Application device for microneedles, system for microneedle application, and method for producing a system for microneedle application
Patent Information
- Application Number
- EP2023833498
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-01-27
- Filing Date
- 2023-12-28
- Publication Date
- 2025-12-03
AI Technical Summary
Current hydrogel microneedle array concepts face issues with moisture-induced swelling and softening, which can prevent effective skin penetration due to diffusion of water and solvents, compromising the delivery of active ingredients.
An application device for microneedles featuring a microneedle holder and a reservoir holder, with a contact barrier such as an air gap or physical barrier to prevent solvent diffusion, allowing for controlled release and ensuring skin penetration by applying manual pressure to overcome the barrier.
The solution enhances the handling and storage of microneedle arrays by preventing premature swelling, ensuring effective skin penetration and controlled delivery of active ingredients, thereby improving the efficacy of microneedle application.
Smart Images
Figure EP2023087922_02082024_PF_FP
Abstract
Description
[0001] ADDlication device for microneedles, system for microneedle application and method for providing a system for microneedle application
[0002] The invention relates to an application device for microneedles, a system for microneedle application and a method for providing a system for microneedle application.
[0003] In addition to traditional forms of drug administration, such as swallowing or injecting medication, there are also concepts for applying drugs through the skin. Microneedles are of particular importance in this regard.
[0004] Microneedle arrays, also called microarrays, comprise a plurality of microneedles, which are typically arranged on or connected to a carrier element, such as a patch, a plaster, or the like. Such microneedle arrays comprise a high number of microneedles, for example, 100 to 600 needles per cm 2 The needles are particularly short, so that when the microneedles are inserted into a patient's skin, they only penetrate the skin to the extent that nerves and blood vessels are not touched by the needle tips. The microneedle arrays contain an active ingredient or a medication. For example, the active ingredient can be attached to a surface of the needles or incorporated into the needles. The needles can be made of a material that dissolves in the skin, for example.
[0005] In addition, approaches to hydrogel microneedle arrays exist, as described, for example, in Donnelly RF, McCrudden MTC, Zaid Alkilani A, Larraheta E, McAlister E, et al. "Hydrogel-Forming Microneedles Prepared from "Super Swelling" Polymers Combined with Lyophilized Wafers for Transdermal Drug Delivery" (2014) PLOS ONE 9(10). These hydrogel microneedle arrays consist of swelling microneedles and generally do not contain an active ingredient. Instead, after application, they absorb fluids, particularly the interstitial fluid of the skin, and form a connection, particularly a continuous and / or unblocked one, between the skin, preferably the dermal microcirculation, and a drug reservoir connected to the microneedles. Such hydrogel microneedle arrays generally serve as a tool for penetrating the stratum corneum barrier. After application, they also function as a rate-controlling delivery device.The speed is controlled, for example, by adjusting the needles, which serve as a membrane.
[0006] Current concepts for hydrogel microneedle arrays pose numerous problems. Depending on the moisture content of the reservoir, the water and / or other solvents contained within the microneedle array can diffuse into the microneedle array. This can, for example, lead to the microneedles swelling prior to application and / or at least becoming so soft that the necessary penetration of the skin, especially the stratum corneum, can no longer be ensured.
[0007] The object of the invention is to provide an application device for microneedles, a system for microneedle application and a method for providing a system for microneedle application, wherein the handling, in particular the storage, of microneedle arrays is improved.
[0008] The object is achieved according to the invention by an application device for microneedles according to claim 1, a system for microneedle application according to claim 12, and a method for providing a system for microneedle application according to claim 15. The application device for microneedles according to the invention is, in particular, an application device for hydrogel microneedles. Preferably, it is an application device for a microneedle array, particularly preferably a hydrogel microneedle array. The application device has a microneedle receptacle, in particular for receiving a microneedle array. Furthermore, the application device has a reservoir receptacle for receiving a reservoir, in particular one containing an active ingredient.The application device, in particular the microneedle receptacle and the reservoir receptacle, is preferably designed to receive the microneedle array and the reservoir opposite one another, preferably at the end. Furthermore, the application device has a contact barrier for spacing a microneedle array received in the microneedle receptacle and a reservoir received in the reservoir receptacle. The contact barrier is in particular a diffusion barrier. The application device preferably has a housing, in particular made of plastic. The microneedle receptacle and / or the reservoir receptacle is preferably designed in one piece, also referred to as integral, with the housing. It is preferred that the microneedle receptacle and / or the reservoir receptacle and the housing are made of a common material, in particular one that merges into one another.Preferably, the microneedle receptacle and / or the reservoir receptacle are designed as an opening in the housing. The contact barrier advantageously prevents the contained water and / or another solvent from diffusing into the microneedle array.
[0009] In a preferred embodiment, the contact barrier is a distance, in particular an air gap (28). The distance, in particular the air gap (28), is preferably formed between a microneedle array accommodated in the microneedle receptacle and a reservoir accommodated in the reservoir receptacle and / or between the microneedle receptacle and the reservoir receptacle.
[0010] In a preferred embodiment, the distance formed by the contact barrier, preferably between a microneedle array accommodated in the microneedle receptacle and a reservoir accommodated in the reservoir receptacle and / or between the microneedle receptacle and the reservoir receptacle, is 0.01 mm to 3 mm, preferably 0.05 mm to 1 mm, particularly preferably 0.1 mm to 0.5 mm.
[0011] In a preferred embodiment, the application device, preferably the contact barrier, is designed such that the contact barrier can be overcome by a relative movement, in particular a force-loaded movement, of a microneedle array accommodated in the microneedle receptacle relative to a reservoir accommodated in the reservoir receptacle. The force-loaded relative movement is in particular a contact pressure, preferably a manual contact pressure, exerted by a user. In particular, a distance must be overcome by the relative movement.
[0012] In a preferred embodiment, the application device comprises an intermediate element, in particular a spacer, between the microneedle receptacle and the reservoir receptacle to form the contact barrier. The intermediate element is in particular a web.
[0013] In a preferred embodiment, the intermediate element has an opening between the microneedle receptacle and the reservoir receptacle, in particular for forming a connection between the microneedle receptacle and the reservoir receptacle. The opening in the intermediate element particularly forms the distance, preferably the air gap (28). Alternatively or in addition to the embodiment of the intermediate element for forming the air gap (28), the intermediate element is particularly designed as a physical barrier between a microneedle array received in the microneedle receptacle and a reservoir received in the reservoir receptacle. In this embodiment of the intermediate element, this intermediate element is particularly designed to be removable and / or breakable in order to overcome the contact barrier, preferably the distance. This intermediate element therefore has, for example, a predetermined breaking point and / or porosity.
[0014] In a preferred embodiment, the application device has a form-fitting and / or frictional connector for, in particular, latching, form-fitting and / or force-fitting reception of a microneedle array in the microneedle receptacle and / or of a reservoir in the reservoir receptacle. The microneedle array preferably has a form-fitting and / or frictional connector for, in particular, latching, form-fitting and / or force-fitting reception of a microneedle array in the microneedle receptacle. Alternatively or additionally, the reservoir receptacle in particular has a form-fitting and / or frictional connector for, in particular, latching, form-fitting and / or force-fitting reception of a reservoir in the reservoir receptacle. It is preferred that at least one, in particular all, form-fitting and / or frictional connectors are designed as a single piece with the housing.
[0015] In a preferred embodiment, the at least one, in particular all, form-fit and / or force-fit connectors have: a groove, in particular for forming a tongue and groove connection; an undercut; a projection; a holding arm, in particular a flexible one; a latch; a closure and / or a fit, in particular for forming a press-fit connection.
[0016] In a preferred embodiment, the microneedle receptacle has a particularly round or rectangular negative mold of a microneedle array to be accommodated in the microneedle receptacle. Alternatively or additionally, the reservoir receptacle preferably has a particularly round or rectangular negative mold of a reservoir to be accommodated in the reservoir receptacle. The at least one negative mold, in particular all negative molds, are preferably designed in one piece with the housing, in particular as openings.
[0017] In a preferred embodiment, the application device has a handle for handling, in particular for placing and / or pressing the application device onto an application site. The handle is in particular a grip plate. The handle is preferably designed such that it can be held from above, below, and / or from the side, e.g., using the thumb and index finger, in particular without impairing a reservoir and / or a microneedle array.
[0018] The system for microneedle application according to the invention is, in particular, a system for hydrogel microneedle application. The system comprises an application device with one or more features of an application device according to the invention. Furthermore, the system comprises a microneedle array, in particular one free of active substances, accommodated in the microneedle receptacle, and / or a reservoir, in particular one containing an active substance, accommodated in the reservoir receptacle. The microneedle array and the reservoir are arranged, in particular, opposite one another, preferably end-to-end. The reservoir is preferably arranged end-to-end on the side of the microneedle array from which the microneedles originate and / or point away. The reservoir is preferably located opposite the back of the microneedle array. The microneedle array preferably has 100 to 600 microneedles per cm 2The microneedle array preferably has conical or pyramid-shaped microneedles. The microneedles of the microneedle array preferably have a length of 100 pm to 1000 pm, preferably of approximately 600 pm. The microneedles of the microneedle array preferably have a root circle diameter of 50 pm to 500 pm, particularly preferably of approximately 300 pm. The reservoir is designed in particular as a plaster-shaped reservoir, also referred to as patch-shaped. The microneedle array and / or the reservoir in particular has a rectangular or round shape. The microneedle array and / or the reservoir preferably has a diameter of 5 to 25 mm, preferably of approximately 11 mm. The microneedle array and / or the reservoir preferably has a width of 5 to 25 mm, preferably of approximately 11 mm. The microneedle array preferably has a carrier element, preferably plate-shaped, which is connected, in particular integrally, to the microneedles.
[0019] In a preferred embodiment, the microneedle array is a particularly swelling hydrogel microneedle array. The microneedles, particularly preferably the entire microneedle array, are preferably designed to be swelling. The microneedle array comprises, in particular, Gantrez, PVP, and / or PVA, and is preferably made of these materials.
[0020] In a preferred embodiment, the reservoir contains at least one active ingredient. The reservoir particularly contains small molecules, also referred to as small chemical molecules, and / or biologics. The reservoir is particularly designed to accommodate larger amounts of active ingredient compared to dissolving or coated microneedle arrays. The reservoir preferably comprises, and preferably consists of, a dissolving film, in particular a polymer film.
[0021] It is preferred that the microneedle array and the reservoir are adhesively bonded to each other. This means, in particular, that the microneedle array and the reservoir bond together adhesively upon contact.
[0022] The method according to the invention for providing a system for microneedle application is, in particular, a method for providing a system for hydrogel microneedle application. The method comprises, in particular, the step of providing a microneedle array and / or the step of providing a reservoir. One step of the method consists in arranging a microneedle array and a reservoir, in particular one containing an active ingredient, opposite one another. The arrangement is preferably carried out such that the microneedle array and the reservoir are arranged opposite one another, preferably opposite one another at the end. The arrangement is preferably carried out such that the reservoir is arranged at the end on the side of the microneedle array from which the microneedles originate and / or point away. The arrangement is preferably carried out such that the reservoir is opposite the back of the microneedle array.When the microneedle array and the reservoir are arranged opposite one another, the microneedle array is spaced apart from the reservoir. The spacing is achieved in particular by means of an application device, particularly preferably with one or more features of the application device according to the invention. The spacing is achieved in particular by means of a contact barrier, wherein the contact barrier is preferably designed as an air gap (28) and / or as a physical barrier. Particularly preferably, the spacing is arranged such that a free space exists between the microneedle array and the reservoir.
[0023] In a preferred embodiment, the method comprises the further step, particularly after the opposing arrangement, of overcoming the distance between the microneedle array and the reservoir to produce a drug-containing microneedle array system. In particular, the distance is overcome in such a way that a, particularly permanent, connection between the microneedle array and the reservoir is formed. Preferably, an adhesive connection is formed between the microneedle array and the reservoir.
[0024] In a preferred embodiment, the distance, in particular the air gap (28), is overcome by a preferably force-loaded relative movement of the microneedle array relative to the reservoir. The relative movement is preferably achieved by applying contact pressure, preferably manual pressure by a user, to the reservoir. Alternatively or in addition to overcoming the distance by the relative movement, the distance is overcome in particular by removing and / or destroying a contact barrier forming the distance.
[0025] It is possible that one of the subject matters of the invention, the application device according to the invention, the system according to the invention and / or the method according to the invention is supplemented with one or more features of the other subject matters of the invention or with one or more features described in the context of the other subject matters of the invention.
[0026] The invention is explained in more detail below using preferred embodiments with reference to the accompanying drawings.
[0027] They show:
[0028] Fig. 1 is a perspective top view of an embodiment of an application device according to the invention,
[0029] Fig. 2 is a sectional view of the application device of Figure 1 along II,
[0030] Fig. 3 a detailed sectional view of the application device from Figure 2 according to III,
[0031] Fig. 4 is a plan view of the application device from Figure 1,
[0032] Fig. 5 is a perspective top view of a further embodiment of an application device according to the invention,
[0033] Fig. 6 is a sectional view of the application device from Figure 5 along II, Fig. 7 is a detailed sectional view of the application device from Figure 6 according to III,
[0034] Fig. 8 is a plan view of the application device of Figure 5, and
[0035] Fig. 9 is a sectional view of an embodiment of a system for microneedle application according to the invention with the application device of Fig. 5.
[0036] Similar or identical components or elements are identified in the figures with the same reference numerals. For the sake of clarity, preferably already identified elements are not provided with reference numerals in all figures.
[0037] Figure 1 shows an embodiment of an application device 10 for microneedles according to the invention. Figure 2 shows a longitudinal sectional view along II of Figure 1, Figure 3 shows a detailed view according to III of Figure 2, and Figure 4 shows a plan view of the embodiment of Figure 1.
[0038] The application device 10 has a housing 12 with a handle 26 for handling.
[0039] A reservoir receptacle 16 for receiving a reservoir 108, in particular containing an active substance (cf. Fig. 9), is embedded in the housing 12 on the upper side shown in Figure 1, and a microneedle receptacle 14 for receiving a microneedle array 102, in particular free of an active substance (cf. Fig. 9), is embedded on the underside.
[0040] The microneedle receptacle 14 and the reservoir receptacle 16 are designed as openings in the housing 12, wherein in particular the microneedle receptacle 14 forms a negative mold for the microneedle array 102 to be accommodated and / or the reservoir receptacle 16 forms a negative mold for the reservoir 108 to be accommodated (cf. Fig. 9).
[0041] For the particularly form-fitting fixation of a reservoir 108 (cf. Fig. 9), the reservoir receptacle 16 has an undercut 20, which in particular forms a form-fitting and / or frictional connector. For the particularly form-fitting fixation of a microneedle array 102 (cf. Fig. 9), the microneedle receptacle 14 has a groove 22, which in particular forms a form-fitting and / or frictional connector. The groove 22 has, shown on an end face of the application device 10, an opening 24 for inserting the microneedle array 102. The reservoir receptacle 16 and / or the microneedle receptacle 14 are further preferably designed to be force-fitting for the fixation of the reservoir 108 or the microneedle array 102, for example by means of a fit.In particular, the application device 10 thus has at least one form-fitting and / or frictional connector such that a reservoir 108 and / or a microneedle array 102 can no longer be removed after insertion and / or is secured against falling out.
[0042] The application device 10 has a contact barrier 17 for spacing a microneedle array 102 received in the microneedle receptacle 14 and a reservoir 108 received in the reservoir receptacle 16 (see Fig. 9).
[0043] The contact barrier 17 is represented by an intermediate element 19, in particular a web-shaped one, which has an opening 18. An air gap 28 is formed through the opening 18 between the microneedle receptacle 14 and the reservoir receptacle 16, or between a microneedle array 102 received in the microneedle receptacle 14 and a reservoir 108 received in the reservoir receptacle 16, for spacing the microneedle array 102 and the reservoir 108 apart. Figures 5-8 show a further embodiment of an application device 10 for microneedles according to the invention in various views.
[0044] The design of Figures 5-8 is based on the design of Figures 1-4. Instead of the rectangular reservoir receptacle 16 of the design of Figures 1-4, the design of Figures 5-8 has a round reservoir receptacle 16.
[0045] Figure 9 shows an embodiment of a system 100 for microneedle application according to the invention. The system comprises an application device 10 according to the embodiment of Figures 5-8.
[0046] A reservoir 108, in particular a round one, is fixedly received in the reservoir receptacle 16, wherein the reservoir 108 preferably contains an active substance.
[0047] A microneedle array 102, in particular one free of active substances, is accommodated in the groove 22 of the microneedle receptacle 14. The microneedle array 102 is shown as having a preferably plate-shaped carrier element 104, which is connected, in particular in one piece, to the microneedles 106.
