Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA; Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS 38677, USA.
Int J Pharm. 2020 Feb 25;576:118989. doi: 10.1016/j.ijpharm.2019.118989. Epub 2020 Jan 11.
Pharmaceutical research, whether industrial or academic, has attempted to adopt approaches most efficient for the development of innovations. With the abundance of literature and growth of modern techniques available to minimize the number of trials, research is becoming more systematic by the day. Screening and selection of polymers for a pharmaceutical formulation can be challenging, considering the variety of polymers available and under development. Multiple considerations and experimentations are required to select a polymer to attain the target product profile. In this review, a stepwise discussion of techniques useful to screen and select polymers suitable for hot melt extrusion processing are explored and reported. First of all, selecting a range of polymers available for certain formulation types, for example, immediate release or modified release. Secondly, the screening of these selected polymers based on their physical and chemical properties as these properties should be in line with the active pharmaceutical ingredients (APIs) and the processing limitations of the equipment. Finally, selecting polymers using theoretical models such as solubility parameters and Flory Huggins modeling. Utilization of these three steps before proceeding to experimental methods will minimize the use of resources and provide a higher degree of accuracy towards the development of efficient, stable, and consistent products.
制药研究，无论是工业界还是学术界，都试图采用最有效的方法来开发创新药物。随着文献的丰富和现代技术的发展，可以最大限度地减少试验次数，研究变得越来越系统。考虑到现有和正在开发的聚合物种类繁多，筛选和选择适合药物制剂的聚合物具有一定的挑战性。需要进行多次考虑和实验，以选择一种聚合物来达到目标产品特性。在这篇综述中，探讨并报道了用于筛选和选择适合热熔挤出加工的聚合物的一系列有用技术。首先，为特定的制剂类型（例如速释或缓控释）选择一系列可用的聚合物。其次，根据这些选定聚合物的物理和化学性质进行筛选，因为这些性质应与活性药物成分（APIs）和设备的加工限制相匹配。最后，使用溶解度参数和 Flory Huggins 模型等理论模型来选择聚合物。在进行实验方法之前，使用这三个步骤将最大限度地减少资源的使用，并提高开发高效、稳定和一致产品的准确性。
