JP2005281152A - Percutaneously absorbable preparation - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a novel percutaneously absorbable preparation which can be accurately contacted by itself with an affected part and can prevent contact dermatosis and smart feeling when stuck for a long time; an underwear suitable for using the preparation; and a bandage for fixing the preparation. <P>SOLUTION: The percutaneously absorbable preparation consists of a flexible supporter, a percutaneously absorbable drug-containing layer formed on one side of the supporter so as to contact with an affected part, and a pressure-sensitive adhesive layer formed on the other side of the supporter so as to adhere to clothing. On the drug-containing layer, a drug release-controlling layer may be formed, and the drug-containing layer may be a fabric impregnated with the drug. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a new type of patch applicable to a skin patch, plaster, etc. for applying a transdermally absorbable drug to the body surface, so as to reduce irritation to the body surface and to be easily applied to a site that is difficult to apply. The present invention relates to a transdermal absorption preparation and an underwear effective for use in combination with the percutaneous absorption preparation and a wound body for fixing a drug.

As an anti-inflammatory and analgesic treatment for stiff shoulders, joint pain, low back pain, muscle pain, etc., so-called adhesives in which a percutaneous absorption agent is applied to a support have been used as an easy and effective drug.
The so-called adhesives are roughly classified into adhesive tape type plasters and poultices in which gauze or nonwoven fabric contains a transdermal drug.

  These adhesives (percutaneous absorption preparations) are all used by being attached to the affected body surface so that the drug is absorbed from the skin, and are attached to the body surface with an adhesive. . As a specific configuration, for example, as shown in Non-Patent Document 1, a drug-containing pressure-sensitive adhesive layer 22 in which a drug is dispersed is laminated on a support 21 (FIG. 5A); A drug storage layer 23 is provided on the body 21, and further an adhesive layer 24 is provided on the body (the body surface side) (FIG. 5 (b)). The drug gradually diffuses into the adhesive layer and reaches the skin. Permeated; adhesive layer 25 is laminated on support 21, and percutaneous absorption medicine storage layer 27 is laminated leaving peripheral edge 26 (FIG. 5 (c)). A structure that is adhered to the skin is generally employed. In FIG. 5, 30 is a liner for protecting the drug-containing layer and the pressure-sensitive adhesive layer from the outside until just before use.

  Since such a transdermally absorbable preparation is directly attached to the skin, there is a problem that the adhesive adhesion is deteriorated unless the affected area is well wiped off after perspiration and dirt. In particular, in the configuration of FIG. 5C, since the adhesive area is small, there is a problem that it cannot be stuck and fixed to the affected area unless an adhesive with strong adhesive strength is used.

  However, those with strong adhesives cause severe pain when peeled off, and if they are applied for a long time or are frequently applied to the same location, they may be rashed or irritated. A feeling may cause the skin to drown. For this reason, various investigations have been made on the pressure-sensitive adhesive used for the medical patch sheet. Further, in order to reduce skin irritation, not only the adhesive is devised, but also an adhesive patch in which the thickness of the substrate and the adhesive layer, moisture permeability, moisture transpiration, etc. are devised has been proposed (Patent Document 1). ).

  Furthermore, in the configuration of FIG. 5 (a), not only irritation to the skin but also the drug needs to be uniformly dispersed, making selection regarding the adhesive more difficult. In this way, in the case of a drug-containing pressure-sensitive adhesive layer, there is a problem that sufficient medicinal effect cannot be obtained if the balance between the solubility of the pressure-sensitive adhesive and the drug is poor. Studies have been made mainly on the structure shown in FIG. 5B, which is provided on the body and laminated with the pressure-sensitive adhesive layer as a separate layer on the support.

  On the other hand, in addition to skin irritation, cold compresses are required to improve the feeling of use, for example, the sensation immediately after application is similar to chills. In addition, when you want to put it on your back, you can't put it on your own because the affected part is not visible to you or you can't reach the affected part. There was also a problem that it was difficult to re-paste.

  As a transdermally absorbable drug sheet that is intended to be applied by one hand without causing wrinkles or the like even with one-hand operation, Patent Document 3 is provided with a weak adhesive surface that can be supported by adhering the back of the drug sheet. A medicinal sheet set with an attached holder part has been proposed.

