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Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
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Residual Content Impacts Critical Quality Attributes and Performance of Risperidone Microspheres.

Saurabh Bhorkade1, Bo Wan1, Pawan Kumar Pandey1

  • 1Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, 69 North Eagleville Road, Unit 3092, Storrs, CT, USA.

Pharmaceutical Research
|May 15, 2026
PubMed
Summary

Residual species in poly (lactic-co-glycolic acid) (PLGA) significantly impact microsphere drug delivery performance. Controlling polymer purity is crucial for consistent drug release from PLGA microspheres.

Keywords:
in vitro releasePLGA microspherepolymer degradationresidual contentrisperidone

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Area of Science:

  • Biomaterials Science
  • Polymer Chemistry
  • Pharmaceutical Technology

Background:

  • Poly (lactic-co-glycolic acid) (PLGA) microspheres are essential for long-acting injectable drug delivery systems.
  • Microsphere performance, including drug release and degradation, is sensitive to polymer properties.
  • The influence of residual species in commercial PLGA on microsphere characteristics remains underexplored.

Purpose of the Study:

  • To investigate the impact of residual content in PLGA on the physicochemical properties and in vitro performance of risperidone-loaded microspheres.
  • To establish correlations between residual species, microsphere structure, degradation, and drug release kinetics.

Main Methods:

  • PLGA with varying residual content was prepared via purification or spiking with monomers/solvents.
  • Risperidone-loaded microspheres were formulated using PLGA with different residual levels.
  • Microspheres were characterized for particle size, morphology, porosity, drug loading, degradation, and in vitro drug release.

Main Results:

  • Residual content significantly affected microsphere formation and performance.
  • High solvent residue altered particle size, porosity, and drug loading.
  • Accelerated polymer degradation and drug release were observed with higher residual content, showing a clear correlation with microsphere structure and release kinetics.

Conclusions:

  • Residual species are a critical material attribute influencing PLGA microsphere performance.
  • Polymer purification and stringent raw-material control are vital for ensuring consistent and predictable microsphere drug delivery.