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A practical guide to the development of microneedle systems - In clinical trials or on the market.

Author information

Affiliations

  • 1. Department of Obstetrics and Gynecology, Korea University Medicine, Seoul 02841, Republic of Korea; Department of Public Health, Korea University Graduate School, Seoul 02841, Republic of Korea.
      Authors
    • Lee KJ 1
    (1 author)
  • 2. College of Pharmacy, Korea University, 2511 Sejong-ro, Sejong 339-700, Republic of Korea.
      Authors
    • Jeong SS 2
    • Roh DH 2
    • Kim DY 2
    • Lee EH 2
    (4 authors)
  • 3. College of Pharmacy, Chosun University, 309 Palmoondae-ro, Gwangju 61452, Republic of Korea.
      Authors
    • Choi HK 3
    (1 author)

ORCIDs linked to this article

International Journal of Pharmaceutics, 31 Oct 2019, 573:118778
https://doi.org/10.1016/j.ijpharm.2019.118778 PMID: 31678394 

Review

Abstract 

Microneedle systems are a rapidly growing and promising technology for delivery of drugs, such as vaccines, small molecules, or biologics and for aesthetic skin treatment in local clinics; however, they remain relatively new from a regulatory perspective. There are strong demands for established procedures, test requirements for approval, and recent trends that industries/researchers related to microneedle systems can refer to. Some microneedle systems are commercially available, many are currently undergoing clinical trials, and some are pending approval for commercialization. This review focuses on microneedle systems that are either on the market or in clinical trials, their applicability and characteristics, and the critical evaluation and test methods necessary for their development and approval.

Full text links 

Read article at publisher's site: https://doi.org/10.1016/j.ijpharm.2019.118778

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Funding 

Funders who supported this work.

College of Pharmacy, Korea University

    Korea University Research Foundation

      Ministry of Food and Drug Safety in 2018 (1)