Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Silver Spring, 20993, Maryland, USA.
Greenwich Biosciences, Inc., Carlsbad, California, USA.
AAPS J. 2021 Jun 29;23(4):92. doi: 10.1208/s12248-021-00611-y.
Poly (lactic-co-glycolic acid) (PLGA) has been used in many long-acting drug formulations which have been approved by the US Food and Drug Administration (FDA). However, generic counterparts for PLGA products have yet to gain FDA approval due to many complexities in formulation, characterization, and evaluation of test products. To address the challenges of generic development of PLGA-based products, the FDA has established an extensive research program to investigate novel methods and tools to aid both product development and regulatory review. The research focus have been: (1) analytical tools for characterization of PLGA polymers; (2) impacts of PLGA characteristics and manufacturing conditions on product performance; (3) in vitro drug release testing and in vitro-in vivo correlation of PLGA-based products, and (4) modeling tools to facilitate formulation design and bioequivalence study design of PLGA-based drugs. This article provides an overview of FDA's PLGA research program and highlights scientific accomplishments as well as regulatory outcomes that have resulted from successful research investigations.
聚（乳酸-共-乙醇酸）（PLGA）已被用于许多已被美国食品和药物管理局（FDA）批准的长效药物制剂中。然而，由于在配方、特性描述和测试产品评估方面存在许多复杂性，PLGA 产品的仿制药仍未获得 FDA 批准。为了解决基于 PLGA 的产品仿制药开发的挑战，FDA 建立了一个广泛的研究计划，以研究新的方法和工具，以帮助产品开发和监管审查。研究重点包括：（1）用于 PLGA 聚合物特性描述的分析工具；（2）PLGA 特性和制造条件对产品性能的影响；（3）基于 PLGA 的产品的体外药物释放测试和体外-体内相关性，以及（4）建模工具，以促进基于 PLGA 的药物的配方设计和生物等效性研究设计。本文概述了 FDA 的 PLGA 研究计划，并重点介绍了成功研究调查所带来的科学成就和监管结果。
