Instantly dissolving film

Abstract

The present application discloses a kind of instant film, comprising: substrate layer and microneedle layer.Substrate layer has surface.Microneedle layer is arranged on the surface of substrate layer, and microneedle layer has multiple microneedles.The material of substrate layer and microneedle layer comprises: 9wt% to 50wt% polyvinylpyrrolidone K30, 40wt% to 90wt% polyvinylpyrrolidone K90 and 0.09wt% to 9wt% small molecule hyaluronic acid.

Description

Technical Field

[0001] The present invention provides a thin film, particularly a fast-dissolving thin film having a microneedle structure and being rapidly soluble. Background Technology

[0002] Microneedle patches are a transdermal drug delivery system that uses microneedles inserted into the stratum corneum of the skin to deliver large-molecule drugs into the body without stimulating pain nerves. Because microneedle patches do not need to pass through the digestive tract or be metabolized by the liver, they avoid the first-pass effect caused by the liver and can deliver drugs rapidly into the body.

[0003] Currently, the most common microneedle patches on the market use three types of microneedles: hollow microneedles, coated microneedles, and dissolvable microneedles. Compared to hollow and coated microneedles, dissolvable microneedles do not pose a risk of drug accumulation leading to decreased drug delivery efficiency or microneedle breakage within the skin. However, microneedle patches with dissolvable microneedles require steps such as molding, drying, and demolding during preparation. During the drying process, the film surface is prone to curling or unevenness, causing the microneedle patch to fail to demold smoothly, resulting in poor delamination and subsequent film breakage, microneedle misalignment, or breakage, thus losing its drug delivery function. Therefore, improving the yield of microneedle patch preparation and increasing the drug delivery rate are worthwhile areas of focus. Summary of the Invention

[0004] This invention provides a fast-dissolving film that has a smooth, non-curling surface, is easy to remove during preparation, and has a high dissolution rate.

[0005] The present invention provides a fast-dissolving film comprising a substrate layer and a microneedle layer. The substrate layer has a surface, and the microneedle layer is disposed on the surface and has a plurality of microneedles. The materials of the substrate layer and the microneedle layer comprise: 9 wt% to 50 wt% polyvinylpyrrolidone K30, 40 wt% to 90 wt% polyvinylpyrrolidone K90, and 0.09 wt% to 9 wt% low-molecule hyaluronic acid, wherein the low-molecule hyaluronic acid has an average molecular weight of 3,000 to 10,000.

[0006] In one embodiment of the present invention, the materials of the base layer and microneedle layer further contain 0.1 wt% to 10 wt% of a first functional component, the first functional component being selected from at least one of the following: tetrapeptide, pentapeptide, hexapeptide, mandelic acid, arbutin, salicylic acid, tranexamic acid, vitamin B, vitamin C, ceramide, glycosides and their derivatives or combinations.

[0007] In one embodiment of the present invention, the materials of the base layer and microneedle layer further include 0.1 wt% to 10 wt% of a second functional component, the second functional component being selected from at least one of the following: biological agents, analgesics, antibiotics, and anti-inflammatory drugs.

[0008] In one embodiment of the invention, the height of the microneedles is between 100 micrometers and 1500 micrometers.

[0009] In one embodiment of the present invention, the microneedles described above are cones or cones.

[0010] The fast-dissolving film of this invention uses polyvinylpyrrolidone K30, polyvinylpyrrolidone K90 and small molecule hyaluronic acid, and is completely free of large molecule hyaluronic acid. Under a specific range of proportions, the film surface of the fast-dissolving film is flat and does not curl during the preparation process, is easy to remove, and has a high dissolution rate.

[0011] 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

[0012] Figure 1 This is a side view schematic diagram of a fast-dissolving film according to an embodiment of the present invention.

[0013] Figure 2 This is a three-dimensional schematic diagram of a fast-dissolving film according to an embodiment of the present invention.

[0014] Figure 3 This is a three-dimensional schematic diagram of another embodiment of the fast-dissolving film of the present invention.

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

[0016] 10, 10A: Instant-dissolving film

[0017] 12: Basal layer

[0018] 14: Microneedle layer

[0019] 16, 16A: Microneedles

[0020] H: Height

[0021] S: Surface Detailed Implementation

[0022] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the present invention.

