作者: A. Chaudhury , D. Barrasso , D.A. Pohlman , J.D. Litster , R. Ramachandran
DOI: 10.1016/B978-0-08-100154-7.00005-3
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摘要: Abstract Particulate processes are ubiquitous in various industries, such as, pharmaceuticals, aerosols, and detergents, challenging to control owing their discrete nature. Granulation is a particle design process used the pharmaceutical industry tailor size other attributes for improved handling. can be efficiently described using population balance models (PBMs) element modeling with efficient numerical techniques accurate solution applicability of Quality by Design (QbD) operation. The recent initiative US FDA suggesting implementation QbD processing has emphasized need model-based system approach. In this chapter, detailed discussion provided on approaches understanding mixer wet granulation processes. development semimechanistic model accentuates ability develop predictive solving PBMs discussed chapter. A brief introduction initially describing underlying mechanisms high-shear equipment, giving readers an overview its principles. following sections focus mathematical developed granulation, that applied more specific case studies problem these techniques. Overall, chapter aims provide comprehensive current state systems-based