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Transfer from High-Shear Batch to Continuous Twin Screw Wet Granulation: A Case Study in Understanding the Relationship Between Process Parameters and Product Quality Attributes
Contributor(s):: Beer, Paul, Wilson, David, Huang, Zhenyu, De Matas, Marcel
A twin screw to high-shear batch granulation technology switch was evaluated for a pharmaceutical development project. Differences in granule (particle size distribution and porosity) and tablet (dissolution) quality attributes were analysed for both continuous and batch technologies. Liquid to...
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Provoking an end-to-end continuous direct compression line with raw materials prone to segregation
Contributor(s):: Lakio, Satu, Ervasti, Tuomas, Tajarobi, Pirjo, Wikstrom, Hakan, Fransson, Magnus, Karttunen, Anssi-Pekka, Ketolainen, Jarkko, Folestad, Staffan, Abrahmsen-Alami, Susanna, Korhonen, Ossi
Continuous manufacturing of solid oral dosage forms is promising for increasing the efficiency and quality of pharmaceutical production and products. In this study a whole train continuous direct compression (CDC) line has been provoked using challenging formulations typically prone to...
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Process Analytical Technology Tools for Monitoring Pharmaceutical Unit operations: A Control Strategy for Continuous Process Verification
Contributor(s):: Kim, Eun, Kim, Ji, Kim, Min-Soo, Jeong, Seong, Choi, Du
Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls...