 7 to 20 g / m ² , when it is attached to the affected area, the components of the plaster body are appropriately infiltrated into the non-woven fabric to provide transparency. , The stuck state is inconspicuous, the fit is good, and the stuck state can be maintained for a long time. In particular, because the support is transparent, the color of the attached skin is transmitted even if the support is not colored to resemble the skin color, so even if the skin has different brightness. The pasted state is inconspicuous. Further, as the non-woven fabric of the present invention, by using an ultra-thin non-woven fabric, there is no feeling of tension when a transparent resin film is used, and a soft sticking feeling is obtained, and a good fit when stuck. In addition, because it is extremely thin, it does not easily come off with clothes and can be kept stuck for a long time.

If the amount of grain is less than 7 g / m ² , the components of the plaster may seep through the non-woven fabric, and if the amount of grain is larger than 20 g / m ² , the flexibility is lost. There remains a problem with the fit. Further, the preferable thickness of the non-woven fabric may be 100 to 200 μm, and when it is thinner than 100 μm, the components of the plaster ooze out through the non-woven fabric and the adhesive strength is reduced as well as the basis weight. Occurs. If it is thicker than 200 μm, the transparent death when it is applied is lost, as is the case with the basis weight.

The support of the present invention is an ultrathin fiber sheet, web or bat in which fibers are unidirectionally or randomly interlaced, and the fibers are bonded by entanglement and / or fusion and / or adhesion. It may be a non-woven fabric. As the web formation of the non-woven fabric, it can be formed by a dry method, a wet method, a spunbond method, a melt blown method, or an air raid method. Further, as the bonding between the fibers of the non-woven fabric, a chemical bond method, a thermal bond method, a needle punch method, a spunlace method or the like can be used for bonding.

In the non-woven fabric of the present invention, in order to prevent the components of the plaster layer from seeping through the non-woven fabric even in an ultrathin state, the support is preferably a span made of polypropylene, polyester, rayon or a composite material thereof. A single-layered non-woven fabric containing only a bonded non-woven fabric or a laminated non-woven fabric of spunbonded non-woven fabric-melt blown non-woven fabric-spunbond non-woven fabric is used.

That is, a spunbonded non-woven fabric alone or a laminate of spunbonded non-woven fabric-melt blow non-woven fabric-spunbond non-woven fabric is used. An ultrathin support with a grain size of 7 to 20 g / m ² is used. As a result, even if it is an ultra-thin non-woven fabric, the components of the plaster do not seep through the non-woven fabric by using the spunbonded non-woven fabric alone or the laminate of spunbonded non-woven fabric-melt blown non-woven fabric-spunbonded non-woven fabric. ..

The plaster layer of the present invention can be produced by a hot melt method or a filling method. For example, in the hot melt method, each component constituting a pressure-sensitive adhesive other than a drug is heated and mixed. Then, the drug is added and further stirred to obtain a uniform lysate. The lysate is obtained by spreading it on a release liner, laminating a support, and cutting it into an appropriate shape.

Further, in the filling method, each component constituting the pressure-sensitive adhesive containing a drug is added to an organic solvent and mixed by stirring. The obtained melt is spread on a release liner, a support is attached, and the solution is cut into an appropriate shape. Alternatively, it can be obtained by spreading the melt on a support, attaching a release liner, and cutting it into an appropriate shape.

In the production of the patch of the present invention, a laminate layer obtained by kneading a medicinal component with a hot melt adhesive is spread and applied to a release liner, and then a support is bonded to the plaster layer to obtain a laminate. A half-cut step of punching the central region of the plaster agent from the obtained laminate leaving a release liner, a half-cut removal step of removing the central region of the punched plaster agent, and a half-cut removal It is provided with a cutting step of cutting the plaster agent together with a release liner into a shape in which two substantially rectangular plaster agents face each other with a predetermined distance between each other from the laminated body after the step.

The spunbonded non-woven fabric of the present invention is an endless length in which rice granular chips of a resin having a low melting temperature such as polypropylene, polyester, rayon and composite materials thereof are heated and melted, extruded from a nozzle and directly spun, and eluted. A number of fibers are laminated on a belt conveyor to form a web, and the formed web is a non-woven fabric heat-welded by a heat roll. The obtained non-woven fabric has the characteristics of being thin but soft and durable.

