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Polymorphism in Solid Dispersions

机译：固体分散体中的多态性

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摘要

Solid dispersions embed active pharmaceutical ingredients in polymeric carriers to improve their solubility. Three solid dispersion preparation techniques are typically employed: solvent evaporation, solventfusion, and fusion methods. Although these are also widely recommended as preparative methods for phase diagram determination, few examples exist concerning their effect on the resulting polymorph, once the solid dispersion is produced. In this study, the influence of these methods on the polymorphic form obtained in crystalline solid dispersions (CSDs) composed of flufenamic acid (FFA) and polyethylene glycol was investigated. The physical mixtures and CSDs were characterized by powder X-ray diffraction, infrared spectroscopy, and differential scanning calorimetry. The results reveal that the fusion method leads to concomitant polymorphs (mainly FFA I and III) in the CSDs. In contrast, the solvent evaporation and solvent-fusion methods lead to FFA III. Collectively, these results demonstrate that preparative methods have a significant influence on the phase diagrams determined (average relative deviation <= 8%), which are often used to justify the design space of manufacturing processes, including those deemed "continuous." Consequently, choosing a preparation method that results in the desired polymorph is crucial to ensure accurate determination of phase diagrams and critical quality attributes of formulations.
机译：固体分散体在聚合物载体中嵌入活性药物成分，以改善它们的溶解度。通常使用三种固体分散制剂：溶剂蒸发，溶剂素和融合方法。尽管这些也被广泛推荐作为用于相图测定的制备方法，但是一旦产生固体分散体，少量存在对所得多晶型物的影响。在该研究中，研究了这些方法对由氟芬酸（FFA）和聚乙二醇组成的结晶固体分散体（CSD）中获得的多态形态的影响。通过粉末X射线衍射，红外光谱和差示扫描量热法表征物理混合物和CSD。结果表明，融合方法导致CSD中伴随多晶型（主要是FFA I和III）。相比之下，溶剂蒸发和溶剂融合方法导致FFA III。总的来说，这些结果表明，制备方法对确定的相图具有显着影响（平均相对偏差<= 8％），这些方法通常用于证明制造过程的设计空间，包括被认为是“连续的。因此，选择产生所需多晶型物的制备方法至关重要，以确保准确确定配方的相图和临界质量属性。

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