A protocol for assay of poly(lactide-co-glycolide) in clinical products

International Journal of Pharmaceutics
John GarnerYan Wang

Abstract

Poly(lactide-co-glycolide) (PLGA) is the key component of long acting drug products responsible for providing sustained release in a controlled manner. The objective of the current study was to develop and validate an analytical protocol to determine key properties of PLGA used in commercial long-acting drug products. Procedures to isolate PLGA from commercial products have been established and the key properties of PLGA, such as polymer molecular weight, lactide:glycolide (L:G) ratio, and nature of polymer end-cap, have been determined. Identification of the polymer end-cap was confirmed by using two PLGA polymers with acid and ester end-caps. Trelstar(®) and Risperdal Consta(®) were chosen as model products. The calculated L:G ratios of PLGA used in Trelstar(®) and Risperdal(®) are 52:48 and 78:22, respectively. PLGAs from both Trelstar(®) and Risperdal Consta(®) possess ester end-caps. Since the properties of specific PLGA in clinically used formulations are not readily available, this protocol will be useful in developing PLGA-based long acting drug products.

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Citations

Jan 17, 2019·Clinical Pharmacology and Therapeutics·Robert A Lionberger
Nov 6, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Kinam ParkYan Wang
Feb 7, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Justin HadarDarby Kozak
Mar 7, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Yabing HuaAiping Zheng
Mar 3, 2021·Nature Communications·Natasha C BrighamMatthew L Becker
Jul 6, 2020·International Journal of Pharmaceutics·Yajie ZhangRobert O Williams
Apr 30, 2021·International Journal of Pharmaceutics·John GarnerYan Wang
Jun 15, 2021·Journal of Controlled Release : Official Journal of the Controlled Release Society·Matthew N O'BrienDavid M Loffredo
Jul 26, 2021·International Journal of Pharmaceutics·Raghad M AbuhamdanSamer R Abulateefeh
Aug 1, 2021·International Journal of Pharmaceutics·Bo WanDiane J Burgess
Aug 21, 2021·Drug Delivery and Translational Research·Jing SunSteven P Schwendeman
Jan 19, 2021·ACS Biomaterials Science & Engineering·Wei TangYazhou Wang

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