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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are employed to...
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Particle size analysis in pharmaceutics: principles, methods and applications.

Boris Y Shekunov1, Pratibhash Chattopadhyay, Henry H Y Tong

  • 1Ferro Pfanstiehl Laboratories, Pharmaceutical Technologies, Independence, Ohio 44131, USA. shekunovb@ferro.com

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Particle size analysis is crucial for drug properties, but different methods yield varied results due to particle shape and dispersion. Cross-correlation of techniques is needed for optimal selection in pharmaceutical production.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Particle size significantly impacts drug substance physicochemical and biopharmaceutical properties.
  • Particle size is a critical process parameter in pharmaceutical manufacturing.
  • Diverse particle sizing methods generate varied equivalent diameters, complicating analysis.

Purpose of the Study:

  • To provide an in-depth review of particle size analysis in pharmaceuticals.
  • To discuss fundamental principles, instrumentation, data interpretation, and regulatory aspects.
  • To highlight the importance of cross-correlation between different sizing techniques.

Main Methods:

  • Review of existing literature on particle size analysis techniques.
  • Discussion of fundamental principles, instrumentation, and data interpretation.
  • Case study on aerosol analysis using time-of-flight and cascade impactor measurements with computational support.

Main Results:

  • Different particle sizing methods produce varied results due to inherent differences in measurement principles.
  • Particle shape and dispersion mechanisms are key factors influencing equivalent particle diameter.
  • Cross-correlation of data from multiple techniques is essential for accurate assessment.

Conclusions:

  • Selecting the appropriate particle size analysis technique requires understanding its principles and limitations.
  • Cross-correlation of data from various methods enhances the reliability of particle size determination.
  • In-line and process analytical technology (PAT) offer opportunities for real-time particle size monitoring.