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1. 发明授权

US06948389B2 Dissolution test sampling 有权
标题翻译：溶出度试样
公开(公告)号：US06948389B2
公开(公告)日：2005-09-27
申请号：US10392368
申请日：2003-03-18
申请人： Gerald Brinker , Michael Cai
发明人： Gerald Brinker , Michael Cai
IPC分类号： G01N13/00 , G01N35/10 , G01N1/14 , G01N1/38
CPC分类号： G01N35/1065 , G01N2013/006 , Y10T436/2575
摘要： Improved sampler apparatus and methods for dissolution testing include a controller that determines whether several different dissolution testing methods can be performed concurrently by the sampler and controls the sampler in response to the determination; fluid delivery apparatus adapted to pierce a septum and to deliver fluid to or from a collection receptacle through a first aperture, and to permit air flow to or from the collection receptacle through a second aperture; a syringe pump including a distributor having apertures through which fluid flows into and out of the pump chamber, the piston of the syringe pump being moveable adjacent the apertures; and/or a leak sensor responsive to the presence of spilled fluids.
摘要翻译：用于溶出测试的改进的取样器装置和方法包括一个控制器，其确定是否可以由采样器同时执行几种不同的溶出度测试方法并响应于该确定来控制采样器; 流体输送装置，其适于刺穿隔膜并且通过第一孔将流体输送到收集容器或从收集容器输送流体，并且允许空气通过第二孔流到收集容器或从收集容器流出; 注射泵，其包括具有孔的分配器，流体通过所述分配器流入和流出所述泵室，所述注射器泵的活塞可邻近所述孔移动; 和/或对泄漏液体的存在作出响应的泄漏传感器。

2. 发明授权

US06497157B1 Intrinsic dissolution apparatus with stationary sample holder 有权
标题翻译：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
申请人： Tacey X. Viegas , Gerald Brinker , Michael Cai
发明人： Tacey X. Viegas , Gerald Brinker , Michael Cai
IPC分类号： G01N3315
CPC分类号： G01N13/00 , G01N33/15 , G01N2013/006
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。

3. 发明授权

US5983515A Apparatus for measuring heights in dissolution testing equipment 失效
标题翻译：用于测量溶出测试设备高度的装置
公开(公告)号：US5983515A
公开(公告)日：1999-11-16
申请号：US903558
申请日：1997-07-31
申请人： Gerald Brinker , Thomas Hauck
发明人： Gerald Brinker , Thomas Hauck
IPC分类号： G01B3/20 , G01B5/14 , G01N33/15
CPC分类号： G01B3/20 , G01B5/14 , G01N33/15
摘要： An apparatus for use with a dissolution testing device comprising a vessel and a shaft with a stir element affixed to one end thereof for placement within the vessel. In one embodiment, the apparatus has a front portion having a first jaw portion and a back portion having a second jaw portion. The front portion is slidably coupled to the front portion, and the first and second jaw portions form a jaw interposable between the bottom of the stir element and the inside bottom of the vessel. The jaw has a jaw distance corresponding to the position of the front portion relative to the back portion. The apparatus also includes a shaft alignment portion for aligning the apparatus parallel to the shaft, and a measurement portion for providing a distance reading corresponding to the gauge jaw distance.
摘要翻译：一种用于溶解测试装置的装置，包括容器和具有固定在其一端上的搅拌元件的轴，用于放置在容器内。在一个实施例中，该装置具有前部，其具有第一钳口部分和具有第二钳口部分的后部部分。前部可滑动地联接到前部，并且第一和第二钳口部分形成在搅拌元件的底部和容器的内部底部之间可插入的钳口。钳口具有与前部相对于后部的位置相对应的钳口距离。该装置还包括用于使设备与轴平行的对准的轴对准部分和用于提供与量规钳口距离对应的距离读数的测量部分。

4. 发明授权

US5589649A Dissolution testing apparatus 失效
标题翻译：溶解试验装置
公开(公告)号：US5589649A
公开(公告)日：1996-12-31
申请号：US389063
申请日：1995-02-14
申请人： Gerald Brinker , Peter Hladik , Alan Gutwillig
发明人： Gerald Brinker , Peter Hladik , Alan Gutwillig
IPC分类号： G01N33/15 , B01L7/00 , G01N13/00
CPC分类号： G01N33/15 , B01L7/00 , G01N13/00 , G01N2013/006
摘要： The dissolution testing apparatus has a plurality of stirring elements for stirring the test solutions within a plurality of test vessels with reflective surfaces. The temperatures of the test solutions are individually controlled by a temperature control system. The temperature control system includes a controller, a heating element for each test vessel to heat the corresponding test solution, and a temperature sensor for each test vessel to measure the temperature of the corresponding test solution. The heating elements are wrapped around the outside of the test vessels and held in place by spring-loaded heater jackets. Each stirring element has a hollow shaft, a detachable stirring attachment (e.g., blade or basket), a temperature sensor inside the hollow shaft, and a signal transfer device to transmit signals from the temperature sensor to the controller. The test vessels are supported and aligned with respect to the stirring elements with a holding plate having openings and corresponding alignment fixtures.
摘要翻译：溶解试验装置具有多个用于在具有反射表面的多个试验容器内搅拌试验溶液的搅拌元件。测试溶液的温度由温度控制系统单独控制。温度控制系统包括控制器，用于每个测试容器的加热元件以加热相应的测试溶液，以及用于每个测试容器的温度传感器以测量相应测试溶液的温度。加热元件缠绕在测试容器的外部，并通过弹簧加热夹套保持在适当位置。每个搅拌元件具有中空轴，可拆卸的搅拌附件（例如，叶片或篮），空心轴内的温度传感器以及用于将信号从温度传感器传输到控制器的信号传递装置。测试容器通过具有开口的保持板和相应的对准夹具相对于搅拌元件被支撑和对准。

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