[0023] Figure 1 This is a side view schematic diagram of a fast-dissolving film according to an embodiment of the present invention. Figure 1As shown, the fast-dissolving film 10 includes a substrate layer 12 and a microneedle layer 14. The substrate layer has a surface S, and the microneedle layer 14 is disposed on the surface S of the substrate layer 12, having a plurality of microneedles 16 spaced apart. In one embodiment, the height H of the microneedles 16 is between 100 micrometers and 1500 micrometers. In an embodiment not shown, the fast-dissolving film 10 further includes a peelable barrier layer disposed on the side of the substrate layer 12 away from the microneedle layer 14 to support or protect the fast-dissolving film 10.

[0024] In one embodiment of the present invention, the quick-dissolving film can be molded into the shape of the microneedles 16 using a mold. The preparation steps include: dissolving the materials of the base layer 12 and the microneedle layer 14 in water to prepare an aqueous solution, mixing them evenly, and then pouring the solution into a mold; then removing air bubbles and drying the film to remove 99% of the moisture; and then performing a demolding step for subsequent processing. The base layer 12 and the microneedle layer 14 are composed of: 9 wt% to 50 wt% polyvinylpyrrolidone K30, 40 wt% to 90 wt% polyvinylpyrrolidone K90, and 0.09 wt% to 9 wt% low-molecular-weight hyaluronic acid; wherein the average molecular weight of polyvinylpyrrolidone K30 is between 30,000 and 60,000, preferably 40,000; the average molecular weight of polyvinylpyrrolidone K90 is between 1,000,000 and 1,300,000, preferably 1,300,000; and the average molecular weight of low-molecular-weight hyaluronic acid is between 3,000 and 10,000, preferably 5,500.

[0025] Table 1 shows the experimental results of mixing the materials of the base layer 12 and the microneedle layer 14 with different solid weight percentages, and compares them with existing technologies using macromolecular hyaluronic acid.

[0026] Table 1

[0027]

[0028]

[0029] Please refer to Table 1. Samples 1 to 3 are composed of polyvinylpyrrolidone K90 and high-molecular-weight hyaluronic acid in different proportions. During the drying and demolding process, the film surface did not curl (see Table 1 for film surface smoothness) or break (see Table 1 for film release properties), but the solubility after 2 hours was not ideal. Samples 4 to 6 are composed of polyvinylpyrrolidone K30 and high-molecular-weight hyaluronic acid in different proportions. Although the solubility after 2 hours was higher than that of samples 1 to 3, there were problems with poor film surface smoothness (i.e., curling) or poor film release properties (i.e., breakage). Samples 7 to 10 are composed of polyvinylpyrrolidone K90, polyvinylpyrrolidone K30, and low-molecular-weight hyaluronic acid in different proportions. During the drying and demolding process, the film surface did not curl (see Table 1 for film surface smoothness) or break (see Table 1 for film release properties), and the solubility after 2 hours reached 60%, especially sample 9, which had a solubility of 89% after 2 hours. Sample 11 is composed of polyvinylpyrrolidone K30 and low-molecule hyaluronic acid. Although the film surface does not curl and the solubility rate is as high as 87% after 2 hours, it has the problem of poor film release. Samples 12 to 13 are composed of polyvinylpyrrolidone K90, polyvinylpyrrolidone K30 and low-molecule hyaluronic acid in different proportions. The proportion of low-molecule hyaluronic acid is higher than that of samples 7 and 8, but the solubility rate after 2 hours is not ideal.

[0030] After multiple sample tests, samples 7 to 10 showed advantages such as good film surface flatness, good film release properties, and good dissolution rate in 2 hours, making them suitable as materials for the base layer 12 and microneedle layer 14 in the fast-dissolving film 10.

[0031] Figure 2 This is a three-dimensional schematic diagram of a fast-dissolving film according to an embodiment of the present invention. Figure 3 This is a three-dimensional schematic diagram of another embodiment of the fast-dissolving film of the present invention. The microneedles can have different shapes depending on the structure of the mold used in the preparation steps. For example... Figure 2 As shown, the microneedles 16 of the fast-dissolving film 10 can be conical in shape; or as shown in the figure. Figure 3 As shown, the shape of the microneedles 16A of the fast-dissolving film 10A can be a pyramid, wherein the pyramid can be selected as a triangular pyramid, a tetragonal pyramid, a hexagonal pyramid, etc., but is not limited to this.

