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

Abstract

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.

Citation

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. https://doi.org/10.1016/j.ijpharm.2022.122234

• 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 BV
• Peer Reviewed: Peer Reviewed
• Volume: 628
• Article Number: 122234
• DOI: https://doi.org/10.1016/j.ijpharm.2022.122234
• Keywords: Microneedles, Diabetes mellitus, Clinical translation, Patient-centred design, Patents, Insulin
• Public URL: https://nottingham-repository.worktribe.com/output/12027858
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S0378517322007888?via%3Dihub