Microneedle patch

Abstract

The invention discloses a microneedle patch. The microneedle patch comprises a substrate layer and a plurality of microneedle structures, the base layer has a first surface, and the base layer is made of a base material. The micro-needle structures are arranged on the first surface, each micro-needle structure comprises a micro-needle outer layer and a micro-needle inner layer, the micro-needle outer layer is made of an outer layer material, the micro-needle outer layer is connected with the first surface, and the micro-needle outer layer is provided with a micro-needle cavity; the microneedle inner layer is made of an inner layer material, and the microneedle inner layer is arranged in the microneedle cavity. The substrate material and the outer layer material comprise at least one hydrophilic material, and the inner layer material comprises at least one solid grease. The microneedle patch carries the fat-soluble functional components through the solid grease, and the fat-soluble functional components can be smoothly transported into the body of a user.

Description

Technical Field

[0001] The present invention relates to a microneedle patch, in particular to a microneedle patch capable of carrying fat-soluble components. Background Art

[0002] Skin films are mainly divided into dry and wet types in the cosmetics market. Dry microneedle patches are a new type of transdermal drug delivery system that combines the advantages of patches and subcutaneous injections. Because the microneedles on the patch are very short and do not touch the nerves, not only is there no pain of subcutaneous injection, but it can also easily carry large molecular drugs through the stratum corneum of the skin into the human body. Compared with wet films, dry microneedle patches are faster and more effective in transmitting active ingredients. However, the base materials of dry microneedle patches are mostly water-soluble ingredients, such as hyaluronic acid, polyvinyl pyrrolidone, polyvinyl alcohol, methylcellulose, etc. Therefore, when some drugs or ingredients are fat-soluble, microneedles are prone to oil-water separation, uneven distribution of fat-soluble ingredients in microneedles, or problems such as microneedles being unable to form or easy to disintegrate during the production process. Therefore, it is necessary to develop a microneedle patch that can carry fat-soluble drugs. Summary of the invention

[0003] The present invention provides a microneedle patch which can carry fat-soluble components through the materials of the microneedle outer layer and the microneedle inner layer with different properties, and achieves the purpose of delivering the fat-soluble components into the human body.

[0004] To achieve one or part or all of the above purposes or other purposes, one embodiment of the present invention provides a microneedle patch, including a base layer and a plurality of microneedle structures, wherein the base layer has a first surface and is made of a base material; the microneedle structure is disposed on the first surface, and the microneedle structure includes a microneedle outer layer and a microneedle inner layer, the microneedle outer layer is made of an outer layer material, the microneedle outer layer is connected to the first surface, and the microneedle outer layer has a microneedle cavity, the microneedle inner layer is made of an inner layer material, and the microneedle inner layer is disposed in the microneedle cavity, wherein the base material and the outer layer material include at least one hydrophilic material, and the inner layer material includes at least one solid oil.

[0005] In one embodiment of the present invention, the hydrophilic material is selected from at least one of hyaluronic acid, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyethyl cellulose, carboxymethyl cellulose, hydroxypropyl methylcellulose, pullulan, dextran, collagen, xanthan gum, pectin, polyglutamic acid, sodium alginate, maltodextrin, cyclodextrin, propylene glycol alginate, polymannan, trehalose, gelatin, gum arabic and methylcellulose.

[0006] In one embodiment of the present invention, the solid fat is selected from at least one of cocoa butter, hydrogenated cocoa butter, triglyceride, palm fat, beeswax, microcrystalline wax, shea butter, carnauba wax, cetyl alcohol, stearyl alcohol, stearic acid, lauric acid, palmitic acid, cinnamic acid, coconut oil, lard, tallow, lanolin, horse oil, sea otter oil, whale oil and cetearyl alcohol.

[0007] In one embodiment of the present invention, the inner layer material further comprises fat-soluble functional ingredients, and the fat-soluble functional ingredients are vitamin C palmitic acid, mandelic acid, sulfur, salicylic acid, tocopherol, plant essential oils, plant functional oils, coenzyme Q10, retinol, ceramide, lutein, tocopherol, thyroxine, vitamin A, vitamin D, vitamin K or a combination thereof.

[0008] In one embodiment of the present invention, the fat-soluble functional ingredients and at least one solid oil in the inner layer material are uniformly mixed, and the mass ratio of the fat-soluble functional ingredients and at least one solid oil in the inner layer material is greater than or equal to 0.05:1 and less than 1:1.

