Cutaneous drug delivery system: Drug delivery characteristics by microneedle structure

---

Jung Dong Kim, Jung Hyun Bae, Hong Kee Kim, Chang Yub Sung, Eunjin An, Keun Ho Lee, Moon Su Lee, Boo Yong Lee, Seong Jin Kim and Do Hyeon Jeong

Raphas Co., Ltd., South Korea

: J Pharm Drug Deliv Res

Abstract

---

The microneedle-based transdermal delivery system has been developed to facilitate a minimal invasive self-administration method for cosmetic, medical device and pharmaceutical applications. Most dissolvable microneedles are fabricated by micro-molding method for the last 15 years. Therefore, Raphas developed a droplet-born air blowing (DAB) method that has some advantages in fast and stable fabrication of dissolving microneedles by drying polymer at room temperature in a few minutes. Additionally, DAB method provides precise control of drug dose in the microneedle by controlling dispensing amount. DAB-based dissolving microneedle products are already commercialized in various countries. This study showed the characteristics of 2 different structured dissolvable microneedles, which manufactured in our mass production system. First structure is single-layered microneedle. Second structure is double-layered microneedle. Various ingredients were loaded within these microneedles. The loaded amount of ingredient was analyzed by enzyme-linked immunosorbent assay (ELISA) or HPLC/UV system. Skin permeability of microneedle was confirmed by OCT (optical coherence tomography) and delivered amount of drug into the skin was analyzed using Franz diffusion cell (Logan, FDC-6T). In vivo OCT images clearly showed that whole length of microneedles could penetrate into human skin. In vitro and ex vivo studies using Franz diffusion cell showed excellent delivery efficacy compared to topical solution. DAB technology suggests a way to solve the problems of conventional micro-molding method to fabricate dissolvable microneedle. Based on the method, we have successfully developed mass production system to manufacture microneedle-arrayed patch. We will start clinical trials using this platform technology in this year. Recent Publications 1. Kim J D, Kim M, Yang H, Lee K, Jung H (2013) Droplet-born air blowing: Novel dissolving microneedle fabrication. Journal of controlled release 170:430-436. 2. Kim J H, Shin J U, Kim S H, Noh J Y, Kim H R, Lee J, Chu H, Jeong K Y, Park K H, Kim J D, Kim H K, Jeong D H, Yong T-S, Park J-W, Lee K H (2018) Successful transdermal allergen delivery and allergen-specific immunotherapy using biodegradable microneedle patches Biomaterials 150:38-48. 3. Lee J H, Jung Y S, Kim G M, Bae J M (2018) A hyaluronic acid‐based microneedle patch to treat psoriatic plaques: A pilot open trial. British Journal of Dermatology British Journal of Dermatology 178:e24-e25. 4. Ogundele M, Okafor H K (2017) Transdermal Drug Delivery: Microneedles, Their Fabrication and Current Trends in Delivery Methods. Journal of Pharmaceutical Research International 18:1-14. 5. Sullivan S P, Koutsonanos D G, del Pilar Martin M, Lee J W, Zarnitsyn V, Choi S O, Murthy N, Compans R W, Skountzou I, Prausnitz M R (2010) Dissolving polymer microneedle patches for influenza vaccination. Nature medicine 16:915-920

Biography

---

Jung Dong Kim got a B S and PhD degree in biotechnology from Yonsei University (South Korea). Dr. Kim has joined to Raphas at 2010 for the industrialization of microneedle using Droplet-born Air Blowing technology. And he was a cooperative researcher of Institute of Industrial Science, The University of Tokyo, since 2014 to 2017. He was also a steering committee of International Conference on Microneedles at 2016. He received IR52 Jang Young Sil Award twice from the Minister of Science, ICT and Future at 2016 and Minister of Science and ICT at 2017. His research is focused on the commercialization of dissolvable microneedle technology in cosmetic and medical area. halfmun@raphas.com