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A New Analytical Method for Quantifying Acid-End-Cap PLGA in Sub-Milligram Quantities.

John Garner1, Sarah Skidmore1, Gary Overdorf1

  • 1Akina, Inc., 3495 Kent Avenue, West Lafayette, Indiana 47906, United States.

Molecular Pharmaceutics
|November 20, 2024
PubMed
Summary
This summary is machine-generated.

A new assay quantifies acid-end-capped poly(lactic-co-glycolic acid) (PLGA-A) in drug products. This method accurately measures PLGA-A in small samples, crucial for generic drug quality control.

Keywords:
GPC-UV/RIPLGATANlong-acting injectablessubmilligramtotal acid number

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Area of Science:

  • Polymer Chemistry
  • Analytical Chemistry
  • Pharmaceutical Sciences

Background:

  • Characterizing poly(lactic-co-glycolic acid) (PLGA) polymers in FDA-approved drug products is vital for quality control and generic formulation evaluation.
  • Existing analytical methods struggle to quantify PLGA-A in mixtures with PLGA-E, especially with limited sample quantities (<1 mg) found in products like Durysta and Ozurdex.
  • Accurate quantification of PLGA-A is essential for understanding drug product stability and performance.

Purpose of the Study:

  • To develop a novel assay for accurately quantifying acid-end-capped PLGA (PLGA-A) in mixtures with ester-end-capped PLGA (PLGA-E).
  • To enable the analysis of submilligram quantities of PLGA polymers in complex drug formulations.
  • To provide a reliable method for quality control of PLGA-containing pharmaceutical products.

Main Methods:

  • A new GPC-UV/RI approach was developed, modifying the acid end-cap with pyrene methylamine (a UV dye) for enhanced signal detection.
  • The method measures the total acid number (TAN) of PLGA-A and converts it to quantity, comparing it with total PLGA measured by refractive index (RI).
  • This technique allows for TAN measurements on submilligram PLGA quantities, overcoming limitations of conventional methods.

Main Results:

  • The GPC-UV/RI method successfully quantifies PLGA-A in mixtures with PLGA-E, even at submilligram sample levels.
  • Application to Ozurdex-similar samples confirmed the expected acid:ester ratio of PLGAs.
  • The developed assay demonstrates high sensitivity and accuracy for PLGA characterization.

Conclusions:

  • The novel GPC-UV/RI assay is a powerful new tool for characterizing PLGA polymers in FDA-approved drug products.
  • This method addresses a critical analytical gap, particularly for small sample quantities found in complex formulations.
  • Accurate PLGA characterization is crucial, as commercial product PLGAs may differ from raw materials due to manufacturing processes.