JPH031452Y2 - - Google Patents

Description

[Detailed Description of the Invention] The present invention relates to a novel skin permeation therapeutic agent, and particularly to a skin permeation therapeutic agent that does not cause pain to the administration site and is less likely to cause the main drug to volatilize during administration.

In recent years, the effectiveness of transcutaneous therapy (TTS), which attempts to transdermally administer drugs that permeate the skin, has been recognized. Therapeutic agents are commercially available or are undergoing clinical research or animal testing.

By the way, there are skin permeation therapy agents (hereinafter abbreviated as "TTS agents") that are currently in practical use or in the research stage.
Generally, the drug is stored inside a dish-shaped container with a shallow flange made of thick aluminum foil, and the opening surface of the container is directly passed through a drug permeation control layer such as EVA, or further through an aluminum foil and adhesive layer. It is covered with a lid made of elastic material. In use, the lid part excluding the container is attached to the skin surface of the application site using the adhesive layer of the part so that the drug part comes into contact with the skin.

However, although conventional products of this type pose no problems when stored, the container is removed when applied, so the key drug may evaporate during use or may be used as a vehicle. It is not uncommon for the solvent in the solution to evaporate and become useless. These drawbacks cannot be ignored since the main purpose of this type of drug is continuous administration over a long period of time (24 hours or more). Furthermore, when the gas is a harmful drug such as nitroglycerin, the volatilized gas may have harmful effects such as headaches and weakness on sensitive people nearby.

The above drawbacks can be improved by directly attaching the container containing the drug instead of the lid to which the drug is attached, but on the other hand, if the container is not subjected to a vertical external force, When applied, the hard drug container presses the administration site, resulting in the disadvantage of causing pain and discomfort to the patient.

(Purpose of the invention) The present invention effectively suppresses the volatilization of the base agent and vehicle in existing TTS agents, thereby making the agent effective over a planned long period of time, and
The aim is to provide a new TTS agent that causes less pain and discomfort to patients.

(Means for achieving the object) In order to achieve the above object, the TTS agent according to the present invention is composed of the following two members A and B joined together, and is configured so that both members are joined together when in use. It is characterized by the presence of

(A) A shallow dish-shaped body made of a gas-impermeable plastic material such as a metal foil or a thin hard plastic sheet, and having a narrow flange on the periphery, and a tube tightly housed within the dish-shaped body. A main body comprising a skin-acting drug and a control membrane covering the opening surface of the dish-shaped body.

(B) made of a spongy elastic material, has a diameter larger than the outer diameter of the main body, has a thickness equal to or greater than the thickness of the main body, and is suitable for fitting the dish-shaped part of the main body; A donut-shaped packing that has a hole of sufficient diameter and has an adhesive layer added to one side.

In the above configuration, the flanged plate-shaped body that forms the main body of the main body A is formed from a gas-impermeable plastic material such as metal foil or a thin hard plastic sheet, but in practical terms, it is laminated with a plastic film and made of aluminum. Preferably it is made from foil. The width of the flange is at most several millimeters, which is sufficient to allow attachment of a control film to be described later, and excessive width is rather harmful to the purpose.

The base agent is stored inside the upper dish-shaped body in a plastic or gel state. Chemicals such as various polysaccharides, lactose, silicone resins, ethanol, acetone, dimethyl sulfoxide, ethylene glycol, and polyethylene glycol are used to matrix the substrate and solubilize the drug. In addition,
For purposes of this invention, the drug must be in intimate contact with the interior surface of the container.

The control film is attached to the surface of the collar so as to cover the opening of the container containing the drug. It is made from a variety of porous membrane materials or non-porous permeable materials such as ethylene vinyl acetate copolymer (EVA) or ethylene vinyl alcohol copolymer to control the rate of exudation of the drug therein. Therefore, the seepage rate can be freely controlled depending on the type of material, the size and density of the micropores, etc. Therefore, the drug inside does not need to be strictly in a plastic or gel state, but may be in a viscous fluid state. Note that the surface of the control film is preferably covered with a covering material such as aluminum foil.

The donut-shaped packing is made of a soft elastic material such as urethane foam or soft rubber. This thing has a dimension larger than the outer diameter of the main body container and equal to or larger than the thickness of the main body, and further has a diameter equal to the dish-shaped part of the main body in the center part. Or a hole with a slightly larger diameter is drilled,
As will be described later, when in use, the dish-shaped portion of the main body is inserted into this hole. The present patch further has an adhesive layer formed on one side thereof, and this adhesive layer holds the flange of the inserted body and allows the formed body/pack skin combination to adhere to the target skin surface. Therefore, the width of the annular portion of the present packing should be large enough to ensure reliable engagement with the main body and at the same time provide a reliable adhesion area to the skin surface. In addition, it is desirable that the adhesive layer of this packing is also protected with a covering material such as release paper.

