Abstract：
OBJECTIVE: This study aims to establish a Flow-through Visualization Dissolution System (FVDS) that combines time-lapse macro-imaging and a flow-through cell to simultaneously elucidate dissolution and disintegration profiles.
METHODS: Three cefaclor extended-release tablets (CEC-1, CEC-2, CEC-3) from different manufacturers were subjected to dissolution tests using both the US Pharmacopeia basket method and the FVDS method. Two dissolution media plans were implemented in FVDS: i) Plan I involved dissolution in pH1.0 medium for 12 h; ii) Plan II initiated dissolution in pH1.0 medium for 1 h, followed by pH6.8 phosphate buffer for 11 h. The resulting dissolution data were fitted using classic mathematical models. Pixel information was further extracted from images obtained using FVDS and plotted over time.
RESULTS: The basket method showed the cumulative dissolution of all three tablets in pH1.0, pH4.0 and water reached 80% within 6 h, but remained below 60% in the pH6.8 medium. The f2 values indicated CEC-2 was similar to CEC-1 in the pH4.0 medium, pH6.8 medium and water. Using FVDS with medium plan II, the cumulative dissolution of CEC-1 and CEC-2 reached about 80% showing similarity, while no similarity was observed between CEC-3 and CEC-1. The f2 factor of the percentage area change profiles also showed consistent results in the dissolution profile of medium plan II. However, FVDS with medium plan I cannot distinguish between CEC-2 and CEC-3.
CONCLUSIONS: FVDS offers an alternative to traditional dissolution methods by integrating imaging analysis as a complementary tool to disintegration and dissolution testing methods.
METHODS: Three cefaclor extended-release tablets (CEC-1, CEC-2, CEC-3) from different manufacturers were subjected to dissolution tests using both the US Pharmacopeia basket method and the FVDS method. Two dissolution media plans were implemented in FVDS: i) Plan I involved dissolution in pH1.0 medium for 12 h; ii) Plan II initiated dissolution in pH1.0 medium for 1 h, followed by pH6.8 phosphate buffer for 11 h. The resulting dissolution data were fitted using classic mathematical models. Pixel information was further extracted from images obtained using FVDS and plotted over time.
RESULTS: The basket method showed the cumulative dissolution of all three tablets in pH1.0, pH4.0 and water reached 80% within 6 h, but remained below 60% in the pH6.8 medium. The f2 values indicated CEC-2 was similar to CEC-1 in the pH4.0 medium, pH6.8 medium and water. Using FVDS with medium plan II, the cumulative dissolution of CEC-1 and CEC-2 reached about 80% showing similarity, while no similarity was observed between CEC-3 and CEC-1. The f2 factor of the percentage area change profiles also showed consistent results in the dissolution profile of medium plan II. However, FVDS with medium plan I cannot distinguish between CEC-2 and CEC-3.
CONCLUSIONS: FVDS offers an alternative to traditional dissolution methods by integrating imaging analysis as a complementary tool to disintegration and dissolution testing methods.
摘要：
目的：本研究旨在建立一种流通式可视化溶解系统（FVDS），该系统结合了延时宏观成像和流通式细胞，以同时阐明溶解和崩解曲线。
方法：使用美国药典篮法和FVDS法对来自不同制造商的三种头孢克洛缓释片（CEC-1、CEC-2、CEC-3）进行了溶出度测试。在FVDS中实施了两种溶出介质计划：i）计划I涉及在pH1.0介质中溶出12h；ii）计划II在pH1.0介质中开始溶出1h，随后用pH6.8磷酸盐缓冲液持续11小时。使用经典数学模型拟合所得溶出数据。从使用FVDS获得的图像中进一步提取像素信息并随时间绘制。
结果：篮法显示所有三种片剂在pH1.0，pH4.0和水中的累积溶出度在6小时内达到80％，但在pH6.8培养基中仍低于60%。f2值表明CEC-2与pH4.0培养基中的CEC-1相似，pH6.8培养基和水。使用FVDS和中等计划II，CEC-1和CEC-2的累积溶出度达到约80%，显示相似性，CEC-3和CEC-1之间没有发现相似性。百分比面积变化曲线的f2因子在培养基计划II的溶出曲线中也显示出一致的结果。然而,具有中等计划的FVDS我无法区分CEC-2和CEC-3。
结论：FVDS通过整合成像分析作为崩解和溶出测试方法的补充工具，为传统溶出方法提供了一种替代方法。
方法：使用美国药典篮法和FVDS法对来自不同制造商的三种头孢克洛缓释片（CEC-1、CEC-2、CEC-3）进行了溶出度测试。在FVDS中实施了两种溶出介质计划：i）计划I涉及在pH1.0介质中溶出12h；ii）计划II在pH1.0介质中开始溶出1h，随后用pH6.8磷酸盐缓冲液持续11小时。使用经典数学模型拟合所得溶出数据。从使用FVDS获得的图像中进一步提取像素信息并随时间绘制。
结果：篮法显示所有三种片剂在pH1.0，pH4.0和水中的累积溶出度在6小时内达到80％，但在pH6.8培养基中仍低于60%。f2值表明CEC-2与pH4.0培养基中的CEC-1相似，pH6.8培养基和水。使用FVDS和中等计划II，CEC-1和CEC-2的累积溶出度达到约80%，显示相似性，CEC-3和CEC-1之间没有发现相似性。百分比面积变化曲线的f2因子在培养基计划II的溶出曲线中也显示出一致的结果。然而,具有中等计划的FVDS我无法区分CEC-2和CEC-3。
结论：FVDS通过整合成像分析作为崩解和溶出测试方法的补充工具，为传统溶出方法提供了一种替代方法。
