JPH0335948B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of the Invention] The present invention provides a powerful and sustained effect over a long period of time with a transdermally absorbable active substance, and at the same time this effect is achieved by the action of heat. The present invention relates to an application device for increasing transdermal absorption of active substances.

TECHNICAL BACKGROUND OF THE INVENTION Many pain, spasms and convulsive disorders are caused by insufficient or uneven blood flow in the integument. In many cases, relief, improvement, or even treatment is achieved by applying heat evenly. Infrared rays, hot bottles, hot pads, hot packs and poultices have always had considerable problems and are therefore not always or easily usable in practice.

In addition, active substances that can be absorbed transdermally, and more particularly, for example, oils of medicinal plants, are able to exert their action for a sufficiently long period of time and, in particular, if they have the opportunity to penetrate the skin. Known to be therapeutically active. Research has already been carried out for a long time to explore the possibility of increasing the efficacy of this percutaneously absorbed active substance.

Punishu Patent Application No. 00163045 (EP-A-
00163045) discloses a device for insulating and distributing heat, in particular for insulating and distributing body heat, in the skin region consisting of a laminate consisting of a foam layer, a flexible thermally conductive metal layer and another foam layer. ing.

[Summary of the Invention] The present invention combines the principles of heat therapy with the principles of transdermally absorbable active substances (particularly medicinal vegetable oils) application in order to increase and optimize therapeutic activity. The purpose is to

Surprisingly, the above object provides a transdermal absorption system consisting of at least one replaceable carrier 1 filled with a transdermal absorption active substance and a support 2 of said carrier consisting of a laminate. An active substance applicator, the laminate comprising: (a) a closed-cell polyethylene foam layer 3 having a layer thickness of 1 to 5 mm; (b) a flexible thermally conductive metal foil 4; (d) a textured closed-cell polyethylene foam layer 5 having a layer thickness of 1 to 4 mm, which may have a layer thickness of 1 to 4 mm; or (a) a closed-cell polyethylene foam layer 3 with a layer thickness of 2-5 mm; (b) a flexible thermally conductive metal foil 4; a closed-cell polyethylene foam layer 6 with a layer thickness of 2 to 5 mm, which may have irregularities, and which is provided with at least one hole 7 having an area equal to or slightly larger than the area of the carrier 1; or (a ) a closed-cell polyethylene foam layer 3 with a layer thickness of 2 to 6 mm, which may be colored; (b) at least one pore 7 having an area equal to or slightly larger than the area of the carrier 1; and one side of the absorbent carrier is firmly bonded to the flexible thermally conductive metal foil 4.
a closed-cell polyethylene foam layer 6 with a layer thickness of 2 to 5 mm, which may be uneven; This can be achieved effectively and easily by using

[Preferred Embodiments of the Invention] Preferred embodiments of the transdermally absorbable active substance applicator according to the present invention are shown in the accompanying drawings.

FIG. 1 is a plan view of a device in the form of a plaster.

FIG. 2 is a cross-sectional view of the tool.

3 and 4 are cross-sectional views of simplified embodiments.

Figures 5, 6 and 7 show embodiments derived from the application device according to Figures 2, 3 and 4, in which additional metal plates and magnetic foils are introduced to join the carrier to the support. There is.

FIG. 8 is a plan view of a carrier 1 containing a magnetically adhesive metal wire net.

In the figures, like parts are designated by like reference numbers and have the following meanings: (1) carrier loaded with transdermally active substance; (2) entire support; (3) closed cells. (4) A flexible thermally conductive metal foil; (5) A closed-cell polyethylene foam layer that may be colored; (6) A layer of polyethylene foam that may be textured or laminated with fabric. Closed-cell polyethylene foam layer; (7) Section with jagged holes; (8) Textile layer made of borscht nylon; (9) Magnetically adhesive metal plate; (10) Magnetically adhesive Metal wire; and (11) magnetic foil that is permanently magnetized alternately in a striped pattern in positive and negative directions, and the spacing between the magnetized stripes is 3 to 10 mm.

