Pharmaceutical Engineering and 3D Printing (PharmE3D) Lab, Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Mississippi 38677-1848, United States.
Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, Texas 78712, United States.
Mol Pharm. 2024 Feb 5;21(2):916-931. doi: 10.1021/acs.molpharmaceut.3c00982. Epub 2024 Jan 18.
Electrospinning has become a widely used and efficient method for manufacturing nanofibers from diverse polymers. This study introduces an advanced electrospinning technique, Xspin - a multi-functional 3D printing platform coupled with electrospinning system, integrating a customised 3D printhead, MaGIC - Multi-channeled and Guided Inner Controlling printheads. The Xspin system represents a cutting-edge fusion of electrospinning and 3D printing technologies within the realm of pharmaceutical sciences and biomaterials. This innovative platform excels in the production of novel fiber with various materials and allows for the creation of highly customized fiber structures, a capability hitherto unattainable through conventional electrospinning methodologies. By integrating the benefits of electrospinning with the precision of 3D printing, the Xspin system offers enhanced control over the scaffold morphology and drug release kinetics. Herein, we fabricated a model floating pharmaceutical dosage for the dual delivery of curcumin and ritonavir and thoroughly characterized the product. Fourier transform infrared (FTIR) spectroscopy demonstrated that curcumin chemically reacted with the polymer during the Xspin process. Thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC) confirmed the solid-state properties of the active pharmaceutical ingredient after Xspin processing. Scanning electron microscopy (SEM) revealed the surface morphology of the Xspin-produced fibers, confirming the presence of the bifiber structure. To optimize the quality and diameter control of the electrospun fibers, a design of experiment (DoE) approach based on quality by design (QbD) principles was utilized. The bifibers expanded to approximately 10-11 times their original size after freeze-drying and effectively entrapped 87% curcumin and 84% ritonavir. release studies demonstrated that the Xspin system released 35% more ritonavir than traditional pharmaceutical pills in 2 h, with curcumin showing complete release in pH 1.2 in 5 min, simulating stomach media. Furthermore, the absorption rate of curcumin was controlled by the characteristics of the linked polymer, which enables both drugs to be absorbed at the desired time. Additionally, multivariate statistical analyses (ANOVA, pareto chart, etc.) were conducted to gain better insights and understanding of the results such as discern statistical differences among the studied groups. Overall, the Xspin system shows significant potential for manufacturing nanofiber pharmaceutical dosages with precise drug release capabilities, offering new opportunities for controlled drug delivery applications.
静电纺丝已成为一种广泛使用且高效的方法,可用于从各种聚合物制造纳米纤维。本研究介绍了一种先进的静电纺丝技术,即 Xspin——一种多功能的 3D 打印平台,与静电纺丝系统相结合,集成了定制的 3D 打印头 MaGIC——多通道和引导内部控制打印头。Xspin 系统代表了制药科学和生物材料领域中静电纺丝和 3D 打印技术的融合。该创新平台在生产具有各种材料的新型纤维方面表现出色,并能够创建高度定制的纤维结构,这是传统静电纺丝方法无法实现的能力。通过将静电纺丝的优势与 3D 打印的精度相结合,Xspin 系统提供了对支架形态和药物释放动力学的增强控制。在此,我们为姜黄素和利托那韦的双重递送制造了一种模型漂浮药物剂量,并对该产品进行了全面表征。傅里叶变换红外(FTIR)光谱表明,姜黄素在 Xspin 过程中与聚合物发生了化学反应。热重分析(TGA)和差示扫描量热法(DSC)证实了 Xspin 处理后活性药物成分的固态性质。扫描电子显微镜(SEM)揭示了 Xspin 生产的纤维的表面形态,证实了双纤维结构的存在。为了优化静电纺丝纤维的质量和直径控制,采用基于质量源于设计(QbD)原理的实验设计(DoE)方法。双纤维在冷冻干燥后膨胀约 10-11 倍,有效地包封了 87%的姜黄素和 84%的利托那韦。释放研究表明,与传统的药物丸相比,Xspin 系统在 2 小时内释放了 35%更多的利托那韦,姜黄素在模拟胃介质的 pH 值 1.2 下在 5 分钟内完全释放。此外,通过链接聚合物的特性控制姜黄素的吸收速率,从而使两种药物都能在所需时间内被吸收。此外,进行了多元统计分析(ANOVA、pareto 图等),以更好地了解结果,例如辨别研究组之间的统计差异。总体而言,Xspin 系统在制造具有精确药物释放能力的纳米纤维药物剂量方面具有显著的潜力,为控制药物释放应用提供了新的机会。