A topical dressing, method of manufacturing a topical dressing and use of a topical dressing

Topical dressing and how to manufacture and use it

Full description

Background of the invention

The invention relates to a topical dressing that is dermal or transdermal and includes the features described in claim (1).

The invention also relates to a method of manufacturing a topical dressing, dermal or transdermal, according to the invention.

This invention relates to topical dressings used for drugs and substances

Other.

It is known that drugs can be used intradermally and transdermally by keeping the drug

In intimate contact with the patient's skin, the active ingredient slowly passes into and through the skin

It is absorbed into the patient's body over a long period of time.

The property is usually fixed for the required period of time using an adhesive patch.

European Application No. 13606 mentions a transdermal drug adhesive patch comprising:

A filled strip made up of strips formed to provide a cavity that is filled with a polymeric matrix

It contains the drug to be given. The cavity is surrounded by a substance that adheres it to the skin and is closed by

A tape wrap made up of strips that is held in position by an adhesive. Provides cover

The tape has a surface layer of peelable material so that it can be easily separated from the packing tape

To expose the polymeric diffusion matrix and the adhesive habit that adheres to the skin until it is ready for use.

European Patent No. 0181333-B reported on an adhesive patch for transdermal use comprising a padding strip having a ring of microporous material attached to a carrier sheet of polyethylene/metal foil/polyester. The ring contains a fine-pore material and a surface layer containing a substance that adheres to the skin, defining a central cavity that contains the drug to be administered. A tape sleeve is formed from the same laminate material as mentioned before for the carrier plate and is fixed in position to close the cavity by gluing the removable layer to the surface of the tape cover with a material that adheres to the skin. Using heat, the ring is welded between the filler material of the filling ring and the tape sleeve behind the circumference. The outer ring is made of fine-pored material. The drug in the cavity and the material attached to the skin are exposed and ready for use by separating a portion of the strip material of a packed strip with the ring of microporous material attached to it by tearing the strip material around a ring of perforations. By means of the aforementioned structures shown, the cavity is closed by the effect of adhesion between the layer of material that adheres to the skin on the padding tape and the layer that can be removed from the tape cover, and also by means of an external welding ring that is heat-welded in the case of European Patent No. 181333-B. A problem with this system is that the drug into the cavity may escape at least in part by diffusion into the surrounding adhesive or other layers, especially if the drug is of a mobile or volatile nature, and particularly if the drug is present in the cavity by itself or has been absorbed onto a pad or It is in a readily emitting form rather than embedded in a barrier medium e.g

Polymeric matrix as in European Patent No. 0013606-A. Since the dressings are intended for transdermal administration of specific amounts of drugs, it is considered that leakage of quantities of the drug from the cavity would constitute a serious problem.

A topical dressing of the type mentioned is also mentioned in Australian Patent Application No. 07597591. This dressing is provided with a padding layer containing a padding pad that only partially covers the elastic layer and which has the features described in claim (1). In the Australian document mentioned before the filler plate is provided from single pieces of filler which, when produced, are placed one on top of the other, on a continuous layer of flexible material at specified positions. However, this procedure creates a new problem. Since the padding pad is made of very thin material, about 10-50 micrometres, the edges of the padding pieces will bend upward making placing the tablets on the flexible formulation more difficult, or almost impossible under certain circumstances. Even if the disc is positioned correctly on the elastomer, the adhesion between the disc and the elastomer may be adversely affected and leakage may occur during patch use. The most obvious way to solve this problem is to provide the disc or padding sheet as a continuous layer that completely covers the continuous layer of elastic material. However, this will provide an inelastic dressing that will be difficult to place on many parts of the body such as elbow, knee, hands, etc. This will also create significant discomfort for the user. Therefore, the padding sheet should be yellow from the elastic material in the final form of the patch. Therefore, it is necessary to solve this problem without damaging the final product.

Therefore, it is an objective of the present invention to provide a topical bandage of the type mentioned before that overcomes the defects of known bandages and to provide a bandage that adheres properly to the user's skin without leakage of the active ingredient and is easy to apply and comfortable for the user when removing it from the skin. They are also simple and convenient to manufacture, and their covers can be easily removed when they are to be placed on the skin.

This is achieved by providing a composite filler with strips extending outward from the circumferential edge of the filler disc toward the circumferential edges of the elastic layer as mentioned in the characteristics portion of the protection element (1).

