Patent Application
20240091515
This application claims the priority benefit of Taiwan application serial no. 111135208 filed on Sep. 16, 2022. The entirety of the above-mentioned patent application is hereby incorporated by reference herein and made a part of this specification.
The present invention relates to a microneedle patch, a manufacturing mold therefor, and a manufacturing method therefor. Specifically, the present invention relates to a transdermally deliverable microneedle patch with microneedles and bumps, a manufacturing mold therefor, and a manufacturing method therefor.
The microneedle patch is a newly developed transdermally deliverable medicament delivery form. Carrying on with the above, since the microneedle patch can conveniently implement subcutaneous injection with less pain through a patch, and a large number of medicines that are difficult to pierce an epidermis can be delivered into the body, the development and application of the microneedle patch have gradually attracted people's attention. However, in the application field where dosage needs to be controlled, the microneedle patch has a technical bottleneck to be overcome due to susceptibility to needle breakage. Therefore, it is expected to develop a technology that can reduce or avoid the damage of microneedles in microneedle patches, thereby improving the integrity and dosage accuracy of microneedles for medicament delivery.
In order to solve the above problems, a transdermally deliverable microneedle patch is provided according to an embodiment of the present invention, including: a basal layer for attaching to an epidermis; a microneedle array, arranged on the basal layer and including a plurality of microneedles that protrude and extend away from the basal layer, where the microneedles are made of a predetermined medicament and a first dissolvable carrier component, and diameters of ends of the microneedles opposite to the basal layer are less than 50 nm; and a bump array, arranged on the basal layer and including a plurality of bumps that protrude and extend away from the basal layer, where diameters of ends of the bumps opposite to the basal layer are greater than 50 μm. The bumps are arranged at intervals along a periphery of the microneedle array, and heights by which the bumps protrude from the basal layer are less than heights by which the microneedles protrude from the basal layer.
Another embodiment of the present invention provides a manufacturing mold for manufacturing the transdermally deliverable microneedle patch as described above, including: a mold body, provided with an accommodating cavity for application of a to-be-cured coating material, where a front side of the mold body defining the accommodating cavity is divided into a first block and a second block. The first block is provided with a plurality of first concave holes on a front side, and the second block is provided with a plurality of second concave holes on the front side. Depths of the first concave holes are greater than depths of the second concave holes. A diameter of a deepest bottom of each of the first concave holes is less than 50 μm, and a diameter of a deepest bottom of each of the second concave holes is greater than 50 μm. The second concave holes are arranged at intervals along a periphery of the first block.
Yet another embodiment of the present invention provides a method for manufacturing a transdermally deliverable microneedle patch by using the above manufacturing mold. The method includes: a coating step, including: filling the first concave holes with a predetermined medicament and a first dissolvable carrier component, and filling the second concave holes with the predetermined medicament and the first dissolvable carrier component, the first dissolvable carrier component, or a second dissolvable carrier component different from the first dissolvable carrier component, to complete application of the coating material of the first block and the second block; a curing step, including: curing the coating material under a predetermined condition to form a body of the transdermally deliverable microneedle patch; and a removal step, including: removing the body from the second block toward the first block to manufacture the transdermally deliverable microneedle patch. In the finally manufactured transdermally deliverable microneedle patch, the microneedles are formed corresponding to the first concave holes, and the bumps are formed corresponding to the second concave holes.
According to the transdermally deliverable microneedle patch, the manufacturing mold therefor, and the manufacturing method therefor provided in the embodiments of the present invention, the unexpected damage, bending, indentation, or fracture of the delivery microneedles can be reduced or avoided, and therefore, a dosage of a medicament expected to be administered to a user can be more accurately controlled by a plurality of microneedles. Carrying on with the above, the transdermally deliverable microneedle patch, the manufacturing mold therefor, and the manufacturing method therefor according to the embodiments of the present invention can be applied to the fields of medicine, aesthetic medicine, vaccines, and the like that require more accurate dosage control, so as to realize more convenient and accurate transdermal medicine delivery.