The melt-blown non-woven fabric is a kind of spunbonded non-woven fabric, which is formed by exposing it to high-temperature air to make the fibers finer. Therefore, in the laminate of the spunbonded non-woven fabric-melt blown non-woven fabric-spunbonded non-woven fabric of the present invention, since the melt-blown non-woven fabric having small voids between fibers is sandwiched between them, it is compared with the spunbonded non-woven fabric alone having the same thickness. , Exudation through the non-woven fabric is further suppressed.

The patch of the present invention is not only a "topical external preparation" to be applied to swelling or pain, but also a "transdermal preparation" in which the drug is delivered to a target organ by systemic blood flow and exerts a medicinal effect. Can also be used. In this case, since it can be attached to a place other than around the indirect part, the attached state is inconspicuous, the fit is good, the attached state can be maintained for a long time, and the non-woven fabric is applied because of the higher fit. It is possible to achieve a high effect that the components of the body do not seep through the non-woven fabric.

In the present invention, it is expected that the stickiness and transparency will vary depending on the degree to which the components in the plaster layer penetrate into the non-woven fabric. Therefore, it is necessary that a sufficient amount of the plaster layer component is infiltrated into the non-woven fabric. Further, if the plaster layer component penetrates too much, the plaster layer component may seep out from the non-woven fabric surface. For this reason, it is necessary to prevent the plaster layer component from seeping out during the bonding of the non-woven fabric during production and the subsequent change over time.

However, if it becomes hard, the adhesiveness will be impaired, so care must be taken to maintain a certain degree of softness. For this reason, for example, by adjusting the temperature and pressing pressure applied when the non-woven fabric is bonded, the amount of penetration is controlled, and as a measure to prevent leaching during storage, the plaster layer component is flowed by heat of about 40 ° C. You may devise a prescription with little change in sex.

As shown in FIG. 1, in the plaster preparation 10 of this example, a substantially rectangular plaster agent 12 having rounded corners chamfered is attached to a release liner 18. The plaster agent 12 is provided with a plaster layer 14 spread and formed between the release liner 18 and the support 16.

As the support 16, a non-woven fabric of a spunbonded non-woven fabric made of polypropylene, polyester, rayon and a composite material thereof, or a laminated non-woven fabric of spunbonded non-woven fabric-melt blow non-woven fabric-spunbond non-woven fabric is used. The amount of graining, which is the weight per unit area of the support 16, is 7 to 20 g / m ² .

The plaster preparation 10 of this example is produced as follows. As shown in FIG. 2A, a strip-shaped release liner tape 28 that becomes a release liner 18 when cut is carried out from the release liner roll 38 while being unwound at one end. The plaster base layer 24 is transferred onto the release liner tape 28 to spread the plaster base layer 24.

As an example of this embodiment, a polypropylene spunbonded non-woven fabric was used. The basis weight of this spunbonded non-woven fabric was 13 g / m ² , and the thickness was about 120 μm. As another example, a non-woven fabric having a three-layer structure of a spunbonded non-woven fabric, a melt-blown non-woven fabric, and a spunbonded non-woven fabric, also made of polypropylene, was used. The weight of the laminate of this non-woven fabric was 15 g / m ² , and the thickness was about 130 μm.

The plaster base 34 was obtained by the following steps. That is, styrene-isoprene-styrene block copolymer (hereinafter abbreviated as SIS), polyisobutylene, alicyclic saturated hydrocarbon resin and liquid paraffin were heat-kneaded at 100 ° C. to 150 ° C. Then, as a medicinal ingredient, indomethacin, an anti-inflammatory analgesic, and other additives were added and kneaded to obtain a plaster base 34 prepared in advance.

The obtained plaster base 34 is spread and applied from below the base tank 33 through the first transfer roll 35 to the second transfer roll 37 as the plaster base layer 24 over substantially the entire width of the strip-shaped release liner tape 28. It is transported while. Further downstream in the transport direction, a strip-shaped support tape 26 that becomes a support 12 when cut is carried out while being unwound from the support roll 32, and is attached onto the surface of the plaster base layer 24 for transport. While being applied, it is adhered by the pressure welding roller 39 and conveyed in the downstream direction as the plaster agent tape 22.

The support roll 32 is a non-woven fabric support tape 26 made of a single layer of spunbonded non-woven fabric or a laminated body of spunbonded non-woven fabric-melt blow non-woven fabric-spunbond non-woven fabric, and one end of the support tape 26 is unwound. However, it is attached on the surface of the plaster base layer 24.

As shown in FIG. 2B, the cutting drum 50 is half-cut by sandwiching the release liner tape 28 between the support drums 52. That is, the laminate of the release liner tape 28, the plaster base layer 24, and the support tape 26 (FIG. 2a) is a cutting drum 50 for half-cutting, and the plaster tape 22 is a continuous plaster agent 12. The region and the regions on both sides thereof are punched out leaving the release liner tape 28.

The punched areas 54 on both sides of the plaster agent 12 are removed upward from the plaster agent tape 22 being conveyed. The cutting drum 60 is individually separated by sandwiching the plaster tape 22 between the support drums 62. That is, the plaster tape 22 from which the region 54 has been removed is divided into individual plaster preparations 10 by the cutting drum 60 for all cuts arranged on the downstream side.

A plurality of the divided plaster preparations 10 are laminated and stored in a sealable bag body such as an aluminum vapor deposition bag so that the plaster layer component does not volatilize outside the bag body, and then sealed with a heat seal or the like. Is made into a product by packing one or more of them in a box.

Although the production of the plaster formulation 10 of this example is shown in one row, the width of the release liner tape 28 and the support tape 26 can be adjusted to the width in which the plaster formulation 10 can produce two or more rows. Then, the width of the plaster base layer 24 may be transferred to match the width, and the cutting drum 50 and the cutting drum 60 may be used for half-cutting and full-cutting.

10 ... Plaster formulation,
12 ... plaster,
14 ... plaster layer,
16 ... Support,
18 ... Peeling liner,
22 ... Plaster tape,
24 ... Plaster base layer,
26 ... Support tape,
28 ... Release liner tape,
32 ... Support roll,
33 ... Base tank,
34 ... plaster base,
35 ... 1st transfer roll,
37 ... Second transfer roll,
38 ... Peeling liner roll,
39 ... Pressure welding roller,
50 ... Cutting drum (for half cut),
52 ... Support drum,
54 ... punched area,
60 ... Cutting drum (for all cuts),
62 ... Support drum,

Claims (6)

A patch comprising a plaster layer containing a medicinal ingredient, a support adhered on one surface of the plaster layer, and a release liner adhered on the other surface of the plaster layer. There,
A patching agent, which is a non-woven fabric having a weight as a weight per unit area of the support of 7 to 20 g / m ² . The claim is characterized in that the support is a non-woven fabric of only a spunbonded non-woven fabric made of polypropylene, polyester, rayon and a composite material thereof, or a laminated non-woven fabric of spunbonded non-woven fabric-melt blow non-woven fabric-spunbond non-woven fabric. The patch according to 1. The patch according to claim 1 or 2, wherein the plaster layer is a plaster layer for ointment. A patch having a plaster layer kneaded with medicinal ingredients, a support adhered on the surface of the plaster layer, and a release liner to be affixed to the plaster layer of this patch. It is a manufacturing method of the agent,
A laminate forming step of obtaining a laminate by laminating and applying a plaster layer obtained by kneading a medicinal ingredient with a hot melt adhesive onto a release liner and then adhering a support to the plaster layer.
A half-cut step of punching the central region of the plaster agent from the obtained laminate leaving the release liner.
A half-cut removal step that removes the central region of the punched plaster agent,
From the laminate after the half-cut removal step, a cutting step of cutting the plaster agent together with the release liner into a shape in which two substantially rectangular plaster agents face each other with a predetermined distance between each other's short sides. Prepare,
A method for producing a patch, which comprises a non-woven fabric having a weight as a weight per unit area of the support of 7 to 20 g / m ² . The claim is characterized in that the support is a non-woven fabric of only a spunbonded non-woven fabric made of polypropylene, polyester, rayon and a composite material thereof, or a laminated non-woven fabric of spunbonded non-woven fabric-melt blow non-woven fabric-spunbond non-woven fabric. 4. The method for producing a patch according to 4. The method for producing a patch according to claim 4 or 5, wherein the plaster layer is a plaster layer for ointment.

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