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Scaling continuous API synthesis from milligram to kilogram: extending the enabling benefits of micro to the plant
Contributor(s):: Berton, M, de, Souza, JMAbdiaj, I, McQuade, DT, Snead, DR
The signature benefits of continuous flow are largely a result of a reactor's micro-sized features. However, as the technology gains industrial traction in the synthesis of active pharmaceutical ingredients (API), the reactors must be scaled to larger size to meet production demands. Often, the...
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Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy
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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Investigation of the effect of impeller rotation rate, powder flow rate, and cohesion on powder flow behavior in a continuous blender using PEPT
Contributor(s):: Portillo, PM, Vanarase, AU, Ingram, A, Seville, JK, Ierapetritou, MG, Muzzio, FJ
In this paper, we examine the movement of particles within a continuous powder mixer using PEPT (Positron Emission Particle Tracking). The benefit of the approach is that the particle movement along the vessel can be measured non-invasively. The effect of impeller rotation rate, powder flow rate,...
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Development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation
Contributor(s):: Harting Julia, Kleinebudde, Peter
Raman spectroscopy was evaluated as a process analytical technology (PAT) tool for continuous API quantification during twin-screw wet granulation. Therefore, a Raman probe was implemented in front of the granulator barrel. This setup enabled the collection of Raman spectra upon a constant...
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Achieving Continuous Manufacturing for Final Dosage Formation: Challenges and How to Meet Them
Contributor(s):: Byrn, Stephen, Futran, Maricio, Thomas, Hayden, Jayjock, Eric, Maron, Nicola, Meyer, Robert F., Myerson, Allan S., Thien, Michael P., Trout, Bernhardt L.
We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to...
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A review of twin screw wet granulation mechanisms in relation to granule attributes
Contributor(s):: Zhang, Yi, Liu, Tongzhou, Kashani-Rahimi, Shahab, Zhang, Feng
Due to the trend of continuous pharmaceutical manufacturing, twin screw wet granulation (TSWG), a continuous process, has gained increased Research Article interest as a potential substitution of traditional batch granulation processes. Despite the complex nature of TSWG, its mechanisms have been...