Application device for microneedles, system for application of microneedles, and method for providing a system for application of microneedles

Abstract

An application device (10) for microneedles comprising a microneedle receptacle (14), a reservoir receptacle (16) for receiving a reservoir (108), and a contact barrier (17) for separating a microneedle array (102) received in the microneedle receptacle (14) from the reservoir (108) received in the reservoir receptacle (16). Also provided is a system (100) for applying microneedles and a method for providing the system (100) for applying microneedles.

Description

[Technical Field]

[0001] The present invention relates to an application device for microneedles, a system for the application of microneedles, and a method for providing a system for the application of microneedles. [Background technology]

[0002] In addition to the classical forms of administration of active ingredients, such as swallowing medicines or injecting drugs, there is also the idea of ​​applying active ingredients through the skin. In this regard, microneedles are of particular importance.

[0003] Microneedle arrays, also known as microarrays, typically have multiple microneedles arranged on or connected to a support element such as a patch or plaster. Such microneedle arrays contain a large number of microneedles, e.g., 100 to 600 needles per cm². Due to their short length, when the microneedles are pressed into a patient's skin, they penetrate only to the extent that their tips avoid contact with nerves and blood vessels. Microneedle arrays contain active ingredients or pharmaceuticals. For example, the corresponding active ingredient may be provided on the surface of the needles or may be disposed within the needles. The needles may be made of a material that dissolves in the skin, for example.

[0004] There are also efforts to develop hydrogel microneedle arrays, as described, for example, in Donnelly RF, McCrudden MTC, Zaid Alkilani A, Larraneta 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 have white, swellable microneedles and generally contain no active ingredients. Instead, after application, they absorb fluids, particularly interstitial fluid in the skin, forming a connection, particularly a continuous and / or unimpeded connection, between the skin, preferably the dermal microcirculation, and a drug reservoir connected to the microneedles. Generally, such hydrogel microneedle arrays initially serve as a tool for penetrating the stratum corneum barrier. After application, they also function as a rate-controlled delivery device, particularly by adjusting the rate, for example, by adjusting the needles that function as membranes.

[0005] Current concepts for hydrogel microneedle arrays present a number of problems. Depending on the water content of the reservoir, this can lead to diffusion of water and / or other solvents contained in the microneedle array. As a result, for example, the microneedles may swell and / or become so soft prior to application that they can no longer ensure the necessary penetration of the skin, particularly the stratum corneum. [Prior art documents] [Non-patent literature]

[0006] [Non-Patent Document 1] Donnelly RF,McCrudden MTC,Zaid Alkilani A,Larraneta 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) Summary of the Invention [Problem to be solved by the invention]

[0007] It is an object of the present invention to provide an application device for microneedles, a system for the application of microneedles, and a method for providing a system for the application of microneedles, which device, system, and method provide improved handling, particularly storage, of microneedle arrays. [Means for solving the problem]

[0008] According to the present invention, this object is achieved by an application device for microneedles as claimed in claim 1, a system for the application of microneedles as claimed in claim 12 and a method for providing a system for the application of microneedles as claimed in claim 15.

[0009] The application device for microneedles according to the present invention is particularly an application device for hydrogel microneedles. It is preferably an application device for microneedle arrays, particularly preferably hydrogel microneedle arrays. The application device has a microneedle receptacle, in particular for receiving the microneedle array. Furthermore, the application device has a reservoir receptacle, in particular for receiving a reservoir containing an active ingredient. The application device, in particular the microneedle receptacle and the reservoir receptacle, are preferably configured to receive the microneedle array and the reservoir facing each other, preferably on their end faces. Furthermore, the application device has a contact barrier for separating the microneedle array received in the microneedle receptacle from the reservoir received in the reservoir receptacle. In particular, the contact barrier is a diffusion barrier. The application device preferably comprises a housing, in particular made of plastic. The microneedle receptacle and / or the reservoir receptacle are preferably designed as one piece, also referred to as integral with the housing. The microneedle receptacle and / or reservoir receptacle and the housing are preferably made of a common material, particularly a material that blends with the other. Preferably, the microneedle receptacle and / or reservoir receptacle are formed as openings in the housing. The contact barrier is particularly advantageous in preventing the diffusion of contained water and / or other solvents into the microneedle array.

