Journal
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
Volume 8, Issue 6, Pages 1740-1750Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s13346-017-0444-x
Keywords
Jet milling; Media milling; Ball milling; Process optimization; Design of experiments; Mathematical modeling; Quality by design; Process analytical technology
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Process control and optimization is a critical aspect of process analytical technology (PAT), quality by design (QbD), and the implementation of continuous manufacturing procedures. While process control and optimization techniques have been utilized in other manufacturing industries for decades, the pharmaceutical industry has only recently begun to adopt these procedures. Micronization, particularly milling, is a generally low-yield, high-energy consumption process that is well suited for a process optimization mindset. This review discusses optimization of the pharmaceutical milling process through design space development, theoretical and empirical modeling, and monitoring of critical quality attributes.
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