Various embodiments are to be described below, and a person with ordinary knowledge in the art can easily understand the spirit and principles of the present invention by referring to the accompanying drawings. However, although some specific embodiments are to be specifically described herein, these embodiments are only illustrative and are not to be considered restrictive or exhaustive in all aspects. Therefore, various changes and modifications of the present invention should be obvious and easily achieved for those with ordinary knowledge in the art without departing from the spirit and principles of the present invention.
Referring to
Carrying on with the above, the plurality of microneedles 210 may protrude and extend away from the basal layer 100, and diameters L1 of ends E1 of the microneedles 210 opposite to the basal layer 100 may be less than 50 μm. Therefore, the plurality of microneedles 210 may be made sharp enough to easily pierce the barrier of the epidermis S1 and enter the dermis S2. Based on the above, the microneedles 210 may be configured with a predetermined dosage in advance, so that a predetermined dosage of predetermined medicament M can be administered to a user after the transdermally deliverable microneedle patch 10 is attached to the user.
In addition, according to some embodiments, in order to maintain sufficient hardness and stability, the diameters L1 of the ends E1 of the microneedle 210 opposite to the basal layer 100 may be at least greater than 3 μm.
Further, according to this embodiment, in order to avoid the possible stress that may damage the plurality of microneedles 210 and change the predetermined dosage when the basal layer 100 is dented, bent, or torn, the bump array 300 may include a plurality of bumps 310 arranged at intervals along a periphery Pr of the microneedle array 200. As described above, like the microneedles 210, the bumps 310 may also extend and protrude away from the basal layer 100. However, diameters L2 of ends E2 of the bumps 310 opposite to the basal layer 100 may be greater than 50 μm, and heights H2 by which the bumps 310 protrude from the basal layer 100 may be less than heights H1 by which the microneedles 210 protrude from the basal layer 100. Therefore, referring to
For example, according to some embodiments, the heights H1 by which the microneedles 210 protrude from the basal layer 100 may be between 100 μm and 1500 μm. For example, the heights H1 by which the microneedles 210 protrude from the basal layer 100 may be between 150 μm and 1000 μm. In contrast, the heights H2 by which the bumps 310 protrude from the basal layer 100 may be between 10 μm and 150 μm. For example, the heights H2 by which the bumps 310 protrude from the basal layer 100 may be between 30 μm and 50 μm. As described above, with this configuration, the bumps 310 will not have the ability to pierce and reach the dermis S2.
Carrying on with above, since a plurality of bumps 310 are arranged around the microneedles 210, the stress transmitted along the basal layer 100, such as the stress that may be transmitted along the basal layer 100 during operations such as applying pressure to, removing, attaching the basal layer 100, may be reduced or prevented from being directly transmitted to the microneedles 210. For example, these stresses or impacts may be transmitted to the bumps 310 first, and may be reduced or prevented from being further transmitted to the microneedles 210 through buffering or absorption of the bumps 310. Alternatively, the stress may be prevented from being directly applied to a turning point where the microneedles 210 are connected to the basal layer 100 along a linear contour of the basal layer 100. Through the changes in the contour of the bumps 310 with lower heights H2, the direction of the stress transmission can be guided and altered and then transmitted to the microneedles 210. Therefore, the unexpected damage, bending, indentation, or fracture caused by direct impact or application of unexpected stress on the microneedles 210 may be reduced or avoided. Therefore, before the microneedles 210 enter the dermis S2 to deliver the predetermined medicament M, the unnecessary loss of the predetermined medicament M or the loss of the piercing function of the microneedles 210 can be reduced or avoided, so that the administration of the predetermined dosage of predetermined medicament M can be realized through the transdermally deliverable microneedle patch 10 of this embodiment.
According to some embodiments, the bump 310 may be damaged, bent, dented, or broken due to being subjected to stress. However, the damage, bending, indentation, or fracture of the bump 310 will not affect or change the dosage of the predetermined medicament M that is finally expected to be administered.
Carrying on with above, the microneedle array 200 may be arranged in an effective area of the transdermally deliverable microneedle patch 10 expected to play the role of administration, and the above bump array 300 may be arranged in another area of the transdermally deliverable microneedle patch 10 not expected to play the role of administration. However, the above are merely examples, and the present invention is not limited thereto. A person of ordinary skill in the art may arrange any area of the microneedle array 200 in the transdermally deliverable microneedle patch 10 as required, so that the periphery Pr of the microneedle array 200 corresponding to the effective area is at least partially provided with the bump array 300 to protect the microneedle array 200, thereby ensuring the dosage accuracy of the predetermined medicament M of the microneedle array 200.
According to some embodiments, the bumps 310 may also be made of a predetermined medicament M and a first dissolvable carrier component R1. However, the predetermined medicament M and the first dissolvable carrier component R1 contained in the bumps 310 are not to be released into the body without piercing the epidermis S1 and reaching the dermis S2. For example, without piercing the epidermis S1 (for example, only pressing and deforming the epidermis S1 without piercing the epidermis S1), the bumps 310 will not release the predetermined medicament M due to dissolution as a result of the body fluid and the body temperature.
In addition, according to some other embodiments, the bumps 310 may be made of any carrier component R without containing the predetermined medicament M. The carrier component R may be another non-dissolvable or dissolvable carrier component. For example, the carrier component R may be a first dissolvable carrier component R1 or a second dissolvable carrier component R2 different from the first dissolvable carrier component R1.
As shown in
Next, referring to
Next, various implementations of the relative arrangement of the microneedle array 200 and the bump array 300 according to other embodiments of the present invention are described with reference to
As described above, according to various embodiments of the present invention, the bumps 310 may be arranged at intervals along a periphery Pr of the microneedle array 200. That is to say, the bump array 300 may be arranged on the periphery Pr of the microneedle array 200. Therefore, the stress transmitted from the outside through the basal layer 100 may reach the bump array 300 before reaching the microneedle array 200 to be properly guided or partially absorbed or relieved. For example, referring to
Next, as shown in
Moreover, as shown in
Next, as shown in
Further, according to some embodiments, the bump array 300 may also be formed by locally arranging bumps 310 on the periphery Pr of the microneedle array 200 according to a direction or range in which stress is most likely to occur in the operation setting. Therefore, the cost of arranging the bumps 310 may be reduced, and the bumps 310 may be arranged based on the expected operation design of the transdermally deliverable microneedle patch, thereby achieving the purpose of protecting the microneedle array 200 through the bump array 300.
In addition, the arrangement and shapes of the bump array 300, the microneedle array 200, and the whole transdermally deliverable microneedle patch may be adjusted according to factors such as the expected removal method, the material of the microneedles 210, or the material of the basal layer 310 depending on requirements. For example, as shown in
Next, a method for manufacturing a transdermally deliverable microneedle patch according to an embodiment of the present invention is to be described.
Carrying on with the above, according to an embodiment, referring to
Carrying on with the above, the manufacturing mold MD may be made of any material that can be fixedly molded and filled with the coating material Q without being affected, for example, but not limited to metal or PDMS. In addition, the manufacturing mold MD itself may be a male mold or a female mold generated from the male mold through mold reproduction, such as electroforming or potting. Carrying on with the above, on the premise that the manufacturing mold MD with the above characteristics can be manufactured, the manner and mode of manufacturing the manufacturing mold MD according to the embodiments of the present invention may not be limited to the specifically stated implementation herein.
Carrying on with the above, referring to the partial enlarged view of
Carrying on with the above, according to some embodiments, the depths D1 of the first concave holes V1 may be between 100 nm and 1500 μm. For example, the depths D1 of the first concave holes V1 may be between 150 nm and 1000 μm. In contrast, the depths D2 of the second concave holes V2 may be between 10 nm and 150 μm. For example, the depths D2 of the second concave holes V2 may be between 30 μm and 50 μm. In addition, although not specifically illustrated herein, according to other embodiments, the first concave holes V1 may be polygonal cones or cones, and the second concave holes V2 may be polygonal cylinders, cylinders, incomplete spheroids, or incomplete ellipsoids. Carrying on with the above, with reference to the above description, a person of ordinary skill in the art may understand that with this configuration, the microneedles 210 formed corresponding to the first concave holes V1 and the bumps 310 formed corresponding to the second concave holes V2 may be manufactured.
Next, referring to
For example, according to an embodiment, as shown in
Carrying on with the above, in the curing step S200, curing may be performed under a predetermined condition based on the curing characteristics of the coated or filled materials. For example, the materials filled in the first concave holes V1, the second concave holes V2, and other spaces of the accommodating cavity K may be air-dried and cured under the predetermined air-drying condition.
In addition, the carrier component mentioned in the above embodiments may be any pharmaceutical-grade carrier component that is harmless to the body and can swell or dissolve in the skin. Carrying on with the above, in the case of coating or carrying the predetermined medicament M, the coated or carried predetermined medicament M may be released through the swelling or dissolution of the carrier component, and diffused into the body to achieve the predetermined effect of administration.
Carrying on with the above, according to some embodiments, various carrier components such as, but not limited to, maltose, sucrose, maltodextrin, hyaluronic acid, methylcellulose, chitosan, gelatin, polylactic acid, or hydroxypropyl methylcellulose may be used to manufacture the transdermally deliverable microneedle patch. However, the embodiments of the present invention are not limited thereto, and various carrier components that can be used to manufacture the transdermally deliverable microneedle patch may have various changes during the implementation of the present invention.
Next, referring to
Specifically, the stress generated in the removal step S300 may be first transmitted to the formed bump 310, and may be guided by the bump 310 to change a direction or an angle, or may be absorbed or buffered by the bump 310. Therefore, referring to the comparative example of
Finally, referring to
Carrying on with the above, according to the manufacturing method 1000 and the manufacturing mold MD of the present invention, in the finally manufactured transdermally deliverable microneedle patch 80, the microneedles 210 may be formed corresponding to the first concave holes V1, and the bumps 310 may be formed corresponding to the second concave holes V2, so that the possible damage, bending, indentation, or fracture to the microneedles 210 can be reduced or avoided in the manufacturing process. Therefore, the number and structural integrity of the microneedles 210 of the transdermally deliverable microneedle patch 80 manufactured according to the manufacturing method 1000 and the manufacturing mold MD of the present invention can be improved, thereby ensuring or improving the accuracy of the dosage of the predetermined medicament M that is expected to be administered. Carrying on with the above, according to the present invention, the transdermally deliverable microneedle patch 80 can be more widely applied to various fields requiring dosage control, such as the field of medicine. In addition, a person of ordinary skill in the art should apply the manufacturing method 1000 and the manufacturing mold MD for manufacturing the transdermally deliverable microneedle patch 80 similarly or identically to manufacture the transdermally deliverable microneedle patches described in the above embodiments, for example, but not limited to the transdermally deliverable microneedle patches 10, 20, 30, 40, 50, 60, and 70.
Besides, the numbers of microneedles 210 and bumps 310 shown in the embodiments of the present invention are only examples, and the present invention is not limited thereto. In addition, proportions and relative proportions of the components or parts shown in the embodiments of the present invention that include the microneedles 210 and the bumps 310 may be enlarged or adjusted for clearer display, a person of ordinary skill in the art should understand that these are only examples, and actual dimensions should not be limited by those shown in the drawings.
Based on the above, according to the embodiments of the present invention, the damage, bending, indentation, or fracture of the drug-carrying microneedles on the transdermally deliverable microneedle patch can be reduced or avoided, and the dosage of the predetermined medicament can be further ensured. Therefore, the transdermally deliverable microneedle patch can be more widely applied in the fields such as aesthetic medicine, medicine, vaccines, and the like for subcutaneous injection. Therefore, according to the embodiments of the present invention, subcutaneous injection of more kinds of predetermined medicaments (for example, but not limited to painkillers, insulin, and vaccines) can be realized more conveniently and accurately under the condition of reducing or avoiding the pain that may be caused by the traditional subcutaneous injection means. Furthermore, it can also help to develop more transdermally deliverable microneedle patches that are convenient for people to carry and operate, and it can help to lower the threshold of technology or knowledge required for operation by setting a predetermined dosage, thereby simplifying and popularizing the procedure of administration more easily.
The above descriptions are only some preferred embodiments of the present invention. It should be noted that various changes and modifications can be made to the present invention without departing from the spirit and principles of the present invention. A person of ordinary skill in the art should clearly understand that the present invention is defined by the appended claims, and all possible changes such as substitutions, combinations, modifications, and diversions are within the scope of the present invention defined by the appended claims in line with the purpose of this invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 111135208 | Sep 2022 | TW | national |