[0009] In one embodiment of the present invention, the melting point of the inner layer material is between 25° C. and 40° C.

[0010] In one embodiment of the present invention, the microneedle structure has a microneedle height, the base layer has a base height, the microneedle height is between 100 μm and 1500 μm, and the base height is between 5 μm and 300 μm.

[0011] In one embodiment of the present invention, the above-mentioned microneedle outer layer has an outer surface, the microneedle cavity has a side wall, and the microneedle inner layer has a side surface, wherein the side surface of the microneedle inner layer contacts the side wall of the microneedle cavity, and there is a wall thickness from the outer surface to the side wall, and the wall thickness is between 5μm and 20μm.

[0012] In one embodiment of the present invention, the cross-section of the outer layer of the microneedle parallel to the first surface has a maximum width of the outer layer, which is between 260 μm and 540 μm, and the cross-section of the inner layer of the microneedle parallel to the first surface has a maximum width of the inner layer, which is between 250 μm and 500 μm.

[0013] In one embodiment of the present invention, the microneedle structure is pyramidal or conical.

[0014] The present invention adopts hydrophilic material and solid oil as the microneedle outer layer and microneedle inner layer respectively, so that the microneedle patch can carry fat-soluble components, and the microneedle structure is stable and not easy to disintegrate.

[0015] In order to make the above and other purposes, features and advantages of the present invention more clearly understood, embodiments are given below with reference to the accompanying drawings for detailed description as follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 Schematic cross-sectional view of a microneedle patch according to an embodiment of the present invention.

[0017] Figure 2 Schematic diagram of a three-dimensional microneedle patch according to an embodiment of the present invention.

[0018] Figure 3 3D is a schematic three-dimensional diagram of a microneedle patch according to another embodiment of the present invention.

[0019] Wherein, the reference numerals are:

[0020] 1.1A: Microneedle patch

[0021] 10: Basal layer

[0022] 12: First surface

[0023] 20, 20A: Microneedle structure

[0024] 22: Microneedle outer layer

[0025] 221: Outer surface

[0026] 24: Microneedle inner layer

[0027] 241: Side surface

[0028] S: Microneedle cavity

[0029] SW: Sidewall

[0030] D1: Wall thickness

[0031] H1: Base height

[0032] H2: Microneedle height

[0033] W1: Maximum width of outer layer

[0034] W2: Maximum width of inner layer DETAILED DESCRIPTION

[0035] The present invention is described in detail below with reference to the accompanying drawings and specific embodiments, but is not intended to limit the present invention.

[0036] Figure 1 FIG. 1 is a cross-sectional schematic diagram of a microneedle patch according to an embodiment of the present invention. Figure 1As shown, the microneedle patch 1 includes a base layer 10 and a plurality of microneedle structures 20, the base layer 10 has a first surface 12, and the base layer 10 is made of a base material; the microneedle structure 20 is disposed on the first surface 12, and the microneedle structure 20 includes a microneedle outer layer 22 and a microneedle inner layer 24, the microneedle outer layer 22 is made of an outer layer material, the microneedle outer layer 22 is connected to the first surface 12, and the microneedle outer layer 22 has a microneedle cavity S, the microneedle inner layer 24 is made of an inner layer material, and the microneedle inner layer 24 is disposed in the microneedle cavity S, wherein the base material and the outer layer material include at least one hydrophilic material, and the inner layer material includes at least one solid oil. In one embodiment, the microneedle outer layer 22 has an outer surface 221, the microneedle cavity S has a side wall SW, and the microneedle inner layer 24 has a side surface 241, wherein the side surface 241 of the microneedle inner layer 24 contacts the side wall SW of the microneedle cavity S.

[0037] Continuing the above description, the base layer 10 of the microneedle patch 1 has a base height H1, which is between 5 μm and 300 μm. The microneedle structure 20 has a microneedle height H2, which is between 100 μm and 1500 μm in order to allow the components contained in the microneedle structure 20 to be transported into the user's body through the skin without stimulating the pain receptors in the dermis.

