WO1990005558A1

WO1990005558A1 - Applicator for transdermally resorbable active substances

Info

Publication number: WO1990005558A1
Application number: PCT/EP1989/001248
Authority: WO
Inventors: Ralf Latzke
Original assignee: Ralf Latzke
Priority date: 1988-11-24
Filing date: 1989-10-19
Publication date: 1990-05-31
Also published as: AU4507889A; KR900701347A

Abstract

The applicator consists of an interchangeable carrier (1) impregnated with the transdermally resorbable active substances and a support (2) for the carrier. The support (2) consists of a) a closed-pore foamed polyethylene (3) 2 to 10 mm thick which is laminated, on the side nearer the skin, with an elastic, adhesive layer (4) which is biologically compatible with the skin and covered before use with a tear-off protective layer (5), and, on the side farther from the skin, with a woven textile layer (6), preferably of brushed nylon, the support being perforated by an approximately central punched hole (7) as large as or slightly larger than the carrier (1); b) an insert (8) which fits into the punched hole (7), consisting of a closed-pore foamed polyethylene (9) 1 to 8 mm thick and 1 to 3 mm thinner than the foamed polyethylene (3) and is laminated, on the side nearer the skin, with a flexible, thermally conductive metal film (10) and possibly, on the side farther from the skin, with a woven textile layer (11), preferably of brushed nylon; and c) a piece of adhesive tape, preferably a Velcro R -type tape, which is longer than, and preferably approximately as wide as, the insert (8).

Description

Device for the application of transdermally absorbable active substances

The present invention relates to a device for the application of transdermally resorbable active substances, which permits intensive and long-lasting action of the transdermally resorbable active substances and increases their effectiveness through simultaneous exposure to heat.

A number of pains, cramps and convulsive disorders are due to insufficient or uneven blood flow to the outer skin. In many cases, even exposure to heat, relief, improvement or even healing can be achieved. Treatment with infrared rays, hot water bottles, heating pads, hot packs and envelopes is always associated with considerable effort and is therefore not always easy to carry out.

Furthermore, it is known that transdermally absorbable active substances, in particular medicinal plant oils, are particularly therapeutically effective when they can act for a sufficiently long time and have the possibility of penetrating the skin. There has long been a search for ways to increase the effectiveness of the transdermally absorbable active ingredients.

EP-A Ö 163 045 discloses means for heat insulation and for storing and distributing heat, in particular body heat, on surfaces of the outer skin which consist of a laminate, a foam layer, a flexible, heat-conducting metal layer and another layer of foam. These agents have already proven themselves as warming plasters, pillows, mats, etc. EP-A-0 258 521 discloses an agent for applying transdermally absorbable active substances, consisting of at least one interchangeable carrier (1) soaked with the transdermally absorbable active substances and a holder (2) for the carrier, consisting of a laminate from a 1 to 5 mm thick, closed-pore polyethylene foam layer (3), a flexible, heat-conductive metal foil (4), one

1 to 4 mm thick, optionally colored closed-pore polyethylene foam layer (5) and a 1 to 4 mm thick, optionally pimpled, closed-pore polyethylene foam layer (6), from which at least one preferably jagged piece (7) is punched out, whereby the piece (7) is of the same area or slightly larger in area than the carrier (1), or a 2 to 5 mm thick, closed-pore polyethylene foam layer (3), a flexible, heat-conductive metal foil (4), a 2 to 5 mm thick, optionally pimpled, closed-pore polyethylene foam layer (6), from which at least one preferably jagged piece (7) is punched out, the piece (7) having the same area or being slightly larger in area than the carrier (1) or one 2 to 6 mm thick, closed-pore polyethylene foam layer (3), which is optionally colored, and one

2 to 5 mm thick, optionally pimpled, closed-pore polyethylene foam layer (6), from which at least one preferably jagged piece (7) is punched out, the absorbent carrier (1) then being coated on one side with the flexible, heat-conductive metal foil (4) is firmly connected.

For easier attachment to the body, these means preferably have one on the foam layer (3) Fabric layer (8), which preferably consists of brushed nylon. This layer of tissue allows the agents to be attached to the body with the aid of skin-compatible, self-adhesive plasters or elastic bandages with Velcro fasteners.