Other preferred models are mentioned in dependent protection elements (2-4). It is also one of the objectives of the present invention to provide a method for manufacturing a topical dressing for transdermal use as mentioned in Protection Element (5), in addition to using it as a topical dressing according to the invention for the transdermal use of an active substance as mentioned in Protection Elements (9) and (10). Other preferred steps are mentioned in Dependent Protections (5-8).

Brief explanation of the drawings

The topical dressing according to the invention will now be described, for example, with reference to the attached drawings, as:

Figure (1) represents a section in a preferred embodiment in a bandage according to the invention taken along line II in Figure (3).

Figure (2) is a front view of the bandage cover structure shown in Figure (1). Figure (3): Frontal view of the bandage filling compound shown in Figure (1). Figure (4) is a diagram of the method of manufacturing the bandage. The preferred model of the bandage according to the invention will now be described. The bandage has a composite insert (1) and a composite cover (2), as shown in Figures (1-3). The composite filling (1) includes a disc (3) which does not have to be circular, but is preferred, and is made of an impermeable material such as a metal strip covered on its opposite sides with polymer layers. One side or one of the polymer layers is centrally attached to a layer (4) of flexible material such as foam plastic. The foam plastic material is covered with a layer (5) of an adhesive that adheres to the user's skin. The cover assembly is made of an impermeable material such as a metal strip covered on one side by a polymer layer.

In a preferred embodiment of the invention the cover composition is made of a metal strip that is thicker and stiffer than the composite filler material. The cap structure provides a holder for the dressing to prevent deformation and also prevents leakage of the active ingredient during storage and handling.

In order to prevent the edges of the disc (3) from bending upward while it is placed on the elastic layer during the manufacturing process, the disc (3) is provided with reinforcement strips (20). It is preferable that the strips (20) be four, but this is not necessary, and that they extend from the circumference of the disc (3) to outside the circumference of the elastic layer (4). It is preferable that they be provided along the circumference of the disc (3), but this is not necessary. So that it creates an angle. 9 with each other, see Figure (3). The strips (20) are of the same material as the disc (3) and are attached to the elastic layer (4). The size of the strips (20) is determined by the distance between the circumferential edges of the disc (3) and the circumferential edges of the elastic material (4). Tests showed that the best result, i.e. obtaining a complete cancellation of the upward bending effect, is achieved when the strips (20) are placed centrally along the sides of the elastic layer (4) as shown in Figure (2).

The strips (20) must extend sideways to a certain degree and width, to obtain the desired effect. But the stretch must be as small as possible so as not to damage the elastic layer significantly (4). The width of the strip (20) in the preferred embodiment is about 5-20%, and preferably about 10% of the length of the sides of the elastic layer.

The disc (3) is installed in the middle of the layer (4). The layer (4) is centrally supplied with a mainly circular part (7). The entire surface of the flexible layer is covered with the adhesive (5) and the central separated part is completely free of this adhesive.

A cavity (8) is defined inside the separated part (7) and a filling (9) in the form of a disc of porous material is placed inside the cavity (8). The thickness of the filling (9) is slightly greater than the thickness of the elastic layer (4). The layer is placed centrally in the cavity and has a diameter smaller than the diameter of the separated part

(7) So that an annular space (10) is formed between them, the gasket is attached to the disc (3) by any suitable method, such as heat welding.

The cover assembly (2) includes a disk (12) of an impermeable material such as a metal strip covered on both sides with polymeric layers. One side of the disc (12) is secured to a plate of removable liner (13) and the disc (12) can be secured to the removable liner (13) by circular heat welding. The removable liner (13) is provided with a central separated portion (15) of the same size as the separated portion (11) in the elastic layer (4).

The cover assembly (2) is placed over the composite filler (1) such that the liner is in a flush overlay relationship with the elastic layer (4). The two components (1) and (2) are fastened together using adhesive (5) and welded to the two discs (3) and (12).

The central circular part (16) of the disk (12) is shaped so that the mainly circular edge (17) is formed and thus the plate (18) is defined. The shape of the edge (17) is chosen so that it is located within the boundaries of the separated portion (15) of the removable liner (13) and the elastic layer (4) when the cover assembly (2) and the composite filler (1) are in contact with each other. In this position, the flange (17) will protrude through the separated parts (15) and (7) in order to engage the disc (3). The flange (17) is heat welded to the disc (3).

