Rege P R, Vilivalam V D, Collins C C
Department of Pharmaceutics, Graduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15282, USA.
J Pharm Biomed Anal. 1998 Sep;17(8):1226-33. doi: 10.1016/s0731-7085(97)00184-2.
The aim of this study was to evaluate an automated method using the Enhancer Cell and compare the release of the corticosteroid triamcinolone acetonide (TA) from commercial semisolid formulations. The method used a modified USP Apparatus 2 using the Enhancer Cell in 200 ml capacity flasks instead of the standard 900 ml flasks. The additional equipment included an adapter plate to position the flasks in the center, a cover to reduce the receptor phase evaporation and smaller sized (1/4 in.) shaft and collets. All products were evaluated prior to their expiration date. Effects of system variables such as the temperature and composition of the receptor medium, stirring speed, and the choice of membrane on the drug release were evaluated. Statistical analysis was carried out using SAS Ver. 6.07 and the slopes and intercepts (of the cumulative release/unit area versus square root of time plots) were compared. TA release was a linear function of the square root of time (P < or = 0.0001), in accordance with Higuchi's model (r2 > or = 0.9 in most cases). Temperature (32 and 37 degrees C) did not affect the drug release (P > 0.32) but a significantly higher release rate was observed (P < or = 0.0001) at 50 degrees C. Stirring speed (50, 100, 200 rpm) (P > 0.26) and receptor media composition (38 and 76% ethanol) (P > 0.68) did not significantly alter the release rates. Membrane selection (regenerated cellulose, polyethylene, and rat skin) was found to be a significant variable (P < or = 0.004). This study demonstrates the use of the Enhancer Cell as an automated quality control tool in the in vitro release testing procedure for semisolid drug formulations.
本研究的目的是评估一种使用增强型细胞的自动化方法，并比较皮质类固醇曲安奈德（TA）从市售半固体制剂中的释放情况。该方法使用改良的美国药典装置2，在200毫升容量的烧瓶中使用增强型细胞，而不是标准的900毫升烧瓶。额外的设备包括一个用于将烧瓶定位在中心的转接板、一个用于减少受体相蒸发的盖子以及较小尺寸（1/4英寸）的轴和夹头。所有产品均在其有效期之前进行评估。评估了系统变量如受体介质的温度和组成、搅拌速度以及膜的选择对药物释放的影响。使用SAS Ver. 6.07进行统计分析，并比较（累积释放/单位面积与时间平方根图的）斜率和截距。根据Higuchi模型，TA释放是时间平方根的线性函数（P≤0.0001）（大多数情况下r2≥0.9）。温度（32和37摄氏度）不影响药物释放（P>0.32），但在50摄氏度时观察到显著更高的释放速率（P≤0.0001）。搅拌速度（50、100、200转/分钟）（P>0.26）和受体介质组成（38%和76%乙醇）（P>0.68）并未显著改变释放速率。发现膜的选择（再生纤维素、聚乙烯和大鼠皮肤）是一个显著变量（P≤0.004）。本研究证明了增强型细胞作为半固体制剂体外释放测试程序中的自动化质量控制工具的用途。
