Composite membrane structure

Abstract

A composite membrane structure comprises a structural membrane and a water-containing membrane, the structural membrane comprises a substrate layer and a plurality of microneedles, the substrate layer is provided with a first surface and a second surface which are opposite, and the microneedles are arranged on the first surface; the water-containing film covers the second surface of the structural film and has a water-containing film area; the composite structure film further comprises fixing pieces, part of the fixing pieces are arranged on part of the second surface, and the fixing pieces are covered with the water-containing film. The side, away from the water-containing film, of the fixing piece is provided with a first area and a second area, the first area makes contact with the second surface, and the second area does not make contact with the second surface. The structural membrane of the composite membrane structure can be quickly dissolved so as to release drugs or active ingredients in a short time.

Description

Technical Field

[0001] The invention pertains to a composite membrane structure, particularly a composite membrane structure with microneedles. Background Technology

[0002] Dry microneedle patches (MNPs) are a type of transdermal drug delivery system (TDDS) that combines the advantages of patches and subcutaneous injections. Because the microneedles on the patch are short and do not irritate nerves, there is no pain associated with subcutaneous injections. They can also easily carry large-molecule drugs across the stratum corneum into the body. Compared to wet microneedle patches, microneedle patches deliver active ingredients faster and more effectively.

[0003] Because dry microneedle patches are applied to the skin surface to release drugs or active ingredients for absorption by the body, the dissolution rate of the microneedles on the patch affects the release rate of the drug or active ingredient it carries. Summary of the Invention

[0004] This invention provides a composite membrane structure in which the structured membrane can dissolve rapidly to release drugs or active ingredients in a short time.

[0005] To achieve one or more of the above objectives or other objectives, an embodiment of the present invention provides a composite membrane structure, including a structural membrane and an aqueous membrane. The structural membrane includes a base layer and a plurality of microneedles. The base layer has a first surface and a second surface opposite to each other. The microneedles are spaced apart on the first surface. The aqueous membrane covers the second surface of the structural membrane and has an aqueous membrane area. The ratio of the aqueous membrane area to the area of ​​the second surface is greater than 1.0.

[0006] In one embodiment of the present invention, the above-mentioned composite membrane structure further includes a fixing sheet, a portion of which is disposed on the second surface of the substrate layer and is covered by an aqueous membrane.

[0007] In one embodiment of the present invention, the fixing piece has a first region and a second region on the side away from the water-containing film. The first region is in contact with the second surface, and the second region is not in contact with the second surface. The first region has a first width, and the second region has a second width. The ratio of the first width to the second width is between 0.1 and 11.5.

[0008] In one embodiment of the present invention, the ratio of the area of ​​the first region of the fixing piece to the area of ​​the second surface is greater than or equal to 0.05 and less than 1.

[0009] In one embodiment of the present invention, the ratio of the area of ​​the second surface to the area of ​​the second region of the fixing piece is greater than 0 and less than 1200.

[0010] In one embodiment of the present invention, the height of the microneedles is greater than or equal to 50µm and less than 2000µm.

[0011] This invention utilizes an aqueous membrane in contact with a structural membrane, allowing the structural membrane to dissolve rapidly and be absorbed by the skin. Furthermore, it provides a fixing sheet to secure the structural membrane in place, achieving optimal performance.

[0012] To make the above and other objects, features and advantages of the present invention more apparent and understandable, specific embodiments are described below in conjunction with the accompanying drawings. Attached Figure Description

[0013] Figure 1 This is a schematic diagram illustrating the application of a composite membrane structure according to an embodiment of the present invention.

[0014] Figure 2 This is a top view schematic diagram of a composite membrane structure according to an embodiment of the present invention.

[0015] In the attached figures, the following labels are used:

[0016] 1: Composite membrane structure

[0017] 10: Aqueous membrane

[0018] 20: Fixing plate

[0019] 30: Structural membrane

[0020] 32: Basal layer

[0021] 321: First Surface

[0022] 322: Second Surface

[0023] 34: Microneedles

[0024] A1: First Area

[0025] A2: Second Area

[0026] S: Skin

[0027] W1: First width

[0028] W2 Second Width Detailed Implementation

[0029] Figure 1 This is a schematic diagram illustrating the application of a composite membrane structure according to an embodiment of the present invention. Figure 2 This is a top view schematic diagram of a composite membrane structure according to an embodiment of the present invention. Figure 1 and Figure 2As shown, the composite membrane structure 1 includes a structural membrane 30 and an aqueous membrane 10. The structural membrane 30 includes a base layer 32 and a plurality of microneedles 34. The base layer 32 has a first surface 321 and a second surface 322 facing each other, and the microneedles 34 are spaced apart on the first surface 321. When using the composite membrane structure 1, the microneedles 34 of the structural membrane 30 are inserted into the skin S, and the aqueous membrane 10 covers the second surface 322 of the structural membrane 30. The aqueous membrane 10 has an aqueous membrane area, and the ratio of the aqueous membrane area to the area of ​​the second surface is greater than 1.0.

