JPH068972Y2 - Skin penetrating agent - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Use of the Invention) The present invention relates to a novel skin-penetrating drug contained in a container, particularly a skin-penetrating drug which is less likely to be consumed during storage or administration.

(Problems of the prior art) Conventionally, it has been common to administer a drug for oral administration orally or transmucosally as a suppository. In recent years, however, drugs that have been conventionally administered orally for the purpose of eliminating gastrointestinal disorders caused by oral administration or imparting a long-lasting effect are dermally permeabilized by imparting dermal permeability to pharmaceuticals. A drug for skin permeation therapy to be administered (hereinafter,
It is also abbreviated as "TTS agent" or "skin penetrating agent". ), The interest in this field is increasing.

However, in a TTS agent, various absorption promoters, surfactants, solubilizers, solvents and the like are often mixed in order to impart skin permeability to the drug (20), but these compounding agents are generally used. A resin such as ethylene-acrylic acid copolymer (EAA) or ionomer (trade name "Sarrin") that adheres the aluminum foil dish-shaped container (21) containing this agent and the aluminum foil lid (22) ( 23) to attack the main drug (20)
However, there is a drawback that it dissolves in the resin during storage and is naturally consumed. Therefore, it can be said that the development of means for avoiding the depletion of the drug (20) is an important key for developing the TTS drug.

(Purpose of the Invention) In view of the above situation, an object of the present invention is to provide a means for effectively suppressing the depletion of the base drug for TTS agents by improving the container for TTS agents.

(Means for achieving the object) The shallow dish-shaped body in which the container (2) is made of a gas-impermeable plastic material such as a metal foil or a thin hard plastic sheet.
A step portion (5) formed in a step shape on the outer periphery of (3), and the step portion (5)
It is configured with a collar portion (4) formed in a stepped shape on the outer periphery of, and the transdermal drug (6) is stored in the dish (3), and the dish ( The outer periphery of the first gas impermeable cover (7) covering the opening surface of (3) is in close contact with the step (5), and the second gas impermeable cover (9) lined with the elastic sheet (10) is used. )
Is adhered to the first gas impermeable cover (7) and is also adhered to the collar portion (4) of the container (2) via the adhesive layer (11), and the second gas impermeable cover ( When the main ingredient (6) is adhered to the first gas impermeable cover (7) together with 9) and the base material (6) is peeled off from the dish (3), the adhesive layer (11) becomes the second gas impermeable cover.
(9) is characterized in that it remains on the outer peripheral portion of the inner surface facing the collar portion and forms an adhesive layer to the skin.

Referring to FIG. 1 (especially exaggerated vertical dimension and exaggerated thickness of members) showing the main structure of the drug of the present invention, the plate-shaped body [container] (2) with the main collar (4) is It is formed from a gas-impermeable plastic material such as a metal foil or a thin hard plastic sheet, but practically, it is preferably made from a laminate together with a thick aluminum foil and a stretched polypropylene film. If desired, the inner surface of the aluminum foil may be coated with a corrosion-resistant resin. In addition, it is preferable that a notch for opening is engraved on the flange portion of the container.

The container (2) further has, as its characteristic configuration, an inwardly facing step (5) inside the opening edge. The depth of the step portion (5) is almost the same as the thickness of the first aluminum foil cover (7) described later.

The main agent (6) is stored in the upper dish-like body (3) in a plastic state or a gel state, and the upper surface thereof comes into close contact with the inner surface of a first aluminum foil cover (7) described later. Compounding agents such as various polysaccharides, lactose, silicone resins, ethanol, acetone, dimethylsulfoxide, ethylene glycol, polyethylene glycol, carboxyvinyl polymer, and higher alcohol esters are used for matrixing the base material and solubilizing the main ingredient. It

The aluminum foil cover has a double structure. The first cover (7) covers the opening surface of the container body, the edge thereof rests on the stepped portion, the lower surface thereof is in close contact with the upper surface of the main agent (6), and the upper surface thereof is EAA or It is adhered to a second aluminum foil cover (9) described below through an adhesive resin layer (8) such as an ionomer.

The second aluminum foil cover (9) has a contour similar to the contour of the entire container, and its upper surface is directly or indirectly bonded to the elastic sheet (10) described below. The elastic sheet (10) is made of a softening agent such as urethane foam or sponge rubber, and is adhered to the second cover (9) on its entire surface through an adhesive (11 '). Further, the inner surface of the second cover (9) facing the opening surface of the container body is bonded to the first cover (7) through the adhesive resin layer (8), but faces the flange portion of the container. Adhesive (11) is applied to the part, and the adhesive layer (11) is applied during administration.
Remains on the inner peripheral edge of the second cover 9 and sticks to the skin.

(Function) The main component, solvent or dispersion medium inside the TTS agent of the present invention is adhered to the step (5) surface by the peripheral edge of the first aluminum foil cover (7), so that the adhesive resin layer (8 ), It is effectively stored for a long time before use. Furthermore, during use, the main ingredient (6) adheres to the first cover (7) and is peeled off from the container (2), and the adhesive layer (11) on the inner peripheral edge of the second cover (9). Since the main agent (6) is adhered to the skin by the use of a volatile main agent, the main agent, etc. is kept in a substantially airtight state by the gas impermeable second cover during use. Does not evaporate, and the medicinal effect continues for a long time.

(Embodiment) Hereinafter, an example of the present invention will be described with reference to an embodiment, but the exemplification is, of course, for the purpose of description, and does not show the inclusion or extension of the idea of the present invention.

