JPH07138152A - Cataplasm for medical use and cataplasm preparation - Google Patents

Abstract

PURPOSE:To provide a cataplasm for medical use compliant with the extension/ contraction movement of the skin at its applied site and reduced in physical skin irritancy or strained feel after applied, and to provide a cataplasm preparation capable of administering in vivo a percutaneously absorbable medicinal substance. CONSTITUTION:The objective cataplasm for medical use can be obtained by the following method: a stretchable substrate is fixed in a stretched state by laminating one side thereof with a backing material and the other side is provided with a tack agent layer; the stretched fixation of the substrate is made so as to be 3-20% in its shrinkage rate on peeling off the backing material. The other objective cataplasm preparation can be obtained by incorporating a percutaneously absorbable medicinal substance in the tack agent layer.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical patch and patch preparation which can reduce physical skin irritation during application to the skin surface.

[0002]

2. Description of the Related Art Conventionally, as medical patches, various dressings, surgical drapes, adhesive plasters, etc. that are adhered to the skin surface by adhesion are commercially available. Further, as a patch preparation containing a drug in an adhesive, a topical drug such as methyl salicylate or glycol salicylate, a plaster or the like containing a menthol and the like is commercially available, and in recent years, a systemic drug Various patch preparations have been developed in which the drug is contained in an adhesive and the drug is administered into the body by transdermal absorption.

All of these medical patches and patch preparations are stuck and fixed on the skin surface with an adhesive, but the skin surface, which is the adherend, is constantly expanding and contracting during sticking. In particular, at the joints such as elbows and knees, the inner skin when contracted is greatly contracted, and the outer skin is elongated. Therefore, when the patch or patch preparation is applied to the skin surface that moves in this way, the stretching motion of the skin surface at the application site is obstructed and the skin surface becomes uncomfortable such as a tightness.

Further, since the expansion and contraction movement of the skin surface is not limited to the sticking site, and the skin surface around it also naturally expands and contracts in accordance with the movement, so that the skin around the sticking area feels a tactile sensation. , Physical skin irritation will occur on the skin at the site of application and the peripheral part of the patch or patch preparation.

From the above facts, in the case of patch preparations containing systemic drugs whose application site is not limited to joints and the like, they are often applied to the chest or back, where skin stretching and contraction are less likely to occur. Since the patch preparation is generally applied over a long period of time, it is difficult to suppress the above skin irritation.

Therefore, as a method for reducing such skin irritation as much as possible, there is a method using a stretchable support, which has been put to practical use.

The patch or patch preparation using the above-mentioned stretchable support is usually applied in a non-stretchable state, or
It is attached and used in the expanded state. When affixed without stretching the support, it follows when the skin surface of the affixed site stretches, but when it contracts, for example, when affixed with the joint bent and the joint extended, The agent does not shrink sufficiently and an unpleasant sensation occurs. On the other hand, when the patch is applied in a stretched state, there is no such drawback, but it is difficult to stick in a constant stretched state at all times, and skin irritation is improved or not improved. It is hard to say that it is a good method.

[0008]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a medical patch and patch preparation capable of reducing skin irritation associated with a tightness during use by applying it to the skin surface. is there.

[0009]

Therefore, as a result of intensive studies to solve the above problems, the inventors of the present invention have used a stretchable support as a support and have a specific ratio of this support. It was found that the above object can be achieved by fixing with a peelable backing material in a stretched state, and the present invention has been completed.

That is, according to the present invention, a peelable backing material is laminated on one surface of a support having elasticity in at least one of two directions substantially perpendicular to each other, and an adhesive layer is formed on the other surface. The adhesive patch according to claim 1, wherein the support is fixed in a stretched state by a backing material, and the support is peeled off in at least one direction by 3 to 2 in at least one direction.
The present invention provides a medical patch, which is characterized by shrinking by 0%.

Furthermore, the present invention provides a tape preparation characterized in that a transdermal drug is contained in the pressure-sensitive adhesive layer in the above-mentioned medical patch.

