a Department of Bioscience and Bioengineering , Indian Institute of Technology , Mumbai , India.
b Department Pharmaceutics, Biopharmaceutics & NutriCosmetics , Freie Universität Berlin, Institute of Pharmacy , Kelchstr. 31, 12169 Berlin , Germany.
Expert Opin Drug Deliv. 2016 Sep;13(9):1257-75. doi: 10.1080/17425247.2016.1182485. Epub 2016 May 17.
Polyethylene glycol (PEG) is a polymer of choice in drug delivery systems. This USFDA-approved polymer is popular due to its tunable properties and well-established safety profile: prime requisites considered during the selection of any excipient in formulation development.
The unique properties and applications of PEG have been discussed at length in the existing literature. However, a proper guidance on selection of PEG grade to cater to one's purpose is lacking. This article provides preliminary guidelines to formulators on selection of appropriate PEG grade, typically based on its physico-chemical properties and role-based functional application in pharmaceuticals. It should be noted that the aim article is not to deep dive in each application area.
Guidance on PEG application and grade of choice is lacking in the available literature. The authors have discussed and provided guidance to formulators on the appropriate PEG grade selection for particular application based on the available in vitro and in vivo literature data. In this review a State-of-the-art use of PEG in therapeutic applications, its clinical status and commercial use is also summarized. Nevertheless, toxicities related to different PEG grades and related impurities are discussed in this review.
聚乙二醇(PEG)是药物传递系统中首选的聚合物。这种获得美国食品和药物管理局(USFDA)批准的聚合物因其可调的性质和成熟的安全特性而广受欢迎:在制剂开发中选择任何赋形剂时都需要考虑这两个首要要求。
PEG 的独特性质和应用在现有文献中已有详细讨论。然而,在选择 PEG 级别的方面缺乏适当的指导,以满足特定目的。本文为制剂设计师提供了选择合适 PEG 级别的初步指南,通常基于其物理化学性质以及在制药中的基于作用的功能应用。需要注意的是,本文的目的不是深入探讨每个应用领域。
现有文献中缺乏关于 PEG 应用和等级选择的指导。作者根据现有体外和体内文献数据,讨论并为制剂设计师提供了针对特定应用的合适 PEG 级别的选择指导。在本综述中,还总结了 PEG 在治疗应用中的最新使用情况、其临床地位和商业用途。然而,本文还讨论了与不同 PEG 等级和相关杂质相关的毒性。