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A novel strategy to produce highly stable and transparent aqueous 'nanosolutions' of water-insoluble drug molecules

机译：产生水不溶性药物分子的高度稳定和透明的水性“纳米溶液”的新策略

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摘要

A surprisingly large proportion of new drug candidates emerging from drug discovery programmes are water-insoluble and, as a result, have poor oral bioavailability. To overcome insolubility, the drug particles are usually dispersed in a medium during product formation, but large particles that are formed may affect product performance and safety. Many techniques have been used to produce nanodispersions - dispersions with nanometre-scale dimensions - that have properties similar to solutions. However, making nanodispersions requires complex processing, and it is difficult to achieve stability over long periods. In this paper, we report a generic method for preparing drug nanoparticles with a combination of antisolvent precipitation in the presence of water-soluble matrices and spray-drying. The spray-dried powder composites (solid dispersion) are microspherical, highly stable and thus form transparent nanodispersions or so-called 'nanosolutions' of water-insoluble drug when simply added to water. Aqueous nanodispersions of silybin (a kind of water-insoluble drug for liver protection) with an average size of 25nm produced with this approach display a 10 times faster dissolution rate than that of raw drug. This has great potential to offer a novel solution for innovative drugs of the future
机译：来自药物发现计划的新候选药物中，出乎意料的是水不溶性的，因此口服生物利用度差。为了克服不溶性，药物颗粒通常在产品形成过程中分散在介质中，但是形成的大颗粒可能会影响产品性能和安全性。已经使用了许多技术来生产具有类似于溶液的性质的纳米分散体-纳米级尺寸的分散体。然而，制备纳米分散体需要复杂的处理，并且难以长期稳定。在本文中，我们报告了在水溶性基质存在下通过喷雾干燥结合抗溶剂沉淀法制备药物纳米颗粒的通用方法。喷雾干燥的粉末复合材料（固体分散体）是微球状的，高度稳定的，因此当简单地添加到水中时，会形成透明的纳米分散体或水不溶性药物的所谓“纳米溶液”。用这种方法生产的平均粒径为25nm的水飞蓟宾（一种水不溶性药物，用于保护肝脏）的水纳米分散体显示出的溶解速度是原料药的10倍。这具有为未来创新药物提供新颖解决方案的巨大潜力

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