PROCESS FOR PREPARING BUFFER SOLUTIONS FOR IN VITRO TESTING OF THE SOLUBILITY OF MEDICAMENTS, PACKAGING FOR PRODUCING THE BUFFER SOLUTION AND KIT FOR TESTING CLINICAL STATES

A method for preparing a buffer solution suitable for physiologically relevant in vitro drug dissolution testing, drug solubility testing and/or drug profiling, the method comprising: (a) dispensing from a deformable container into a second container a predetermined quantity of a concentrate of the...

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Hauptverfasser: LEIGH MATHEW LOUIS STEVEN, MCCULLOUGH ORLAITH TESS, DOS SANTOS VASCO RAFAEL FERNANDES, LEIGH STEVEN, LEIGH DARYL LOUIS VAN
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:A method for preparing a buffer solution suitable for physiologically relevant in vitro drug dissolution testing, drug solubility testing and/or drug profiling, the method comprising: (a) dispensing from a deformable container into a second container a predetermined quantity of a concentrate of the buffer solution, said deformable container having an orifice or aperture configured to dispense theconcentrate in a dropwise manner and/or in a controlled stream, and (b) diluting the predetermined quantity of the concentrate with a predetermined quantity of a solvent to produce the buffer solution. A pack comprising a container and a concentrate of said buffer solution within the container, and a method for preparing the said pack, are also provided. 一种缓冲溶液的制备方法,所述缓冲溶液适用于生理相关的体外药物溶出度试验、药物溶解度试验和或药物特征分析,该制备方法包括(a)将预定量的缓冲液浓缩液从可变形容器分配到第二容器中,所述可变形容器具有节流口或孔,构造为以逐滴方式和/或受控流的方式分配浓缩液,并且(b)用预定量的溶剂稀释预定量的浓缩液以生成缓冲液。本发明还提供了一种包括容器和容器内缓冲液浓缩液的包装以及所述包装的制备方法。