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Lubricant Sensitivity of Direct Compression Grades of Lactose in Continuous and Batch Tableting Process
| Contributor(s):: Gerald A. Hebbink, Pauline H. M. Janssen, Jurjen H. Kok, Lorenzo Menarini, Federica Giatti, Caterina Funaro, Salvatore Fabrizio Consoli, Bastiaan H. J. Dickhoff
Modern pharmaceutical manufacturing based on Quality by Design and digitalisation is revolutionising the pharmaceutical industry. Continuous processes are promoted as they increase efficiency and improve quality control. Compared to batch blending, continuous blending is easier to scale and...
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Material tracking in a continuous direct capsule-filling process via residence time distribution measurements
| Contributor(s):: Kruisz, Julia, Rehrl, Jakob, Faulhammer, Eva, Witschnigg, Andreas, Khinast, Johannes G.
Continuous production of pharmaceuticals requires traceability from the raw material to the final dosage form. With that regard, understanding the residence time distribution (RTD) of the whole process and its unit operations is crucial. This work describes a structured approach to characterizing...
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Integrating sensors for monitoring blend content in a pharmaceutical continuous manufacturing plant
| Contributor(s):: Panikar, Savitha, Li, Jingzhe, Rane, Varsha, Gillam, Sean, Callegari, Gerardo, Kurtyka, Bogdan, Lee, Sau, Muzzio, Fernando
In a pharmaceutical manufacturing process, Critical Quality Attributes (CQAs) need to be monitored not only for the final product but also for intermediates. Blend uniformity of powders is one such attribute that needs to be measured to ensure the quality of the final product. Multiple in-line...
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End-to-end continuous manufacturing of conventional compressed tablets: From flow synthesis to tableting through integrated crystallization and filtration
| Contributor(s):: Domokos, A, Nagy, BGyurkes, M, Farkas, A, Tacsi, K, Pataki, H, Liu, YC, Balogh, A, Firth, P, Szilagyi, B, Marosi, G, Nagy, ZK
An end-to-end continuous pharmaceutical manufacturing process was developed for the production of conventional direct compressed tablets on a proof-of-concept level for the first time. The output reaction mixture of the flow synthesis of acetylsalicylic acid was crystallized continuously in a...
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Continuous manufacturing: the future in pharmaceutical solid dosage form manufacturing
| Contributor(s):: Desai, Parind Mahendrakumar, Van Vaerenbergh, Griet, Holman, Jim, Liew, Celine Valeria, Heng, Paul Wan Sia
As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and...
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Continuous manufacturing of tablets with PROMIS-line. Introduction and case studies from continuous feeding, blending and tableting
| Contributor(s):: Simonaho, Simo-Pekka, Ketolainena, Jarkko, Ervasti, Tuomas, Toiviaine, Maunu, Korhonen, Ossi
Drug manufacturing technology is in the midst ofmodernization and continuousmanufacturing of drug products is especially the focus of great interest. The adoption of new manufacturing approaches requires extensive cooperation between industry, regulatory bodies, academics and equipment...