Particle size analysis in pharmaceutics: Principles, methods and applications

Boris Y. Shekunov, Pratibhash Chattopadhyay, Henry H.Y. Tong, Albert H.L. Chow

Research output: Contribution to journalReview articlepeer-review

398 Citations (Scopus)

Abstract

Physicochemical and biopharmaceutical properties of drug substances and dosage forms can be highly affected by the particle size, a critical process parameter in pharmaceutical production. The fundamental issue with particle size analysis is the variety of equivalent particle diameters generated by different methods, which is largely ascribable to the particle shape and particle dispersion mechanism involved. Thus, to enable selection of the most appropriate or optimal sizing technique, cross-correlation between different techniques may be required. This review offers an in-depth discussion on particle size analysis pertaining to specific pharmaceutical applications and regulatory aspects, fundamental principles and terminology, instrumentation types, data presentation and interpretation, in-line and process analytical technology. For illustration purposes, special consideration is given to the analysis of aerosols using time-of-flight and cascade impactor measurements, which is supported by a computational analysis conducted for this review.

Original languageEnglish
Pages (from-to)203-227
Number of pages25
JournalPharmaceutical Research
Volume24
Issue number2
DOIs
Publication statusPublished - Feb 2007

Keywords

  • Aerodynamic diameter
  • Aerosols
  • Agglomeration
  • Dispersion
  • Impactor
  • Inhaler
  • Micro and nanosuspensions
  • PAT
  • Particle size distribution
  • Powders
  • Respiratory drug delivery
  • Shape
  • Tablets

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