1)Laboratory of Biologicals and Biomaterials, College of Pharmacy, Zhejiang University of Technology, Hangzhou 310014, China;2)Hangzhou Yesskin Medical Beauty Clinic Xinya Branch, Hangzhou 310015, China;3)College of Mechanical Engineering, Zhejiang University of Technology, Hangzhou 310023, China
This work was supported by a grant from The Key Science and Technology Innovation Team of Zhejiang Province (2013TD15).
The force, speed and depth of microneedle array penetration process are usually used to evaluate the degree and efficiency of its penetration into the skin.The skin is the basis of its performance evaluation. The physical properties of the skin are mainly determined by the combination of keratin filaments, collagen fibers, elastic fibers and subcutaneous tissues, and reflect its impact on microneedle penetration from dimensions such as thickness, elasticity, hardness and toughness. Mechanical, permeable, tissue and barrier skin models are used to explain and simulate this aspect of real skin functions. Similarly, various skin mechanics models including constitutive models established after skin mechanics analysis also analyze the mechanical characteristics of the skin from the physical dimension. Real skin is complicated, with large differences, difficult access and storage, and some ethical issues. Skin model can replace real skin assisted to a certain extent for the design, development and performance evaluation of microneedle delivery system. The material involved in the model may be different from the physical properties of the real skin, it cannot fully simulate the chemical composition and distribution of the real skin, the tissue structure, and the interaction between the skin tissue and other tissues. However, the skin model can be easily adjusted by changing those characteristic materials comparable to the skin and form a simulation system. As for microneedle evaluation, it is more necessary to consider the mechanical properties of the skin and the skin model. The skin model needs to have a surface barrier that is difficult to puncture like the stratum corneum, and the hardness, elasticity and toughness under the barrier are similar to the real skin to simulate the reaction force after the microneedle penetration. In these aspects, the simulation of a single performance is relatively easy to achieve, but it is not easy to achieve a comprehensive performance similar to the real skin. The application of advanced methods with higher resolution, accurate quantitative and real-time dynamic evaluation of the penetration force and penetration rate of microneedle puncture can help us systematically and accurately analyze microneedle penetration behavior, and the development and application of 3D skin tissue engineering products that are closer to the composition, structure and physical properties of real skin can provide an effective solution path to help establish a more economical and applicable skin model. The establishment of a standardized evaluation model will undoubtedly help advance related research and promote the better industrialization and commercial application of microneedle array technology. In addition, the inherent hardness difference caused by different materials constructed by microneedles, such as metal, monocrystalline silicon and polymer materials, may have a corresponding difference in the penetration rate and penetration depth of real skin or skin model, but this can be solved by providing differentiated judgment methods for different rigid microneedles and formulating different indicators when setting skin model. Therefore, there is no need to design a special skin model to evaluate the puncture behavior of different microneedle.
WANG Yuan, MA Feng-Sen, WANG Yan-Ni, XIU Xue-Liang, LIU Yong, SONG Wei-Min, HU Xia-Xia. Skin Models and Its Related Evaluation of Microneedle Puncture Performance[J]. Progress in Biochemistry and Biophysics,2022,49(8):1406-1421
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