Puri Goswami Kaushal, Jania Rupalben Kaushalkumar, Upadhye Vijay, Sharma Mukesh Chandra, Hassan Salah M S, Alsaidan Omar Awad, Hajare Sunil Tulshiram
Department of Pharmaceutics, Parul Institute of Pharmaceutical Education and Research, Parul University, Ta. Waghodia, Vadodara, Gujarat, 391760, India.
Center of Research for Development (CR4D), Parul Institute of Applied Science (PIAS), Parul University, Vadodara, Gujarat, India.
Sci Rep. 2025 Jul 2;15(1):23335. doi: 10.1038/s41598-025-05982-2.
Diabetic foot problems pose a substantial global health challenge as a major complication of diabetes mellitus. These issues encompass a spectrum of conditions affecting the feet of individuals with diabetes, including neuropathy (nerve damage), peripheral artery disease (impaired blood circulation), foot ulcers, infections, and, in critical situations, amputation. To mitigate the burden of lower extremity amputations, the development of innovative wound dressings and drug delivery systems is crucial. One such advancement is the "lyophilized wafer formulation," a recently developed medicated dressing material known for its rapid healing properties and high exudate absorption capacity in chronic wounds. Following successful completion of assessment tests for lymphatic fluid retention, viscosity, in vitro drug release, FTIR, DSC, and XRD, the exudate absorption capacity of calcium alginate was evaluated in the current study. Notably, the wafer formulation composed of 2% calcium alginate, 1% gelatin (bloom 150), and water as the solvent demonstrated excellent performance across exudate management properties, as well as in FTIR, DSC, XRD, and in vitro drug release assays using a dialysis membrane. This optimal formulation achieved a significant drug release of 96.9 ± 0.1% after 24 h. The Linezolid-loaded calcium alginate wafer formulation exhibited promising outcomes concerning antimicrobial properties, exudate handling, and drug release. Furthermore, the animal study indicated the absence of adverse effects, underscoring the formulation's potential as a safe and effective treatment for diabetic foot ulcers without inducing skin irritation. To fully realize its therapeutic value, comprehensive investigations into its stability profile and detailed pharmacological effects are strongly recommended.
糖尿病足问题作为糖尿病的主要并发症，是一项重大的全球健康挑战。这些问题涵盖了一系列影响糖尿病患者足部的病症，包括神经病变（神经损伤）、外周动脉疾病（血液循环受损）、足部溃疡、感染，以及在危急情况下的截肢。为减轻下肢截肢的负担，开发创新的伤口敷料和药物递送系统至关重要。其中一项进展是“冻干薄片制剂”，这是一种最近开发的药用敷料材料，以其在慢性伤口中的快速愈合特性和高渗液吸收能力而闻名。在成功完成淋巴液潴留、粘度、体外药物释放、傅里叶变换红外光谱（FTIR）、差示扫描量热法（DSC）和X射线衍射（XRD）的评估测试后，本研究评估了海藻酸钙的渗液吸收能力。值得注意的是，由2%海藻酸钙、1%明胶（勃氏硬度150）和水作为溶剂组成的薄片制剂在渗液管理特性以及使用透析膜的FTIR、DSC、XRD和体外药物释放试验中均表现出优异性能。这种最佳制剂在24小时后实现了96.9±0.1%的显著药物释放。载有利奈唑胺的海藻酸钙薄片制剂在抗菌特性、渗液处理和药物释放方面显示出良好的效果。此外，动物研究表明没有不良反应，这突出了该制剂作为一种安全有效的糖尿病足溃疡治疗方法的潜力，且不会引起皮肤刺激。为充分实现其治疗价值，强烈建议对其稳定性概况和详细药理作用进行全面研究。
