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用于治疗小儿哮喘的含泼尼松龙纳米颗粒口腔崩解片的研发。

Development of oral dispersible tablets containing prednisolone nanoparticles for the management of pediatric asthma.

作者信息

Chen Yi-Dan, Liang Zhong-Yuan, Cen Yan-Yan, Zhang He, Han Mei-Gui, Tian Yun-Qiao, Zhang Jie, Li Shu-Jun, Yang Da-Sheng

机构信息

College of Pharmacy, The Third Military Medical University, Chongqing, People's Republic of China.

Department of Pediatrics, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, People's Republic of China.

出版信息

Drug Des Devel Ther. 2015 Nov 20;9:5815-25. doi: 10.2147/DDDT.S86075. eCollection 2015.

Abstract

The purpose of the present study was to develop oral dispersible tablets containing prednisolone (PDS)-loaded chitosan nanoparticles using microcrystalline cellulose (MCC 101), lactose, and croscarmellose sodium (CCS). The PDS-loaded chitosan nanoparticles were formulated by ionotropic external gelation technique in order to enhance the solubility of PDS in salivary pH. Prepared nanoparticles were used for the development of oral fast disintegrating tablets by direct compression method. The prepared tablets were evaluated for disintegration time (DT), in vitro drug release (DR), thickness, weight variation, drug content uniformity, friability, and hardness. The effect of concentrations of the dependent variables (MCC, lactose, CCS) on DT and in vitro DR was studied. Fast disintegrating tablets of PDS can be prepared by using MCC, CCS, and lactose with enhanced solubility of PDS. The minimum DT was found to be 15 seconds, and the maximum DR within 30 minutes was 98.50%. All independent variables selected for the study were statistically significant. Oral fast disintegrating tablets containing PDS nanoparticles could be the better choice for the pediatric patients that would result in better patient compliance. From this study, it can be concluded that fast disintegrating tablets could be a potential drug delivery technology for the management of asthma in pediatrics.

摘要

本研究的目的是使用微晶纤维素(MCC 101)、乳糖和交联羧甲基纤维素钠(CCS)开发含有载有泼尼松龙(PDS)的壳聚糖纳米颗粒的口腔崩解片。通过离子型外部凝胶化技术制备载有PDS的壳聚糖纳米颗粒,以提高PDS在唾液pH值下的溶解度。将制备的纳米颗粒用于通过直接压片法开发口腔速崩片。对制备的片剂进行崩解时间(DT)、体外药物释放(DR)、厚度、重量差异、药物含量均匀度、脆碎度和硬度的评估。研究了因变量(MCC、乳糖、CCS)浓度对DT和体外DR的影响。使用MCC、CCS和乳糖可以制备具有增强PDS溶解度的PDS速崩片。发现最小DT为15秒,30分钟内的最大DR为98.50%。本研究选择的所有自变量均具有统计学意义。含有PDS纳米颗粒的口腔速崩片可能是儿科患者的更好选择,这将导致更好的患者依从性。从这项研究可以得出结论,速崩片可能是一种用于儿科哮喘管理的潜在药物递送技术。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/83a9/4662371/87afd8b6c35d/dddt-9-5815Fig1.jpg

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