Docetaxel (DTX) finds extensive use in treating various cancers, but its limited solubility, side effects, and multi-drug resistance (MDR) hinder its effectiveness. To enhance DTX's properties, the study aimed to formulate DTX-loaded mixed micelles (MMs) and evaluate their anticancer potential using Quality by Design (QbD) approach. Using solvent evaporation, DTX-loaded MMs were prepared and optimized via a 32 full factorial design. The optimized formulation (R5) displayed a % entrapment efficiency (%EE) of 74.81 ± 4.27%, % drug loading capacity (%DLC) of 29.27 ± 0.70%, and mean particle size (MPS) of 71.4 ± 1.24 nm. TEM images confirmed well-dispersed spherical MMs. Analytical studies (IR, DSC, and P-XRD) showed no adverse drug-excipient interactions. The MMs were converted into vacuum foam-dried (VFD) products for enhanced stability. The optimized VFD products exhibited low residual moisture, rapid reconstitution, consistent drug content, and high %EE. Notably, sustained drug release from the VFD product reduced hemolysis and in vitro cytotoxicity against B16F10 melanoma cells. This study creatively tackled DTX's challenges through targeted MM development, transformed them into VFD products, demonstrating the potential for melanoma treatment. The QbD approach ensures the formulation’s safety, efficacy, and quality, underscoring the promising VFD technology and multifunctionality of mixed micelles.

中文翻译：

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开发负载多西紫杉醇 (Soluplus®–PF108) 混合胶束真空泡沫干燥产品，通过 QbD 方法提高稳定性和黑色素瘤治疗

多西他赛 (DTX) 广泛用于治疗各种癌症，但其有限的溶解度、副作用和多重耐药性 (MDR) 阻碍了其有效性。为了增强 DTX 的特性，该研究旨在配制负载 DTX 的混合胶束 (MM)，并使用质量源于设计 (QbD) 方法评估其抗癌潜力。使用溶剂蒸发，通过 32 全因子设计制备并优化负载 DTX 的 MM。优化制剂 (R5) 的包封率 (%EE) 为 74.81 ± 4.27%，载药量 (%DLC) 为 29.27 ± 0.70%，平均粒径 (MPS) 为 71.4 ± 1.24 nm。 TEM 图像证实了分散良好的球形 MM。分析研究（IR、DSC 和 P-XRD）显示没有不良的药物-辅料相互作用。 MM 被转化为真空泡沫干燥 (VFD) 产品以增强稳定性。优化后的 VFD 产品表现出低残留水分、快速重构、一致的药物含量和高 %EE。值得注意的是，VFD 产品的持续药物释放减少了溶血和针对 B16F10 黑色素瘤细胞的体外细胞毒性。这项研究通过有针对性的MM开发创造性地解决了DTX的挑战，将其转化为VFD产品，展示了黑色素瘤治疗的潜力。 QbD 方法确保了配方的安全性、有效性和质量，强调了 VFD 技术和混合胶束的多功能性的前景。