JP-A-6-271461 JP 2000-355535 A JP 2001-247454 A Kitazaki, N. et al., “Adhesives learned from the beginning” published by the Industrial Research Council, May 20, 2001, p. 62-63

  The present invention has been made in view of the circumstances as described above, and its purpose is to make it possible to accurately contact the affected part by itself and to suppress skin irritation and tingling when applied for a long time. It is an object of the present invention to provide a new type of transdermally absorbable preparation.

  The transdermally absorbable preparation of the present invention comprises a flexible support, a transdermally absorbable drug-containing layer in contact with an affected area provided on one surface of the flexible support, and the other surface of the flexible support. And a pressure-sensitive adhesive layer to be attached to the clothes provided on the skin.

  A drug release control layer may be laminated on the drug-containing layer. The drug-containing layer may be a fabric impregnated with a drug. Both sides of the preparation, that is, the adhesive layer and the transdermally absorbable drug-containing layer (when the drug release control layer is laminated, the drug release control layer instead of the transdermal absorbable drug-containing layer) are respectively protective sheets. Or you may be covered with the film.

  The undergarment of the present invention is an undergarment for detachably attaching the transdermal absorption preparation of the present invention, and is composed of an elastic material, and the body contact surface side of the undergarment shows an opposite body part. Has been.

  The wound body for drug fixation of the present invention is a wound body for drug fixation for bringing the percutaneously absorbable preparation of the present invention into contact with the affected part of the head, limbs, or neck, and includes the affected part. Engagement means for making the base material annular is provided at the longitudinal end of the belt-like base material wound around the part, limb, or neck.

  The transdermally absorbable preparation of the present invention is in contact with the skin, but is not directly attached to the skin with an adhesive, and can prevent skin irritation and tingling due to the adhesive component. In addition, by using the underwear of the present invention or the wound body for fixing a drug of the present invention, it is possible to accurately contact an affected part to which an adhesive sheet such as an affected part or a hair, which has conventionally been difficult to apply by itself, cannot be applied. In addition, it can be adhered to the skin to the same extent as when directly applied to the affected area, and a desired medicinal effect can be obtained.

One embodiment of the transdermally absorbable preparation of the present invention will be described with reference to FIG.
In this transdermally absorbable preparation 4, a transdermal drug-containing layer 2 is provided on one surface of a flexible support 1, and an adhesive layer 3 is provided on the other surface.
Therefore, when the adhesive layer 3 is adhered to a position corresponding to the affected area on the back surface (skin contact surface) of the clothing such as an underwear, and the underwear is worn, the transdermal absorbable drug-containing layer 2 comes into contact with the affected area. become.

  The flexible support 1 may be a film-like or sheet-like support having flexibility so as to be attached to the body surface, and specifically, a synthetic resin film such as a polyethylene film or a polyester film, or a non-woven fabric. Fabrics such as woven fabrics and knitted fabrics can be used. A thin film or sheet is preferably used so that it does not stand out when attached to the underwear. In addition, the support 1 is adhesive so that the drug in the drug-containing layer 2 does not diffuse into the pressure-sensitive adhesive in the pressure-sensitive adhesive layer 3 and the adhesive does not diffuse into the drug-containing layer. Agents and agents that are impermeable to agents are preferably used. You may laminate | stack a chemical | medical agent content layer on the cotton of the side by which the adhesive is not apply | coated using a conventionally well-known adhesive sheet.

  As the transdermally absorbable drug used for the transdermally absorbable drug-containing layer 2, a drug conventionally used for a patch can be used. That is, any of a systemically acting drug that penetrates from the skin and distributes throughout the body through capillaries and a locally acting drug that migrates into the tissue by infiltration from the skin can be applied. Specifically, anti-inflammatory / analgesic ingredients such as indomethacin, horse chestnut extract, arnica tincture, felbinac, ketoprofen flurbiprifen, camphor, menthol, etc. Capsicum extract; and nitroglycerin and isosorbide nitrate for heart disease to widen blood vessels; tubuterol as a patch used to widen the airway and make breathing easier; As the drug, fentanyl; hormonal agents such as steroids can be used.

