Yun Taek-Seon, Na Young-Guk, Baek Jong-Suep, Lee Hong-Ki, Cho Cheong-Weon
College of Pharmacy, Chungnam National University, 99 Daehak-ro, Yuseong-gu, Daejeon 34134, Republic of Korea.
Department of Bio-Health Convergence, Kangwon National University, Chuncheon 24341, Republic of Korea; Department of Herbal Medicine Resource, Kangwon National University, 346 Hwangjo-gil, Dogye-eup, Samcheok-si, Gangwon-do 25949, Republic of Korea.
Biomed Pharmacother. 2025 Sep;190:118368. doi: 10.1016/j.biopha.2025.118368. Epub 2025 Jul 17.
Carfilzomib (CFZ) is a potent second-generation proteasome inhibitor that blocks the ubiquitin-proteasome pathway, inducing apoptosis in cancer cells. Currently, commercially available CFZ formulations contain large amounts of excipients, require intravenous (IV) infusion, and have a short half-life of less than 1 h. Recent research trends have focused on developing alternative CFZ formulations to address these limitations; however, all attempts thus far have been restricted to injectable formulations. In this study, we developed a self-nanoemulsifying drug delivery system (SNEDDS) containing CFZ based on a Quality by Design (QbD) approach (CFZ-SN) to enhance the oral bioavailability of CFZ. The uniform, nanosized CFZ-SN droplets exhibited significantly improved water solubility and drug release profiles compared to raw CFZ. Furthermore, CFZ encapsulated in the optimized droplets demonstrated stability against enzymatic and lipolytic degradation in vivo. The uptake and permeation of CFZ-SN in enterocytes were notably enhanced through inhibition of the P-glycoprotein (P-gp) efflux pump. Additionally, CFZ-SN significantly increased cellular uptake and proteasome inhibition in cancer cells. Overall, our findings suggest that CFZ-SN has the potential to enable oral administration of CFZ, offering a promising alternative to existing injectable formulations.
卡非佐米(CFZ)是一种强效的第二代蛋白酶体抑制剂,可阻断泛素-蛋白酶体途径,诱导癌细胞凋亡。目前,市售的CFZ制剂含有大量辅料,需要静脉输注,且半衰期短,不到1小时。最近的研究趋势集中在开发替代CFZ制剂以解决这些局限性;然而,迄今为止所有尝试都局限于注射剂剂型。在本研究中,我们基于质量源于设计(QbD)方法开发了一种含CFZ的自纳米乳化药物递送系统(SNEDDS)(CFZ-SN),以提高CFZ的口服生物利用度。与未加工的CFZ相比,均匀的纳米级CFZ-SN液滴表现出显著改善的水溶性和药物释放曲线。此外,包裹在优化液滴中的CFZ在体内对酶解和脂解降解具有稳定性。通过抑制P-糖蛋白(P-gp)外排泵,CFZ-SN在肠细胞中的摄取和渗透显著增强。此外,CFZ-SN显著增加了癌细胞中的细胞摄取和蛋白酶体抑制作用。总体而言,我们的研究结果表明CFZ-SN有潜力实现CFZ的口服给药,为现有的注射剂剂型提供了一种有前景的替代方案。