睡眠紊乱会导致认知障碍等健康问题,情绪低落,对心血管的负面影响,内分泌,和免疫功能。本研究制定并优化了三层合右旋佐匹克隆快速溶解膜。
制备的Eszopiclone三层合快速溶解膜(EszopicloneTFDF)的特征在于崩解时间,药物释放,抗拉强度(TS),伸长率(EB%),折叠耐力,掩味试验,和体外溶出度试验。所选配方为F2(0.5%黄原胶,10%丙二醇),F4(3%海藻酸钠,10%丙二醇)和F6(1.5%普鲁兰,与常规Lunesta®片剂相比,对10%丙二醇)进行体内研究。
结果表明,崩解时间在940μm范围内。发现药物释放在78.51%-99.99%的范围内,而TS值和EB%从11.12到25.74(MPa)和25.38%-36.43%,分别。折叠耐力在200到300倍之间。所有配方均表现出可接受的均匀性含量,表面pH值,薄膜厚度,和良好的味觉。
在其它配方和常规片剂中,F4具有最高的Cmax(39.741±6.785μg/l)和较低的Tmax(1.063小时)。因此,FDFs技术可以提高右佐匹克隆的治疗效果。
Disturbed sleep can cause to m health problems such as cognitive impairment, depressed mood, and negative effects on cardiovascular, endocrine, and immune function. This
study formulates and optimizes Eszopiclone trilaminate fast dissolving film.
Prepared Eszopiclone trilaminate fast dissolving film (Eszopiclone TFDF) was characterized by disintegration time, drug release, tensile strength (TS), percentage elongation (EB%), folding endurance, taste masking test, and in vitro dissolution test. The selected formulas were F2 (0.5% xanthan gum, 10% propylene glycol), F4 (3% sodium alginate, 10% propylene glycol) and F6 (1.5% pullulan, 10% propylene glycol) were subjected to in vivo
study compared to conventional Lunesta® tablet.
The results indicated that disintegration time was in the range of 940 m. Drug release was found to be in the field of 78.51%-99.99%, while TS values and EB% differed from 11.12 to 25.74 (MPa) and 25.38%-36.43%, respectively. The folding endurance went between 200 and 300 times. All formulas exhibited acceptable uniformity content, surface pH, film thickness, and a good taste feeling.
F4 had the highest Cmax (39.741 ± 6.785-μg/l) and lower Tmax (1.063 hr) among other formulas and conventional tablets. Therefore, FDFs\' technology could increase the therapeutic effect of Eszopiclone.