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首页> 外文期刊>Crystal growth & design >Dehydration without Heating: Use of Polymer-Assisted Grinding for Understanding the Stability of Hydrates in the Presence of Polymeric Excipients
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Dehydration without Heating: Use of Polymer-Assisted Grinding for Understanding the Stability of Hydrates in the Presence of Polymeric Excipients

机译：无需加热的脱水：使用聚合物辅助研磨以了解聚合物赋形剂存在下水合物的稳定性

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摘要

Hydrates are ubiquitous multicomponent solids of particular interest in the pharmaceutical field. As such, there is a practical need of monitoring the stability of this class of solids, especially when formulated with one or more excipients. In this paper, we propose an innovative solid state method, namely, polymer-assisted grinding (POLAG), for exploring the stability of carbamazepine dihydrate under the simultaneous effects of manufacturing-induced stress (milling) and the presence of polymeric excipients. We demonstrate that, while milling alone did not cause any dehydration, the presence of specific polymers induced partial or total dehydration of the selected model drug carbamazepine dihydrate. Through detailed experimental evidence, it is concluded that the polymer chain length plays a main role in the kinetics of the solid state reaction, while a combination of the amount of polymer and the milling time allowed the isolation of different polymorphic forms of the resulting dehydrated carbamazepine solid. Additional POLAG experiments suggested that polymers of a high molecular weight are less likely to cause dehydration due to their lower affinity for water. POLAG may therefore be used both as a screening method for determining the dehydration propensity of a specific hydrated form in the presence of polymers and for isolating highly metastable forms of the resulting anhydrous product.
机译：水合物是在药物领域特别兴趣的普遍存在的多组分固体。因此，实际需要监测这类固体的稳定性，特别是当用一种或多种赋形剂配制时。在本文中，我们提出了一种创新的固态方法，即聚合物辅助研磨（PolAg），用于在制造诱导的应力（研磨）和聚合物赋形剂的同时效应下探讨卡巴马嗪二水合物的稳定性。我们证明，当单独碾磨没有引起任何脱水的同时，特定聚合物的存在诱导所选模型药物尿嘧啶二水合物的部分或全脱水。通过详细的实验证据，得出结论，聚合物链长在固态反应的动力学中起主要作用，而聚合物的量和铣削时间的组合允许分离所得脱水的脱水的脱水碳碱的不同多态性形式坚硬的。额外的擦亮试验表明，由于它们对水的亲和力较低，高分子量的聚合物不太可能导致脱水。因此，可以使用彩色作为用于在聚合物存在下确定特定水合形式的脱水倾向的筛选方法，并用于分离所得无水产物的高稳定形式。

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