[0038] In the microneedle structure 20, the microneedle outer layer 22 has a wall thickness D1. In one embodiment, it can be understood that the wall thickness D1 of the microneedle outer layer 22 is defined as the thickness between the outer surface 221 of the microneedle outer layer 22 and the side wall SW of the microneedle cavity S. For example, the distance from the outer surface 221 of the microneedle outer layer 22 to the side wall SW of the microneedle cavity S along the X direction is defined as the wall thickness D1 of the microneedle outer layer 22, but it is not limited thereto. Since the microneedle outer layer 22 has a microneedle cavity S, if the wall thickness is too thick, the microneedle cavity S is too small, which is not conducive to the formation of the microneedle inner layer 24; if the wall thickness D1 is too thin, when the microneedle inner layer 24 in the microneedle cavity S melts due to high temperature, the microneedle structure 20 is easy to collapse or disintegrate, causing the microneedle inner layer 24 to overflow. Therefore, the wall thickness D1 of the microneedle outer layer 22 is between 5μm and 20μm. In one embodiment, the wall thickness D1 of the microneedle outer layer 22 is uniform along the positive Z direction; or, the farther away from the first surface 12 (along the positive Z direction), the thicker the wall thickness D1 of the microneedle outer layer 22; or, the farther away from the first surface 12 (along the positive Z direction), the thinner the wall thickness D1 of the microneedle outer layer 22.

[0039] In one embodiment, the cross section of the microneedle outer layer 22 parallel to the first surface 12 has a maximum outer layer width W1, and the cross section of the microneedle inner layer 24 parallel to the first surface 12 has a maximum inner layer width W2. The maximum outer layer width W1 is between 260 μm and 540 μm, and the maximum inner layer width W2 is between 250 μm and 500 μm.

[0040] Figure 2is a three-dimensional schematic diagram of a microneedle patch according to an embodiment of the present invention, Figure 3 is a three-dimensional schematic diagram of a microneedle patch according to another embodiment of the present invention, wherein: Figure 2 Microneedle patch 1 and Figure 3 The difference between the microneedle patch 1A and the microneedle patch 1A is that the shapes of the microneedle structures 20 and 20A are different. Figure 2 and Figure 3 As shown, the microneedle structures 20 / 20A are evenly distributed on the first surface 12 of the base layer 10 and arranged in an array on the first surface 12, but are not limited thereto. The microneedle structures 20 / 20A may be arranged in a staggered manner on the first surface 12. Figure 2 As shown, the microneedle structure 20 is, for example, a quadrangular pyramid shape, but is not limited thereto. The microneedle structure 20 can be any angular pyramid shape, or as shown in FIG. Figure 3 As shown, the microneedle structure 20A is, for example, conical.

[0041] The hydrophilic material contained in the base material and the outer layer material may be selected from at least one of hyaluronic acid, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyethyl cellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose, pullulan, dextran, collagen, xanthan gum, pectin, polyglutamic acid, sodium alginate, maltodextrin, cyclodextrin, propylene glycol alginate, polymannan, trehalose, gelatin, gum arabic and methyl cellulose. The base material and the outer layer material may be the same or different.

[0042] Among them, the solid fat contained in the inner layer material can be selected from at least one of cocoa butter, hydrogenated cocoa butter, triglyceride, palm fat, beeswax, microcrystalline wax, shea butter, Brazilian palm wax, cetyl alcohol, stearyl alcohol, stearic acid, lauric acid, palmitic acid, cinnamic acid, coconut oil, lard, beef tallow, lanolin, horse oil, sea otter oil, whale oil and cetearyl alcohol.

[0043] In one embodiment, the inner layer material may further include fat-soluble functional ingredients, such as fat-soluble drugs or fat-soluble vitamins, but is not limited thereto. The fat-soluble functional ingredients are selected from vitamin C palmitic acid, mandelic acid, sulfur, salicylic acid, tocopherol, plant essential oils, plant functional oils, coenzyme Q10, retinol, ceramide, lutein, tocopherol, thyroxine, vitamin A, vitamin D, vitamin K or a combination thereof.

[0044] Continuing with the above description, in one embodiment, when the inner layer material is formed by uniformly mixing at least a fat-soluble functional component and at least one solid oil, the weight ratio of the fat-soluble functional component and the solid oil depends on the solubility of the fat-soluble functional component in the solid oil. For example, the weight ratio of the fat-soluble functional component and the solid oil is greater than or equal to 0.05:1 or less than 1:1, but is not limited to this. In order for the microneedle patch 1 / 1A to solidify at room temperature, and when the microneedle patch 1 / 1A is used on the user's skin, the microneedle inner layer 24 can be smoothly melted to facilitate entry into the user's body, the melting point range of the uniformly mixed inner layer material needs to be between 25°C and 40°C, preferably between 30°C and 40°C.

