Designing a unique feedback mechanism for hydrogel-forming microneedle array patches: a concept study

Abstract

Although microneedle array patch (MAP) technology is reaching ever closer to regulatory approval, it remains imperative that approaches to further improve patient acceptance are still explored. Addressing this perception, a water-filled reservoir was incorporated into a hydrogel-forming MAP system to provide a novel feedback mechanism. To confirm successful MAP skin insertion, the end user would both hear and feel the rupture of the water-filled reservoir. Interestingly, a 50-µL water-filled reservoir ruptured at 30.27 ± 0.39 N, which has previously been shown as the mean application force for MN insertion in human subjects following appropriate instruction. Importantly, no significant difference in % cumulative permeation of FITC-dextran 10 kDa and fluorescein sodium after 24 h was observed between a 50-µL reservoir and the current method of application that has been successfully used in both in vitro and in vivo studies (p > 0.05). Therefore, as drug delivery was not affected, this proof-of-concept study has shown that a water-filled reservoir feedback mechanism has the potential to serve as a viable tool for consistent MAP skin insertion. Graphical abstract

Swellable Microneedles in Drug Delivery and Diagnostics

“…This feature ensures effective skin penetration without compromising drug delivery, facilitating accurate and reliable self-application. Such advancements are crucial for clinical reliability and patient adherence [ 75 ].…”

“…Regulatory and Clinical Validation: Before clinical adoption, MNs must clear stringent regulatory and validation hurdles. It is crucial to conduct in vivo and ex vivo validation studies to demonstrate their practical efficacy and reliability [ 19 , 26 , 50 , 54 , 59 , 75 ]. Comparative studies evaluating swellable MNs against other delivery systems are also beneficial to benchmark their clinical performance and utility [ 71 , 72 ].…”

“…Their high efficiency in targeted drug delivery and biomarker extraction enhances timely metabolic analysis of interstitial fluid, thereby improving therapeutic and diagnostic outcomes [ 20 , 23 , 30 , 33 ]. The design features of these microneedles, such as sensor films for insertion depth confirmation and feedback mechanisms like water-filled reservoirs, ensure painless application, reduce infection risks, and improve patient compliance, making self-application more feasible [ 8 , 22 , 75 ].…”

mRNA nanodelivery systems: targeting strategies and administration routes

“…MNs based on mRNA are still in the research phase [ 272 ]. Despite the current lack of commercialized MNs, the consensus on MNs technology remains positive [ 276 ]. With in-depth research into mRNA NPs, the future of MN-based mRNA vaccines is bright.…”

Design of a Novel Delivery Efficiency Feedback System for Biphasic Dissolving Microarray Patches Based on Poly(Lactic Acid) and Moisture‐Indicating Silica

“…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, [ 5 ] a water‐filled reservoir, [ 6 ] and snap‐based devices. [ 7 ] Interestingly, to date, no all‐in‐one feedback mechanism has the ability to both confirm the successful insertion of the DMAP and indicate when the DMAP should be removed.…”