<< Example 1 >> FIG. 2 is a cutaway perspective view of an example of the TTS agent according to the present invention, and FIG. 3 is a perspective view showing an opened state.

As described above, the drug (1) of this example is a shallow dish-shaped container (2) with a collar (4), a skin-permeable main agent (6) contained in the main body of the container, and the main agent. A first cover (7) for covering the first
Second cover (9) covering the entire surface of the container (2), including the cover of
And an elastic sheet (10) covering the entire surface of the second cover (9) and a pressure-sensitive adhesive layer (11) applied to the peripheral surface of the second cover (9) facing the flange (4). And are configured as main members.

The container (2) is made from a laminated sheet of an aluminum foil (2a) and a stretched polypropylene film (2b), and its dish (3).
An inward step (5) between the collar and the collar (4), for example, a main ingredient (6) containing an anti-inflammatory analgesic such as indomethacin as an active ingredient.
Is filled inside the second body (3).

The first cover (7) is made of aluminum foil, the edge of which is located on the step (5) of the body (3). And this cover has the following second cover through the EAA adhesive layer (8) coated on the upper surface.
It is glued to the back of (9). The second cover (9) has a collar part.
An aluminum foil sheet (9a) having a size including the entire container (2) including (4) and a PET sheet (9b) of the same shape attached to the upper surface thereof, the former (9a) The first cover (7) is integrally heat-bonded to the first cover (7) through the EAA adhesive layer (8), and an adhesive layer (11) is applied to the peripheral portion of the lower surface thereof.

The elastic sheet (10) is made of polyurethane foam, which is integrated with the PET sheet (9b) by an adhesive layer (11 ') formed on the lower surface thereof.

A semicircular notch (12) for opening is engraved on the collar portion (4) of the container (2) to assist opening of the present drug at the time of use.

When using, use the notch (12) as shown in Fig. 3 to make a container.
When the integrated cover part and elastic sheet parts (7, 9 and 10) are peeled from (1), the container (2) is removed and the first cover is removed.
Since the main agent (6) is exposed by adhering to (7), the second cover
The adhesive layer (11) on the outer peripheral edge of the inner surface of (9) is used to adhere to an appropriate skin surface.

In the drug of this example, since the main agent (6) does not come into contact with the adhesive (11), there is no fear that the drug efficacy during storage will decrease.

<< Example 2 >> FIG. 4 is a sectional view similar to FIG. 1, showing another example of the drug of the present invention.

The drug of this example is structurally similar to the ones in FIGS. 1 to 3, but differs from the previous ones in that it is provided with a sealing packing (13).

The chemical agent of this example is mainly composed of silicone rubber, and an annular elastic packing (13) in which aluminum foil, PET film, etc. are laminated as necessary is formed on the back surface of the elastic sheet (10) with an adhesive layer (11 '). ), And the lower surface (in this figure) adheres to the adhesive layer (11) on the upper surface of the flange of the dish. Therefore, the size of the second cover (9) in this example is reduced by the width of the packing.

At the time of use, the elastic packing (13), the first cover (7) to which the main agent (6) is attached, the second cover (9) to which the first cover (7) is attached, and the elastic sheet ( Peel off 10),
The lower surface of the annular packing (13) is attached to the skin surface of the application site.

Since the drug of this example is provided with the annular packing (13), its effect is durable even in the case of a volatile main agent.

(Effects) As described above, according to the present invention, a skin permeation therapy agent that can be stored for a long period of time and that remains effective over a long period of time can be provided, which can greatly contribute to medical treatment.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view (dimensions in the vertical direction and exaggerated thickness of members) schematically showing the structure of the drug of the present invention, FIG. 2 is a cutaway perspective view of an example of the TTS agent according to the present invention, and FIG. FIG. 4 is a perspective view showing an opened state, FIG. 4 is a sectional view similar to FIG. 1 showing another example of the drug of the present invention, and FIG. 5 is a sectional view of a conventional example. The meanings of the main symbols in the figure are as follows. :-1: Whole of the main ingredient of the present invention 2: 1 container 3: 2 main body 4: 2 collar part 5: 2 step 6: 1 main ingredient 7: 1 first cover 8: adhesive resin layer 9: 1st 2nd cover 10: 1 elastic sheet 11: 9 adhesive layer 11 ': elastic sheet (10) Adhesive adhesive layer 12: 2 opening notch 13: 1 annular packing (Fig. 4 only ).

Claims (3)

[Scope of utility model registration request] 1. A shallow dish-shaped body in which a container is formed of a gas-impermeable plastic material such as a metal foil or a thin hard plastic sheet, and a stepped portion formed in a step-like shape on the outer circumference of the dish-shaped body. A first gas that covers the opening surface of the dish-shaped body, wherein the dish-shaped body contains a percutaneously permeable drug The outer periphery of the impermeable cover is in close contact with the stepped portion, the second gas impermeable cover lined with an elastic sheet is adhered to the first gas impermeable cover, and the adhesive layer is interposed therebetween. When the base material is adhered to the flange portion of the container and adheres to the first gas impermeable cover together with the second gas impermeable cover to separate the main agent from the dish, the adhesive layer causes the second gas impermeable cover It is characterized in that it remains as an adhesive layer on the skin by remaining on the outer peripheral portion of the inner surface facing the collar of the elastic cover. Skin permeation drug. 2. The utility model registration according to claim 1, wherein an annular packing having an adhesive layer on both sides is interposed between the peripheral edge of the flange and the peripheral edge of the second gas impermeable cover. Skin penetrant. 3. The skin-penetrating drug according to claim 1, wherein the container is provided with a nail hook portion for opening at a flange portion of the container for utility model registration.