溶出度测试期间评估变异性的量具重复性和再现性：技术说明
Gauge repeatability and reproducibility for accessing variability during dissolution testing: a technical note.
作者信息
Gao Zongming, Moore Terry, Smith Anjanette P, Doub William, Westenberger Benjamin, Buhse Lucinda
机构信息
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA.
出版信息
AAPS PharmSciTech. 2007 Oct 12;8(4):E82. doi: 10.1208/pt0804082.
An attempt was made to develop a gastroretentive drug delivery system of carbamazepine using HPMC, sodium bicarbonate, and EC as matrixing agent, gas-generating agent, and floating enhancer, respectively. A simplex lattice design was applied to investigate the combined effect of 3 formulation variables (ie, amount of HPMC (), EC (), and sodium bicarbonate (). Results of multiple regression analysis indicated that low levels of and and a high level of should be used to manufacture the tablet formulation with desired in vitro floating time and dissolution. Formulation S3 was selected as a promising formulation and was found stable at 40°C temperature and 75% RH for 3 months.
尝试开发一种以羟丙甲纤维素（HPMC）、碳酸氢钠和乙基纤维素（EC）分别作为基质剂、产气剂和漂浮增强剂的卡马西平胃滞留给药系统。采用单纯形格子设计来研究3个处方变量（即HPMC用量、EC用量和碳酸氢钠用量）的联合效应。多元回归分析结果表明，应使用低水平的HPMC和EC以及高水平的碳酸氢钠来制备具有所需体外漂浮时间和溶出度的片剂处方。处方S3被选为有前景的处方，并且发现在40°C温度和75%相对湿度条件下3个月内稳定。
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