EP-4739377-A1 - A MICROARRAY PATCH

Abstract

A microarray patch (1) comprising a baseplate (2) and an array of microneedles (3) arranged on the baseplate (2) is disclosed. The baseplate is (2) configured to indicate the detection of moisture. The baseplate (2) may comprise a dye that changes colour on contact with moisture. The colour change of the baseplate is configured to align with the delivery of a substance through or from the microneedle, or the capture of a substance into the microneedle. The dye may be configured to yield gradual colour change according to the degree of moisturisation. The baseplate (2) may be insoluble with water and hydrophobic. Also disclosed is a method of manufacturing the microarray patch (1).

Inventors

• DONNELLY, RYAN
• LI, Huanhuan

Assignees

• Queen's University of Belfast

Dates

Publication Date

20260513

Application Date

20240627

Claims (20)

1. 1. A microarray patch comprising a baseplate and an array of microneedles arranged on the baseplate, wherein the microneedles are integrated into the baseplate and are either integrally formed with the baseplate or directly connected thereto, and wherein the baseplate is configured to indicate the detection of moisture, wherein the baseplate comprises a dye that changes colour on contact with moisture, wherein the baseplate changes colour after the microarray patch has been applied to the skin and after the microneedles have dissolved, or after moisture travels through the microneedles, and moisture from the skin contacts the baseplate.
2. 2. The microarray patch of claim 1 , wherein the baseplate is insoluble in water.
3. 3. The microarray patch of claim 1 or claim 2 wherein the dye is able to yield gradual colour change according to the degree of moisturisation.
4. 4. The microarray patch of claim 3 wherein the dye is a coloured dye such as crystal violet, salt or hydrate formed by Fe, Cu or Br ions, bromophenol blue, or any dye that changes colour on contact with moisture.
5. 5. The microarray patch of claim 3 or claim 4 wherein the dye is encapsulated by a carrier.
6. 6. The microarray patch of claim 5 wherein the dye is trapped inside the carrier.
7. 7. The microarray patch of claim 5 or claim 6 wherein the carrier operates as a moisture absorbent.
8. 8. The microarray patch of claim 7 wherein the carrier is silica, nanomaterial or cellulose or a combination thereof.
9. 9. The microarray patch of claim 8, wherein the carrier comprises particles having a width of less than 1 mm.
10. 10. The microarray patch of any preceding claim wherein the baseplate is hydrophobic.
11. 11. The microarray patch of any preceding claim wherein the baseplate comprises a molding agent.
12. 12. The microarray patch of claim 10 or claim 11 wherein the molding agent is a polymer.
13. 13. The microarray patch of claim 10 or claim 11 wherein the molding agent is polylactic acid, acrylic resin, epoxy resin, polyethylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, polysiloxane, polyester, polyurethane, or combinations thereof.
14. 14. The microarray patch of claim 10 wherein the baseplate comprises up to 70% w/w molding agent, with the remainder being the dye, dye carrier, or both.
15. 15. The microarray patch of any preceding claim wherein the microneedles are dissolvable microneedles, hydrogel microneedles or hollow microneedles.
16. 16. The microarray patch of any preceding claim wherein the microneedles contain a bioactive substance such as a drug or other cosmetic or health-related substance and combinations thereof.
17. 17. The microarray patch of claim 16wherein the bioactive substance is a small molecule drug, peptide, antibody, nucleic acid, cells or vaccines or combinations thereof.
18. 18. The microarray patch of any preceding claim wherein the microneedle dissolves within 30-60 min after application on the skin.
19. 19. The microarray patch of any preceding claim wherein the baseplate provides structural support for the array of microneedles and is solid and optionally flexible.
20. 20. A method of manufacturing the microarray patch of any preceding claim, comprising the steps of: i) providing an array of microneedles; ii) preparing a baseplate by preparing a solution comprising a molding agent and a dye and forming the baseplate in a mould; and iii) connecting the array of microneedles to the baseplate.