The agents can then be produced in the form of plasters, but also headbands or pillows, headbands or pillows usually having several punched-out pieces (7) and interchangeably inserted carriers (1) soaked with transdermally absorbable active substances.

Of these agents, the third variant has proven itself best and was introduced to the trade in Germany under the name "Original Swisstherm". In practice it has been shown that although very good results are achieved, practical handling is somewhat cumbersome. The manufacturing costs are also relatively high.

The object of the invention is therefore to improve the agents according to EP-A-0 258 521 (application no. 87 102 306.5), to simplify handling, to reduce manufacturing costs and to more easily control the condition of the skin under the device to be able to.

This object was achieved by a device consisting of an exchangeable carrier (1) soaked with the transdermally absorbable active substances and a holder (2) for the carrier, characterized in that the holder (2) consists of a) a 2 to 10 mm thick closed-pore polyethylene foam (3), which is laminated on the side facing the skin with an elastic, self-adhesive, skin-compatible adhesive Layer (4) which is covered with a protective layer (5) which can be removed before use and which is optionally laminated on the side facing away from the skin with a fabric layer (6) which preferably consists of brushed nylon, the holder as a whole approximately has a continuous punch hole (7) in the middle which is the same size as or slightly larger than the carrier (1),

b) an insert (8) which fits into the punching hole (7),

10 consisting of a 1 to 8 mm thick closed-pored polyethylene foam (9), which is 1 to 3 mm weaker than the polyethylene foam (3) and is laminated on the side facing the skin with a flexible, heat-conductive metal foil (10) lo and optionally on the side facing away from the skin with a fabric layer (11), which preferably consists of brushed nylon, and

c) a piece of adhesive tape, preferably Velcro fastener _ ₀ (12), which is longer than and preferably about as wide as the insert (8).

Nonwovens and in particular all skin-compatible random fiber nonwovens can preferably be used as the carrier (1)

25, which have sufficient rigidity and can be soaked with the transdermally absorbable active ingredients. In principle, however, there are also other sufficiently stiff, skin-compatible, absorbent carriers that are resistant to transdermally resorbable active ingredients.

30 such as open-pore foams, fabrics etc., in question. The shape of these impregnated supports can be chosen as desired, for example square, rectangular or polygonal. The circular shape is particularly simple and preferred. These with transdermally absorbable Carriers impregnated with active ingredients can either be freshly prepared by the user themselves, or can be supplied sealed in by the manufacturer, similar to refreshment wipes.

According to the invention, the holder (2) is no longer fastened to the body with the aid of skin-compatible, self-adhesive plasters or elastic bandages with Velcro fasteners, but instead by means of the elastic, self-adhesive, skin-compatible adhesive layer (4) firmly connected to it, which is provided with a before Use removable protective layer (5) is covered. After removing this protective layer (5), the device as a whole can be glued to the desired location on the body. The carrier impregnated with transdermally absorbable active substances can be inserted into the punched hole (7) during the first application before the holder (2) is glued to the skin. According to the invention, however, it is possible to open the device from behind even after the holder has been glued to the skin and to insert the carrier (1) soaked with transdermally absorbable active substances only afterwards and then to close the holder. According to the invention, it is above all possible to leave the holder glued on for a relatively long time and yet to add further transdermally absorbable active ingredient at shorter intervals; For this purpose, the holder is preferably opened again from behind and the carrier is either impregnated again or exchanged for a new impregnated carrier. Then the holder can be closed again from behind.

The closure is made by the insert (8), which is held firmly in the punched hole (7) with the aid of the adhesive tape or Velcro fastener (12). The punched hole (7) and the insert (8) are therefore of the same area or slightly larger in area than the carrier (1), so that the carrier can be easily inserted and removed. The insert (8) is the same size as the punched hole (7), so that the device is closed as tightly as possible after sealing and can only escape as little as possible of the transdermally absorbable active substance. Lateral escape of the active ingredient is largely prevented by the fact that the holder is glued to the surrounding skin.

If it is not a problem or even desirable that part of the active substance escapes, the punched hole (7) can be enlarged by means of additional punched-outs (13) that are more or less large. Through these punched-out portions (13), on the one hand a part of the active ingredient, but also a part of the heat and water vapor developed can escape. If these punched-outs (13) are large enough, it is possible to reach into them and pull the insert (8) up a little in order to control the skin below the device.