In order to facilitate its application to the human body, the device for applying transdermal active substances preferably has on the foam layer 3 a textile layer 8, preferably a textile layer of Borsched nylon. This fabric layer allows the application device of the invention to be attached to the human body using an elastic bandage with skin-compatible and self-adhesive plaster or Velcro strip fasteners.

The device of the present invention has a location 7 in which several holes are provided.
They can be manufactured as plasters, headbands or pads comprising a carrier filled with a percutaneously absorbable active substance and inserted replaceably into the hole.

As the carrier 1, a nonwoven fabric is preferably used,
Particularly preferred is a randomly stacked nonwoven fabric that is skin compatible and has sufficient rigidity to be filled with a transdermally absorbable active substance. However, essentially any absorbent carrier, such as open cell foam, cloth, etc., which is resistant to transdermal absorption of the active substance, sufficiently rigid and compatible with the skin can be used. This filled carrier can have any desired shape, for example square, rectangular or polygonal. Particularly simple and preferred is a circular shape. These carriers loaded with transdermally absorbable active substances may be prepared fresh by the user or may be supplied sealed in bags such as supplementary fabric by the manufacturer.

The size of the portion 7 provided with holes is equal to or slightly larger than the area of the carrier 1. Preferably, the cut surface of the hole has a jagged shape.
This shape allows a good retention of the carrier in the recess and is also advantageous for forming air chambers at the edges of the carrier where vapors of the percutaneously absorbed active substance may accumulate.

Closed cell polyethylene foam layers 3, 5, 6 each have a layer thickness of 1 to 5 mm as described.
Or it can be changed within the range of 1 to 6 mm. On the other hand, the thickness of the entire laminate is in the range of 5 to 12 mm,
Preferably it is in the range of 6 to 10 mm. Thinner laminates are difficult to manufacture and do not store heat well. Thicker laminates would be too stiff, less portable, and also very bulky.

As the flexible thermally conductive metal foil, aluminum foil is mainly used. Preferably, its thickness is between 20 and 50 μm.

In a simple embodiment preferred for manufacturing, the foam layer 5 is omitted, in which case the carrier 1 is in direct contact with the metal foil 4. This allows the carrier to warm up even more rapidly and to higher temperatures, causing the effect to occur more quickly and be more intense.

A thermally conductive metal foil with flexibility on one side of the absorbent carrier 4
If the support laminate 2 is firmly bonded to
It is also possible to omit the metal foil 4 from the whole.
In this embodiment, the remaining two foam layers 3, 6
Preferably, the colors are different. Furthermore, in this embodiment, layer 3 is especially selected to be thicker and/or to consist of a foam with coarser pores and a higher insulating capacity.

The surprisingly high efficiency of the device according to the invention is due to the following mechanism of action. As in the case of the applicator according to Patent Application No. 0163045 (EP-A0163045), the entire stack of supports 2 results in a good accumulation and distribution of body heat to be achieved. It has been shown that the heat feedback to the human body is particularly high in the hole 7. It is precisely at this point that the carrier 1 filled with the transdermally absorbable active substance is located.
For this purpose, the transdermally active substances are heated to particularly high temperatures. As a result, the vapor pressure of the transdermally absorbed active ingredient increases, increasing its activity in the pores 7. The vapor of the percutaneously absorbed active ingredient accumulates in the air chambers near the edge of the carrier, allowing the ingredient to exert its activity over a long period of time. The metal foil 4 simultaneously acts as a barrier and prevents steam from escaping through the foam prematurely.

The skin-contacting foam layer 6 is preferably provided with irregularities, so that local ventilation and ventilation occurs and undesired sweat formation is suppressed. Due to this irregularity, a portion of the vapor of the transdermally absorbable active substance can reach beyond the pore area to exert its effect. Therefore, it is preferable that the unevenness is provided in a rectangular pattern with an interval of 1 to 3 mm. The groove is approx.
The depth can be between 0.5 and 2 mm. Instead of the irregularities, layer 6 can also be laminated with a fabric layer.

