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- W3025786366 abstract "In the pharmaceutical industry, it is a major challenge to maintain consistent quality of drug products when the batch scale of a process is changed from a laboratory scale to a pilot or commercial scale. Generally, a pharmaceutical manufacturing process involves various unit operations, such as blending, granulation, milling, tableting and coating and the process parameters of a unit operation have significant effects on the quality of the drug product. Depending on the change in batch scale, various process parameters should be strategically controlled to ensure consistent quality attributes of a drug product. In particular, the granulation may be significantly influenced by scale variation as a result of changes in various process parameters and equipment geometry. In this study, model-based scale-up methodologies for pharmaceutical granulation are presented, along with data from various related reports. The first is an engineering-based modeling method that uses dimensionless numbers based on process similarity. The second is a process analytical technology-based modeling method that maintains the desired quality attributes through flexible adjustment of process parameters by monitoring the quality attributes of process products in real time. The third is a physics-based modeling method that involves a process simulation that understands and predicts drug quality through calculation of the behavior of the process using physics related to the process. The applications of these three scale-up methods are summarized according to granulation mechanisms, such as wet granulation and dry granulation. This review shows that these model-based scale-up methodologies provide a systematic process strategy that can ensure the quality of drug products in the pharmaceutical industry." @default.
- W3025786366 created "2020-05-21" @default.
- W3025786366 creator A5009774536 @default.
- W3025786366 creator A5013554846 @default.
- W3025786366 creator A5028070594 @default.
- W3025786366 creator A5073206077 @default.
- W3025786366 date "2020-05-14" @default.
- W3025786366 modified "2023-10-18" @default.
- W3025786366 title "Model-Based Scale-up Methodologies for Pharmaceutical Granulation" @default.
- W3025786366 cites W1484825190 @default.
- W3025786366 cites W1890520228 @default.
- W3025786366 cites W1966119769 @default.
- W3025786366 cites W1966183296 @default.
- W3025786366 cites W1969343105 @default.
- W3025786366 cites W1969857724 @default.
- W3025786366 cites W1972167165 @default.
- W3025786366 cites W1972717080 @default.
- W3025786366 cites W1973333826 @default.
- W3025786366 cites W1974496303 @default.
- W3025786366 cites W1975691015 @default.
- W3025786366 cites W1978185404 @default.
- W3025786366 cites W1978317835 @default.
- W3025786366 cites W1979156269 @default.
- W3025786366 cites W1979180164 @default.
- W3025786366 cites W1980391442 @default.
- W3025786366 cites W1981595445 @default.
- W3025786366 cites W1982582862 @default.
- W3025786366 cites W1984535516 @default.
- W3025786366 cites W1989169734 @default.
- W3025786366 cites W1989878281 @default.
- W3025786366 cites W1991508827 @default.
- W3025786366 cites W1993348564 @default.
- W3025786366 cites W1997931981 @default.
- W3025786366 cites W1998808691 @default.
- W3025786366 cites W2002880551 @default.
- W3025786366 cites W2004439028 @default.
- W3025786366 cites W2007269248 @default.
- W3025786366 cites W2007811123 @default.
- W3025786366 cites W2009857423 @default.
- W3025786366 cites W2010013656 @default.
- W3025786366 cites W2010400045 @default.
- W3025786366 cites W2011076623 @default.
- W3025786366 cites W2011453571 @default.
- W3025786366 cites W2014461319 @default.
- W3025786366 cites W2015767328 @default.
- W3025786366 cites W2016461110 @default.
- W3025786366 cites W2020926852 @default.
- W3025786366 cites W2021544867 @default.
- W3025786366 cites W2022933499 @default.
- W3025786366 cites W2022945666 @default.
- W3025786366 cites W2023372112 @default.
- W3025786366 cites W2027136806 @default.
- W3025786366 cites W2029675971 @default.
- W3025786366 cites W2032169012 @default.
- W3025786366 cites W2032385599 @default.
- W3025786366 cites W2033734297 @default.
- W3025786366 cites W2034960565 @default.
- W3025786366 cites W2037459325 @default.
- W3025786366 cites W2038843347 @default.
- W3025786366 cites W2041142983 @default.
- W3025786366 cites W2042345281 @default.
- W3025786366 cites W2043081194 @default.
- W3025786366 cites W2044152609 @default.
- W3025786366 cites W2044693103 @default.
- W3025786366 cites W2045569037 @default.
- W3025786366 cites W2045628344 @default.
- W3025786366 cites W2046696768 @default.
- W3025786366 cites W2047601825 @default.
- W3025786366 cites W2048928667 @default.
- W3025786366 cites W2049696418 @default.
- W3025786366 cites W2051422597 @default.
- W3025786366 cites W2051427213 @default.
- W3025786366 cites W2053149893 @default.
- W3025786366 cites W2057153365 @default.
- W3025786366 cites W2057929115 @default.
- W3025786366 cites W2059211838 @default.
- W3025786366 cites W2065967013 @default.
- W3025786366 cites W2066331846 @default.
- W3025786366 cites W2067548381 @default.
- W3025786366 cites W2070266970 @default.
- W3025786366 cites W2071218450 @default.
- W3025786366 cites W2071680657 @default.
- W3025786366 cites W2073750282 @default.
- W3025786366 cites W2074696465 @default.
- W3025786366 cites W2075455679 @default.
- W3025786366 cites W2077130229 @default.
- W3025786366 cites W2077885684 @default.
- W3025786366 cites W2078941751 @default.
- W3025786366 cites W2082368269 @default.
- W3025786366 cites W2083911892 @default.
- W3025786366 cites W2084861388 @default.
- W3025786366 cites W2085703635 @default.
- W3025786366 cites W2085751077 @default.
- W3025786366 cites W2085843727 @default.
- W3025786366 cites W2087183496 @default.
- W3025786366 cites W2087378881 @default.
- W3025786366 cites W2090840596 @default.
- W3025786366 cites W2092504715 @default.