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; applied protocol; clinical trials; efficacy; human study; safety.