Department of Pharmaceutics and Pharmaceutical Technology, Institute of Pharmacy, Nirma University, Ahmedabad, 382481, India.
Drug Deliv Transl Res. 2020 Aug;10(4):1032-1043. doi: 10.1007/s13346-020-00730-7.
The study focuses on the in vitro and in vivo evaluation of the developed gentamicin sulphate (GS)-loaded poly lactic-co-glycolic acid (PLGA) nanoparticle (PNP)-based pullulan film (PNP-F). Sterilization being an essential pre-requisite for the dosage form was carried out using ethylene oxide. Post-sterilization, PNP-F was evaluated for mechanical properties, percentage drug loading, antimicrobial effectiveness study, test for sterility and in vitro dissolution study using Strat-M® membrane. In vitro dissolution study revealed that GS gradually released from PNP-F and the highest cumulative percentage drug release was found to be 86.76 ± 0.03% at 192 h. Wound healing assay was performed to study the effect of PNP-F over migratory potential of dermal fibroblast cells (NIH-3T3) in the presence of micro-organisms, Pseudomonas aeruginosa (PA) and Staphylococcus aureus (SA). PNP-F inhibited the growth of PA and SA, allowing the growth of fibroblast cells indicating its suitability for application. In vivo study of surgical site was performed by superficial incision model in Wistar rats. Measurement of in vivo incision healing confirmed faster wound healing in the incision which received PNP-F compared to marketed cream containing GS. Graphical abstract.
本研究专注于硫酸庆大霉素(GS)负载聚乳酸-共-羟基乙酸(PLGA)纳米颗粒(PNP)基于普鲁兰多糖薄膜(PNP-F)的体外和体内评价。作为剂型的基本前提,采用环氧乙烷进行灭菌。灭菌后,对 PNP-F 的机械性能、药物载量百分比、抗菌效果研究、无菌性测试和使用 Strat-M®膜的体外溶解研究进行了评估。体外溶解研究表明,GS 逐渐从 PNP-F 中释放出来,在 192 小时时发现最高累积药物释放百分比为 86.76±0.03%。进行了伤口愈合测定,以研究在微生物(铜绿假单胞菌(PA)和金黄色葡萄球菌(SA))存在下,PNP-F 对真皮成纤维细胞(NIH-3T3)迁移潜力的影响。PNP-F 抑制了 PA 和 SA 的生长,允许成纤维细胞生长,表明其适合应用。通过 Wistar 大鼠的浅表切口模型进行了手术部位的体内研究。体内切口愈合测量证实,与含有 GS 的市售乳膏相比,接受 PNP-F 的切口的愈合更快。图表摘要。