[0045] Table 1 shows the weight percentage composition of the fat-soluble functional ingredients and solid fats in the inner layer material in one embodiment of the present invention and the results thereof, wherein the total weight of the fat-soluble functional ingredients and solid fats is less than or equal to the total weight of the inner layer material.

[0046] Table 1

[0047]

[0048]

[0049] As shown in Table 1, the fat-soluble functional ingredients take plant essential oils as an example, and the solid oils take cocoa butter as an example. The weight percentage of plant essential oils decreases from 90% to 5%, and the weight percentage of cocoa butter increases from 10% to 95%. The weight ratio of plant essential oils to cocoa butter is between 0.05:1.00 and 9.00:1.00, that is, the weight of plant essential oils is between 0.05 and 9 times the weight of cocoa butter.

[0050] From the results in Table 1, it can be seen that when the content of fat-soluble functional ingredients is too high, that is, when the weight ratio of plant essential oil to cocoa butter is greater than 1:1, the melting point of the microneedle inner layer 24 of the microneedle structure 20 is lower than 25°C, so that the microneedle inner layer 24 cannot be solidified, resulting in the failure of the microneedle structure 20 to be smoothly formed. When the weight ratio of plant essential oil to cocoa butter is between 0.05:1.00 and 1.00:1.00, the microneedle inner layer 24 can be smoothly solidified in the microneedle cavity S to form a cone structure, and when the ambient temperature is 25°C to 40°C, the microneedle inner layer 24 can be smoothly melted.

[0051] Table 2 shows the weight percentage composition of the fat-soluble functional ingredients and solid fats in the inner layer material in another embodiment of the present invention and the results thereof, wherein the total weight of the fat-soluble functional ingredients and solid fats is less than or equal to the total weight of the inner layer material.

[0052] Table 2

[0053]

[0054]

[0055] As shown in Table 2, in order to make the microneedle inner layer 24 solidify smoothly in the microneedle cavity S at room temperature to form a cone structure, and the microneedle inner layer 24 can be melted smoothly when the ambient temperature is 25°C to 40°C, the inner layer material can include more than one solid fat, for example, the first mixed fat in Table 1 includes hydrogenated cocoa butter and microcrystalline wax, but is not limited thereto, and the weight ratio of hydrogenated cocoa butter to microcrystalline wax is between 1.0:1.0 and 9.5:1.0, and the melting point ranges from 25°C to 40°C. The fat-soluble functional ingredient plant essential oil and hydrogenated cocoa butter are both lower in melting point than microcrystalline wax, and in this formula, both have the effect of lowering the melting point of the inner layer material.

[0056] Table 3 shows the weight percentage composition of the fat-soluble functional ingredients and solid fats in the inner layer material in another embodiment of the present invention and the results thereof, wherein the total weight of the fat-soluble functional ingredients and solid fats is less than or equal to the total weight of the inner layer material.

[0057] Table 3

[0058]

[0059]

[0060] As shown in Table 3, the weight ratio of the fat-soluble effective ingredient (plant essential oil) to the solid oil (second mixed oil) is between 0.05:1.00 and 1.00:1.00, and the melting point range of the inner layer material is 25°C to 40°C, wherein the inner layer material, for example, comprises a second mixed oil of triglycerides and shea butter, and the weight ratio of triglycerides to shea butter is between 0.05:1.0 and 0.67:1.0.

[0061] According to the results of Table 1, Table 2 and Table 3, considering the content of fat-soluble functional ingredients in the microneedle patch 1 / 1A and the solid oil suitable for the fat-soluble functional ingredients, the weight ratio of the fat-soluble functional ingredients and the solid oil in the inner layer material can be between 0.05:1.00 and 1.00:1.00, and in order to make the melting point of the uniformly mixed inner layer material between 25°C and 40°C, solid oils within the melting point range can be selected, or according to the melting point of the added fat-soluble functional ingredients, solid oils with different melting points can be mixed, such as but not limited to the first mixed oil and the second mixed oil, so that the melting point of the mixed inner layer material is between 25°C and 40°C. In one embodiment, the fat-soluble functional ingredient is coenzyme Q10, and the solid oil can be selected from animal fats, nut fats, coconut oil or a combination thereof, but is not limited thereto.

