Yoshida Hiroyuki, Kuwana Akemi, Shibata Hiroko, Izutsu Ken-Ichi, Goda Yukihiro
Division of Drugs, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
Pharm Res. 2016 Jun;33(6):1327-36. doi: 10.1007/s11095-016-1874-8. Epub 2016 Feb 11.
To clarify the effects of pump pulsation and flow-through cell (FTC) dissolution system settings on the hydrodynamic properties and dissolution profiles of model formulations.
Two FTC systems with different cell temperature control mechanisms were used. Particle image velocimetry (PIV) was used to analyze the hydrodynamic properties of test solutions in the flow-through dissolution test cell. Two pulsation pumps (semi-sine, full-sine) and a non-pulsatile pump were used to study the effects of varied flows on the dissolution profiles of United States Pharmacopeia standard tablets.
PIV analysis showed periodic changes in the aligned upward fluid flow throughout the dissolution cell that was designed to reduce the temperature gradient during pump pulsation (0.5 s/pulse). The maximum instantaneous flow from the semi-sine pump was higher than that of the full-sine pump under all conditions. The flow from the semi-sine wave pump showed faster dissolution of salicylic acid and prednisone tablets than those from other pumps. The semi-sine wave pump flow showed similar dissolution profiles in the two FTC systems.
Variations in instantaneous fluid flow caused by pump pulsation that meets the requirements of pharmacopoeias are a factor that affects the dissolution profiles of tablets in FTC systems.
阐明泵脉动和流通池（FTC）溶出系统设置对模型制剂的流体动力学性质和溶出曲线的影响。
使用两种具有不同细胞温度控制机制的FTC系统。粒子图像测速技术（PIV）用于分析流通溶出试验池中测试溶液的流体动力学性质。使用两台脉动泵（半正弦、全正弦）和一台无脉动泵来研究不同流速对美国药典标准片剂溶出曲线的影响。
PIV分析表明，在整个溶出池中，旨在降低泵脉动期间温度梯度（0.5秒/脉冲）的向上对齐流体流存在周期性变化。在所有条件下，半正弦泵的最大瞬时流速均高于全正弦泵。半正弦波泵的流速显示水杨酸和泼尼松片剂的溶出速度比其他泵更快。半正弦波泵流速在两种FTC系统中显示出相似的溶出曲线。
符合药典要求的泵脉动引起的瞬时流体流速变化是影响FTC系统中片剂溶出曲线的一个因素。
