萘普生钠口腔崩解缓释片的设计与表征
Design and Characterization of Orally Disintegrating Modified Release Tablets of Naproxen Sodium.
作者信息
Hussain Amjad, Misbah Maham, Abbas Nasir, Irfan Muhammad, Arshad Muhammad Sohail, Shamim Rahat, Bukhari Nadeem Irfan, Mahmood Faisal
机构信息
University College of Pharmacy, University of the Punjab, Lahore, Pakistan.
Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, GC University Faisalabad, Pakistan.
出版信息
Turk J Pharm Sci. 2020 Oct;17(5):486-491. doi: 10.4274/tjps.galenos.2019.24445. Epub 2020 Oct 30.
OBJECTIVES
The aim of this study was to prepare orally disintegrating, slow release tablets of naproxen sodium for prompt onset and sustained action required in many types of acute pain.
MATERIALS AND METHODS
Tablet formulations containing varying concentrations of croscarmellose sodium (a superdisintegrant) and Soluplus (as release modifier) were prepared by wet granulation method using a single punch tablet machine. The prepared granules were evaluated for their bulk properties and the tablets were evaluated for hardness, disintegration time, and drug release profiles.
RESULTS
The results showed that the granules so prepared have good flow and compressional properties. A disintegration time of tablets <30 s was achieved by selecting an optimum concentration of croscarmellose sodium. The drug release from the tablets was sustained for 2 h by incorporating a suitable amount of Soluplus.
CONCLUSION
This study examined the use of Soluplus (a novel solubilizer) for the first time as a release modifier of API from tablets.
目的
本研究的目的是制备萘普生钠口腔崩解缓释片，以满足多种急性疼痛所需的快速起效和持续作用。
材料与方法
采用单冲压片机通过湿法制粒法制备含有不同浓度交联羧甲基纤维素钠（一种超级崩解剂）和固体分散体（作为释放调节剂）的片剂配方。对制备的颗粒进行堆密度性质评估，对片剂进行硬度、崩解时间和药物释放曲线评估。
结果
结果表明，如此制备的颗粒具有良好的流动性和压缩性。通过选择交联羧甲基纤维素钠的最佳浓度，片剂的崩解时间<30秒。通过加入适量的固体分散体，片剂的药物释放持续2小时。
结论
本研究首次考察了固体分散体（一种新型增溶剂）作为片剂中活性成分释放调节剂的应用。
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