[0062] Since the present invention uses a hydrophilic material as the outer layer of the microneedle and solid oil as the inner layer of the microneedle, the microneedle patch can carry fat-soluble functional ingredients, and by controlling the melting point of the inner layer material of the microneedle inner layer, the fat-soluble functional ingredients, such as drugs or vitamins, are transported to the user's body through the skin. When the solid oil melts, the outer layer of the microneedle using the hydrophilic material can still maintain a stable structure, so that the microneedle structure will not disintegrate and the fat-soluble functional ingredients in the inner layer of the microneedle will not overflow. The microneedle patch of the present invention is more widely used than the traditional microneedle patch.

[0063] Although the present invention has been disclosed as above by way of embodiments, it is not intended to limit the present invention. A person having ordinary knowledge in the technical field to which the present invention belongs may make some changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be determined by the scope of the attached patent application.

Claims

1. A microneedle patch, characterized in that: Include: a base layer having a first surface, the base layer being made of a base material; and A plurality of microneedle structures are disposed on the first surface, each of the microneedle structures comprising: a microneedle outer layer, made of an outer layer material, the microneedle outer layer is connected to the first surface, and the microneedle outer layer has a microneedle cavity; and A microneedle inner layer is made of an inner layer material and is disposed in the microneedle cavity, wherein the base material and the outer layer material contain at least one hydrophilic material, and the inner layer material contains at least one solid oil.

2. The microneedle patch according to claim 1, characterized in that in, The at least one hydrophilic material is selected from at least one of hyaluronic acid, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyethyl cellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose, pullulan, dextran, collagen, xanthan gum, pectin, polyglutamic acid, sodium alginate, maltodextrin, cyclodextrin, propylene glycol alginate, polymannos, trehalose, gelatin, gum arabic and methyl cellulose.

3. The microneedle patch according to claim 1, characterized in that in, The at least one solid fat is selected from at least one of cocoa butter, hydrogenated cocoa butter, triglyceride, palm fat, beeswax, microcrystalline wax, shea butter, carnauba wax, cetyl alcohol, stearyl alcohol, stearic acid, lauric acid, palmitic acid, cinnamic acid, coconut oil, lard, tallow, lanolin, horse oil, sea otter oil, whale oil and cetearyl alcohol.

4. The microneedle patch according to claim 3, characterized in that: in, The inner layer material further comprises a fat-soluble functional ingredient, which is vitamin C palmitic acid, mandelic acid, sulfur, salicylic acid, tocopherol, plant essential oil, plant functional oil, coenzyme Q10, retinol, ceramide, lutein, tocopherol, thyroxine, vitamin A, vitamin D, vitamin K or a combination thereof.

5. The microneedle patch according to claim 4, characterized in that in, The fat-soluble functional component and the at least one solid oil in the inner layer material are uniformly mixed, and the mass ratio of the fat-soluble functional component and the at least one solid oil in the inner layer material is greater than or equal to 0.05:1 and less than 1:

1.

6. The microneedle patch according to claim 1, characterized in that in, The melting point of the inner layer material ranges from 25°C to 40°C.

7. The microneedle patch according to claim 1, characterized in that in, The microneedle structure has a microneedle height, the base layer has a base height, the microneedle height is between 100 μm and 1500 μm, and the base height is between 5 μm and 300 μm.

8. The microneedle patch according to claim 1, characterized in that in, The microneedle outer layer has an outer surface, the microneedle cavity has a side wall, and the microneedle inner layer has a side surface, wherein the side surface of the microneedle inner layer is in contact with the side wall of the microneedle cavity, and there is a wall thickness between the outer surface and the side wall, and the wall thickness is between 5μm and 20μm.

9. The microneedle patch according to claim 8, characterized in that in, The cross section of the outer layer of the microneedle parallel to the first surface has a maximum width of the outer layer, which is between 260μm and 540μm. The cross section of the inner layer of the microneedle parallel to the first surface has a maximum width of the inner layer, which is between 250μm and 500μm.

10. The microneedle patch according to claim 1, characterized in that: in, The microneedle structure is pyramidal or conical.

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