PDF(Pubmed)
Abstract：
Nanocomposite gels consist of nanoparticles dispersed in a gel matrix. The main aim of this work was to develop nanocomposite gels for topical delivery of Flurbiprofen (FB) for humans and farm animals. Nanocomposite gels were prepared stemming from nanoparticles (NPs) freeze-dried with two different cryoprotectants, D-(+)-trehalose (NPs-TRE) and polyethylene glycol 3350 (NPs-PEG), sterilized by gamma (γ) irradiation, and gelled with Sepigel® 305. Nanocomposite gels with FB-NPs-TRE and FB-NPs-PEG were physiochemically characterized in terms of appearance, pH, morphological studies, porosity, swelling, degradation, extensibility, and rheological behavior. The drug release profile and kinetics were assessed, as well as, the ex vivo permeation of FB was assessed in human, porcine and bovine skin. In vivo studies in healthy human volunteers were tested without FB to assess the tolerance of the gels with nanoparticles. Physicochemical studies demonstrated the suitability of the gel formulations. The ex vivo skin permeation capacity of FB-NPs nanocomposite gels with different cryoprotectants allowed us to conclude that these formulations are suitable topical delivery systems for human and veterinary medicine. However, there were statistically significant differences in the permeation of each formulation depending on the skin. Results suggested that FB-NPs-PEG nanocomposite gel was most suitable for human and porcine skin, and the FB-NPs-TRE nanocomposite gel was most suitable for bovine skin.
摘要：
纳米复合凝胶由分散在凝胶基质中的纳米颗粒组成。这项工作的主要目的是开发用于人类和农场动物的氟比洛芬（FB）局部递送的纳米复合凝胶。纳米复合凝胶是由两种不同的冷冻保护剂冷冻干燥的纳米颗粒（NP）制备的，D-(+)-海藻糖(NPs-TRE)和聚乙二醇3350(NPs-PEG)，通过γ（γ）辐照灭菌，并用Sepigel®305凝胶化。具有FB-NP-TRE和FB-NP-PEG的纳米复合凝胶在外观方面进行了物理化学表征，pH值,形态学研究,孔隙度,肿胀,降解，可扩展性，和流变行为。评估了药物释放曲线和动力学，还有,在人体内评估FB的离体渗透，猪和牛的皮肤.在没有FB的情况下测试健康人类志愿者的体内研究,以评估具有纳米颗粒的凝胶的耐受性。物理化学研究证明了凝胶制剂的适用性。具有不同冷冻保护剂的FB-NP纳米复合凝胶的离体皮肤渗透能力使我们得出结论，这些制剂是适用于人类和兽医学的局部递送系统。然而,每种制剂的渗透根据皮肤有统计学上的显著差异。结果表明，FB-NPs-PEG纳米复合凝胶最适合人和猪皮肤，FB-NP-TRE纳米复合凝胶最适用于牛皮。
