Airis PHARMA PVT LTD, ALEAP Industrial Area, Gajularamaram, Hyderabad, Telangana, India.
Department of Pharmacy & Pharmacology, School of medicine, University of Tasmania, Hobart, Australia.
Recent Pat Nanotechnol. 2022;16(3):235-249. doi: 10.2174/1872210515666210531112006.
The present study aims to develop and characterize simvastatin niosomal film for effective buccal delivery.
Simvastatin niosomes were developed by film hydration technique followed by highpressure homogenization using chiller at 5°C. The simvastatin niosomes were characterized for various physicochemical parameters, and simvastatin plain and niosomal films were prepared using PEO as the base by solvent casting technique.
From the simvastatin niosomes suspension, the percentage assay was found in the range of 96% to 103%, particles size was found in the range of 112nm to 308nm, the zeta potential was found in the range of -9mV to -25.8mV, the %EE was found in the range of 28% to 91% and the in vitro permeation was found in the range of 43.41% to 98% respectively. The niosomal film shown superior results as compared to simvastatin plain film. The FTIR and DSC confirm the compatibility among the existed excipients.
Niosomes alter the physicochemical properties of simvastatin by the buccal route. The prolonged permeation (96.12% up to 24hrs) of simvastatin was observed from niosomes film across the porcine buccal cavity due to the presence of CPE in the composition, which would be useful for effective buccal delivery.
本研究旨在开发并表征辛伐他汀的脂质体膜，以实现有效的经口腔给药。
采用薄膜水化法制备辛伐他汀脂质体，然后在 5°C 的制冷器中进行高压匀质。对辛伐他汀脂质体进行各种理化参数的表征，并采用 PEO 作为基质，通过溶剂浇铸技术制备辛伐他汀普通膜和脂质体膜。
从辛伐他汀脂质体混悬液中，发现含量在 96%至 103%之间，粒径在 112nm 至 308nm 之间，Zeta 电位在-9mV 至-25.8mV 之间，%EE 在 28%至 91%之间，体外渗透在 43.41%至 98%之间。脂质体膜的结果优于辛伐他汀普通膜。FTIR 和 DSC 证实了存在的赋形剂之间的相容性。
脂质体通过经口腔途径改变了辛伐他汀的理化性质。由于组合物中存在 CPE，辛伐他汀脂质体膜的渗透时间延长（24 小时内达到 96.12%），这将有助于有效的经口腔给药。
