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首页> 外文期刊>Chemical Engineering Research & Design: Transactions of the Institution of Chemical Engineers >Thermodynamically stable amorphous drug dispersions in amorphous hydrophilic polymers engineered by hot melt extrusion
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Thermodynamically stable amorphous drug dispersions in amorphous hydrophilic polymers engineered by hot melt extrusion

机译：热力学稳定的无定形药物分散在非晶态亲水性聚合物工程通过热熔挤出

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摘要

In this study thermodynamically stable dispersions of amorphous quinine, a model BCS class 2 therapeutic agent, within an amorphous polymeric platform (HPC), termed a solid-in-solid dispersion, were produced using hot melt extrusion. Characterisation of the pre-extrudates and extrudates was performed using hyper-differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD) and Raman spectroscopy. Water uptake by the raw materials was determined using dynamic vapour sorption (DVS) analysis. Furthermore, the presence or absence of crystalline drug following storage at 25 degrees C/60% relative humidity and 40 degrees C/75% relative humidity in a sealed glass jar, and at 40 degrees C/75% relative humidity in an open glass jar for 3 months was determined using PXRD. Amorphous quinine was generated in situ during extrusion from both quinine base (5%, 10%, 20% w/w drug loading) and from quinine hydrochloride (5%, 10% w/w drug loading) and remained thermodynamically stable as a solid-in-solid dispersion within the HPC extrudates. When processed with HPC, quinine hydrochloride (20% w/w) was converted to amorphous quinine hydrochloride. Whilst stable for up to 3 months when stored under sealed conditions, this amorphous form was unstable, resulting in recrystallisation of the hydrochloride salt following storage for 1 month at 40 degrees C/75% relative humidity in an open glass jar. The behaviour of the amorphous quinine hydrochloride (20% w/w) HPC extrudate was related, at least in part, to the lower stability and the hygroscopic properties of this amorphous form. (C) 2014 The Institution of Chemical Engineers. Published by Elsevier BM. All rights reserved.
机译：在这项研究中热力学稳定的分散体系非晶态奎宁的模型BCS类2治疗代理,在一个非晶态聚合物平台(HPC),称为solid-in-solid分散,生产用热融化挤压。和挤出物进行使用hyper-differential扫描量热法(DSC),粉末x射线衍射(PXRD)和拉曼光谱学。确定使用动态蒸汽吸附(dv)分析。没有晶体药物后存储25摄氏度/ 60%相对湿度和40度C / 75%相对湿度在一个密封的玻璃罐,在40度C / 75%相对湿度开3个月确定使用的玻璃罐PXRD。在挤压两奎宁基地(5%,10%,20% w / w药物加载)和奎宁盐酸(5%、10% w / w药物加载)保持热力学稳定的作为在HPC solid-in-solid分散挤出物。盐酸(20% w / w)转换为非晶态盐酸奎宁。当储存在密封的长达3个月条件下,这种非晶态形式是不稳定的,导致的重结晶盐酸盐后存储为1个月在40摄氏度/开放75%的相对湿度玻璃罐中。盐酸(20% w / w) HPC挤出物相关的,至少在某种程度上,较低的稳定和非晶的吸湿性能的形式。工程师。保留。

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