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Particle Size Analysis in Pharmaceutics: Principles, Methods and Applications

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Abstract

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.

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Acknowledgment

One of the authors (Henry H. Y. Tong) would like to acknowledge the financial support of Macao Polytechnic Institute [Project No. RP/ESS-7/2005].

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Authors and Affiliations

  1. Ferro Pfanstiehl Laboratories, Pharmaceutical Technologies, Independence, Ohio, 44131, USA

    Boris Y. Shekunov & Pratibhash Chattopadhyay

  2. School of Health Sciences, Macao Polytechnic Institute, Macao SAR, China

    Henry H. Y. Tong

  3. School of Pharmacy, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China

    Albert H. L. Chow

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  1. Boris Y. Shekunov
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  2. Pratibhash Chattopadhyay
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  3. Henry H. Y. Tong
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  4. Albert H. L. Chow
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Correspondence to Boris Y. Shekunov.

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Shekunov, B.Y., Chattopadhyay, P., Tong, H.H.Y. et al. Particle Size Analysis in Pharmaceutics: Principles, Methods and Applications. Pharm Res 24, 203–227 (2007). https://doi.org/10.1007/s11095-006-9146-7

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  • DOI: https://doi.org/10.1007/s11095-006-9146-7

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