[0048] The air gap 28 of the contact barrier 17 prevents contact between the microneedle array 102 and the reservoir 108 prior to application, thus preventing, in particular, an exchange of water and / or solvent. This advantageously prevents, in particular, swelling of the microneedle array 102 prior to application.
[0049] During application, the required force can be applied to the reservoir, causing it to deform downward and press against the microneedle array 102. The applied force then ensures, in particular, penetration of the stratum corneum and provides sufficient contact between both components. This contact is also advantageous for the active ingredient to diffuse into the skin via the microneedle array 102.
Claims
Claims 1. Application device for microneedles (10), in particular hydrogel microneedles, with a microneedle receptacle (14), a reservoir receptacle (16) for receiving a reservoir (108), in particular one containing an active substance, and a contact barrier (17) for spacing a microneedle array (102) received in the microneedle receptacle (14) and a reservoir (108) received in the reservoir receptacle (16).
2. Application device (10) according to claim 1, characterized in that the contact barrier (17) is a distance, in particular an air gap (28).
3. Application device (10) according to claim 2, characterized in that the distance formed by the contact barrier (17) is 0.01 mm to 3 mm, preferably 0.05 mm to 1 mm, particularly preferably 0.1 mm to 0.5 mm.
4. Application device (10) according to one of claims 1-3, characterized in that the contact barrier (17) can be overcome by, in particular force-loaded, relative movement of a microneedle array received in the microneedle receptacle (14) to a reservoir (108) received in the reservoir receptacle (16).
5. Application device (10) according to one of claims 1-4, characterized by an intermediate element, in particular a spacer, between the microneedle receptacle (14) and the reservoir receptacle (16) for forming the contact barrier.
6. Application device (10) according to claim 5, characterized in that the intermediate element has an opening between the microneedle receptacle (14) and the reservoir receptacle (16).
7. Application device (10) according to claim 5 or 6, characterized in that the intermediate element is removable and / or breakable to overcome the contact barrier (17).
8. Application device (10) according to one of claims 1-7, characterized by a form-fitting and / or force-fitting connector for, in particular, latching, form-fitting and / or force-fitting reception of a microneedle array (102) in the microneedle receptacle (14) and / or of a reservoir (108) in the reservoir receptacle (16).
9. Application device (10) according to claim 8, characterized in that the form-fitting and / or frictional connector comprises: a groove; an undercut; a projection; a holding arm, in particular a flexible one; a latch; a closure and / or a fit.
10. Application device (10) according to one of claims 1-9, characterized in that the microneedle receptacle (14) has a, in particular round or rectangular, negative shape of a microneedle array (102) to be received in the microneedle receptacle (14), and / or the reservoir receptacle (16) has a, in particular round or rectangular, negative shape of a reservoir (108) to be received in the reservoir receptacle (17).
11. Application device (10) according to one of claims 1-10, characterized by a handle for handling, in particular placing and / or pressing the application device (10) onto an application site.
12. System (100) for microneedle application, in particular hydrogel microneedle application, with an application device (10) according to one of claims 1-11, a microneedle array (102) received in the microneedle receptacle (14), in particular one free of active substances, and / or a reservoir (108) received in the reservoir receptacle (16), in particular one containing active substances.
13. System (100) according to claim 12, characterized in that the microneedle array (102) is a, in particular swelling, hydrogel microneedle array.
14. System (100) according to claim 12 or 13, characterized in that the microneedle array (102) and the reservoir (108) are adhesive to one another.
15. A method for providing a system (100) for microneedle application, in particular a system for hydrogel microneedle application, comprising the step of arranging a microneedle array (102) and a reservoir (108), in particular one containing an active substance, opposite one another, wherein, during the opposing arrangement, the microneedle array (102) is spaced apart relative to the reservoir (108), preferably by means of an application device (10), particularly preferably by means of an application device (10) according to one of claims 1-11.
16. The method according to claim 15, characterized by the further step of overcoming the distance between the microneedle array (102) and the reservoir (108) to produce a drug-containing microneedle array system (100).
17. The method according to claim 16, characterized in that the distance is overcome by a relative movement, in particular a force-loaded movement, of the microneedle array (102) to the reservoir (108).
18. Method according to claim 16 or 17, characterized in that the distance is overcome by removing and / or destroying a contact barrier (17) forming the distance.