The active ingredient to be administered is absorbed into the skin or transdermally using the pad according to the invention into the pad (9). The filling is made of a porous material, preferably cellulosic

cellulose-material

Examples of active substances that can be administered intradermally or transdermally using a topical dressing according to the invention include topical anesthetics such as EMLA®, anesthetic steroids, and nicotine antibiotics.

Due to the preferred composition of the dressing, the active substance is completely trapped between disc (3) and disc (12) and thus there is no possibility of the substance leaking into the adjacent layers. When you want to use the bandage, the covering composition is peeled off and thus separated from the adhesive layer (5) at the removable lining (13), the edge (17) is moved away from the disc (3) and the seam between them is cut off. The bandage can then be placed on the skin so that the adhesive layer (5) holds the bandage in place so that the padding (9) comes into contact with the skin.

The topical dressing according to the invention can be easily filled as well as tightly adhered, and can be advantageously manufactured on an industrial basis while ensuring adequate levels of hygienic and safety. Moreover, the resulting bandage is particularly suitable for use and can be effectively used as a medicine while avoiding the leakage of substances that could potentially contaminate the patient's clothing and cause discomfort to him. The bandage mentioned before can be manufactured using a method such as the one mentioned below and referring to Figure (4).

The cover assembly slide is prefabricated and supplied as a first continuous longitudinal plate (21) on a first reel (22). The edge (17) of the first plate (21) is formed at the tear forming site (23), thus providing a layer (18).

The flexible layer (4) with adhesive (5) and removable liner (13) are supplied as a second continuous longitudinal plate (41) of the second pulley (42) and the separated parts (7) are supplied at the cutting station (43). The separated parts define cavities (8) in the flexible assembly. After cutting, this second longitudinal plate (41) is placed on top of the cover assembly bracket, like the first plate (21), and fixed to it, preferably by heat welding.

In a parallel production line, the composite filler is manufactured (1). The impermeable strip is preferably prefabricated for composite filler and is supplied as a continuous longitudinal plate (51) and is supplied on a third reel.

(٥٢)

The previously manufactured gaskets (9) are then taken from the long parts (91), placed on the gasket plate and welded in the welding station (92). After that, the active ingredient is placed on the fillings (9) in the place of fullness (93). According to the above, it is preferable to fill the fillings with the active material after placing them on the filling plate and welding them to it, but it is also possible to fill the active material before the placement and welding step. After filling the fillings, the longitudinal plate (51) is passed over the cutting station (53), where in this station the parts of the strip material that are not part of the disc (3) and the strips (20) are separated so that the filling material remains as a longitudinal plate and thus the strips on the discs are connected. adjacent to each other. This avoids upward bending of the edges of the discs, which facilitates, as mentioned before, manufacturing

And trading to a large extent.

In the next step, the continuous longitudinal plate of discs (3) and strips (20) with gaskets (9) is turned back to back and placed on top of the elastic layer (4) as shown in Figure (4). Thus, the fillings (9) are placed inside the plate (18) defined by the edge (17). After that, the layer is installed

The elastic (4) and the cover (2) on the one hand and the filler disc (3) and the edge (17) on the other hand together. It is preferable to use heat welding at the welding site (55). Thus, circular thermal welding rings (6) are provided surrounding the cavity (8), the edge (17), the plate (18) with the filling (9) and the separated parts (7).

The continuous sheet of bandages resulting from the above method is cut at the cutting station (56) to provide single pieces of bandages. Possible modifications to the invention

The dressing can of course be modified according to the invention and the method of its manufacture within the scope of the attached protective elements. Thus the materials chosen can be changed as well as the shapes and sizes of the different parts. In particular, the separated portions of the composite filling tablet may not necessarily be circular but may be of any other suitable shape - oval, square or rectangular. The strips (20) can be supplied differently around the circumference of the composite filler disc and can have different shapes. However, it is important to avoid the effect of upward bending of the disc edges during dressing manufacture. The composite filler must be flexible but at the same time provide an impermeable filler carrier for the active agent. The composite filling and covering composition may be made of the same material or of different materials, preferably metal foil/polymer, but any other material with similar properties may be used. The polymer content may be polyethylene, polypropylene, polyester, or ionomer.

The workplace and manufacturing line steps can also be modified within the scope of the attached protective elements.