a Department of Pharmaceutics, School of Pharmaceutical Education and Research , Jamia Hamdard , New Delhi , India.
b Nano Biotech Lab, Department of Zoology, Kirori Mal College , University of Delhi , Delhi , India.
Drug Dev Ind Pharm. 2019 Jul;45(7):1181-1192. doi: 10.1080/03639045.2019.1602139. Epub 2019 Apr 21.
The aim of this investigation is the management of rheumatoid arthritis (RA) by developing methotrexate-loaded calcium phosphate nanoparticles (MTX-CAP-NP) and to evaluate pharmacokinetic and pharmacodynamic behavior in adjuvant induced arthritis model. The nanoparticles were synthesized by wet precipitation method and optimized by Box-Behnken experimental design. MTX-CAP-NPs were characterized by TEM, FTIR, DSC and XRD studies. The particle size, zeta potential and entrapment efficiency of the optimized nanoparticles were found to be 204.90 ± 64 nm, -11.58 ± 4.80 mV, and 88.33 ± 3.74%, respectively. TEM, FTIR, DSC and XRD studies revealed that the developed nanoparticles were nearly spherical in shape and the crystalline structure of CAP-NP was not changed after MTX loading. The pharmacokinetic studies revealed that MTX-CAP-NP enhanced bioavailability of MTX by 2.6-fold when compared to marketed formulation (FOLITRAX-10). Under pharmacodynamic evaluation, arthritic assessment, radiography and histopathology studies revealed that CAP has ability to regenerate cartilage and bone therefore, together with MTX, MTX-CAP-NPs have shown significant reduction in disease progression. The overall work demonstrated that the developed nanodelivery system was well tolerated and more effective than the marketed formulation.
本研究旨在通过制备甲氨蝶呤载钙磷纳米粒(MTX-CAP-NP)来治疗类风湿关节炎(RA),并在佐剂诱导关节炎模型中评价其药代动力学和药效学行为。采用湿沉淀法制备纳米粒,并通过 Box-Behnken 实验设计进行优化。通过 TEM、FTIR、DSC 和 XRD 研究对 MTX-CAP-NP 进行了表征。优化后的纳米粒的粒径、Zeta 电位和包封率分别为 204.90±64nm、-11.58±4.80mV 和 88.33±3.74%。TEM、FTIR、DSC 和 XRD 研究表明,所制备的纳米粒呈近球形,载药后 CAP-NP 的晶体结构未发生变化。药代动力学研究表明,与市售制剂(FOLITRAX-10)相比,MTX-CAP-NP 使 MTX 的生物利用度提高了 2.6 倍。在药效学评价中,关节炎评估、放射学和组织病理学研究表明,CAP 具有再生软骨和骨的能力,因此,MTX-CAP-NP 与 MTX 联合使用可显著减缓疾病进展。综上所述,该递药系统具有良好的耐受性,且比市售制剂更有效。