For the medical patch and patch preparation of the present invention
The support is in at least one direction out of the two orthogonal directions.
If it is a stretchable film or sheet, its material
There is no limit to the number, and for example, polyurethane (tensile elastic modulus of 0.
6 kg / mm²), Polyethylene (same 14kg / m
m²), Polypropylene (same as 116kg / mm²), Po
Polyvinyl chloride (same as 0.4 kg / mm²), Ethylene-vinegar
Vinyl acetate copolymer (2.5 kg / mm²), Graft
Ethylene-vinyl acetate copolymer (same 1 kg / m
m ²), Polybutadiene (same 0.7kg / mm²)Such
Can be used. The thickness of the support depends on the material.
Can be changed as appropriate, but there is less discomfort when attaching.
In order to reduce the thickness, it is usually 5 to 100 μm, preferably 10
It is set to about 30 μm.

The degree of stretchability of the support used in the present invention depends on the value of the tensile elastic modulus (kg / mm ² ) of the support and the thickness of the support from the viewpoint of followability to the movement of the skin surface to be applied. The product of (μm) and the cube value is preferably 4800 to 110000 or less.

In the present invention, the backing material to be laminated on one surface of the support is for fixing the support in the stretched state and does not require flexibility, so the thickness may be set appropriately. As a method for laminating on the above support, laminating via viscous / adhesive, laminating by heat fusion, laminating with natural rubber binder, pressure laminating with raised kraft paper, impulse sealing or ultrasonic sealing, high frequency There is a method using a seal. As the material for the backing material, papers such as synthetic paper and kraft paper, various plastic films or sheets, various foam sheets, cloths and the like can be used. In addition, such a backing material has an adhesive force to a support, which is described below as skin adhesion of a pressure-sensitive adhesive layer, so that the medical patch or patch preparation of the present invention can be peeled and removed after being applied to the skin surface. It is necessary to set it so that it is smaller than the force.

To fix the support in the stretched state with the backing material as described above, for example, the simultaneous biaxial stretching method by the flat method can be used.

That is, a stretchable support produced by a conventional method is sent to a tenter, and both lateral ends of the support are clamped and held by clips of the tenter, and are stretched in the lateral direction, and at the same time, they are vertically extended at a constant pitch. The clip interval is expanded and expanded in the direction (length direction). Extending in the horizontal direction is to prevent this because it contracts in the horizontal direction when it is extended in the vertical direction, so it is sufficient to fix it with clips so that the horizontal width before extension can be maintained. , It is not necessary to actively perform the extension operation (expansion operation).

Then, a backing material can be laminated in a stretched state of the support to obtain a support in which the stretched state is maintained.

In the present invention, the pressure-sensitive adhesive layer formed on the other surface of the support, that is, the surface opposite to the laminated surface of the backing material, is an acrylic-based pressure-sensitive adhesive as long as it has no toxicity to the skin as a medical pressure-sensitive adhesive. A rubber-based, silicone-based, vinyl ether-based pressure-sensitive adhesive can be used, but a hydrophobic polymer substance is preferable from the viewpoint of excellent adhesion to the skin surface,
In terms of stable adhesive properties and drug release properties when a drug is contained, it is preferable to use an acrylic adhesive obtained by polymerizing (meth) acrylic acid alkyl ester as a main monomer. preferable. The pressure-sensitive adhesive layer is formed on the support surface with a thickness of 10 μm or more to prevent the adhesive layer from peeling off due to movement of the skin surface, and to have a thickness of about 40 to 80 μm to prevent the adhesive residue phenomenon during peeling. It is preferable. The pressure-sensitive adhesive layer may be coated and laminated with a known separator in order to prevent contamination of the pressure-sensitive surface.

