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    • 1. 发明申请
    • APPARATUS AND METHODS FOR DISINTEGRATION TESTING
    • 装置和方法进行消毒试验
    • WO2015070262A1
    • 2015-05-14
    • PCT/US2014/065331
    • 2014-11-12
    • DISTEK, INC.BRINKER, JeffreyCRAIG, ShawnWANG, Wenyu
    • BRINKER, JeffreyCRAIG, ShawnWANG, Wenyu
    • G01N33/15G01N21/95
    • G01N33/15G01N13/00G01N21/49G01N21/8507G01N21/9508G01N2013/006
    • In one embodiment, a disintegration or dissolution testing apparatus (100) including at least one area for a compartment (205) to hold a dosage form during disintegration testing, and at least one light emitter (302) and at least one light detector (303) arranged around each of the areas so as to face the area. The light detector (303) is adapted to provide, when a compartment (205) is disposed within the area, a signal indicative of the amount of detected light provided by the light emitter (302). In another embodiment, a bottom flange (202) for disintegration test apparatus (100) is encapsulated in a material that (i) permits the bottom flange (202) to be immersed in a liquid medium during disintegration testing without the liquid contacting any of the light emitters (302) or detectors (303), and (ii) permits light from the emitter (302) to pass through the material and be received by the light detector (303). The apparatus (100) comprises as well a drive assembly for driving the compartment (205) between a lowered position immersing the dosage form in the liquid medium and a raised postion.
    • 在一个实施方案中,一种崩解或溶解测试装置(100)包括至少一个用于在分解测试期间保持剂型的隔室(205)的区域,以及至少一个光发射器(302)和至少一个光检测器(303) )布置在每个区域周围以面对该区域。 光检测器(303)适于在隔室(205)设置在区域内时提供指示由光发射器(302)提供的检测光量的信号。 在另一个实施例中,用于分解测试装置(100)的底部凸缘(202)被封装在以下材料中:(i)允许底部凸缘(202)在分解测试期间浸没在液体介质中,而液体接触任何 光发射器(302)或检测器(303),和(ii)允许来自发射器(302)的光通过材料并被光检测器(303)接收。 装置(100)还包括用于在将剂型浸入液体介质中的降低位置和升高的位置之间驱动隔室(205)的驱动组件。