Design of three-section microneedle towards low insertion force and high drug delivery amount using the finite element method

A microneedle has been greatly recognized as one of the most promising devices for novel transdermal drug delivery system due to its capacity of piercing the protective stratum corneum with a minimally invasive and painless manner. During the past two decades, although numerous achievements have been made in the structure and material combination of microneedles, they mostly focus on the pharmacology and functionality of microneedles, and little is reported about how to design the shape of microneedles to reduce insertion force and especially improve penetration efficiency. Using the developed finite element method, we designed three-section microneedles (TSMN) with various sizes and evaluated their maximum insertion force, penetration efficiency, drug delivery amount and strength. The simulation results demonstrate that the well-designed TSMN with shaft width of 60 mu m exhibits a lower maximum insertion force of 116.68 mN relative to 167.92 mN of conical microneedle and an effective penetration length of 81.6% relative to 71.38% of conical microneedle. Besides, the optimized TSMN with shaft width of 80 mu m shows similar maximum insertion force and 2.3 times the drug delivery amount compared to conical microneedle. These excellent properties are attributed to the optimized design of the shape curve of TSMN sidewall. Such results may provide an inspiration of microneedle design for low insertion force and high penetration efficiency.