[0010] In a preferred embodiment, the contact barrier is a gap, in particular a void 28. The gap, in particular a void 28, is preferably formed between the microneedle array received in the microneedle receptacle and the reservoir received in the reservoir receptacle, and / or between the microneedle receptacle and the reservoir receptacle.

[0011] In a preferred embodiment, the gap formed by the contact barrier between the microneedle array preferably received in the microneedle receptacle and the reservoir received 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.

[0012] In a preferred embodiment, the application device, preferably the contact barrier, is configured such that the contact barrier can be overcome by a relative movement of the microneedle array received in the microneedle receptacle relative to the reservoir received in the reservoir receptacle, in particular caused by a force. The force-induced relative movement is in particular a contact pressure, preferably a manual contact pressure, by a user. In particular, a gap must be overcome by the relative movement.

[0013] In a preferred embodiment, the application device comprises an intermediate element, in particular a spacer, between the microneedle receptacle and the reservoir receptacle for forming a contact barrier. In particular, the intermediate element is a web.

[0014] 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, and a gap, preferably a void (28), is formed in particular by the opening in the intermediate element.

[0015] Alternatively or additionally to the embodiment of the intermediate element for forming the gap 28, the intermediate element is specifically designed as a physical barrier between the microneedle array received in the microneedle receptacle and the reservoir received in the reservoir receptacle. In this embodiment of the intermediate element, the intermediate element is specifically configured to be removable and / or breakable to overcome the contact barrier, preferably the gap. Thus, the intermediate element has, for example, a predetermined breaking point and / or porosity.

[0016] In a preferred embodiment, the application device has form-fitting and / or press-fit connectors for receiving, in particular locking, the microneedle array in the microneedle receptacle and / or the reservoir in the reservoir receptacle in a form-fitting and / or press-fit manner. Preferably, the microneedle array has form-fitting and / or press-fit connectors for receiving, in particular locking, the microneedle array in the microneedle receptacle in a form-fitting and / or press-fit manner. Alternatively or additionally, the reservoir receptacle has form-fitting and / or press-fit connectors for receiving, in particular locking, the reservoir in the reservoir receptacle in a form-fitting and / or press-fit manner. Preferably, at least one, in particular all, of the form-fitting and / or press-fit connectors are integrally formed with the housing.

[0017] In preferred embodiments, at least one, and in particular all, of the form-fit and / or press-fit connectors comprise grooves, in particular for forming tongue and groove connections, undercuts, protrusions, retention arms, in particular flexible retention arms, latches, closures and / or mating portions, in particular for forming press-fit connections.

[0018] In a preferred embodiment, the microneedle receptacle has a shadow form, particularly a circular or rectangular form, of the microneedle array to be received in the microneedle receptacle. Alternatively or additionally, the reservoir receptacle has a shadow form, particularly a circular or rectangular form, of the reservoir to be received in the reservoir receptacle. At least one shadow form, particularly all shadow forms, are preferably formed integrally with the housing, particularly as openings.

[0019] In a preferred embodiment, the application device comprises a handle for handling, particularly for positioning and / or pressing the application device to the application site. In particular, the handle is a handle plate. Preferably, the handle is configured so that it can be held from above, below, and / or laterally, for example with the thumb and index finger, without interfering with the reservoir and / or microneedle array.

[0020] The system for applying microneedles according to the present invention is particularly a system for applying hydrogel microneedles. The system comprises an application device having one or more features of the application device according to the present invention. Furthermore, the system comprises a microneedle array received in a microneedle receptacle, particularly a microneedle array without an active ingredient, and / or a reservoir received in a reservoir receptacle, particularly a reservoir with an active ingredient. In particular, the microneedle array and the reservoir are arranged opposite each other, preferably on opposite end faces. Preferably, the reservoir is arranged on the end face of the microneedle array opposite the side from which the microneedles arise and / or protrude. Preferably, the reservoir is arranged opposite the back surface of the microneedle array. The microneedle array preferably has 100 to 600 microneedles per cm2. Preferably, the microneedle array has conical or pyramidal microneedles. The microneedles of the microneedle array preferably have a length of 100 μm to 1000 μm, preferably about 600 μm. Preferably, the microneedles of the microneedle array have a base diameter of 50 μm to 500 μm, particularly preferably about 300 μm. In particular, the reservoirs are formed as reservoirs that can be called plaster-like or patch-like. The microneedle array and / or reservoirs have, in particular, a rectangular or circular shape. Preferably, the microneedle array and / or reservoirs have a diameter of 5 to 25 mm, preferably about 11 mm. Preferably, the microneedle array and / or reservoirs have a width of 5 to 25 mm, preferably about 11 mm. Preferably, the microneedle array has a support element, preferably plate-shaped, integrally connected to the microneedles.

[0021] In a preferred embodiment, the microneedle array is a swellable hydrogel microneedle array. Preferably, the microneedles, particularly the entire microneedle array, are swellable. The microneedle array comprises, and preferably consists of, Gantrez, PVP, and / or PVA.

[0022] In a preferred embodiment, the reservoir contains at least one active ingredient. In particular, the reservoir contains a small molecule, also known as a small chemical molecule, and / or a biological agent. In particular, the reservoir is configured to accommodate a larger amount of the active ingredient than a dissolved or coated microneedle array. The reservoir preferably comprises, and preferably consists of, a dissolved film, particularly a polymer film.

[0023] Preferably, the microneedle array and the reservoir are configured to adhere to each other, which in particular means that the microneedle array and the reservoir adhere to each other when they come into contact.

[0024] The method according to the present invention for providing a system for applying microneedles is particularly a method for providing a system for applying hydrogel microneedles. In particular, the method comprises the steps of providing a microneedle array and / or providing a reservoir. One step of the method comprises arranging the microneedle array and a reservoir, in particular a reservoir containing an active ingredient, opposite each other. Preferably, the arrangement is such that the microneedle array and the reservoir are arranged opposite each other, preferably on opposite end faces. Preferably, the arrangement is such that the reservoir is arranged on the end face of the microneedle array opposite the side from which the microneedles arise and / or protrude. Preferably, the arrangement is such that the reservoir is arranged opposite the rear face of the microneedle array. When the microneedle array and the reservoir are arranged opposite each other, the microneedle array is spaced apart from the reservoir. The spacing is particularly preferably performed by an application device having one or more features of the application device according to the present invention. The separation is achieved in particular by a contact barrier, which is preferably formed as a gap 28 and / or a physical barrier, and it is particularly preferred that the separation includes an arrangement in which there is free space between the microneedle array and the reservoirs.

[0025] In a preferred embodiment, the method comprises the further step of overcoming a gap between the microneedle array and the reservoir, particularly after the face-to-face placement, to produce a microneedle array system containing an active ingredient. In particular, the gap is overcome so that the microneedle array and the reservoir are connected, particularly permanently. Preferably, an adhesive bond is formed between the microneedle array and the reservoir.

[0026] In a preferred embodiment, the gap, particularly the void (28), is overcome by a relative movement of the microneedle array with respect to the reservoir, particularly a force-induced movement, which is preferably achieved by applying contact pressure to the reservoir, preferably manual contact pressure by a user.

[0027] Alternatively or in addition to overcoming the gap by relative movement, the gap may be overcome by removing and / or destroying the contact barrier that specifically creates the gap.

[0028] Preferably, one of the subject matters of the present invention, the application device according to the present invention, the system according to the present invention and / or the method according to the present invention can be supplemented with one or more features of other subject matters of the present invention or with one or more features described in the context of other subject matters of the present invention. In the following, the present invention will be explained in more detail by preferred embodiments with reference to the accompanying drawings. [Brief explanation of the drawings]

[0029] [Figure 1] 1 shows a perspective top view of one embodiment of an applicator according to the present invention. [Figure 2] 2 shows a cross-sectional view of the application device of FIG. 1 along II. [Figure 3] 3 shows a detailed cross-sectional view of the application device of FIG. 2 along III. [Figure 4] 2 shows a top view of the application device of FIG. 1; [Figure 5] 1 shows a perspective top view of another embodiment of an application device according to the present invention. [Figure 6] 6 shows a cross-sectional view of the application device of FIG. 5 along II. [Figure 7] 7 shows a detailed cross-sectional view of the application device of FIG. 6 along III. [Figure 8] 6 shows a top view of the application device of FIG. 5. [Figure 9]6 shows a cross-sectional view of one embodiment of a system for microneedle application according to the present invention having the application device of FIG. 5. DETAILED DESCRIPTION OF THE INVENTION

[0030] In the figures, similar or identical components or elements are identified by the same reference numerals. In particular, to improve clarity, preferably already-identified elements are not numbered in all figures.

[0031] Figure 1 shows an embodiment of an application device 10 for microneedles according to the present invention, Figure 2 shows a longitudinal section along II in Figure 1, Figure 3 shows a detail according to III in Figure 2, and Figure 4 shows a top view of the embodiment in Figure 1.

[0032] The applicator 10 includes a housing 12 having a handle 26 for handling.

[0033] A reservoir receptacle 16 for receiving a reservoir 108 (see Figure 9), particularly a reservoir containing an active ingredient, is recessed into the housing 12 on the upper side as shown in Figure 1, and a microneedle receptacle 14 for receiving a microneedle array 102 (see Figure 9), particularly a microneedle array not containing an active ingredient, is recessed into the housing 12 on the lower side.

[0034] The microneedle receptacle 14 and the reservoir receptacle 16 are formed as openings in the housing 12, and in particular the microneedle receptacle 14 forms a shadow form for receiving the microneedle array 102 and / or the reservoir receptacle 16 forms a shadow form for receiving the reservoir 108 (see Figure 9).

[0035] In particular, for form-fitting fixation of the reservoir 108 (see FIG. 9 ), the reservoir receptacle 16 has an undercut 20 that in particular forms a form-fitting and / or press-fit connector. In particular, for form-fitting fixation of the microneedle array 102 (see FIG. 9 ), the microneedle receptacle 14 has a groove 22 that in particular forms a form-fitting and / or press-fit connector. The groove 22 shown on one end face of the application device 10 has an opening 24 for inserting the microneedle array 102. Furthermore, the reservoir receptacle 16 and / or the microneedle receptacle 14 are preferably configured to be press-fitted, for example to fix the reservoir 108 or the microneedle array 102 by fitting. Thus, in particular, the application device 10 has at least one form-fitting and / or press-fit connector so that the reservoir 108 and / or the microneedle array 102 can no longer be removed after insertion and / or is fixed against dislodging.

[0036] The application device 10 includes a contact barrier 17 for separating the microneedle array 102 received in the microneedle receptacle 14 and the reservoir 108 received in the reservoir receptacle 16 (see FIG. 9).

[0037] The contact barrier 17 is formed by an intermediate element 19, in particular a web-like intermediate element 19, having openings 18. The openings 18 form gaps 28 between the microneedle receptacle 14 and the reservoir receptacle 16, or between the microneedle array 102 received in the microneedle receptacle 14 and the reservoir 108 received in the reservoir receptacle 16, separating the microneedle array 102 and the reservoir 108.

[0038] 5-8 show in various views another embodiment of an application device 10 for microneedles according to the present invention.

[0039] The embodiment of Figures 5 to 8 is based on the embodiment of Figures 1 to 4. Instead of the rectangular reservoir receptacle 16 of the embodiment of Figures 1 to 4, the embodiment of Figures 5 to 8 comprises a circular reservoir receptacle 16.

[0040] 9 shows an embodiment of a system 100 for microneedle application according to the present invention. The system comprises an application device 10 according to the embodiment of FIGS.

[0041] A reservoir 108, particularly a circular reservoir, is received and secured in reservoir receptacle 16, and reservoir 108 preferably contains an active ingredient.

[0042] A microneedle array 102, particularly a microneedle array without an active ingredient, is housed in the groove 22 of the microneedle receptacle 14. The illustrated microneedle array 102 has a preferably plate-shaped support element 104 integrally connected to, among other things, microneedles 106.

[0043] The voids 28 in the contact barrier 17 prevent contact between the microneedle array 102 and the reservoir 108 prior to application, thus preventing, inter alia, water and / or solvent exchange, and therefore advantageously preventing swelling of the microneedle array 102 prior to application.