[0030] Continuing from the above description, the base layer 32 and microneedles 34 of the structural membrane 30 are, for example, made of the same material and integrally formed. The structural membrane 30 stores drugs or active ingredients. When the composite membrane structure 1 is used, the microneedles of the structural membrane 30 are inserted into the epidermis to the dermis. When the structural membrane 30 dissolves, the drugs or active ingredients within the structural membrane 30 can be delivered to the dermis and then absorbed by the body. In one embodiment, the height of the microneedle 34 is greater than or equal to 50µm and less than 2000µm, for example, but not limited to 50µm, 100µm, 150µm, 200µm, 250µm, 300µm, 350µm, 400µm, 450µm, 500µm, 550µm, 600µm, 650µm, 700µm, 750µm, 800µm, 850µm, 900µm, 950µm, 1000µm, 1100µm, 1200µm, 1300µm, 1400µm, 1500µm, 1600µm, 1700µm, 1800µm or 1900µm.

[0031] In one embodiment, the composite membrane structure 1 further includes, for example, a fixing sheet 20. A portion of the fixing sheet 20 is disposed on the second surface 322 of the base layer 32. The fixing sheet 20 has a first region A1 and a second region A2 on the side away from the aqueous membrane 10. The first region A1 of the fixing sheet 20 is in contact with the second surface 322, while the second region A2 is not in contact with the second surface 322. The fixing sheet 20 is used to reinforce the position of the structural membrane 30 on the skin; for example, during use, the second region A2 adheres to the skin S.

[0032] Direct contact between the aqueous membrane 10 and the structural membrane 30 in the composite membrane structure 1 effectively promotes the rapid dissolution of the structural membrane 30, thereby releasing the drug or active ingredient within it. In one embodiment, the aqueous membrane 10, the fixation sheet 20, and the structural membrane 30 have a specific width ratio or area ratio to improve the dissolution efficiency of the structural membrane and the fixation effect of the structural membrane 30 on the skin S. Figure 2As shown, the shapes of the aqueous membrane 10, the fixing sheet 20, and the structural membrane 30 are, for example, but not limited to, rectangles, and may also be, for example, circles, ellipses, crescents, arcs, polygons, but are not limited thereto. In one embodiment, the shapes of the first region A1 and the second region A2 are, for example, but not limited to, rectangles, and may also be, for example, circles, ellipses, crescents, arcs, polygons, but are not limited thereto.

[0033] When using the composite membrane structure 1, the microneedles 34 of the structural membrane 30 are inserted into the skin S, and the fixing sheet 20 is used to fix the structural membrane 30 to the skin. The aqueous membrane 10 covers both the structural membrane 30 and the fixing sheet 20. In an embodiment not shown, the surface of the fixing sheet 20 away from the aqueous membrane 10 has an adhesive layer. The material of the fixing sheet 20 is, for example, but not limited to, breathable tape, artificial skin, etc. The adhesive layer can also be disposed on both opposing surfaces of the fixing sheet 20, i.e., on the surface away from the aqueous membrane 10 and the surface facing the aqueous membrane 10, for example, to fix the structural membrane 30 to the skin S while simultaneously fixing the aqueous membrane 10 to cover the structural membrane 30, thus maintaining contact between the aqueous membrane 10 and the structural membrane 30. The composite membrane structure 1 enhances the fixing effect of the fixing sheet 20 in fixing the structural membrane 30 to the skin by adjusting the ratio between the first width W1 of the first region A1 and the second width W2 of the second region A2 of the fixing sheet 20. In a composite membrane structure 1 according to an embodiment of the present invention, the ratio of the first width W1 to the second width W2 is between 0.1 and 11.5. For example, but not limited to, the ratio of the first width W1 to the second width W2 is 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, and 10. Experiments showed that different ratios of the first width W1 to the second width W2 and the fixing effect of the fixing piece 20 on fixing the structural membrane 30 and the aqueous membrane 10 to the skin are shown in Table 1 below.

