Azman Syahiera Ezzah Noor, Abd Razak Fashli Syafiq, Kamal Wan Hamirul Bahrin Wan, Zheng Gan Kok, Ming Long Chiau, Uddin Abm Helal, Sarker Zaidul Islam, Bin Liew Kai
Department of Pharmaceutical Sciences, Faculty of Pharmacy, University of Cyberjaya, Cyberjaya, Selangor, Malaysia.
Medical Technology Division, Malaysia Nuclear Agency, Bangi, Selangor, Malaysia.
Int J Pharm Compd. 2020 Nov-Dec;24(6):509-514.
Orally disintegrating tablets are a solid dosage form that will disintegrate rapidly within 3 minutes upon contact with saliva. Fillers or diluents are excipients that are used to make up the volume of orally disintegrating tablets, and some might act as a disintegrant or binder that will affect the physical properties of orally disintegrating tablets. The objective of this study was to formulate and evaluate physical properties of orally disintegrating tablets containing Annona muricata leaves extract by a freeze-drying method using different fillers at different concentrations. In this study, fifteen formulations of orally disintegrating tablets were prepared by a freeze-drying method with different fillers such as starch, lactose, microcrystalline cellulose, StarLac, and CombiLac at 5%, 10%, and 15%. The orally disintegrating tablets were evaluated for hardness, thickness, weight variation, friability, and disintegration time test. The optimum formulation was chosen and incorporated with Annona muricata leaves extract. The results obtained in this work indicated that Formulation 3, with 15% starch, was the most optimum formulation due to the shortest disintegration time (21.08 seconds ± 4.24 seconds), and all the physical tests were within the acceptable range. The orally disintegrating tablets containing Annona muricata leaves extract possessed antioxidant activity and stable at least for 3 months under 60°C and 75% relative humidity.
口腔崩解片是一种固体剂型,与唾液接触后3分钟内会迅速崩解。填充剂或稀释剂是用于补充口腔崩解片体积的辅料,有些可能充当崩解剂或黏合剂,会影响口腔崩解片的物理性质。本研究的目的是采用冷冻干燥法,使用不同浓度的不同填充剂,制备并评估含有番荔枝叶提取物的口腔崩解片的物理性质。在本研究中,采用冷冻干燥法,使用淀粉、乳糖、微晶纤维素、StarLac和CombiLac等不同填充剂,以5%、10%和15%的浓度制备了15种口腔崩解片配方。对口腔崩解片进行了硬度、厚度、重量差异、脆碎度和崩解时间测试。选择了最佳配方并加入番荔枝叶提取物。本研究获得的结果表明,含15%淀粉的配方3是最佳配方,因为其崩解时间最短(21.08秒±4.24秒),且所有物理测试均在可接受范围内。含有番荔枝叶提取物的口腔崩解片具有抗氧化活性,在60°C和75%相对湿度下至少可稳定保存3个月。