Department of Electronics and Communication Engineering, Sri Sivasubramaniya Nadar College of Engineering, Kalavakkam, Tamil Nadu, 603110, India.
Drug Deliv Transl Res. 2023 Jun;13(6):1813-1827. doi: 10.1007/s13346-023-01296-w. Epub 2023 Feb 20.
Microneedle-based transdermal drug delivery into the skin has gained attraction for the past few years. An affordable and effective fabrication methodology is required for the development of micron size needle. Manufacturing cost-effective microneedle patches in batch production is a challenging process. In this work, we proposed a cleanroom-free technique for fabrication of conical and pyramidal geometry of microneedle array for transdermal drug delivery. Using the COMSOL Multiphysics tool, the mechanical strength of the designed microneedle array under axial, bending, and buckling loads for the geometries during skin insertion was investigated. A CO laser and polymer molding technique are used to fabricate 10 × 10 designed microneedle array structure. On an acrylic sheet, a designed pattern is engraved to produce a 20 mm × 20 mm sharp conical and pyramidal shape master mold. We successfully created a biocompatible polydimethylsiloxane (PDMS) microneedle patch with an average height of 1200 µm, base diameter of 650 µm, and a tip diameter of 50 µm using acrylic master mold. According to structural simulation analysis, the microneedle array will experience resultant stress that is within a safe range. The mechanical stability of the fabricated microneedle patch was investigated using hardness test and universal testing machine. The depth of penetration studies were performed in an in vitro Parafilm M model by manual compression tests and its detailed insertion depth was reported. The developed master mold is efficient to replicate several polydimethylsiloxane microneedle patches. The proposed combined method of laser processing and molding mechanism is simple and low-cost for rapid prototyping of microneedle array.
基于微针的经皮药物递送至皮肤在过去几年中受到了关注。需要一种经济实惠且有效的制造方法来开发微尺寸针。批量生产具有成本效益的微针贴片是一个具有挑战性的过程。在这项工作中，我们提出了一种无洁净室的技术，用于制造用于经皮药物传递的锥形和金字塔形微针阵列。使用 COMSOL Multiphysics 工具，研究了设计的微针阵列在轴向、弯曲和屈曲载荷下的机械强度，以及在皮肤插入过程中的几何形状。使用 CO 激光和聚合物成型技术来制造 10×10 个设计的微针阵列结构。在丙烯酸片上，刻有设计图案以产生 20×20 毫米的锋利锥形和金字塔形主模具。我们成功地使用丙烯酸主模具制造了具有平均高度为 1200 微米、基底直径为 650 微米和尖端直径为 50 微米的生物相容性聚二甲基硅氧烷（PDMS）微针贴片。根据结构模拟分析，微针阵列将经历在安全范围内的总应力。使用硬度测试和万能试验机研究了制造的微针贴片的机械稳定性。通过手动压缩测试在体外 Parafilm M 模型中进行了穿透深度研究，并报告了其详细的插入深度。开发的主模具可有效地复制多个聚二甲基硅氧烷微针贴片。激光加工和成型机制的组合方法简单且成本低廉，适用于微针阵列的快速原型制作。
