PLGA公司
赋形剂
创新者
微球
纳米技术
化学
剂型
生物医学工程
生化工程
材料科学
计算机科学
色谱法
化学工程
医学
工程类
纳米颗粒
操作系统
知识产权
作者
Bo Wan,Quanying Bao,Diane J. Burgess
标识
DOI:10.1016/j.addr.2023.114857
摘要
Poly(lactic-co-glycolic acid) (PLGA) microspheres are a sustained-release drug delivery system with several successful commercial products used for the treatment of a variety of diseases. By utilizing PLGA polymers with different compositions, therapeutic agents can be released over durations varying from several weeks to several months. However, precise quality control of PLGA polymers and a fundamental understanding of all the factors associated with the performance of PLGA microsphere formulations remains challenging. This knowledge gap can hinder product development of both innovator and generic products. In this review, variability of the key release controlling excipient (PLGA), as well as advanced physicochemical characterization techniques for the PLGA polymer and PLGA microspheres are discussed. The relative merits and challenges of different in vitro release testing methods, in vivo pharmacokinetic studies, and in vitro-in vivo correlation development are also summarized. This review is intended to provide an in-depth understanding of long-acting microsphere products and consequently facilitate the development of these complex products.
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