DisperSol Technologies, LLC, 111 W. Cooperative Way, Building 3, Suite 300, Georgetown, Texas, 78626, USA.
College of Pharmacy, The University of Texas at Austin, 1 University Station, Campus Mail Code A1902, Austin, Texas, 78712, USA.
AAPS PharmSciTech. 2018 Jul;19(5):1933-1956. doi: 10.1208/s12249-018-1007-2. Epub 2018 May 30.
Due to the high number of poorly soluble drugs in the development pipeline, novel processes for delivery of these challenging molecules are increasingly in demand. One such emerging method is KinetiSol, which utilizes high shear to produce amorphous solid dispersions. The process has been shown to be amenable to difficult to process active pharmaceutical ingredients with high melting points, poor organic solubility, or sensitivity to heat degradation. Additionally, the process enables classes of polymers not conventionally processable due to their high molecular weight and/or poor organic solubility. Beyond these advantages, the KinetiSol process shows promise with other applications, such as the production of amorphous mucoadhesive dispersions for delivery of compounds that would also benefit from permeability enhancement.
由于在研发管道中有大量水溶性差的药物,因此越来越需要新型的传递这些具有挑战性的分子的方法。一种新兴的方法是 KinetiSol,它利用高剪切力生产无定形固体分散体。该工艺已被证明适用于处理具有高熔点、低有机溶解度或对热降解敏感的难处理的活性药物成分。此外,该工艺还可以处理由于分子量高和/或有机溶解度低而通常无法处理的聚合物类别。除了这些优势之外,KinetiSol 工艺在其他应用方面也显示出了潜力,例如生产无定形的粘膜粘附性分散体,用于传递那些也将受益于通透性增强的化合物。