Another advantage of the device according to the invention with or without additional punched-outs (13) is that when the carrier (1) is replaced or renewed, the skin treated with the active ingredient can, if desired, be inspected and it can be determined whether any heating phenomena etc. have occurred are.

The part of the holder which can be glued onto the skin consists of a 2 to 10 mm thick closed-pore polyethylene foam layer which is cut round, oval or rectangular, preferably with rounded corners. The size is chosen so that the holder is not unnecessarily large on the one hand, but on the other hand is large and stable enough to hold the carrier (1) and the insert (8) that fits into the punched hole (7). For this purpose it is also necessary that there is a sufficiently large area for the adhesive tape or the Velcro fastener (12).

The thickness of the closed-pore polyethylene foam layer (3) can fluctuate within the stated range, but the closed-pore polyethylene foam layer (9) must accordingly be correspondingly weaker so that there is sufficient space for the metal foil (10) and the carrier (1). The polyethylene foam layer (9) is therefore generally chosen to be 1 to 3 mm weaker than the polyethylene foam layer (3). It goes without saying that thicker layers of polyethylene foam lead to more stable devices which, however, have the disadvantage of being thicker. In general, devices of larger area will therefore be produced from thicker layers of polyethylene foam and smaller ones from thinner layers of polyethylene foam.

Aluminum foil, which preferably has thicknesses between 10 and 30 μm, is used in particular as the flexible, heat-conductive metal foil. The metal foil mainly serves as a vapor barrier and together with the polyethylene foam layer (9) of the insert (8) for thermal insulation, so that there is a storage and an increase in the skin temperature below the insert (8). Measurements of skin temperature in the range of Trä¬ gers have shown that the skin temperature up to 5 C ^β is higher than outside the invention Vorrich¬ processing. The surprisingly good effectiveness of the device according to the invention is based to a considerable extent on this increase and storage of the skin temperature. The increase in skin temperature leads to a clear one Increasing the vapor pressure and a clearly accelerated and increased absorption of the transdermally absorbable active substances. In the case of essential oils, an increase in the bioavailability, that is to say the amount which reaches the muscles and the vessels in the efficient range, has more than tripled. Furthermore, the device according to the invention effects long-term treatment for hours, whereas with simple rubbing in this has to be done much more frequently and only significantly smaller portions penetrate into the tissue. This effect based on the increase in temperature

10 is further reinforced by the fact that in the case of essential oils which are simply rubbed in, a considerable part does not penetrate into the cornea at all, but rather with the water vapor which constantly removes the skin from the inside to the outside

J.D leaves, is eliminated again. The metal foil thus acts not only as a vapor barrier with regard to the transdermally absorbable active ingredients, but also with regard to the water vapor normally emitted by the skin. If active substances with this water vapor

20 are led out of the skin, these are fed back to the depot according to the invention and can penetrate the skin again.

Both the fabric layer (6) on the outer part of the

The holder and the fabric layer (11) on the insert (8) serve primarily to reversibly hold the adhesive tape or the Velcro fastener (12). Particularly when a Velcro fastener is to be used, brushed nylon is preferably used as the fabric layer.

30

The Velcro fastener is preferably ring-shaped and has an outer diameter that is larger than that of the insert (8) and an inner diameter that is smaller than that of the insert (8). The fabric layer (6) and the fabric layer (11) can also be omitted if adhesive tape is used. Optionally, the insert (8) can also be held in the holder (2) by using conventional bandage clips that can get caught in the foam layer (3). Normal bandage clips usually consist of an elongated piece of gum ¬ miband with a wide metal hook on both ends.

The closed-pore polyethylene foam layers (3) and (9) can fluctuate between 2 and 10 or 1 and 8 mm thick in the frame mentioned, but overall the layer (9) should be 1 to 3 mm weaker than the layer (3), so enough space remains for the metal foil (10) and the carrier (1).

Finally, the support (1) and the insert (8) may be joined together firmly. ^"Preferably, this is done by 1 to 2 mm thick closed cell polyethylene foam (14) connected to both the metal foil (10) and the support (1 ) is laminated.

