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Continuous Manufacturing for Pharmaceutical Solid Dosage Forms (On-Demand)
| Contributor(s):: Atul Dubey, Fernando Muzzio, Gerardo Callegari, Lucy L. Botros, Ravendra Singh, James Scicolone, Andres Roman, Sonia Modarres Razavi
Course Description: This self-paced curriculum contains fourteen self-paced modules and three recordings of live virtual education on Pharmaceutical Continuous Manufacturing (PCM). Learners will have access to the following: A recording of the introductory session covering topics such as...
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Edmond Biba
https://cmkc.usp.org/members/1140
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Starch Products as Candidate Excipients in a Continuous Direct Compression Line
| Contributor(s):: Sonia M. Razavi, Yi Tao, James Scicolone, Tami Morker, Charles Cunningham, Ali Rajabi-Siahboomi, Douglas B. Hausner, Fernando J. Muzzio
Purpose Direct compression (DC) remains the most preferred technique to produce tablets, and its effectiveness is directly influenced by raw material attributes. Therefore, the selection of specific grades of excipients to achieve desirable powder flow and compression properties is of importance....
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Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing
| Contributor(s):: Stauffer, F, Vanhoorne, VPilcer, G, Chavez, PF, Rome, S, Schubert, MA, Aerts, L, De;Beer, T
Active Pharmaceutical Ingredients (API) raw material variability is not always thoroughly considered during pharmaceutical process development, mainly due to low quantities of drug substance available. However, synthesis, crystallization routes and production sites evolve during product...
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Modeling the effects of material properties on tablet compaction: A building block for controlling both batch and continuous pharmaceutical manufacturing processes
| Contributor(s):: Escotet-Espinoza, M Sebastian, Vadodaria, Shishir Singh, Ravendra Muzzio, Fernando J, Ierapetritou, Marianthi G
As the pharmaceutical industry modernizes its manufacturing practices and incorporates more efficient processing approaches, it is important to reevaluate which process design elements affect product quality and the means to study these systems. The purpose of this work is to provide insight on a...
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Managing API raw material variability during continuous twin-screw wet granulation
| Contributor(s):: Stauffer, F, Vanhoorne, VPiker, G, Chavez, PF, Vervaet, C, De;Beer, T
Very few studies have investigated the impact of raw material variability upon the granule critical quality attributes (CQAs) produced via twin-screw wet granulation (i.e., granule size distribution, density, flowability). In this study, the impact of the raw material variability of an active...
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Improving Feedability of Highly Adhesive Active Pharmaceutical Ingredients by Silication
| Contributor(s):: Escotet-Espinoza, M. Sebastian, Moghtadernejad, Sara, Sanchez, Eric, Cappuyns, Philippe, Van Assche, Ivo, Di Pretoro, Giustino, Ierapetritou, Marianthi, Scicolone, James V., Muzzio, Fernando J.
Purpose: Loss-in-weight feeders play a vital role in assuring blend and content uniformity as well as lot-to-lot powder traceability in continuous manufacturing. Irregular flow from the feeders propagates through the system, potentially resulting in out-of-specification product. Powder properties...
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Impact of material properties and process variables on the residence time distribution in twin screw feeding equipment
| Contributor(s):: Van Snick, B, Kumar, A, Verstraeten, M, Pandelaere, K, Dhondt, J, Di Pretoro, G, De Beer, T, Vervaet, C, Vanhoorne, V
Screw feeders are integrated as dispensing units in most continuous manufacturing platforms. Hence, characterizing and modelling the residence time distribution (RTD) of materials in feeders is indispensable to understand the traceability of raw materials from the drum till tablet, enabling the...
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Effect of material properties on the residence time distribution (RTD) of a tablet press feed frame
| Contributor(s):: Furukawa, Ryoichi, Singh, Ravendra, Ierapetritou, Marianthi
In continuous manufacturing (CM) of pharmaceutical tablets, the residence time distribution (RTD) of the tablet press feed frame plays an important role in ensuring the critical quality attributes (CQAs) of the final product. Knowledge of factors affecting the RTD of the feed frame is necessary...
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Development and applications of a material library for pharmaceutical continuous manufacturing of solid dosage forms
| 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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A multivariate approach to predict the volumetric and gravimetric feeding behavior of a low feed rate feeder based on raw material properties
| Contributor(s):: Bostijn, N, Dhondt, J, Ryckaert, A, Szabo, E, Dhondt, W, Van Snick, B, Vanhoorne, V, Vervaet, C, De Beer, T
In this study, the volumetric and gravimetric feeding behavior of 15 pharmaceutical powders on a low feed rate feeder was correlated with their material properties through a multivariate approach. The powders under investigation differ substantially in terms of material properties, making the...