Lactide (or lactic acid) and Glycolide (or glycolic) (LG) Polymers

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.

magnifying glass iconHow 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 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.

Use our expert-approved comprehensive LG polymer solutions with confidence

Monographs published in Pharmacopeial Forum (PF)
Upcoming USP 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
  • Over 10 Analytical Reference Materials (ARMs)* for LG polymers of different ratios and molecular weights

*Analytical Reference Materials are different than official USP RS and are not required for compendial compliance and many more.

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FAQs

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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