Liquids such as oils, but also tablets, pastes and powders are particularly suitable as active ingredients which can be transdermally absorbed in the heat, provided that they have a sufficiently high vapor pressure. Medicinal plant oils are particularly suitable. Essential oils such as camphor oil, green oil, lavender oil, pepper oil, rosemary oil and turpentine oil and mixtures thereof are preferably used as medicinal plant oils. These oils, along with the long-lasting warming, are used therapeutically for muscle and joint pains, witch-shot, sciatica, intervertebral disc complaints and rheumatic complaints. They can also be used , " _M 0555 _ _

are used for the prevention and after-treatment of sports damage, strains and bruises. In all of these cases, there is an increase in tissue metabolism and better blood circulation. The compositions of the invention thus represent an excellent applicator ins¬ special ^"for medicinal plants oils and their vapors will wo¬ intensified with the effectiveness and prolonged.

In the attached figures, two preferred embodiments of the device according to the invention are shown. 1 shows the first embodiment in a top view. FIG. 2 shows a section through the device according to FIG. 1, but in a disassembled form. Fig. 3 shows the same device and the Schnitt¬ plane A -... A 'and a section through this device with an inserted ^"carrier (1) and unfolded insert (8) further shown herein additional outs (13) Figure 4 shows a second embodiment and the sectional plane B - B ', in which the carrier (1) and the insert (8) are firmly connected to one another, specifically via a layer of polyethylene foam.

In the figures each mean

1 a carrier impregnated with the transdermally absorbable active substances

2 the entire bracket

3 a closed-pore polyethylene foam layer

4 an elastic, self-adhesive, skin-friendly adhesive layer

5 a protective layer that can be removed before use

6 a laminated fabric layer, which preferably consists of brushed nylon

7 a continuous punch hole

8 an insert that fits into the punching hole

9 a closed-pore polyethylene foam layer 10 a flexible, thermally conductive metal foil 5.1 a fabric layer, which preferably consists of brushed nylon

12 adhesive tape or Velcro

13 additional die cuts

14 a closed-pore polyethylene foam layer.

In the preferred embodiment according to FIGS. 1 to 3, the thickness of the polyethylene foam layer (3) is 6 mm and the thickness of the polyethylene foam layer (9) is 5 mm. The metal foil (10) consists of aluminum and is 12 μm thick. The fabric layers (6) and (11) consist of brushed nylon and are firmly connected to the foam layers (3) and (9) by lamination. The carrier (1) consists of a 1 mm thick, skin-compatible, non-woven fabric. A Velcro hook tape is used as a Velcro fastener. In the embodiment according to FIG. 4, the thickness of the polyethylene foam layer (3) is only _. 4 mm and the thickness of the polyethylene foam layers (9) and (14) each 2 mm.

Claims

Patent claims

1. Device for applying transdermally resorbable active substances, consisting of an interchangeable carrier (1) and a holder (2) for the carrier, soaked in the transdermally resorbable active substances, characterized in that the holder (2) consists of a) a 2 to 10 mm thick closed-pore polyethylene foam (3) which is laminated on the side facing the skin with an elastic, self-adhesive, skin-compatible adhesive layer (4) which can be peeled off before use Protective layer (5) is covered and is optionally laminated on the side facing away from the skin with a fabric layer (6), which preferably consists of brushed nylon, the holder overall having a continuous punch hole (7) approximately in the middle, of the same size is like or is slightly larger than the carrier (1),

b) an insert (8) which fits into the punching hole (7) and consists of a 1 to 8 mm thick closed-pore polyethylene foam (9) which is 1 to 3 mm weaker than the polyethylene foam (3) and is laminated on the Skin-facing side with a flexible, heat-conductive metal foil (10) and optionally on the side facing away from the skin with a fabric layer (11), which preferably consists of brushed nylon, and

c) a piece of adhesive tape, preferably Velcro (12), which is longer than and preferably about as wide as the insert (8).

2. Device according to claim 1, characterized in that the punch hole (7) by additional punchings

(13) is enlarged.

3. Device according to claim 1, characterized in that the carrier (1) is fixedly connected to the insert (8).

4. The device according to claim 3, characterized in that the carrier (1) and the insert (8) over a 1 to 2 mm thick closed-pore polyethylene foam

(14) are connected.

Device according to one of claims 1 to 4, characterized in that the Velcro fastener (12) is annular and has an outer diameter which is larger than that of the insert (8) and an inner diameter which is smaller than that of the Insert (8).