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首页> 外文期刊>Crystal growth & design >Use of a Plasticizer for Physical Stability Prediction of Amorphous Solid Dispersions
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Use of a Plasticizer for Physical Stability Prediction of Amorphous Solid Dispersions

机译：使用增塑剂进行无定形固体分散体的物理稳定性预测

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Utilizing glycerol as a plasticizer, an accelerated physical stability testing method of amorphous solid dispersions (ASDs) was developed. The influence of glycerol concentration on the glass transition temperature and ?-relaxation time (a measure of molecular mobility) of amorphous ketoconazole, celecoxib, and the solid dispersions of each prepared with polyvinylpyrrolidone was investigated. By temperature scaling (T-g/T), the effects of glycerol concentration and temperature on the relaxation time were simultaneously evaluated. Glycerol, in a concentration dependent manner, accelerated crystallization in all of the systems without affecting the fragility. In celecoxib-PVP ASDs, the drug crystallization was well coupled to molecular mobility and was essentially unaltered at glycerol concentrations up to 2% w/w. The acceleration in crystallization brought about by glycerol expedited the determination of the coupling between molecular mobility and crystallization. As a result, we were able to predict the physical stability of the unplasticized ASD. This approach is especially useful for ASDs with high polymer content where drug crystallization is extremely slow at the relevant storage temperature.
机译：利用甘油作为增塑剂，开发了无定形固体分散体（ASD）的加速物理稳定性试验方法。研究了甘油浓度对无定形酮烷唑，塞克昔尔和各种用聚乙烯吡咯烷酮制备的玻璃迁移温度和β--筛选时间（分子迁移率的量度）的影响。通过温度缩放（T-G / T），同时评估甘油浓度和温度对松弛时间的影响。甘油以浓度依赖性方式，在所有系统中加速结晶而不影响脆性。在Celecoxib-PVP ASD中，药物结晶良好地偶联至分子迁移率，并且基本上在甘油浓度下灭绝，高达2％w / w。通过甘油带来的结晶加速加速了分子迁移率和结晶之间的偶联的测定。结果，我们能够预测不完整的ASD的物理稳定性。这种方法对于具有高分子含量的高分子含量特别有用，其中药物结晶在相关储存温度下极慢。

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