A multivariate formulation and process development platform for direct compression

Sample Size Requirements of a Pharmaceutical Material Library: A Case in Predicting Direct Compression Tablet Tensile Strength by Latent Variable Modeling

“…In practice, the material library was presented in the form of tabular data, in which the rows were different materials, and the columns were material quality attributes. Table 1 shows the typical sizes of reported pharmaceutical material libraries after retrieving articles in Web of Science using “material library” or “material database” as key words [ 1 , 3 , 4 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ]. The material name and attributes in each material library are shown in Table S1 in the Supplementary Materials .…”

“…Supplementary Materials S2: Table S2: The information of 45 materials including names, abbreviations, batch numbers suppliers and physical attributes. References [ 1 , 3 , 4 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ] are cited in the supplementary materials.…”

Batch vs. continuous direct compression – a comparison of material processability and final tablet quality

“…only 3 unit operations required) of (continuous) direct compression ((C)DC) makes it one of the most used production techniques. This is evident from the wide variety of studies published on this topic, ranging from fully integrated CDC systems ( Järvinen et al, 2013a ; Järvinen et al, 2013b ; Simonaho et al, 2016 ; Van Snick et al, 2017a ; Van Snick et al, 2017b ; García-Muñoz, 2017 Roth et al, 2017 ; Van Snick, 2019 ; Galbraith et al, 2019 ; Galbraith et al, 2020 ; Bekaert et al, 2022c ) to more in-depth investigations of each unit operation: feeding ( Engisch and Muzzio, 2014 ; Blackshields and Crean, 2018 ; Hanson, 2018 ; Bostijn et al, 2019 ; Sacher et al, 2020 ; Bekaert et al, 2021 ; Bekaert et al, 2022b ); blending ( Pernenkil and Cooney, 2006 ; Portillo et al, 2008 ; Gao et al, 2011 ; Osorio and Muzzio, 2016 ; Palmer et al, 2020 ; Bekaert et al, 2022a ; Jaspers et al, 2021 ); and tableting ( Patel et al, 2006 ; Sun, 2010 ; Peeters et al, 2018 ; Van Snick et al, 2018a ; Galbraith et al, 2020 ; Ervasti et al, 2020 ; Dhondt et al, 2022 ).…”

A tabletability change classification system in supporting the tablet formulation design via the roll compaction and dry granulation process

“…The materials used in such models could be all materials in the material library, or could be a representative material subset selected by the material sparing approaches ( Dhondt et al, 2022b ; Wang et al, 2019 ). Currently, the process models on the basis of the material library approach were mainly implemented on single unit operations, such as the direct compression process ( Dhondt et al, 2022a ; Hayashi et al, 2021 ; Paul et al, 2019 ), the roller compaction process ( Yu et al, 2019 ), etc. At last, the obtained process knowledge or process models can enable in-silico exploring the material properties space and the process parameters space ( Dai et al, 2019a ), help predict process and product performance, reduce the impact of raw material variability on the drug product quality ( Zhang et al, 2019 ) or avoid potential process failures ( Hancock, 2019 ).…”