Description

A MICROARRAY PATCH Field of the Invention The invention relates to microarray patches for transdermal or intradermal delivery or capture of bioactive substances. In particular, the present invention relates to a microarray patch with microneedles. Background Microarray patch (MAP) technology for transdermal drug delivery has expanded exponentially in recent times. During the early stages of development, MAP technology saw considerable success in the cosmetic industry, however, through both academic and industrial collaboration, a wide range of small and large therapeutic molecules have now been successfully delivered across the skin using MAPs. Encouragingly, both patients and healthcare advisors have responded positively to MAP technology. For example, in a recent Phase 1 clinical trial, 98.6% of participants receiving an inactivated influenza vaccine through a dissolving MAP (DMAP) reported an overall positive experience (Frew et al. 2020 Vaccine, 38, 7175). This is somewhat unsurprising given the pain-free, minimally invasive nature of DMAP vaccine administration, in contrast to a conventional hypodermic needle and syringe. Furthermore, MAPs can be self-applied, only requiring thumb pressure to achieve successful skin insertion. Removing the need for administration by a healthcare professional has the potential to increase patient acceptance and improve vaccine coverage, particularly in low-resource countries. Nevertheless, end-user input remains vitally important to the commercial success of MAP technology. Regulatory authorities have also provided valuable input into this field and have proposed requirements that should be considered before MAPs can be accepted for clinical use. One such requirement is based on the ease and reliability of MAP application to the skin. Indeed, several concept studies have developed feedback mechanisms as an indirect method of confirming successful skin insertion. This has included the use of a pressure-indicating sensor film (Vicente- Perez etal. 2016 Pharm. Res. 33, 3072), a water-filled reservoir (Hutton et al. 2022 Drug Deliv. Transl. Res. 12, 838) and snap-based devices (Norman et al. 2014, Vaccine 32, 1856). Interestingly, to date, no feedback mechanism has the ability to confirm the successful insertion of the MAP directly or indicate the complete dissolution of microneedles when the MAP should be removed. The present invention seeks to obviate or mitigate the problems outlined above associated with MAPs. In particular, the present invention seeks to provide a MAP with a feedback mechanism to confirm successful insertion of the MAP. Further, the present invention seeks to provide a MAP that can indicate delivery of a substance through or from the microneedle, or the capture of a substance into the microneedle. Summary of the Invention According to a first aspect of the invention there is provided a microarray patch comprising a baseplate and an array of microneedles arranged on the baseplate, wherein the baseplate is configured to indicate the detection of moisture. The term “moisture” may refer to biological fluids such as blood, plasma, sweat and sebum. Advantageously, as the baseplate can indicate the detection of moisture, it can indicate when the microneedles have been inserted into the skin. Further advantageously, by indicating detection of moisture, the baseplate can also indicate when the microarray patch has been exposed to moisture before it has been applied to the skin. Such a situation may occur when a microarray patch packaging has ruptured or has been tampered with. Pre-exposing the microarray patch to moisture may compromise the efficacy of the microarray patch or even render it dangerous. Thus, the baseplate also provides an indication as to whether the microarray patch is safe to use. The colour change of the baseplate is configured to align with the delivery of a substance through or from the microneedle, or the capture of a substance into the microneedle. The baseplate provides structural support for the array of microneedles, and is ideally solid. The term “solid” as used herein means the baseplate is generally not hollow or filled with empty spaces. The baseplate may be flexible as well as solid. Ideally, the microneedles are integrated into the baseplate and are either integrally formed with the baseplate or directly connected thereto. Ideally, the baseplate comprises a dye that changes colour on contact with moisture. Preferably, the dye is able to yield gradual colour change according to the degree of moisturisation. The dye may be a coloured dye such as crystal violet, salt or hydrate formed by Fe, Cu, or Br ions, bromophenol blue, or any dye that changes colour on contact with moisture. Preferably, the baseplate is insoluble in water. Ideally, the baseplate is hydrophobic. Advantageously, a hydrophobic baseplate prevents migration of hydrophilic substances from the microneedles into the baseplate. Ideally, the dye is encapsulated by a