LG polymers are biodegradable polyesters of lactide (or lactic acid) and glycolide (or glycolic acid) monomers that are used in controlled-release formulations with varying drug-release periods.
FDA has approved many medical devices and extended-release drugs containing LG polymers, including innovator and complex generic drugs. However, given the complexities of LG polymers, their characterization and testing, use in formulations, and regulatory evaluation of LG polymer-containing drug products remain challenging.
Accurate LG polymer profiling in drug formulations requires robust tools that ensure reproducibility and confidence. USP offers a suite of solutions that will help you meet regulatory expectations and characterization challenges.
How can USP LG polymer solutions help you?