These drugs may be contained in a necessary amount by appropriately dispersing in a matrix.
As the matrix used for the drug-containing layer 2, a material having little skin irritation, a material that does not affect the drug, and a material excellent in drug dispersibility are preferably used. Specifically, those mainly composed of a cellulose derivative such as sodium carboxymethyl cellulose and hydroxypropyl cellulose, and a hydrophilic polymer such as polyvinyl alcohol polyacrylic acid are preferably used.

  In addition, since the transdermally absorbable drug-containing layer 2 is not directly attached to the affected area, adhesion to the skin and adhesion are not required. Therefore, the matrix used for the transdermally absorbable drug-containing layer 2 may be selected in consideration of the affinity with the drug, the drug release controllability, and the mild irritation to the skin without considering the adhesive strength.

  The transdermal absorption preparation 4 shown in FIG. 1 is composed only of the support 1, the drug-containing layer 2, and the pressure-sensitive adhesive layer 3. However, the configuration of the transdermal absorption preparation of the present invention is not limited to this, A non-woven fabric such as a non-woven fabric or gauze in which a percutaneously absorbable drug is absorbed as the percutaneous absorbable drug-containing layer 2 is laminated on the percutaneously absorbable drug-containing layer 2 May be used. By adopting such a configuration, it becomes easy to adjust the sustained release of the transdermal drug.

  The pressure-sensitive adhesive layer 3 is a layer composed of a pressure-sensitive adhesive for adhering to clothing such as underwear, so that there is no adhesive residue when peeled off and adhesion to the clothing so that it does not deviate from the affected area. Is required. Specifically, (meth) acrylic acid butyl ester, (meth) acrylic acid pentyl ester, (meth) acrylic acid hexyl ester and other (meth) acrylic acid alkyl esters, and acrylics such as copolymers of these with vinyl monomers A rubber-based pressure-sensitive adhesive such as silicone rubber, polypropylene rubber, polyisobutylene rubber, or SBR can be used. The adhesive used for the pressure-sensitive adhesive layer 3 does not need to consider the irritation to the skin except that there is no adhesive residue on the clothing, so mainly the adhesion (rough surface adhesion, tack), Just choose.

  The adhesive layer 3 and the transdermally absorbable drug-containing layer 2 are covered with a protective film or film such as a resin film such as polyethylene or polypropylene, a release film, or an aluminum foil in order to protect from the outside until just before use. Preferably it is. When a drug release control layer is further laminated on the transdermal absorbable drug-containing layer 2 and this is the outermost surface on the body surface side of the transdermal absorption preparation, the drug release control layer is a protective sheet or film. It will be covered with.

  When the percutaneous absorption preparation having the above-described structure has a protective sheet or film (hereinafter simply referred to as “protective cover” when the two are not distinguished from each other), the protective cover is peeled off at the time of use. The agent layer 3 is attached to the affected part corresponding position on the back surface (body surface contact surface) of the undergarment. If the underwear is worn in this state, the transdermal drug-containing layer 2 comes into contact with the affected area. The protective cover of the transdermal absorbable drug-containing layer 2 may be peeled off when being attached to the underwear, or may be removed after the underwear is worn.

  By wearing an undergarment with excellent body surface adhesion to the undergarment, specifically an undergarment made of a stretchable material, the undergarment can be adhered to the affected area without directly attaching the transdermal absorption preparation to the skin. In addition, since it is not attached to the skin, users who are not good at feeling of wear when wearing it should be relaxed by putting air between the underwear and the percutaneous absorption preparation after attaching the underwear. Can do. And even if it adheres for a long time, since the adhesive agent is not contained in the transdermally absorbable drug-containing layer 2, the rash caused by the adhesive agent can be prevented. Furthermore, since a hydrophilic substance gentle to the skin can be selected from a wide range as the drug matrix, a material that is gentler to the skin than before can be selected.

  The percutaneous absorption preparation of the present invention can be preferably used as long as it is usually an undergarment to be worn, preferably an undergarment with good adhesion to the body, but it is particularly preferred to be used in combination with the undergarment of the present invention.

  The undergarment used in combination with the transdermally absorbable preparation of the present invention is made of an elastic material, and the body part is described on the body contact surface side of the undergarment, for example, as shown in FIG. The body part to be described may be a muscle part where poultice is frequently used, or a tissue part in the case of a heart medicine, a hormonal agent, or a respiratory medicine.