[0034] Table 1

[0035]

[0036] In one embodiment, please refer to... Figure 1 and Figure 2As shown, the second surface 322 of the base layer 32 of the structural membrane 30 faces the aqueous membrane 10. The ratio of the area of ​​the second surface 322 to the area of ​​the first region A1, and the ratio of the area of ​​the second surface 322 to the area of ​​the second region A2, also affect the fixation effect of the structural membrane 30 on the skin. In the composite membrane structure 1 of one embodiment of the present invention, the ratio of the area of ​​the second surface 322 to the area of ​​the first region A1 is greater than or equal to 0.05, but is not limited to this. For example, but not limited to, the ratio of the area of ​​the second surface 322 to the area of ​​the first region A1 is 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1. The different ratios of the area of ​​the first region A1 of the fixing piece 20 to the area of ​​the second surface 322, and the fixing effect of the fixing piece 20, are shown in Table 2 below:

[0037] Table 2

[0038]

[0039] Furthermore, in one embodiment of the composite membrane structure 1 of the present invention, the ratio of the area of ​​the second surface 322 to the area of ​​the second region A2 is greater than 0 and less than 1200, but is not limited to this. The ratio of the area of ​​the second surface 322 to the area of ​​the second region A2 can be, for example, but not limited to, 1, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000. Experiments have shown that different ratios of the area of ​​the second surface 322 to the area of ​​the second region A2 and their fixing effects are as shown in Table 3 below.

[0040] Table 3

[0041]

[0042] Please refer to Table 2. The material of the aqueous membrane 10 is, for example, but not limited to, non-woven fabric and hydrogel, and the material of the structural membrane 30 is, for example, a water-soluble biodegradable material, such as, but not limited to, hyaluronic acid and dextran. When the aqueous membrane 10 of the composite membrane structure directly contacts the structural membrane 30, it can accelerate the dissolution of the structural membrane 30. Therefore, when the base layer 32 of the structural membrane 30 is completely in contact with the first region A1 of the fixing sheet 20 and not in contact with the aqueous membrane 10, the effect of rapid dissolution of the structural membrane 30 cannot be achieved. In order to balance the fixing effect of the structural membrane 30 and the effect of rapid dissolution of the structural membrane 30, the ratio of the area of ​​the first region A1 to the area of ​​the second surface 322 is greater than or equal to 0.05 and less than 1.

[0043] The ratio of the area of ​​the aqueous film to the area of ​​the second surface 322 of the substrate 32 affects the dissolution rate of the structural membrane 30. Currently, the complete dissolution time of microneedles in commercially available dry microneedle patches is approximately 4 hours. In one embodiment, the ratio of the area of ​​the aqueous film to the area of ​​the second surface 322 is greater than 1.0, and the dissolution rate of the substrate 32 and microneedles 34 of the structural membrane 30 can reach 100% dissolution within 2 minutes. The experimental results regarding the ratio of the area of ​​the aqueous film to the area of ​​the second surface 322 and the dissolution effect of the structural membrane 30 within 2 minutes are shown in Table 4 below.

[0044] Table 4

[0045]

[0046] The composite membrane structure of this invention employs direct contact between the aqueous membrane and the structural membrane, allowing the structural membrane to dissolve rapidly and be absorbed by the skin. A fixing plate then secures the structural membrane to the skin, achieving optimal performance. This invention also provides the width ratio and area ratio between the aqueous membrane, the fixing plate, and the structural membrane to improve the dissolution efficiency and fixation effect of the structural membrane.

[0047] Although the present invention has been disclosed above by way of embodiments, it is not intended to limit the present invention. Those skilled in the art to which this invention pertains may make some modifications and refinements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. A composite membrane structure, characterized in that, include: A structural membrane comprising a base layer and a plurality of microneedles, the base layer having a first surface and a second surface opposite to each other, the microneedles being spaced apart on the first surface; as well as An aqueous membrane is covered on the second surface of the structural membrane, the aqueous membrane having an aqueous membrane area, the ratio of the aqueous membrane area to the area of ​​the second surface being greater than 1.

0.

2. The composite membrane structure as described in claim 1, characterized in that, It further includes a fixing sheet, part of which is disposed on the second surface of the substrate layer and is covered by the water-containing film.

3. The composite membrane structure as described in claim 2, characterized in that, The fixing plate has a first region and a second region on the side away from the water-containing film. The first region is in contact with the second surface, and the second region is not in contact with the second surface. The first region has a first width, and the second region has a second width. The ratio of the first width to the second width is between 0.1 and 11.

5.

4. The composite membrane structure as described in claim 3, characterized in that, The ratio of the area of ​​the first region of the fixing plate to the area of ​​the second surface is greater than or equal to 0.05 and less than 1.

5. The composite membrane structure as described in claim 3, characterized in that, The ratio of the area of ​​the second surface to the area of ​​the second region of the fixing piece is greater than 0 and less than 1200.

6. The composite membrane structure as described in claim 1, characterized in that, The height of these microneedles is greater than or equal to 50µm and less than 2000µm.

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