Measurements of the skin temperature under the action of the device of the invention have shown that the strongest heating occurs at the edge of the carrier 1, ie at the ventilation chamber. This result can only be explained by the fact that thermal insulation is minimal at that location. For this reason, the heat collected around the support 2 can be returned to the human body without much hindrance, and the vapor of the transdermally absorbable active substance acts on the skin at a relatively high concentration at these locations. be able to.

Basically, when manufacturing the support 2, the polyethylene foam layers 5 and 6 or 4 and 6 are
or even after forming 3 and 6 in each case, it is possible to provide the layers with holes 7 such that up to 4 mm of the foam layer is retained between the carrier 1 and the metal foil 4. . However, from a manufacturing point of view, the method described above is substantially more difficult than stacking two partial layers on top of each other. This has the further advantage that by coloring the foam layers 5 and/or 3 respectively, the holes 7 become more visible. This results in
It becomes easy to insert the carrier 1 into the hole. Hole 7
It is, of course, also possible to stamp the area under heat instead of providing it, but this method would hardly produce sharp burrs. In order to improve the bonding of carrier 1 to support 2, pressure-sensitive adhesive films or double-sided adhesive films may be used.

After use, carrier 1 is often discarded, while support 2 is often reused. Further, the support may be washed at a temperature of 30° C., so that it can be kept in a sanitary condition.

Percutaneously absorbable active substances include, for example, liquids such as oils, as well as tablets, pastes and powders, provided they have a sufficiently high vapor pressure. In particular, herbal oils can be used. Preferred herbal oils include plant essential oils, such as camphor oil, green oil, lavender oil, mustard oil, rosmarin oil, turpentine oil, and mixtures thereof. These oils are used for the therapeutic treatment of muscle and joint pain, low back pain, sciatica, intervertebral disc and rheumatic diseases, subject to prolonged heating. Additionally, it is used for prophylactic and post-treatment of athletic injuries, strains and bruises.
In all these cases there is an increase in tissue metabolism and an improvement in blood circulation. Therefore, the device of the present invention is an excellent application device, especially for medicinal oils and their vapors. This intensifies and prolongs efficacy.

Tests of the device according to the invention have shown that, especially when the support is used repeatedly, the support is no longer sufficiently supported and tends to shift or dislodge from its preset position. In principle, the carrier can be bonded to the support with a pressure-sensitive adhesive film or a double-sided adhesive film, but the following auxiliary fastening applications have proven more suitable. Velcro strip fasteners (magic tape) are provided on the side surface of the carrier 1 facing the support 2 and on the side surface of the support 2 facing the carrier 1. A preferred embodiment is to provide a magnetically adhesive metal plate 9 or a magnetically adhesive metal wire 10 on the surface of the carrier 1 facing the support 2, and the support 2 is provided with a magnetically adhesive metal plate 9 or a magnetically adhesive metal wire 10 facing the carrier 1. A foil 11 is provided. This magnetic foil is permanently magnetized alternately in positive and negative directions in a striped pattern, and the spacing between the magnetized bands is 3 to 3.
It is 10mm.

Double-sided bonding using Velcro strip fasteners is relatively simple and effective without being expensive. However, Velcro strip fasteners have the disadvantage of being quite bulky, resulting in an undesirable bulge in the device of the present invention. Therefore, only devices that can have a high overall thickness can accommodate this drawback.

Bonding using the magnetically adhesive metal plate 9 or the magnetically adhesive metal wire 10 allows these metal fixing devices to be easily provided on the surface of the carrier 1 facing the support 2 (the surface farther from the human body surface). It has been shown to be particularly advantageous because it allows for This can be done, for example, by internal bonding with non-woven materials or by gluing. In embodiments in which one side of the absorbent carrier 1 is firmly connected to the flexible thermally conductive metal foil 4, a metal plate 9 or a metal wire 10 can be inserted between the carrier and the metal foil.

