Materials Reports  2021, Vol. 35 Issue (z2): 593-599 |
| POLYMERS AND POLYMER MATRIX COMPOSITES |
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| Optimization of Preparation Process of Dissolving Microneedles by Plackett-Burman Design and Response Surface Analysis |
| LIU Zhe, LIU Yong, GAO Guangzhi, LI Qigui, BAO Yangyang, MA Fengsen
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| Laboratory of Biologicals and Biomaterials, College of Pharmacy, Zhejiang University of Technology, Hangzhou 310014, China |
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Abstract The aim of this study was to explore the influence of preparation process on the mechanical, puncture and moisture absorption perfor-mance of dissolving microneedles, and optimize the preparation process. The Plackett-Burman design was adopted to screen the major influential factors, then the preparation process of microneedles was optimized by Box-Behnken design-response surface methodology. 3D microscope and scanning electron microscope were used to observe the morphological appearance of the microneedles. The puncture perfor-mance was examined by parafilm puncturing method, the moisture absorption performance was calculated by weighing method, and a texture analyzer was applied to investigate the mechanical properties, the feasibility of microneedles puncturing into the skin was verified by histological sections. The results showed that the ratio of tough and brittle material of the microneedles (P=0.002 3), the percentage of the drug (P=0.007 5), dry temperature (P=0.001 3), air velocity (P=0.002 7) and centrifugal time (P=0.002 8) had a significant effect on the puncture performance, the ratio of tough and brittle material (P=0.017 7) had a significant effect on the mechanical properties, and various parameters in the test had no significant in-fluence on the moisture absorption performance. The optimal preparation process parameters of microneedles was as follows, the ratio of the tough and brittle material was 9,50, the percentage of drug was 6.0%, the percentage of solvent was 60%, centrifugal speed was 4 000 r/min, centrifugal time was 28 min, centrifugal temperature was 25 ℃, drying temperature was 38 ℃, drying humidity was 10%, air velocity was 0.5 L·min-1, the puncture depth of the microneedles was (412.03±2.85) μm, the deviation between the verification values and the predicted value was less than 1%. The force of the optimal microneedles can reach 1.3 N/needle, which can successfully puncture the stratum corneum.
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Published: 09 December 2021
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| Fund:This work was financially supported by the Key Science and Technology Innovation Team of Zhejiang Province (2013TD15) |
About author:: Zhe Liu received his B.S. degree in pharmacy from the Hebei University of Technology in 2019. He is currently pursuing his M.S. at College of Pharmaceutical Science, Zhejiang University of Technology (ZJUT) under the supervision of Prof. Fengsen Ma. His research has focused on the preparation process of dissolving microneedles and delivery of vaccines.
Fengsen Ma obtained his M.E. degree from Zhejiang University. He is currently a professor and PhD supervisor of Zhejiang University of Technology (ZJUT). He is the principal person in charge of the two professional committees including biopharmaceuticals and medical devices. His laboratory has been engaged in the research and development of novel transdermal preparations, biopharmaceuticals and biological materials for many years. |
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