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Microneedle-based insulin transdermal delivery system: current status and translation challenges.

ABSTRACT: Diabetes mellitus is a metabolic disease manifested by hyperglycemia. For patients with type 1 and advanced type 2 diabetes mellitus, insulin therapy is essential. Subcutaneous injection remains the most common administration method. Non-invasive insulin delivery technologies are pursued because of their benefits of decreasing patients' pain, anxiety, and stress. Transdermal delivery systems have gained extensive attention due to the ease of administration and absence of hepatic first-pass metabolism. Microneedle (MN) technology is one of the most promising tactics, which can effectively deliver insulin through skin stratum corneum in a minimally invasive and painless way. This article will review the research progress of MNs in insulin transdermal delivery, including hollow MNs, dissolving MNs, hydrogel MNs, and glucose-responsive MN patches, in which insulin dosage can be strictly controlled. The clinical studies about insulin delivery with MN devices have also been summarized and grouped based on the study phase. There are still several challenges to achieve successful translation of MNs-based insulin therapy. In this review, we also discussed these challenges including safety, efficacy, patient/prescriber acceptability, manufacturing and scale-up, and regulatory authority acceptability.

SUBMITTER: Zhao J

PROVIDER: S-EPMC8528479 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Microneedle-based insulin transdermal delivery system: current status and translation challenges.

Zhao Jing J Xu Genying G Yao Xin X Zhou Huirui H Lyu Boyang B Pei Shuangshuang S Wen Ping P

Drug delivery and translational research 20211020 10

Diabetes mellitus is a metabolic disease manifested by hyperglycemia. For patients with type 1 and advanced type 2 diabetes mellitus, insulin therapy is essential. Subcutaneous injection remains the most common administration method. Non-invasive insulin delivery technologies are pursued because of their benefits of decreasing patients' pain, anxiety, and stress. Transdermal delivery systems have gained extensive attention due to the ease of administration and absence of hepatic first-pass metab ...[more]

PMID: 34671948

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Project description:Levothyroxine (LT-4) sodium has shown variable bioavailability following oral administration. This can be assigned to the significant influence of gastrointestinal conditions, food and drugs administered concomitantly on the rate and extent of absorption from the gastrointestinal tract. Thus, the aim of this research study was to establish an efficient transdermal delivery system of LT-4 sodium via the application of hyaluronic acid dissolving microneedles. Microneedles-based drug delivery system consists of sharp-tip needles that puncture the top layers of the skin in a minimally invasive manner to create physical channels through which therapeutic molecules can easily diffuse into/across the skin. Hyaluronic acid polymer at different ratios (5-60 %) was used to prepare microneedle arrays (100 needles per array) using a micromoulding technique. Characterisation tests were carried out to select the optimum formulation. F11 formula containing 50% w/v hyaluronic acid and 1% v/v Tween 80 formula showed an appropriate needle shape with dimensions of 432 ± 6.4 μm in height and a tip diameter of 9.8 ± 1.3 μm. The microneedle arrays demonstrated a suitable mechanical strength after applying a force of 32 N per array and an excellent insertion ability both in Parafilm M® and human skin. The in vivo dissolution of microneedles was started rapidly within 5 minutes following the insertion in the skin and completed at 1 hour. Ex vivo permeation study using human skin has shown a significant improvement in LT-4 sodium delivery across the skin compared to control preparations (drug solution and microneedle free film). The microneedle array F11 has significantly (P ≤ 0.05) increased LT-4 sodium permeation through the skin (cumulative permeated amount of 32 ± 2 μg/cm2) in comparison to the control solution (cumulative permeated amount of 0.7 ± 0.07 μg/cm2) and the microneedle free film (cumulative permeated amount of 0.1 ± 0.02 μg/cm2) over 7 hours. The findings from the irritation test revealed that mild erythema was produced from the application of microneedle arrays which disappeared within 24 hours. Accordingly, dissolving hyaluronic acid microneedles could be a feasible and effective approach to delivering LT-4 sodium transdermally without causing significant skin damage.

Project description:Background: Precise and dynamic blood glucose regulation is paramount for both diagnosing and managing diabetes. Continuous glucose monitoring (CGM) coupled with insulin pumps forms an artificial pancreas, enabling closed-loop control of blood glucose levels. Indeed, this integration necessitates advanced micro-nano fabrication techniques to miniaturize and combine sensing and delivery modules on a single electrode. While microneedle technology can mitigate discomfort, concerns remain regarding infection risk and potential sensitivity limitations due to their short needle length. Methods: This study presents the development of an integrated electronic/fluidic microneedle patch (IEFMN) designed for both glucose sensing and insulin delivery. The use of minimally invasive microneedles mitigates nerve contact and reduces infection risks. The incorporation of wired enzymes addresses the issue of "oxygen deprivation" during glucose detection by decreasing the reliance on oxygen. The glucose-sensing electrodes employ wired enzyme functionalization to achieve lower operating voltages and enhanced resilience to sensor interference. The hollow microneedles' inner channel facilitates precise drug delivery for blood glucose regulation. Results: Our IEFMN-based system demonstrated high sensitivity, selectivity, and a wide response range in glucose detection at relatively low voltages. This effectively reduced interference from both external and internal active substances. The microneedle array ensured painless and minimally invasive skin penetration, while wired enzyme functionalization not only lowered sensing potential but also improved glucose detection accuracy. In vivo, experiments conducted in rats showed that the device could track subcutaneous glucose fluctuations in real-time and deliver insulin to regulate blood glucose levels. Conclusions: Our work suggests that the IEFMN-based system, developed for glucose sensing and insulin delivery, exhibits good performance during in vivo glucose detection and drug delivery. It holds the potential to contribute to real-time, intelligent, and controllable diabetes management.

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Microneedle-based insulin transdermal delivery system: current status and translation challenges.

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Microneedle-based insulin transdermal delivery system: current status and translation challenges.

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