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Analyzing ophthalmic suspension particle size distributions using laser diffraction: Placebo background subtraction

Anh Vo1, Xin Feng2, William C Smith1

  • 1Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

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|February 26, 2021
PubMed
Summary

Excipients in ophthalmic suspensions can interfere with particle size distribution (PSD) measurements using laser diffraction (LD). A placebo background subtraction method effectively removes excipient interference, ensuring accurate PSD analysis for ophthalmic drug products.

Keywords:
Background subtractionExcipient interferenceLaser diffractionLightscatteringParticle sizingSuspension

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Materials Science

Background:

  • Particle size distribution (PSD) is a critical quality attribute for ophthalmic suspensions.
  • Laser diffraction (LD) is a common technique for PSD measurement, but excipients can interfere.
  • Accurate PSD measurement is crucial for drug efficacy and safety in ophthalmic formulations.

Purpose of the Study:

  • To investigate the interference of excipients in ophthalmic suspensions on particle size distribution (PSD) measurements by laser diffraction (LD).
  • To develop and validate a placebo background subtraction approach to eliminate excipient interference in PSD analysis.
  • To ensure accurate characterization of active pharmaceutical ingredient (API) particle size in complex ophthalmic formulations.

Main Methods:

  • Utilized commercially available loteprednol etabonate and brinzolamide ophthalmic suspensions as model systems.
  • Employed a one-factor-at-a-time experimental design with NIST-traceable polystyrene particle size standards.
  • Developed and validated a placebo background subtraction method for LD analysis, confirmed with polarized light microscopy and scanning electron microscopy (SEM).

Main Results:

  • Identified polyacrylic acid-containing polymers as significant interferents in LD measurements, generating signals mimicking large particles.
  • Observed erroneous PSD interpretations due to overlapping signals from excipients and API particles.
  • Demonstrated that the placebo background subtraction approach successfully eliminated excipient interference, yielding accurate API PSD.
  • Noted dissolution of brinzolamide particles in unsaturated solutions, leading to underestimation of particle size range.

Conclusions:

  • Excipients, particularly polyacrylic acid polymers, can significantly interfere with laser diffraction (LD) based particle size distribution (PSD) measurements of ophthalmic suspensions.
  • A placebo background subtraction method is a robust strategy to mitigate excipient interference and achieve accurate PSD analysis.
  • This approach enhances the reliability of quality control for ophthalmic suspensions and may be applicable to other heterogeneous dispersions.