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.
The FDA has approved many medical devices and extended-release drugs containing LG polymers, including innovator and complex generic drugs. However, the complexity of LG polymers continues to pose challenges in nomenclature, characterization, use in advanced formulations (injectables, implants, ophthalmics, inhalants), and regulatory evaluation.
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?
No matter what stage you are – whether developmental or manufacturing, get a suite of solutions that provide quality products without compromise.
Our LG polymer (Poly (lactic-co-glycolic acid), (PLGA) polymers, Polylactic acid (PLA) polymers, Poly (lactide-co-glycolide) (PLG) polymers, and Polylactide (PL) polymers) solutions will:
- Bring uniformity while testing and evaluating innovator or generic drugs using LG polymers
- Help in the analytical characterization and testing of LG polymer, which will further aid in ensuring quality and the selection of the appropriate LG polymer.
- Aid in evaluating qualitative/quantitative (Q1/Q2) and similarity (Q3) sameness with respect to the reference listed drug (RLD).
- Help meet regulatory requirements and characterization challenges
- Save cost and time
- Seamless analytical work will help you bring your medicines to the market faster.
Monographs
Reference Standards and Materials
- USP DL-Lactide and Glycolide (50:50) Copolymer 12000 Acid RS
- USP DL-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester RS
- USP DL-Lactide and Glycolide (50:50) Copolymer 46000 Acid RS
- USP DL-Lactide Homopolymer 14000 Acid RS
- 14 LG polymer *Analytical Reference Materials (ARMs) for LG polymers of different ratios and molecular weights
General Chapters in PF
- <315> NMR Number-Average Molecular Weight Determination for LG Polymers. PF 50(5)
- <316> GPC Molecular Weight and Polydispersity Determination for LG Polymers using Universal Calibration. PF 50(5)
- <318> NMR Spectroscopy Monomer Ratio Determination for Lactide-Glycolide Polymers. PF 51(4)
*Analytical Reference Materials (ARM) are released using a process developed by USP’s subject matter experts. The release process is based on internal policies, standard operating procedures, and requirements as defined by USP’s Quality Management System. USP is an ISO 9001:2015 certified facility. ARMs are different from official USP Reference Standards. ARMs are not required for compendial compliance.
Stimuli articles
A Practical Approach to Compendial Nomenclature and Testing for Lactide and Glycolide Polymers and Related Polymeric Excipients, PF 48 (2)
USP Responses to Comments on Stimuli Article: "A Practical Approach to Compendial Nomenclature and Testing for Lactide and Glycolide Polymers and Related Polymeric Excipients", PF 49 (6)
Novel Excipients Hub
Get updates on USP’s work on novel excipients. Tell us your top novel excipient challenges – We’re here to help!
LG polymer publication
Learn how a comprehensive evaluation approach establishes a reliable SEC-MALS/RI chromatographic method to determine MW parameters in LG polymers.
Robust LG polymer characterization
Take a deep dive into our new case study of a reference listed drug, Lupron Depot
Advanced Injectables
Steering you through the maze of advanced injectables
LG polymer education course
Evolving Approaches for GCs (312 to 316) and LG Polymers
FAQs
What are LG polymers?
Lactide and Glycoide (lactic acid or glycolic acid) LG polymers (PLGAs, PLGs, PLA, PL, Polyesters: Poly (lactic-co-glycolic acid), (PLGA) polymers, Polylactic acid (PLA) polymers, Poly (lactide-co-glycolide) (PLG) polymers, and Polylactide (PL) polymers) are biodegradable polyesters of lactide and glycolide monomers that are used in controlled-release formulations with varying drug-release periods.
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What are the top challenges when working with LG polymers?
- Inherent structural heterogeneity of LG polymers
- Lack of standardized quality parameters
- Knowledge gap delaying product development and approval of innovator and generic products
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How can USP support your work using LG polymers?
USP offers a suite of solutions including ARMs, Stimulai articles, General Chapters, monographs, RS, etc. to navigate LG polymer complexities with confidence, certainty and ease.
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Why are our LG polymer solutions important?
- High value methods will help bring uniformity in testing and characterization – thus ensuring quality
- Help meet regulatory expectations and structural characterization challenges
- Ease selection and use of LG polymer excipients in drug products
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Who can I contact to ask questions on LG polymers?
Talk to our experts and learn how our solutions can support your every need!
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