创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

无定形态药物制备技术研究进展

Recent Progress in Manufacturing Process of Amorphous Pharmaceutical Solids

  • 摘要: 将药物的固体形态由晶态转变成分子无序排列的无定形态,可用于提高难溶性药物溶解度和溶出速率。无定形药物制剂已经成为提高难溶性药物生物利用度的最常用策略之一。目前,已有多种技术方法可将药物从晶态转变为无定形态,其中应用最成熟的技术包括喷雾干燥、热熔挤出技术等,在药物制剂工业中得到广泛的运用。此外,一些新型的技术方法例如3D打印技术和电纺丝技术等近年来也被报道用于无定形态药物的制备。这些不同的制备方法将会对无定形态药物的理化性质产生重要的影响。对无定形态药物制备方法的最新研究进行总结和分析,为无定形态药物的开发提供借鉴。

     

    Abstract: Compared with the crystalline form, the amorphous form can increase the solubility and dissolution rate of poorly water-soluble drugs. Amorphous pharmaceutical solid has become one of the most effective formulation approaches to enhance the oral bioavailability of poorly water-soluble drugs. A number of preparation methods have been developed to manufacture amorphous drugs. For instance, spray drying and hot melt extrusion have been widely used in pharmaceutical industry to manufacture amorphous drugs in large scales. In recent years, some new technologies have been developed to produce amorphous solid dispersions, including 3D printing, solvent-based electrospinning method, etc.. Different manufacturing methods will significantly affect the physicochemical properties and performances of amorphous pharmaceutical solids. This review outlined and analyzed the most recent advances in the preparation of amorphous pharmaceutical solids, so as to provide reference for the development of amorphous drugs.

     

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