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Tablet Quality-Prediction Model Using Quality Material Attributes: Toward Flexible Switching Between Batch and Continuous Granulation
Contributor(s):: Arai, H, Nagato, TKoide, T, Yonemochi, E, Yamamoto, H, Sugiyama, H
Purpose The purpose of the study was to develop a model to predict the critical quality attribute (CQA) of tablets during continuous and batch manufacturing using only critical material attributes (CMAs). Methods Experiments were performed using ethenzamide as the active pharmaceutical ingredient...
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Supervisory Control System for Monitoring a Pharmaceutical Hot Melt Extrusion Process
Contributor(s):: Markl, Daniel, Wahl, Patrick R, Menezes, José C, Koller, Daniel M, Kavsek, Barbara, Francois, Kjell, Roblegg, Evaa, Khinast, Johannes G.
Continuous pharmaceutical manufacturing processes are of increased industrial interest and require uni- and multivariate Process Analytical Technology (PAT) data from different unit operations to be aligned and explored within the Quality by Design (QbD) context. Real-time pharmaceutical process...
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Rapid and nondestructive analysis of pharmaceutical products using near-infrared diffuse reflectance spectroscopy
Contributor(s):: Li, P, Du, GRCai, WS, Shao, XG
Near-infrared diffuse reflectance spectroscopy (NIRDRS) was applied to classification and quantification of azithromycin tablets with the aid of chemometric multivariate analysis. Repeatability was investigated by repeated measurements, and the effect of morphology was examined by preparing the...
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Quality-by-Design III: Application of Near-Infrared Spectroscopy to Monitor Roller Compaction In-process and Product Quality Attributes of Immediate Release Tablets
Contributor(s):: Kona, Ravikanth, Fahmy, Raafat M., Claycamp, Gregg, Polli, James E., Martinez, Marilyn, Hoag, Stephen W.
The objective of this study is to use near-infrared spectroscopy (NIRS) coupled with multivariate chemometric models to monitor granule and tablet quality attributes in the formulation development and manufacturing of ciprofloxacin hydrochloride (CIP) immediate release tablets. Critical roller...
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Intelligent Alarm Management Applied to Continuous Pharmaceutical Tablet Manufacturing: An Integrated Approach
Contributor(s):: Gupta, Anshu, Giridhar, Arun, Venkatasubramanian, Venkat., Reklaitis, Gintaras V.
One important aspect of effective real time process management is the implementation of intelligent systems that can assist human operators in making supervisory control decisions. Conventional practice is to simply sound alarms when process variables go out of range leaving it to the operator to...
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In-Depth Evaluation of Data Collected During a Continuous Pharmaceutical Manufacturing Process: A Multivariate Statistical Process Monitoring Approach
Contributor(s):: Silva, Ana F., Vercruysse, Jurgen, Vervaet, Chris, Remon, Jean P., Lopes, João A., De Beer, Thomas, Sarraguça, Mafalda C.
The present work presents an in-depth evaluation of continuously collected data during a twin-screw granulation and drying process performed on a continuous manufacturing line. During operation, the continuous line logs 49 univariate process variables, hence generating a large amount of data....
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A multivariate raw material property database to facilitate drug product development and enable in-silico design of pharmaceutical dry powder processes
Contributor(s):: Van;Snick, B, Dhondt, JPandelaere, K, Bertels, J, Mertens, R, Klingeleers, D, Di, Pretoro, G, Remon, JP, Vervaet, C, De, Beer, T, Vanhoorne, V
In current study a holistic material characterization approach was proposed and an extensive raw material property database was developed including a wide variety of APIs and excipients with different functionalities. In total 55 different materials were characterized and described by over 100...