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A novel scalable fabrication process for the production of dissolving microneedle arrays

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Abstract

Microneedle arrays have emerged as an alternative method for transdermal drug delivery. Although micromolding using a centrifugation method is widely used to prepare microneedles in laboratory, few researchers were focused on manufacturing processes capable of facile scale-up. A novel female mold was initially designed in this study, namely double-penetration female mold (DPFM) with the pinpoints covered by waterproof breather membrane which was beneficial to reduce the influence of gas resistance and solution viscosity. In addition, DPFM-based positive-pressure microperfusion technique (PPPT) was proposed for the scale-up fabrication of dissolving microneedle arrays (DMNA). In this method, polymer solution and base solution were poured into the DPFM by pressure difference, followed by drying and demolding. The results of optimal microscopy and SEM revealed that the obtained microneedles were uniformly distributed conical-shaped needles. The skin penetration test showed that DMNA prepared using PPPT were able to penetrate the rat skin with a high penetration rate. To realize the transition of microneedles fabrication from laboratory to industry, an automatic equipment was further designed in this study. Different from micromolding method using centrifugation, the equipment based on PPPT and DPFM has superiorities in the scale-up fabrication of microneedles in a highly effective, controllable, and scalable way.

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Funding

The authors appreciate financial support from the National Natural Science Foundation of China (81502994), the Natural Science Foundation of Guangdong Province (2016A030312013), and the Natural Science Foundation of Anhui Province (1608085QH179).

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Author notes

  1. Hangping Chen and Biyuan Wu contributed equally to this work.

Authors and Affiliations

  1. School of Pharmaceutical Sciences, Sun Yat-sen University, 132 East Circle at University Town, Guangzhou, 510006, China

    Hangping Chen, Biyuan Wu, Minmin Zhang, Peipei Yang, Beibei Yang, Wanbing Qin, Guilan Quan, Xin Pan & Chuanbin Wu

  2. Department of Pharmacy, Bengbu Medical College, Bengbu, 233030, China

    Qingqing Wang

  3. Guangzhou Neworld Micnanobio Pharmatech Co. Ltd, Guangzhou, 510006, China

    Xinguo Wen

  4. Institute of Chinese Medical Sciences, University of Macau, Macau, China

    Meiwan Chen

Authors
  1. Hangping Chen
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  2. Biyuan Wu
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  3. Minmin Zhang
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  4. Peipei Yang
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  5. Beibei Yang
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  7. Qingqing Wang
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  8. Xinguo Wen
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  9. Meiwan Chen
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  10. Guilan Quan
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Correspondence to Guilan Quan.

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Chen, H., Wu, B., Zhang, M. et al. A novel scalable fabrication process for the production of dissolving microneedle arrays. Drug Deliv. and Transl. Res. 9, 240–248 (2019). https://doi.org/10.1007/s13346-018-00593-z

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  • DOI: https://doi.org/10.1007/s13346-018-00593-z

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