El Bejjaji Sheimah, Ramos-Yacasi Gladys, Domínguez-Villegas Valeri, Chaves Moreira Dos Santos Délia, Braza Antonio, Sosa Lilian, Rodríguez-Lagunas Maria José, Calpena Ana Cristina, Zelaya Mireia, Parra Alexander
Department of Pharmacy, Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.
Facultad de Ciencias Farmacéuticas, Bioquímicas y Biotecnológicas, Universidad Católica de Santa María (UCSM), Arequipa 04001, Peru.
Gels. 2025 Apr 15;11(4):292. doi: 10.3390/gels11040292.
(1) Background: Controlled skin perforations, such as ear tags, piercings, and microdermal implants, induce inflammation and stress in individuals undergoing these procedures. This localized trauma requires care to optimize healing, reduce inflammation, and prevent infections. (2) Methods: Two formulations were developed: an FB-suspension and an FB-gel. Their in vivo efficacy was evaluated, along with drug retention in porcine and human skin after 30 min of administration, chemical stability at different temperatures, cytotoxicity, histological changes induced via transdermal application, and irritative potential, assessed using the HET-CAM assay. (3) Results: Both formulations reduced inflammation when applied 30 min before perforation compared to the positive control. The FB-suspension demonstrated no cytotoxicity and exhibited greater efficacy than the free flurbiprofen solution, highlighting the advantages of using nanoparticle-mediated drug delivery. Moreover, the FB-gel maintained chemical stability for up to 3 months across a temperature range of 4 to 40 °C. Histologically, no significant changes in skin composition were observed. (4) Conclusions: The FB-suspension is viable for both pre- and post-perforation application, as it is a sterile formulation. In contrast, the FB-gel is a convenient and easy application, making it a practical alternative for use in both clinical and veterinary settings.
(1) 背景:可控的皮肤穿孔,如耳标、穿孔和微皮植入物,会在接受这些操作的个体中引发炎症和应激反应。这种局部创伤需要精心护理以优化愈合、减轻炎症并预防感染。(2) 方法:开发了两种制剂:FB悬浮液和FB凝胶。评估了它们的体内疗效,以及给药30分钟后在猪和人皮肤中的药物保留情况、不同温度下的化学稳定性、细胞毒性、经皮应用引起的组织学变化以及使用HET-CAM试验评估的刺激潜力。(3) 结果:与阳性对照相比,两种制剂在穿孔前30分钟应用时均能减轻炎症。FB悬浮液无细胞毒性,且比游离氟比洛芬溶液表现出更高的疗效,突出了使用纳米颗粒介导的药物递送的优势。此外,FB凝胶在4至40°C的温度范围内长达3个月保持化学稳定性。组织学上,未观察到皮肤成分有显著变化。(4) 结论:FB悬浮液作为无菌制剂,在穿孔前后应用均可行。相比之下,FB凝胶使用方便,是临床和兽医环境中实用的替代选择。