Intrinsic dissolution apparatus with stationary sample holder
    31.
    发明授权
    Intrinsic dissolution apparatus with stationary sample holder 有权
    具有固定样品架的固有溶解装置

    公开(公告)号:US06497157B1

    公开(公告)日:2002-12-24

    申请号:US09711287

    申请日:2000-11-13

    IPC分类号: G01N3315

    摘要: For intrinsic dissolution testing, a drug pellet (i.e., the dissolution test sample) is retained within a cylindrical recess in a sample holder that is placed at the bottom of a dissolution vessel containing an appropriate dissolution medium with the sample holder oriented with the drug pellet facing up. During the testing cycle, the dissolution medium may be stirred, e.g., using a conventional USP 2 rotating paddle, while the sample holder (and drug pellet) remain stationary at the bottom of the vessel. The orientation of the drug pellet during testing (i.e., facing up) decreases the likelihood of retention of air bubbles formed at the surface of the drug pellet (which bubbles could otherwise decrease the effective dissolution rate), thereby providing more accurate and consistent intrinsic dissolution test results.

    摘要翻译: 对于固有溶解试验,将药物丸粒(即溶出试验样品)保留在样品保持器的圆柱形凹部内,该样品保持器放置在含有适当溶解介质的溶解容器的底部,样品保持器与药物颗粒 朝上。 在测试循环期间,可以例如使用常规的USP 2旋转桨来搅拌溶解介质,同时样品保持器(和药物颗粒)在容器的底部保持静止。 在测试期间药物颗粒的取向(即面朝上)降低了在药物颗粒表面形成的气泡的保留的可能性(该气泡否则可能降低有效溶解速率),从而提供更准确和一致的内在溶解 检测结果。