The adhesive layer in the patch preparation of the present invention contains a transdermal drug in a dissolved or dispersed state. The drug to be contained can be arbitrarily selected according to the therapeutic purpose, and specifically, corticosteroids, analgesic and anti-inflammatory agents, hypnotics, tranquilizers, antihypertensive agents, antihypertensive diuretics, antibiotics, Anesthetics, antibacterial agents, antifungal agents, vitamins, coronary vasodilators, antihistamines, antitussives, sex hormones, antidepressants, cerebral circulation improvers, antiemetics, antitumor agents, biomedicals, etc. If necessary, two or more kinds of these drugs may be used in combination.

The content of these drugs can be appropriately set according to the type of drug and the purpose of administration, but it is usually contained in the pressure-sensitive adhesive layer in an amount of 1 to 40% by weight, preferably 2 to 30% by weight. When the content is less than 1% by weight, a therapeutically effective amount of the drug cannot be expected to be released, and when it exceeds 40% by weight, the therapeutic effect is limited and it is economically disadvantageous.

In the present invention, if necessary, a lower alcohol, glycols, N-methyl-2-pyrrolidone, dimethylsulfoxide, dimethylacetamide, polyhydric alcohol, sebacates, liquid rubber, etc. may be added to the pressure-sensitive adhesive layer. Plasticizers and transdermal absorption promoters as auxiliary substances such as tackifying resins, various fillers such as silica powder, talc, titanium white, calcium carbonate, cellulosic powder, lactose, etc. within the range that does not hinder the adhesive properties. Can be included.

The medical patch and patch preparation of the present invention have the above-mentioned constitution, and the backing material is characterized in that the support is laminated and fixed in a stretched state. In the present invention, the support needs to be stretched so that the support contracts in at least one direction in the range of 3 to 20%, preferably 3 to 10% when the backing material is removed. That is, when the amount is less than 3%, the shrinkage of the skin cannot be sufficiently followed, which causes wrinkles or a feeling of tightness in the patch, and the object of the present invention cannot be sufficiently achieved. On the other hand, if it exceeds 20%, the patch may cause a floating phenomenon or may cause irritation to the skin.

Furthermore, the medical patch and patch preparation of the present invention have a width of 1 cm with the longest side in the maximum stretching direction of the support,
When the backing material is peeled off with the short side fixed while being cut into a 5 cm long strip, the contraction stress of the support is 1 to 300 g.
It will be about. By having the contraction stress in this range, excellent skin followability is exhibited without giving physical skin irritation when applied to the skin surface.

As a method for applying the medical patch and patch preparation of the present invention as described above to the skin surface, first, the adhesive layer surface is applied to the skin surface which is the adherend, and then one surface of the support. It is only necessary to peel off and remove the backing material laminated on, but it is preferable that the skin surface is not artificially stretched or expanded during application because the effect of the present invention can be maximized. In addition, it is preferable that the direction of expansion and contraction of the support is described on the surface of the backing material by a symbol such as an arrow, because the adherence can be made in accordance with the direction of expansion and contraction of the skin surface when sticking, from the viewpoint of skin followability.

[0025]

As described above, the medical patch and patch preparation of the present invention are laminated and fixed with a backing material in a state where a stretchable support is stretched at a specific ratio. When the backing material is peeled off after being attached to the skin surface, it is possible to follow the expansion and contraction movement of the skin surface and reduce physical skin irritation. In particular, by stretching at a constant ratio as in the present invention, the range that can follow the expansion and contraction movement of the skin surface becomes large, and it is necessary to apply it for a long time like a patch preparation containing a transdermal drug. In that case, the effect is remarkably exhibited.

Further, since the followability to the movement of the skin surface is improved, it is not necessary to strengthen the skin adhesive force of the adhesive itself, and the irritation such as pain at the time of peeling and removing can be reduced.

[0027]

EXAMPLES Examples of the present invention will be shown below and will be described more specifically. In the following, parts mean parts by weight.

Examples 1 to 6 A polyurethane sheet having a thickness of 20 μm was used as a support, and this support was stretched in the lateral direction at the elongation rate shown in Table 1 and a polystyrene sheet (0.25 m in thickness) as a backing material.
m) was thermocompression bonded and laminated.

