Particle size analysis in pharmaceutics: Principles, methods and applications

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

研究成果: Review article同行評審

444 引文 斯高帕斯(Scopus)

摘要

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.

原文English
頁(從 - 到)203-227
頁數25
期刊Pharmaceutical Research
24
發行號2
DOIs
出版狀態Published - 2月 2007

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