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Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy
09 Jun 2023 | Contributor(s):: Vanarase, Aditya, Alcalà, Manel, Jerez-Rozo, Jackeline, Muzzio, Fernando, Romañach, Rodolfo
A non-destructive NIR spectroscopic method was used to acquire on-line spectra of a continuous mixing process, and evaluate the performance of this novel system. Partial least squares (PLS) calibration models were developed and used for real-time determination of active ingredient concentration...
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Prediction of segregation tendency occurrence in dry particulate pharmaceutical mixtures: Development of a mathematical tool adapted for granular systems application
09 Jun 2023 | Contributor(s):: Abatzoglou, N;, Simard, JS
Segregation phenomena are of importance in nearly all processes involving dry granular and powder mixtures. The extent of segregation directly influences the eventual rejection of a considerable percentage of the final product in the majority of pharmaceutical processes; among these are those...
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Method for characterization of loss-in-weight feeder equipment
09 Jun 2023 | Contributor(s):: William E. Engisch, Fernando J. Muzzio
This paper presents a method for evaluating the steady state performance of loss-in-weight powder feeding equipment and then demonstrates the use of the method in evaluating the performance of a K-Tron KT35 loss-in-weight feeder for three pharmaceutical grade powders. The method describes in...
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Effects of processing parameters and blade patterns on continuous pharmaceutical powder mixing
09 Jun 2023 | Contributor(s):: Osorio, JG, Muzzio, FJ
The present study summarizes the experimental characterization of a new continuous powder mixer (GCG-70 by Glatt (R)) using common pharmaceutical ingredients. The powder hold-up and residence time distribution were used to characterize the bulk behavior of the mixer as a function of impeller...
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Development and applications of a material library for pharmaceutical continuous manufacturing of solid dosage forms
09 Jun 2023 | Contributor(s):: Yifan Wang, ThomasO'Connor, TianyiLi, Muhammad Ashraf
The purpose of this study is to establish a material library and discuss its potential application to the development and lifecycle management of a continuous manufacturing process for solid dosage forms. Particularly, this study addresses the importance of selecting process-relevant testing...
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Deep UV Raman and fluorescence spectroscopy for real-time in situ process monitoring
09 Jun 2023 | Contributor(s):: Hug, WF, Nguyen, QReid, M, Sijapati, K, Reid, RD
Raman spectroscopy has become an increasingly common analytical method for real-time, on-line, in-line, and off-line in situ monitoring of product quality in a variety of pharmaceutical, chemical, and biological manufacturing environments, including wastewater quality [1]. The major shortcomings...