review · Journal of Controlled Release
Dissolving microneedles offer a minimally invasive alternative to traditional hypodermic injections and oral medications for transdermal drug delivery. Despite extensive academic interest, clinical translation remains constrained by several technical and manufacturing challenges. Key limitations include poor drug loading capacity, low dosing consistency, and difficulties in achieving therapeutic drug concentrations. Consequently, practical use is largely confined to niche applications, such as vaccination or delivering highly potent compounds requiring low doses. Commercial progress is further impeded by complex manufacturing, high costs associated with sterile production, a lack of standardised quality control, and undefined regulatory pathways. Addressing these barriers requires focusing on pragmatic formulation science, advanced material engineering, and scalable production methods, coupled with clearer regulatory guidance, to enable the broader medical implementation of microneedle systems.
Microneedles present an attractive, painless alternative to conventional needles and oral drugs, potentially improving patient compliance and treatment delivery. However, academic research frequently overlooks practical clinical obstacles. Identifying and resolving critical manufacturing, quality control, and regulatory barriers is vital for transforming experimental delivery systems into safe, dependable treatments that can be produced reliably at an industrial scale for routine healthcare.
Dissolving microneedles are aimed at transdermal delivery of vaccines and potent, low-dose therapeutics. Although widely studied, the technology remains early-stage in practical terms and distant from widespread commercialisation. Medical device and pharmaceutical manufacturers face substantial hurdles, including high-cost sterile production, undefined regulatory approval processes, and low manufacturing scalability. Moving towards market readiness depends on standardising quality control protocols and engineering scalable, cost-effective fabrication systems.
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Microneedles (MNs) have emerged as an innovative approach for transdermal drug delivery, offering an efficient and minimally invasive alternative to conventional injections and oral delivery systems. While their potential has been widely recognized and extensively studied, the translation of MN technology into clinical practice remains limited. Despite the vast amount of published research, much of it involves over-complexification without addressing the core barriers to practical application. For example, dissolving/degradable MNs face key limitations such as poor drug loading capacity, low dosing consistency, and challenges in delivering effective therapeutic concentrations. These constraints restrict their utility to niche applications, such as vaccination or delivering potent drugs that require minimal doses. Additionally, the lack of standardized quality control measures, the complex manufacturing processes, and the high costs associated specifically with sterile/aseptic production further impede clinical translation. Regulatory frameworks for MNs remain vague, slowing the development of products that meet approval standards. This review critically examines the fundamental barriers to dissolving/degradable MN commercialization, as the most studied type of MN, while exploring promising strategies to overcome them. Advances in formulation science, fabrication techniques, and material engineering have demonstrated potential in enhancing drug loading efficiency and delivery consistency. Moreover, the establishment of clearer regulatory guidelines and scalable production strategies could significantly accelerate the commercialization of MN technology. By shifting focus toward pragmatic and clinically relevant solutions, this review aims to bridge the gap between research innovations and real-world applications, paving the way for broader implementation of MN technology in medicine.
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DOI: 10.1016/j.jconrel.2025.113794
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