Particle size analysis: AAPS workshop report, cosponsored by the Food and Drug Administration and the United States Pharmacopeia.
The concepts of particle engineering and dosage form design have become dominant themes in pharmaceutical manufacturing. This trend is not simply a reflection of the development of new, more sophisticated manufacturing methods of particles or dispersed systems but also recognition of the importance of quality control even in more traditional manufacturing processes. However, the diversity of particle treatments, methods of particle size analysis, expression and interpretation of data, and process applications results in complicated and sometimes confusing criteria for selection, adoption, or relevance of the available techniques.
Burgess
Diane J
DJ
Department of Pharmaceutical Sciences, University of Connecticut, 372 Fairfield Road, Storrs, CT, USA. diane.burgess@uconn.edu
Duffy
Eric
E
Etzler
Frank
F
Hickey
Anthony J
AJ
D010316:Particle Size; D010602:Pharmacopoeias as Topic; D013678:Technology, Pharmaceutical / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration