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Frontiers of Chemical Science and Engineering >> 2019, Volume 13, Issue 1 doi: 10.1007/s11705-018-1729-4

Recent research and development of PLGA/PLA microspheres/nanoparticles: A review in scientific and industrial aspects

1. Beijing Nuokangda Pharmaceutical Technology Co., Ltd, Beijing 100176, China
2. Department of Mechanical and Aerospace Engineering, University of Missouri, MO 65211, USA
3. National Key Laboratory of Biochemical Engineering, Key Laboratory of Biopharmaceutical Production and Formulation Engineering, PLA, Institute of Process Engineering, Chinese Academy of Sciences, Beijing 100190, China

Accepted: 2018-06-07 Available online:2019-02-25

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Poly(D,L-lactic-co-glycolic acid) (PLGA)/poly(lactic acid) (PLA) microspheres/nanoparticles are one of the most successful drug delivery systems (DDS) in lab and clinic. Because of good biocompatibility and biodegradability, they can be used in various areas, such as long-term release system, vaccine adjuvant, tissue engineering, etc. There have been 15 products available on the US market, but the system still has many problems during development and manufacturing, such as wide size distribution, drug stability issues, and so on. Recently, many new and modified methods have been developed to overcome the above problems. Some of the methods are easy to scale up, and have been available on the market to achieve pilot scale or even industrial production scale. Furthermore, the relevant FDA guidance on the DDS is still incomplete, especially for abbreviated new drug application. In this review, we present some recent achievement of the PLGA/PLA microspheres/nanoparticles, and discuss some promising manufacturing methods. Finally, we focus on the current FDA guidance on the DDS. The review provides an overview on the development of the system in pharmaceutical industry.

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