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Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression
Peer-reviewed journal | 20 Nov 2024 | Contributor(s):: Martin Prostredny, Hikaru Graeme Jolliffe, Richard Elkes, Khalid Maqsood, Yunfei Li Song, Gavin Reynolds, Bernhard Meir, John Robertson
Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified...
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Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression
Peer-reviewed journal | 13 Nov 2024 | Contributor(s):: Martin Prostredny, Hikaru Graeme Jolliffe, Richard Elkes, Khalid Maqsood, Yunfei Li Song, Gavin Reynolds, Bernhard Meir, John Robertson
Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified...
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Lubricant Sensitivity of Direct Compression Grades of Lactose in Continuous and Batch Tableting Process
Peer-reviewed journal | 16 Nov 2023 | 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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Process analytical technology for continuous manufacturing tableting processing: A case study
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Pauli, Victoria, Pellegatti, Laurent, Nguyen Trung, Nhat Quang, Elbaz, Frantz, Ensslin, Simon, Kleinebudde, Peter, Roggo, Yves, Krumme, Markus
The use of Near Infrared Spectroscopy (NIRS) as a fast and non-destructive technique was employed for the control and monitoring of the tableting step during a continuous manufacturing process. Two NIRS methods were optimized in order to in-line control the blend uniformity in the tablet feed...
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Integrated twin-screw wet granulation, continuous vibrational fluid drying and milling: A fully continuous powder to granule line
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Fulop, G., Domokos, A., Galata, D., Szabo, E., Gyurkes, M., Szabo, B., Farkas, A., Madarasz, L., Demuth, B., Lender, T., Nagy, T., Kovacs-Kiss, D., Van der Gucht, f, Marosi, G., Nagy, Z. K.
Highly homogeneous low-dose (50 mu g) tablets were produced incorporating perfectly free-flowing granules prepared by a fully integrated Continuous Manufacturing (CM) line. The adopted CM equipment consisted of a Twin-Screw Wet Granulator (TSWG), a Continuous Fluid Bed Dryer (CFBD) and a...
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Direct compaction: An update of materials, trouble-shooting, and application
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Li, Z, Zhao, LJLin, X, Shen, L, Feng, Y
Direct compaction (DC) is the preferred choice for tablet manufacturing; however, only less than 20% of active pharmaceutical ingredients could be compacted via DC as its high requirement for functional properties of materials. Materials with improper functionalities could lead to serious...
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Continuous direct tablet compression: effects of impeller rotation rate, total feed rate and drug content on the tablet properties and drug release
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Jarvinen, Maiju A., Paaso, Janne, Paavola, Marko, Leiviska, Kauko, Juuti, Mikko, Muzzio, Fernando, Jarvinen, Kristiina
Context: Continuous processing is becoming popular in the pharmaceutical industry for its cost and quality advantages. Objective: This study evaluated the mechanical properties, uniformity of dosage units and drug release from the tablets prepared by continuous direct compression process....
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Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity-A Review
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Jakubowska, E, Ciepluch, N
Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend...
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Assessment of blend uniformity in a continuous tablet manufacturing process
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Sierra-Vega, Nobel, Román-Ospino, Andrés, Scicolone, James, Muzzio, Fernando, Romañach, Rodolfo, Mendez, Rafael
Blend uniformity was monitored throughout a continuous manufacturing (CM) process by near infrared (NIR) spectroscopic measurements of flowing blends and compared to the drug concentration in the tablets. The NIR spectra were obtained through the chute after the blender and within the feed frame,...