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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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A reproducible accelerated in vitro release testing method for PLGA microspheres.

Jie Shen1, Kyulim Lee1, Stephanie Choi2

  • 1School of Pharmacy, University of Connecticut, Storrs, CT 06269, USA.

International Journal of Pharmaceutics
|December 26, 2015
PubMed
Summary

Developing an accelerated in vitro release method for poly(lactic-co-glycolic acid) (PLGA) microspheres is crucial. The USP apparatus 4 method demonstrated good reproducibility for quality control of porous microspheres.

Keywords:
Accelerated in vitro releaseCompositionally equivalentPLGA microspheresPorousRisperidoneUSP apparatus 4

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Long-acting injectable formulations, such as poly(lactic-co-glycolic acid) (PLGA) microspheres, are vital for sustained drug delivery.
  • Characterizing the in vitro release profiles of these complex systems is essential for quality control and predicting in vivo performance.
  • Differences in microsphere inner structure, particularly porosity, can significantly impact drug release kinetics and product performance.

Purpose of the Study:

  • To develop and validate a discriminatory and reproducible accelerated in vitro release method for long-acting PLGA microspheres.
  • To evaluate the influence of inner structure/porosity differences on drug release and microsphere degradation.
  • To identify a suitable accelerated testing method for quality control of PLGA microspheres with varying porosity.

Main Methods:

  • Preparation of qualitatively and quantitatively equivalent risperidone-loaded PLGA microspheres with varying inner structures/porosity using different manufacturing processes.
  • Physicochemical characterization and degradation profiling of the prepared microspheres.
  • In vitro release testing using sample-and-separate and USP apparatus 4 (flow-through) methods under real-time (37 °C) and accelerated (45 °C) conditions.

Main Results:

  • PLGA microspheres with similar drug loading but different porosity exhibited distinct degradation and drug release profiles.
  • Porous microspheres demonstrated faster degradation and drug release compared to less porous counterparts when particle size was comparable.
  • Both tested in vitro methods differentiated formulations based on porosity at 37 °C and 45 °C.
  • The accelerated USP apparatus 4 method showed superior reproducibility, especially for highly porous microspheres.

Conclusions:

  • Accelerated in vitro release testing can effectively distinguish PLGA microspheres with varying porosity.
  • The accelerated USP apparatus 4 method is a reliable and rapid tool for quality control of long-acting PLGA microspheres, including those with porous structures.
  • This method facilitates efficient batch-to-batch consistency assessment for complex drug delivery systems.