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Published on: October 17, 2016
FDA's Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes
Yan Wang1, Bin Qin2, Grace Xia2
1Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Silver Spring, 20993, Maryland, USA. Yan.Wang3@fda.hhs.gov.
The AAPS Journal
|June 30, 2021
Summary
Developing generic Poly (lactic-co-glycolic acid) (PLGA) drug products is complex. The US Food and Drug Administration (FDA) research program addresses challenges in PLGA characterization, performance, and regulatory review for generic approvals.
Area of Science:
- Biomaterials Science
- Pharmaceutical Sciences
- Drug Delivery
Background:
- Poly (lactic-co-glycolic acid) (PLGA) is a key excipient in FDA-approved long-acting drug formulations.
- Generic PLGA-based products face significant regulatory hurdles due to formulation and characterization complexities.
- The US Food and Drug Administration (FDA) initiated a comprehensive research program to overcome these generic development challenges.
Purpose of the Study:
- To provide an overview of the FDA's research program focused on Poly (lactic-co-glycolic acid) (PLGA) products.
- To highlight scientific advancements and regulatory outcomes stemming from FDA's PLGA research initiatives.
- To address the complexities hindering generic Poly (lactic-co-glycolic acid) (PLGA) product approval.
Main Methods:
- Development and application of advanced analytical tools for Poly (lactic-co-glycolic acid) (PLGA) polymer characterization.
- Investigation into the influence of Poly (lactic-co-glycolic acid) (PLGA) characteristics and manufacturing processes on drug product performance.
- Establishment of in vitro drug release testing methodologies and in vitro-in vivo correlations for Poly (lactic-co-glycolic acid) (PLGA)-based formulations.
- Utilization of modeling tools to aid in Poly (lactic-co-glycolic acid) (PLGA) formulation design and bioequivalence study planning.
Main Results:
- Advancements in analytical techniques for precise Poly (lactic-co-glycolic acid) (PLGA) characterization.
- Enhanced understanding of the relationship between Poly (lactic-co-glycolic acid) (PLGA) properties, manufacturing, and drug release profiles.
- Development of robust in vitro release methods and successful in vitro-in vivo correlations for Poly (lactic-co-glycolic acid) (PLGA) products.
- Improved modeling approaches for efficient formulation development and bioequivalence assessment of Poly (lactic-co-glycolic acid) (PLGA) generics.
Conclusions:
- The FDA's research program has yielded significant scientific insights and regulatory tools for Poly (lactic-co-glycolic acid) (PLGA) products.
- These advancements facilitate the development and regulatory review of generic Poly (lactic-co-glycolic acid) (PLGA) long-acting drug formulations.
- Successful research outcomes are paving the way for increased availability of generic Poly (lactic-co-glycolic acid) (PLGA) therapies.
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