2020
DOI: 10.1002/adtp.202000033
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Safety Assessment of Microneedle Technology for Transdermal Drug Delivery: A Review

Abstract: The promising development of the microneedle (MN) drug delivery system has prompted its clinical application as a substitute for traditional hypodermic injection needles. In addition to the satisfactory MN technology design for various application prospects, safety issues during MN use are increasingly an important consideration. This review aims to gather data from published literature regarding safety evaluations on MNs in relation to pain, skin irritation, in vivo degradation, as well as storage stability. … Show more

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Cited by 24 publications
(11 citation statements)
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“…This is usually done by storing MNs and their cargo at various temperatures, including −25 • C, 4 • C, 20 • C, 40 • C and 60 • C, followed by analytical assessments. Generally, the protein cargo of MNs has better storage stability and longer shelf-life due to the rigid glassy microneedle matrices restraining the molecular mobility and limiting access to atmospheric oxygen [74]. This can be further extended by the incorporation of stabilisers, including trehalose and sucrose.…”
Section: Biocompatibility Biodegradability and Stabilitymentioning
confidence: 99%
“…This is usually done by storing MNs and their cargo at various temperatures, including −25 • C, 4 • C, 20 • C, 40 • C and 60 • C, followed by analytical assessments. Generally, the protein cargo of MNs has better storage stability and longer shelf-life due to the rigid glassy microneedle matrices restraining the molecular mobility and limiting access to atmospheric oxygen [74]. This can be further extended by the incorporation of stabilisers, including trehalose and sucrose.…”
Section: Biocompatibility Biodegradability and Stabilitymentioning
confidence: 99%
“…The immunogenicity of the skin makes it a highly sensitive organ for MN vaccine delivery, but MNs could also cause side effects such as mild and temporary erythema to the skin during the insertion process [ 126 ]. This is one of the safety issues that should be considered with all types of MN vaccines.…”
Section: Challenges and Prospects Of Mns Delivery Of Vaccinesmentioning
confidence: 99%
“…Despite the fact that MNs do penetrate the skin, they are labeled “safe” due to their small size. Microneedles’ safety can be assessed by the resultant pain, degree of skin irritation, stability during storage, and in vivo degradation ( 58 ).…”
Section: Microneedles’ Safetymentioning
confidence: 99%