[0032] In different embodiments, the quick-dissolving film 10 / 10A of the present invention further comprises 0.1 wt% to 10 wt% of a first functional component in the materials of the base layer 12 and the microneedle layer 14, and the composition of the quick-dissolving film 10 / 10A containing the first functional component does not exceed 100%. The first functional component is selected from at least one of the following: tetrapeptide, pentapeptide, hexapeptide, mandelic acid, arbutin, salicylic acid, tranexamic acid, vitamin B, vitamin C, ceramide, glycosides and their derivatives or combinations. The quick-dissolving film 10 / 10A containing the first functional component can be effectively used in the preparation of pharmaceutical products for reducing melanin deposition, smoothing wrinkles, relieving skin inflammation, and repairing wounds.

[0033] In different embodiments of the fast-dissolving film 10 / 10A of the present invention, the materials of the base layer 12 and the microneedle layer 14 further contain 0.1 wt% to 10 wt% of a second functional component, and the composition of the fast-dissolving film 10 / 10A containing the second functional component does not exceed 100%. The second functional component is selected from at least one of the following: biological agents, analgesics, antibiotics, and anti-inflammatory drugs. The biological agents can be selected from at least one of the following: proteins, peptides, amino acids or nucleotides, and cell extracts; the anti-inflammatory drugs can be selected from allantoin. The fast-dissolving film 10 / 10A containing the second functional component can be effectively used in the preparation of medicines for the prevention or treatment of diseases, and for relieving symptoms such as pain or skin inflammation.

[0034] Table 2 shows the solid weight percentages of the first functional component and the second functional component contained in the instant-dissolving film 10 / 10A of the present invention.

[0035] Table 2

[0036] Polyvinylpyrrolidone K90 47.90％ Polyvinylpyrrolidone K30 41.90％ Small molecule hyaluronic acid 0.10％ First functional ingredient 10.00％ Second functional ingredient 0.10％ Total content 100％

[0037] Because the fast-dissolving film is made from polyvinylpyrrolidone K30, polyvinylpyrrolidone K90, and low-molecule hyaluronic acid, and contains no high-molecule hyaluronic acid, and is formed by mixing them in a specific ratio, the film surface is smooth and does not curl during the preparation process, making it easy to remove and dissolve at a high rate. Furthermore, the microneedles, with a height between 100 and 1500 micrometers, can precisely, rapidly, and painlessly deliver specific components, such as primary or secondary functional components, to a single site within the body, ensuring that the specific components retain their drug properties.

[0038] 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 fast-dissolving film, characterized in that, The material comprises a base layer and a microneedle layer, the base layer having a surface, the microneedle layer being disposed on the surface and having a plurality of microneedles, wherein the material of the base layer and the microneedle layer comprises: 9 wt% to 50 wt% polyvinylpyrrolidone K30, 40 wt% to 90 wt% polyvinylpyrrolidone K90 and 0.09 wt% to 9 wt% low molecular weight hyaluronic acid, the low molecular weight hyaluronic acid having an average molecular weight of 3,000 to 10,000.

2. The fast-dissolving film as described in claim 1, characterized in that, in, The material of the base layer and the microneedle layer further contains 0.1 wt% to 10 wt% of a first functional component, and the total content of the instant film containing the first functional component does not exceed 100%. The first functional component is selected from at least one of the following: tetrapeptide, pentapeptide, hexapeptide, mandelic acid, arbutin, salicylic acid, tranexamic acid, vitamin B, vitamin C, ceramide, glycosides and their derivatives or combinations.

3. The fast-dissolving film as described in claim 1, characterized in that, in, The material of the base layer and the microneedle layer further contains 0.1 wt% to 10 wt% of a second functional component, and the total content of the instant film containing the second functional component does not exceed 100%. The second functional component is selected from at least one of the following: biological agents, analgesics, antibiotics, and anti-inflammatory drugs.

4. The fast-dissolving film as described in claim 1, characterized in that, in, The height of these microneedles ranges from 100 micrometers to 1500 micrometers.

5. The fast-dissolving film as described in claim 4, characterized in that, in, These microneedles are in the shape of a pyramid or a cone.

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