[0044] Upon application, the necessary force can be applied to the reservoir to deform it downwards and press it against the microneedle array 102. The applied force then ensures penetration, particularly of the stratum corneum, and provides sufficient contact between the two components, which is also favorable for allowing diffusion of the active ingredient through the microneedle array 102 into the skin.

Claims

1. An application device (10) for microneedles, in particular hydrogel microneedles, comprising: a microneedle receptacle (14); a reservoir receptacle (16) for receiving a reservoir (108), in particular a reservoir containing an active ingredient; a contact barrier (17) for separating the microneedle array (102) received in the microneedle receptacle (14) from the reservoir (108) received in the reservoir receptacle (16); An application device (10) comprising:

2. 2. The application device (10) according to claim 1, characterized in that the contact barrier (17) is a gap, in particular an air gap (28).

3. 3. The application device (10) according to claim 2, characterized in that the distance formed by the contact barrier (17) is between 0.01 mm and 3 mm, preferably between 0.05 mm and 1 mm, particularly preferably between 0.1 mm and 0.5 mm.

4. The application device (10) of any one of claims 1 to 3, characterized in that the contact barrier (17) is configured to be overcome by a relative movement of the microneedle array received in the microneedle receptacle (14) with respect to the reservoir (108) received in the reservoir receptacle (16), in particular caused by a force.

5. An application device (10) according to any one of claims 1 to 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. 6. The application device (10) of claim 5, wherein the intermediate element has an opening between the microneedle receptacle (14) and the reservoir receptacle (16).

7. 7. Applicator (10) according to claim 5 or 6, characterized in that the intermediate element is removable and / or destructible to overcome the contact barrier (17).

8. 8. The application device (10) of any one of claims 1 to 7, characterized by a form-fitting and / or press-fitting connector for receiving, in particular locking, the microneedle array (102) in the microneedle receptacle (14) and / or the reservoir (108) in the reservoir receptacle (16) in a form-fitting and / or press-fitting manner.

9. 9. The application device (10) according to claim 8, characterized in that the form-fit and / or press-fit connector comprises a groove, an undercut, a protrusion, a retaining arm, in particular a flexible retaining arm, a latch, a closure, and / or a fitting.

10. 10. The application device (10) of claim 1, wherein the microneedle receptacle (14) has a shadow form, in particular a circular or rectangular form, of the microneedle array (102) to be received in the microneedle receptacle (14), and / or the reservoir receptacle (16) has a shadow form, in particular a circular or rectangular form, of the reservoir (108) to be received in the reservoir receptacle (17).

11. An application device (10) according to any one of claims 1 to 10, characterized by a handle for handling, particularly positioning and / or pressing the application device (10) towards the application site.

12. A system (100) for the application of microneedles, in particular for the application of hydrogel microneedles, comprising: An application device (10) according to any one of claims 1 to 11, a microneedle array (102) received in said microneedle receptacle (14), in particular a microneedle array that does not contain an active ingredient; and / or A reservoir (108), particularly a reservoir containing an active ingredient, received in said reservoir receptacle (16). A system (100) comprising:

13. 13. The system (100) of claim 12, wherein the microneedle array (102) is in particular a swellable hydrogel microneedle array.

14. 14. The system (100) of claim 12 or 13, wherein the microneedle array (102) and the reservoir (108) are configured to be adhesive to one another.

15. A method for providing a system (100) for the application of microneedles, in particular a system for the application of hydrogel microneedles, comprising a step of placing a microneedle array (102) and a reservoir (108), in particular a reservoir containing an active ingredient, opposite each other, wherein during said opposing arrangement, the microneedle array (102) is spaced apart from the reservoir (108), preferably by an application device (10), in particular by an application device (10) according to any one of claims 1 to 11.

16. 16. The method of claim 15, characterized by the further step of overcoming the distance between the microneedle array (102) and the reservoir (108) to produce a microneedle array system (100) containing an active ingredient.

17. 17. The method of claim 16, wherein the distance is overcome by a relative movement of the microneedle array (102) with respect to the reservoir (108), in particular caused by a force.

18. 18. A method according to claim 16 or 17, characterized in that said distance is overcome by removing and / or destroying a contact barrier (17) forming said distance.

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