Human studies with microneedles for evaluation of their efficacy and safety

ABSTRACT

Introduction: During the past two decades, many studies have documented the development of microneedles (MNs) as a feasible technique for the effective administration of drugs. More and more human studies have been done with MNs to bridge the gap between research and market applications that provide efficacious techniques for clinical implementation.

Areas covered: The aim of this review is provide a brief description of the status of human study with MNs and to demonstrate progress for the right use of microneedle arrays in clinical settings. It also describes the considerations for clinical application with each type of MNs.

Expert opinion: Microneedle systems were introduced to overcome the limitations of conventional methods of drug administration. Lots of microneedle systems have undergone clinical evaluation to determine their efficacy and safety, and many studies have demonstrated positive results. The successful clinical use of the microneedle in vaccine therapy is remarkable and supports the importance of conducting further tests in a wide range of medical applications. Self-administered MNs appeared to be an attractive alternative method that needs further research to become a reality in the near future.

KEYWORDS:

• Microneedle
• human study
• efficacy
• safety
• applied protocol
• clinical trials

Article highlights

• MNs have become an attractive alternative drug delivery system through the skin because they provide several benefits, including painlessness, convenience, self-administration, and noninvasive application.

• There are five types of MNs that facilitate improved permeability of molecules and macromolecules: hollow MNs, solid MNs, dissolving MNs, coated MNs, and hydrogel-forming MNs.

• Human studies and clinical trials of MNs have demonstrated their features, safety, and efficacy in human beings.

• The applied protocol is suggested as a critical element for successful application and satisfactory delivery of pharmaceutical agents.

• Human studies of MN applications were performed to provide the evidence for patient compliance, acceptability, tolerance, and usability of this unique system.

This box summarizes key points contained in the article.

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

Additional information

Funding

This research was supported by Industrial Strategic Technology Development Program (10067809, Development of vaccine formulation and patient-convenient vaccine microneedle) funded By the Ministry of Trade, Industry & Energy (MOTIE, Korea).