Iron can be used in particular as the magnetically adhesive metal plate or magnetically adhesive metal wire, but other ferromagnetic alloys or metals can also be used.
If iron or steel is used, in order to prevent corrosion it may be advantageous to use iron plates or iron wires whose surfaces are galvanized or protected against corrosion.

Magnetic foil is permanently magnetized in a striped pattern with alternating positive and negative directions and the spacing between the magnetized stripes is 3 to 10 mm. Any suitable commercially available magnetic foil, magnetized as desired, is used. The stripes may be straight or circular, such that the magnetic stripes are arranged in concentric circles.

The spacing of the magnetization stripes of 3 to 10 mm ensures good adhesion by magnetic attraction even if the magnetization stripes and the metal plate or metal wire are not close to each other. This is based on the fact that striped magnetic foils that are permanently magnetized alternately in positive and negative directions create a sufficiently strong magnetic field even at intervals of several millimeters.

The size of the plate 9 may be larger or smaller than the size of the magnetic foil 11. The size of the magnetic plate is hole 7
It is preferable that it be about the same as. The use of larger magnetic foils requires higher technical and material outlays. A magnetic foil 11 that is too small in size cannot provide sufficient magnetic attraction to the metal plate 9 or metal wire 10.

Although it is basically possible to replace the position of the metal plate 9 or the metal wire 10 with the position of the magnetic foil 11, this means that in practice the carrier, which is used only once, is thrown away together with the relatively expensive magnetic foil. It means to end up. On the other hand, in the claimed embodiment the magnetic foil can be used with the support 2 several times.

It has also been found that in some cases it is preferable in the device of the invention for the surface of the support 2 facing the skin to be coated with a material that is compatible with the skin. For this purpose, it is preferable to laminate a prefabricated adhesive layer to a thin cotton fabric or other skin-compatible fabric, such as the Mefix product from the Mo¨lnlycke factory.

In a preferred embodiment according to FIG. 2, the layer thickness of the polyethylene foam layer 3 is approximately 2 mm, the layer thickness of the polyethylene foam layer 5 is approximately 3 mm, and the layer thickness of the polyethylene foam layer 6 is approximately 2 mm in the initial state. , 1-1.8mm in uneven conditions
It is. The depth of the hole 7 is therefore also approximately 1.8 mm. In the embodiments according to FIGS. 3 and 4, the foam layer is usually somewhat thicker.

For attaching the device of the invention to the skin, a removable and removable skin-compatible plaster or elastic bandage with Velcro strip fasteners is not shown. For the fabric layer 8, preferably consisting of borscht nylon,
Self-adhesive plasters and Velcro strip fasteners adhere well enough to support 2
It can be pulled apart again without causing any damage. This support 2 can therefore be repeatedly reused.

The holes 7 according to FIG. 1 are cut in serrations so that serrated ventilation chambers are formed. Together with the inlaid carrier, they form the image of flower petals or the halo of the sun. However, basically, it is possible to use a recess that is curved in a straight line or a wave shape. Furthermore, round recesses can also be used as long as they can sufficiently support the support 1 filled with the transdermally absorbable active substance.

In manufacturing a suitable headband, a longitudinally extending support is prepared which has a length of 5 to 30 cm and a width of 2 to 4 cm. The support is provided with holes in one or more parts 7, into which suitable small carriers 1 are inserted. On the other hand, in the manufacture of the parts, larger sizes are used, holes are likewise drilled in several parts 7, and suitably larger carriers 1 are inserted.

[Brief explanation of drawings]

FIG. 1 is a plan view of a plaster-shaped applicator according to the invention. FIG. 2 is a cross-sectional view of the applicator. 3 and 4 are cross-sectional views of a simple embodiment. 5, 6 and 7 are cross-sectional views of the embodiment derived from the applicator according to FIGS. 2, 3 and 4; FIG. FIG. 8 is a plan view of a carrier 1 containing a magnetically adhesive metal wire net. 1: Carrier filled with transdermally absorbable active substance,
2: Entire support, 3: Closed cell polyethylene foam layer, 4: Flexible thermally conductive metal foil, 5: Closed cell polyethylene foam layer which may be colored, 6: May have irregularities or cloth. a closed cell polyethylene foam layer which may be laminated with 7: a portion having holes in a jagged shape;
8: borscht nylon fabric layer, 9: magnetically adhesive metal plate, 10: magnetically adhesive metal wire,
11: Magnetic foil that is permanently magnetized alternately in a striped pattern in positive and negative directions, and the spacing between the magnetized stripes is 3 to 10 mm.

