Department of Agricultural and Biological Engineering, Purdue University, 225 South University St., West Lafayette, IN 47907, United States; Davidson School of Chemical Engineering (by courtesy), Purdue University, 480 Stadium Mall Drive, West Lafayette, IN 47907, United States.
J Control Release. 2024 Sep;373:962-966. doi: 10.1016/j.jconrel.2024.07.016. Epub 2024 Aug 16.
Formulation scale-up remains a major hurdle in drug development in part because preliminary formulation research efforts rarely consider the challenges of scaling up production for commercialization. This Perspective outlines considerations around scalability that can be incorporated into formulation design work in order to increase the chances of successful translation. Both technical (unit operations, excipient selection, scaling principles) and non-technical (funding, publications, and personnel) considerations are discussed, with a focus on lab-scale work by academic researchers.
制剂放大仍然是药物开发中的一个主要障碍，部分原因是初步制剂研究工作很少考虑为商业化扩大生产的挑战。本观点概述了可纳入制剂设计工作以提高成功转化机会的可扩展性考虑因素。讨论了技术（单元操作、赋形剂选择、缩放原则）和非技术（资金、出版物和人员）考虑因素，重点是学术研究人员的实验室规模工作。
