Kovács Andrea, Kecskés Bálint Attila, Filipszki Gábor, Farkas Dóra, Tóth Bence, Antal István, Kállai-Szabó Nikolett
Department of Pharmaceutics, Semmelweis University, Hőgyes E. Str. 7-9, 1092 Budapest, Hungary.
Center for Pharmacology and Drug Research & Development, Semmelweis University, 1085 Budapest, Hungary.
Pharmaceutics. 2025 Aug 15;17(8):1063. doi: 10.3390/pharmaceutics17081063.
: The melt-spinning process has seen limited application in the pharmaceutical industry. However, nano- and microfibrous structures show significant potential for novel drug delivery systems, due to their high specific surface area. To facilitate broader adoption in pharmaceutical technology, critical parameters influencing fiber quality and yield must be investigated. In this study, we aimed to develop an isomalt-based microfibrous carrier system for active pharmaceutical ingredients. : The effects of different isomalt compositions-specifically, varying ratios of GPS (6--α-d-glucopyranosyl-d-sorbitol) and GPM (1--α-d-glucopyranosyl-d-mannitol)-as well as key process parameters, were systematically investigated to optimize fiber formation. The prepared fibers underwent different treatments. Morphological changes were monitored with a microscope, and microstructural changes were studied using a differential scanning calorimeter and X-ray diffractometer. The macroscopic behavior of the fibers was evaluated by image analysis under monitored conditions. Statistical analysis was used to determine the optimal setting to produce isomalt-based fibers. We found that storage over ethanol vapor has a positive effect on the stability of the fibers. We successfully prepared ibuprofen sodium-containing fibers that remained stable after alcohol treatment and enabled drug release within 15 s. It was found that the applied GPS:GPM isomalt ratio significantly influenced fiber formation and that storage over ethanol positively influenced the processability and stability of the fibrous structure. An isomalt-based microfibrous system with advantageous physicochemical and structural properties was successfully developed as a potential drug carrier. The system is also resistant to the destructive effects of ambient humidity, enabling preparation of suitable dosage forms.
熔融纺丝工艺在制药行业的应用有限。然而，纳米和微纤维结构因其高比表面积，在新型药物递送系统中显示出巨大潜力。为了促进其在制药技术中的更广泛应用，必须研究影响纤维质量和产量的关键参数。在本研究中，我们旨在开发一种用于活性药物成分的基于异麦芽酮糖醇的微纤维载体系统。系统研究了不同异麦芽酮糖醇组成（具体为GPS（6-α-D-吡喃葡萄糖基-D-山梨醇）和GPM（1-α-D-吡喃葡萄糖基-D-甘露糖醇）的不同比例）以及关键工艺参数对纤维形成的影响，以优化纤维形成。制备的纤维经过不同处理。用显微镜监测形态变化，并用差示扫描量热仪和X射线衍射仪研究微观结构变化。在监测条件下通过图像分析评估纤维的宏观行为。采用统计分析确定生产基于异麦芽酮糖醇纤维的最佳设置。我们发现，在乙醇蒸气中储存对纤维的稳定性有积极影响。我们成功制备了含布洛芬钠的纤维，其在乙醇处理后保持稳定，并能在15秒内实现药物释放。结果发现，所应用的GPS:GPM异麦芽酮糖醇比例显著影响纤维形成，且在乙醇中储存对纤维结构的可加工性和稳定性有积极影响。成功开发了一种具有有利物理化学和结构性质的基于异麦芽酮糖醇的微纤维系统作为潜在的药物载体。该系统还能抵抗环境湿度的破坏作用，从而能够制备合适的剂型。
