University of New Mexico, College of Pharmacy, Department of Pharmaceutical Sciences, Albuquerque, NM 87131, USA.
Expert Opin Drug Deliv. 2013 Apr;10(4):421-35. doi: 10.1517/17425247.2013.763792. Epub 2013 Jan 23.
Pharmaceutical coating processes have generally been transformed from what was essentially an art form in the mid-twentieth century to a much more technology-driven process.
This review article provides a basic overview of current film coating processes, including a discussion on polymer selection, coating formulation additives and processing equipment. Substrate considerations for pharmaceutical coating processes are also presented.
While polymeric coating operations are commonplace in the pharmaceutical industry, film coating processes are still not fully understood, which presents serious challenges with current regulatory requirements. Novel analytical technologies and various modeling techniques that are being used to better understand film coating processes are discussed. This review article also examines the challenges of implementing process analytical technologies in coating operations, active pharmaceutical ingredients in polymer film coatings, the use of high-solids coating systems and continuous coating and other novel coating application methods.
制药包衣工艺从 20 世纪中叶的一门艺术形式逐渐转变为更依赖技术的过程。
本文综述了当前的薄膜包衣工艺,包括对聚合物选择、包衣配方添加剂和加工设备的讨论。还介绍了药物包衣工艺的基材考虑因素。
虽然聚合物包衣操作在制药行业很常见,但薄膜包衣工艺仍未被充分理解,这给当前的监管要求带来了严峻挑战。本文还探讨了在包衣操作中实施过程分析技术、聚合物薄膜包衣中的原料药、高固含量包衣系统和连续包衣以及其他新型包衣应用方法的挑战。