As a pressure-sensitive adhesive, a copolymer of acrylic acid 2-ethylhexyl ester / acrylic acid (95 parts / 5 parts) was used. As a pressure-sensitive adhesive solution, a separator whose surface was treated with silicone had a dry thickness of 40 μm. It was applied and dried to form an adhesive layer.

The formed pressure-sensitive adhesive layer was transferred and formed on the surface of the support opposite to the surface on which the backing material was laminated to prepare a medical patch of the present invention.

Example 7 Polypropylene sheet having a thickness of 10 μm (tensile modulus 11
A medical patch was produced in the same manner as in Example 1 except that 0 kg / mm ² ) was stretched by 3% and laminated on a backing agent.

The contraction rate and contraction stress of the support when the backing material was peeled from the obtained medical patch were the values shown in Table 1.

Comparative Example 1 A medical patch was prepared in the same manner as in Example 1 except that the backing material was laminated without stretching the support. The elongation rate, contraction rate, and contraction stress of the support are as shown in Table 1.

Comparative Example 2 A medical patch was prepared in the same manner as in Example 1 except that the support was stretched 30% and a backing material was laminated in the above example. The elongation rate, contraction rate, and contraction stress of the support are as shown in Table 1.

Comparative Example 3 A polytetrafluoroethylene film (manufactured by Nitto Denko Co., Ltd.) that does not exhibit stretchability but only stretchability as a support.
A medical patch was produced in the same manner as in Comparative Example 1 except that an NTF film, which did not exhibit elasticity)) was used. The elongation rate, contraction rate, and contraction stress of the support are as shown in Table 1.

Comparative Example 4 A polyethylene terephthalate film having a thickness of 12 μm (tensile elastic modulus of 200 kg / mm ² ) was used as a support,
A medical patch was produced in the same manner as in Comparative Example 1 except that the backing material was not laminated. Elongation rate, contraction rate of the support,
The shrinkage stress is as shown in Table 1.

[0037]

[Table 1]

Experimental Example 1 5 cm × 5 of each medical patch obtained as described above
It was cut to a size of cm square, and attached to the skin surface of the chest of the subject, and the lining material was removed (n = 2). After daily living for 24 hours, each patch was removed, and the skin surface after removal was visually evaluated to examine the skin irritation and the feeling of sticking during application. The results are shown in Table 2.

Experimental Example 2 2 cm × 2 of each medical patch obtained as described above
Cut into cm-sized pieces so that the center of the patch is located approximately 5 cm from the joint of the subject's upper right arm on the wrist side, and the line connecting the joint and the wrist and the direction of most contraction of the patch match And the backing material was removed. After sticking, the plate was left standing for 5 minutes, and then the arm was flexed and extended slowly for 3 minutes. The floating of the patch during bending and stretching, the wrinkles of the patch, the feeling of tightness, and the feeling of application were examined. The results are shown in Table 2.

[0040]

[Table 2]

As is clear from the results shown in Table 2, the medical patch of the present invention has excellent followability to the movement of the skin surface to which it is applied, has less skin irritation, and has a good patch feeling. When a patch preparation was prepared by incorporating a transdermal drug into the medical patch of the present invention, the results such as skin followability, skin irritation, and feeling of sticking were substantially the same as those of the medical patch described above. It was something.

Claims (3)

[Claims] 1. A patch comprising a support having elasticity in at least one of two directions substantially perpendicular to each other, a releasable backing material laminated on one surface, and an adhesive layer formed on the other surface. The medical patch, wherein the support is fixed in a stretched state by a backing material, and the support contracts 3 to 20% in at least one direction due to peeling of the backing material. . 2. The medical patch according to claim 1, wherein the adhesive force of the adhesive layer on the skin is greater than the adhesive force between the backing material and the support. 3. A medicated patch according to claim 1, wherein the adhesive layer contains a percutaneously absorbable drug.