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The clinical and translational prospects of microneedle devices, with a focus on insulin therapy for diabetes mellitus as a case study

Smith, Fiona; Sabri, Akmal H.; Heppel, Matthew; Fonseca, Ines; Chowdhury, Faz; Cheung, Karmen; Willmor, Stephen; Rawson, Frankie; Marlow, Maria


Fiona Smith

Akmal H. Sabri

Matthew Heppel

Ines Fonseca

Faz Chowdhury

Karmen Cheung

Stephen Willmor


Microneedles have the clinical advantage of being able to deliver complex drugs across the skin in a convenient and comfortable manner yet haven't successfully transitioned to medical practice. Diabetes mellitus is a complicated disease, which is commonly treated with multiple daily insulin injections, contributing to poor treatment adherence. Firstly, this review determines the clinical prospect of microneedles, alongside considerations that ought to be addressed before microneedle technology can be translated from bench to bedside. Thereafter, we use diabetes as a case study to consider how microneedle-based-technology may be successfully harnessed. Here, publications referring to insulin microneedles were evaluated to understand whether insertion efficiency, angle of insertion, successful dose delivery, dose adjustability, material biocompatibility and therapeutic stability are being addressed in early stage research. Moreover, over 3,000 patents from 1970 to 2019 were reviewed with the search term '"microneedle" AND "insulin"' to understand the current status of the field. In conclusion, the reporting of early stage microneedle research demonstrated a lack of consistency relating to the translational factors addressed. Additionally, a more rational design, based on a patient-centred approach is required before microneedle-based delivery systems can be used to revolutionise the lives of people living with diabetes following regulatory approval.


Smith, F., Sabri, A. H., Heppel, M., Fonseca, I., Chowdhury, F., Cheung, K., …Marlow, M. (2022). The clinical and translational prospects of microneedle devices, with a focus on insulin therapy for diabetes mellitus as a case study. International Journal of Pharmaceutics, 628, Article 122234.

Journal Article Type Article
Acceptance Date Sep 21, 2022
Online Publication Date Oct 13, 2022
Publication Date Nov 25, 2022
Deposit Date Oct 4, 2022
Publicly Available Date Oct 5, 2022
Journal International journal of pharmaceutics
Print ISSN 0378-5173
Electronic ISSN 1873-3476
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 628
Article Number 122234
Keywords Microneedles, Diabetes mellitus, Clinical translation, Patient-centred design, Patents, Insulin
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