Abstract

MICRO NEEDLE-BASED DRUG DELIVERY SYSTEMS: RECENT ADVANCES, APPLICATIONS, AND FUTURE PERSPECTIVE

Dr. Nidhi Chauhan*, Zarakh Saad Mo Saeed Hashan*, Mrs. Hemangi Patel, Mrs. Khushali Rathod, Ghanchi Husen Hamidbhai

ABSTRACT

Microneedle-based drug delivery has evolved from a largely conceptual alternative to conventional transdermal therapy into a versatile platform with tangible clinical and translational relevance. By creating transient microchannels across the stratum corneum, microneedles overcome the principal barrier that limits passive skin delivery while preserving the advantages of local administration, self-use, and improved patient acceptance. Over the last few years, progress has been particularly visible in dissolving, hydrogel-forming, and smart microneedle systems, together with renewed interest in vaccine delivery, insulin administration, dermatologic therapy, and emerging cancer applications. Recent studies have shown that microneedles can support dose-sparing vaccine strategies, closed-loop glucose-responsive insulin release, and minimally invasive delivery of biologics that would otherwise remain unsuitable for topical or transdermal use.[1,8] Nevertheless,clinical translation remains constrained by several practical issues. These include limited payload capacity for many solid-state systems, variability in insertion performance, concerns around sterility and storage stability, mechanical robustness during manufacturing and application, and the absence of fully harmonized regulatory terminology and quality standards.[9,14] At the same time, advances in 3D printing, smart polymers, hybrid nanoparticle-micro needle systems, and quality-by-design-based development are gradually addressing some of these barriers. This review critically discusses the skin architecture relevant to transdermal transport, the mechanism and classification of micro needles, materials and fabrication strategies, performance evaluation, major applications, limitations, recent innovations, and regulatory and commercial considerations. Taken together, the evidence suggests that micro needle platforms are moving toward a more mature therapeutic class, but their success will depend on reproducible manufacturing, clinically meaningful endpoints, and application-specific design rather than one universal micro needle format.

Keywords: microneedles; transdermal drug delivery; dissolving microneedles; hydrogel-forming microneedles; vaccines; insulin; smart drug delivery; regulatory science.