Claims (1)

[Scope of Claims] 1. An application device for percutaneously absorbable active substances, which comprises at least one replaceable carrier filled with a percutaneously absorbable active substance, and a support for the carrier consisting of a laminate. The laminate comprises (a) a closed cell polyethylene foam layer with a layer thickness of 1 to 5 mm, (b) a flexible thermally conductive metal foil, and (c) a layer thickness of 1 to 5 mm, which may be colored. (d) a layer of closed-cell polyethylene foam of 4 mm, provided with at least one pore having an area equal to or slightly larger than that of the carrier, with a layer thickness of 1 to 4, which may be uneven;
or (a) a layer of closed-cell polyethylene foam having a layer thickness of 2 to 5 mm; (b) a flexible thermally conductive metal foil; (c) an area equal to or slightly greater than the area of the carrier. At least one hole having a large area is provided, and the layer thickness may be uneven, from 2 to 5.
or (a) a layer of closed-cell polyethylene foam having a layer thickness of 2 to 6 mm, which may be colored; (b) at least one layer of closed-cell polyethylene foam having an area equal to or slightly larger than that of the carrier; A layer of closed-cell polyethylene foam with a layer thickness of 2 to 5 mm, which may have irregularities, and which is provided with two pores and which is firmly bonded to a flexible thermally conductive metal foil on one side of the absorbent carrier. An application device for transdermally absorbable active substances consisting of; 2. The applicator according to claim 1, wherein the hole has a jagged shape. 3. The applicator according to claim 1, characterized in that a textile layer is laminated on the closed-cell polyethylene foam layer of (a). 4. The applicator according to claim 1, wherein the applicator is in the form of a plaster, a headband, or a patch. 5. The applicator according to claim 2 or 3, characterized in that the applicator has the shape of a plaster, a headband, or a patch. 6. The application device according to claim 1, wherein the surface of the carrier support facing the skin is covered with a skin-compatible cloth. 7 A magnetically adhesive metal plate or a magnetically adhesive metal wire is provided on the surface of the carrier facing away from the skin, and a striped pattern is provided on the surface of the carrier facing away from the carrier. Claim 1, characterized in that a magnetic foil is provided which is permanently magnetized in positive and negative directions and whose magnetic stripes have an interval of 3 to 10 mm.
Applicable equipment as described in section. 8 A magnetically adhesive metal plate or magnetically adhesive metal wire is provided on the surface of the carrier facing away from the skin, and a striped pattern is provided on the surface of the carrier facing away from the carrier. Claim 3, characterized in that a magnetic foil is provided which is permanently magnetized in positive and negative directions and whose magnetic stripes have an interval of 3 to 10 mm.
Applicable equipment as described in section. 9 A magnetically adhesive metal plate or magnetically adhesive metal wire is provided on the surface of the carrier facing away from the skin, and a striped pattern is provided on the surface of the carrier facing away from the carrier. Claim 4, characterized in that a magnetic foil is provided which is permanently magnetized in positive and negative directions and whose magnetic stripes have an interval of 3 to 10 mm.
Applicable equipment as described in section. 10 A magnetically adhesive metal plate or a magnetically adhesive metal wire is provided on the surface of the carrier facing away from the skin, and a striped pattern is provided on the surface of the carrier facing away from the carrier. is permanently magnetized in the positive and negative directions,
6. The applicator according to claim 5, further comprising a magnetic foil whose magnetized stripes have an interval of 3 to 10 mm. 11. The application device according to claim 1, characterized in that a strip fastener is provided on the surface of the carrier facing away from the skin and the surface of the support facing the carrier. .