  The stretchable material constituting the underwear of the present invention may be one that has been given stretchability by devising the knitting method of knitting, or blended and mixed with urethane excellent in stretchability to cotton and polyester. It may be a woven fabric or a woven fabric using stretched fibers, yarns. In short, it is possible to use an underwear material having good adhesion to the body, which has been frequently used conventionally.

  In the undergarment of the present invention, the body part is described on the back surface (body contact surface) of the undergarment, so that it is possible to know where the target affected area is located on the undergarment, thereby sticking to the undergarment. The prepared preparation can be brought into contact with the affected area. Moreover, since it is described on the back side of the undergarment, it is possible to select a thin or light garment to be worn on the undergarment even when going out without being conspicuous from the outside.

The percutaneously absorbable preparation of the present invention can be applied to a part where an undergarment such as the head, limbs, and neck is not worn by being used in combination with the preparation fixing wound body of the present invention.
In FIG. 3, one Embodiment of the winding body for fixation of this invention is shown. This fixing wound body is provided with an engaging means at the longitudinal end portion of the belt-like substrate 11 so that the wound body can be formed into an annular shape. The engaging means may be the magic tape 12 as shown in FIG. 3 (a), or a set of a hook portion 13a and a ring-shaped portion 13b for hooking the hook as shown in FIG. 3 (b). It may be a combination.

  Although it does not specifically limit as the strip | belt-shaped base material 11, It is preferable that it is a material which is easy to follow a body surface and is kind to a skin, a material which can be washed, etc., and is comprised by the textile fabric, a nonwoven fabric, a knitting, a towel cloth, etc. It is preferable.

  The adhesive layer of the transdermally absorbable preparation of the present invention may be attached to the affected part corresponding to the wound wound body for fixing, and the base material 11 may be annularly wound around the affected part as shown in FIG. . Since the adhesive does not come into contact with the affected area, it can also be applied to a site such as the back of the head where the poultice cannot be applied due to the presence of hair. Moreover, since the winding body for fixation can be reused only by replacing the transdermally absorbable preparation, it is economical.

  The transdermal absorption preparation of the present invention has no skin irritation caused by an adhesive, and can relieve tingling and tingling immediately after application. Useful as a patch.

  The underwear of the present invention is effective when used together with the transdermally absorbable preparation of the present invention when it is difficult to specify the position of the affected area or when the position is accurately applied to the affected area.

  Moreover, the winding body for fixation of the present invention is effective when it is desired to apply a percutaneous absorption medicine to a site where an undergarment such as a head or a limb is not worn.

1 is a schematic cross-sectional view showing one embodiment of a transdermally absorbable preparation of the present invention. It is a schematic diagram which shows the structure by the side of the front body of one Embodiment of the underwear of this invention. It is a structure schematic diagram which shows one Embodiment of the winding body for fixation of this invention. It is a figure which shows the usage example of the winding body for fixation of this invention. It is a schematic cross section for demonstrating the structure of the conventional percutaneous absorption preparation.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Flexible support body 2 Percutaneous absorbable medicine content layer 3 Adhesive layer 4 Percutaneous absorption preparation 11 Band-shaped base material 12, 13 Engagement means

Claims (6)

A flexible support;
A transdermally absorbable drug-containing layer that comes into contact with an affected area provided on one surface of the flexible support;
A transdermally absorbable preparation comprising an adhesive layer adhered to clothing provided on the other surface of the flexible support. The percutaneous absorption preparation according to claim 1, wherein a drug release control layer is laminated on the drug-containing layer. The transdermally absorbable preparation according to claim 1 or 2, wherein the drug-containing layer is a fabric impregnated with a drug. The transdermally absorbable preparation according to any one of claims 1 to 3, wherein both surfaces of the preparation are respectively covered with a protective sheet or a film. An undergarment for removably attaching the transdermal absorption preparation according to any one of claims 1 to 3,
An undergarment made of an elastic material and having an opposite body part shown on the body contact surface side of the undergarment. A wound body for fixing a drug for contacting the percutaneously absorbable preparation according to any one of claims 1 to 3 to an affected part of the head, limbs, or neck,
A wound body for fixing a medicine, wherein an engagement means for making the base material annular is provided at a longitudinal end portion of a belt-like base material wound around the head, limbs, or neck including the affected part.

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