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    • 1. 发明申请
    • APPARATUS AND METHOD FOR TESTING MEDICAMENTS
    • 用于测试药物的装置和方法
    • WO2013164629A1
    • 2013-11-07
    • PCT/GB2013/051145
    • 2013-05-02
    • UCL BUSINESS PLC
    • MERCHANT, Hamid AliFROST, John AndrewBASIT, Abdul Waseh
    • G01N33/15
    • G01N33/84G01N27/302G01N33/15
    • Apparatus for testing the solubility of a medical dosage form includes a chamber (12) for holding a solvent medium (18), in the preferred embodiment a bicarbonate based buffer system. The apparatus also includes a pH probe (66) which is connectable to a supply of carbon dioxide (32, 34),as well as to a supply of helium (40), the supplies being controlled by a control unit (50). The control unit (50) monitors changes in pH of the solvent medium (18) and, as appropriate, feeds pH increasing and/or p H reducing gas from the supplies(32, 34, 40) into the chamber (12). The control unit (50) is able to maintain a uniform pH during testing or to provide a dynamically adjustable pH during testing, for example to three or more different pH levels in order to test the performance of a drug carrier at different levels of acidity or alkalinity for example, mimicking the conditions of the gastrointestinal tract. The apparatus(20) and associated method are particularly suitable for testing and developing dosage forms for oral delivery of drugs.
    • 用于测试医用剂型的溶解度的装置包括用于保持溶剂介质(18)的室(12),在优选实施方案中为基于碳酸氢盐的缓冲系统。 该装置还包括可连接到二氧化碳(32,34)的供应源以及氦(40)的供应源的pH探针(66),所述供应由控制单元(50)控制。 控制单元(50)监测溶剂介质(18)的pH变化,并且适当地将来自供给源(32,34,40)的pH增加和/或p H还原气体进料到室(12)中。 控制单元(50)能够在测试期间保持均匀的pH,或者在测试期间提供动态可调节的pH,例如达到三个或更多个不同的pH水平,以测试不同酸度水平的药物载体的性能, 碱度为例,模拟胃肠道的状况。 装置(20)和相关方法特别适用于测试和开发口服药物的剂型。
    • 2. 发明公开
    • APPARATUS AND METHOD FOR TESTING MEDICAMENTS
    • VORRICHTUNG UND VERFAHREN ZUM TESTEN VON ARZNEIMITTELN
    • EP2844999A1
    • 2015-03-11
    • EP13727316.5
    • 2013-05-02
    • UCL Business Plc.
    • MERCHANT, Hamid AliFROST, John AndrewBASIT, Abdul Waseh
    • G01N33/15
    • Apparatus for testing the solubility of a medical dosage form includes a chamber (12) for holding a solvent medium (18), in the preferred embodiment a bicarbonate based buffer system. The apparatus also includes a pH probe (66) which is connectable to a supply of carbon dioxide (32, 34),as well as to a supply of helium (40), the supplies being controlled by a control unit (50). The control unit (50) monitors changes in pH of the solvent medium (18) and, as appropriate, feeds pH increasing and/or pH reducing gas from the supplies(32, 34, 40) into the chamber (12). The control unit (50) is able to maintain a uniform pH during testing or to provide a dynamically adjustable pH during testing, for example to three or more different pH levels in order to test the performance of a drug carrier at different levels of acidity or alkalinity for example, mimicking the conditions of the gastrointestinal tract. The apparatus(20) and associated method are particularly suitable for testing and developing dosage forms for oral delivery of drugs.
    • 用于测试医用剂型的溶解度的装置包括用于保持溶剂介质(18)的室(12),在优选实施方案中为基于碳酸氢盐的缓冲系统。 该设备还包括可连接到二氧化碳(32,34)供应的pH探针(66)以及氦气供应源(40),所述供应由控制单元(50)控制。 控制单元(50)监测溶剂介质(18)的pH变化,并且酌情将来自供给装置(32,34,40)的pH增加和/或pH降低气体进料到室(12)中。 控制单元(50)能够在测试期间保持均匀的pH,或者在测试期间提供动态可调节的pH,例如达到三个或更多个不同的pH水平,以便测试不同酸度水平的药物载体的性能, 碱度为例,模拟胃肠道的状况。 装置(20)和相关方法特别适用于测试和开发用于口服药物的剂型。