(Effect) Since the drug, solvent, or dispersion medium inside the TTS agent of the present invention is protected by a gas-impermeable container during use, its medicinal efficacy remains for a long time. Moreover, since it does not require a flange as large as the known drug containers of this type, it not only greatly reduces the cost of packaging materials, but also dramatically reduces patient pain and discomfort due to the cushioning effect of the donut-shaped packing. .

(Example) Hereinafter, an example of the embodiment of the invention will be introduced by way of an example, but the example is of course for illustrative purposes and does not indicate the connotation or extension of the idea of the invention. In particular, it is self-evident that the act of manufacturing or selling the main body A or the packing B, which constitute the main part of the invention, belongs to the invention and the implementation.

Embodiment FIG. 1A is a vertical cross-sectional view of the central part of the main body of an example of the TTS agent according to the present invention, FIG. , a sectional view similar to FIG. 1 explaining the assembly method, FIG. 3 is a perspective view thereof,
FIG. 4 is an explanatory diagram showing the state of use thereof.

[Structure] The entire agent 1 includes a main body 1A and an annular packing 1B.
It consists of

The main body 1A includes a TTS drug 4 filled in a plate-shaped container 2 made of thick aluminum foil and equipped with a flange 3 on the periphery.
and cover the opening surface of the container with an adhesive layer 5 interposed therebetween.
A control film 6 made of EVA, and a covering material 8 made of aluminum foil that covers the surface of the film 6 with an adhesive layer 7 interposed therebetween.
It consists of

The annular packing 1B is made of urethane foam, and its outer diameter 0D is sufficiently larger than the outer diameter D of the main body 1A, and the inner diameter ID of its hollow portion 9 is as follows.
It is slightly smaller than the outer diameter D' of the dish-shaped part 2a of the main body 1A, and the thickness T is slightly smaller than the outer diameter D' of the dish-shaped part 2a of the main body.
The depth T′ is greater than the depth T′. An adhesive layer 10 is applied to one side of the packing, and a release paper 11 is attached to the surface.

[How to use] When using, peel off the covering 8 of the main body 1A and the release paper 11 of the packing 1B as shown in FIGS. After inserting it into the patient's body and integrating the two with the adhesive layer 10, the remaining portion of the adhesive layer is used to adhere it to the affected area as shown in FIG. 4. As is clear from Fig. 2, the thickness T of the packing 1B
Since T' is sufficiently larger than the depth T' of the dish-shaped portion 2a of the main body, the external force transmitted through clothing etc. is absorbed by the gasket, and the patient is relieved from pain and discomfort caused by administration.

In the above example, if necessary, an opening cut or a puller may be added to both or one of the main body and the packing. Furthermore, if possible, the cushioning effect can be further increased by providing a bottom in the hollow part 9 of the packing 1B so that the bottom of the container 2 during use can also be covered with an elastic material.

(Effects) As explained above, according to the present invention, it is possible to provide a skin permeation therapeutic agent that maintains its efficacy over a long period of time and does not cause pain or discomfort to patients, and therefore can make a significant medical contribution.

[Brief explanation of drawings]

FIG. 1A is a longitudinal cross-sectional view of the central part of the main body of an example of the TTS agent according to the present invention, FIG. A sectional view similar to FIG. 1 explaining the assembly method, FIG. 3 is a perspective view thereof,
FIG. 4 is an explanatory diagram showing the state of use thereof. The meanings of the symbols in the figure are as follows: 1: Whole drug;
1A: 1 main body, 2: 1A container, 3: 2 flange, 4: 1A drug, 5: 1A adhesive layer, 6:
1A control film, 7:1A adhesive layer, 8:1A covering, 1B:1 packing, 9:1B hollow part, 10:1B adhesive layer, 11:1B release paper.

Claims (1)

[Claims for Utility Model Registration] (1) A skin permeation therapy drug consisting of the combination of the following two parts A and B, and configured so that both parts are joined together during use; (A ) A shallow dish-shaped body made of a gas-impermeable plastic material such as a metal foil or a thin hard plastic sheet and having a narrow flange at the periphery, and a transdermal agent housed in the dish-shaped body in close contact with each other. and a control membrane covering the opening surface of the dish-shaped body. (B) is made of a sponge-like elastic material, has a diameter larger than the outer diameter of the main body, has a thickness equal to or greater than the thickness of the main body, and is suitable for fitting the dish-shaped member of the main body; A donut-shaped packing that has a hole of sufficient diameter and has an adhesive layer added to one side. (2) The agent according to claim 1, wherein the surface of the control membrane of the main body is covered with a gas-impermeable membrane. (3) The drug according to claim 1 of the utility model registration, wherein the adhesive layer of the sponge-like elastic body is protected by a release paper.