Exploring new frontiers in drug delivery with minimally invasive microneedles: fabrication techniques, biomedical applications, and regulatory aspects

ABSTRACT

Introduction

Transdermal drug delivery is limited by the stratum corneum, inhibiting the therapeutic potential of the permeants. Microneedles (MNs) have opened new frontiers in transdermal drug delivery systems. These micro-sized needles offer painless and accentuated delivery of drugs even with high molecular weights.

Areas covered

The review embodies drug delivery strategies with MNs with a description of MN types and fabrication techniques using various materials. The application of MN is not limited to drug delivery, but it also encompasses in vaccine delivery, diagnosis, phlebotomy, and even in the cosmetic industry. The review also tabulates MN-based marketed formulations. In a nutshell, we aim to present a panoramic view of MNs, including the design, applications, and regulatory aspects of MN.

Expert opinion

With the availability of numerous materials at the disposal of pharmaceutical scientists; the MN-based drug delivery technology has offered significant interventions toward the management of chronic maladies, including cardiovascular disorders, diabetes, asthma, mental depression, etc. As happens with any new technology, there are concerns with MN also such as biocompatibility issues with the material used for the fabrication. Nevertheless, the pharmaceutical industry must strive for preparing harmless, efficient, and cost-effective MN-based delivery systems for wider acceptance and patient compliance.

GRAPHICAL ABSTRACT

KEYWORDS:

• Microneedle
• drug delivery
• cosmetics
• evaluation
• diagnosis
• phlebotomy

Article highlights

• Microneedle drug delivery is used worldwide making a $31.5 billion market.

• Widely used in areas of drug delivery and vaccine delivery.

• Recently, MNs are being used in phlebotomy and diagnosis.

• Microneedling in the form of a derma roller is now commonly used in the cosmetic industry.

• MN products are regulated by USFDA by considering them in class I (where MNs should not be more than 0.3 mm)

Acknowledgments

Author Niha Sultana sincerely acknowledges the University Grants Commission, New Delhi, India, for grant of Maulana Azad National Fellowship (UGC-Ref. No.: 210510820214).

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.