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Effect of binary additive combinations on solution crystal growth of the poorly water-soluble drug, ritonavir

机译：二元添加剂组合对水溶性差的药物利托那韦溶液晶体生长的影响

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摘要

Combinations of additives (polymers and surfactants) are often used in pharmaceutical products to improve the delivery of poorly water-soluble active pharmaceutical ingredients (API). Additive interactions have not been widely studied and may promote or inhibit crystallization (nucleation and crystal growth) in an unpredictable manner, which in turn has an impact on the extent and duration of supersaturation. In this study, the effect of a series of polymer/polymer and polymer/surfactant combinations on crystal growth inhibition was investigated. Surprisingly, the majority of the polymer/polymer combinations investigated had a synergistic effect on crystal growth inhibition. The effectiveness of the polymer/polymer combinations was ascribed to the formation of interpolymer complexes through hydrophobic interactions that adsorb and interact favorably with the crystallizing solute and/or, interaction of individual polymers at different adsorption sites. The acceleration of crystal growth in the presence of polymer/surfactant combinations was attributed to weakened interactions between the polymer and the surface of the crystallizing solute brought about by the presence of surfactant molecules. Based on these observations, careful evaluation of the impact of combinations of additives on crystallization behavior is recommended in order to optimize the performance of supersaturating dosage forms.
机译：添加剂（聚合物和表面活性剂）的组合经常用于药物产品中，以改善水溶性差的活性药物成分（API）的输送。加性相互作用尚未得到广泛研究，并且可能以不可预测的方式促进或抑制结晶（成核和晶体生长），进而影响过饱和的程度和持续时间。在这项研究中，研究了一系列聚合物/聚合物和聚合物/表面活性剂组合对晶体生长抑制的影响。出乎意料的是，所研究的大多数聚合物/聚合物组合对晶体生长的抑制具有协同作用。聚合物/聚合物组合物的有效性归因于通过疏水性相互作用形成互聚物配合物，该疏水性相互作用吸收和有利地与结晶溶质相互作用和/或单个聚合物在不同吸附位点的相互作用。在存在聚合物/表面活性剂组合的情况下晶体生长的加速归因于表面活性剂分子的存在导致聚合物与结晶溶质表面之间的相互作用减弱。基于这些观察结果，建议仔细评估添加剂组合对结晶行为的影响，以优化过饱和剂型的性能。

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