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Five key factors to consider when selecting a granulation system for tablet manufacturing
| Contributor(s):: Fi Forrest
Granulation is a vital process in pharmaceutical dosage forms, transforming powders into granules. Michael Schupp from Gerteis - specialists in dry granulation systems for the pharmaceutical industry - discusses what you should be looking for when choosing your granulation method.
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RTD-based material tracking in a fully-continuous dry granulation tableting line
| Contributor(s):: Martinetz, M. C., Karttunen, A-P, Sacher, S., Wahl, P., Ketolainen, J., Khinast, J. G., Korhonen, O
Continuous manufacturing (CM) offers quality and cost-effectiveness benefits over currently dominating batch processing. One challenge that needs to be addressed when implementing CM is traceability of materials through the process, which is needed for the batch/lot definition and control...
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RTD modeling of a continuous dry granulation process for process control and materials diversion
| Contributor(s):: Kruisz, Julia, Rehrl, Jakob, Sacher, Stephan, Aigner, Isabella, Horn, Martin, Khinast, Johannes G., Krumme, Markus
Disturbance propagation during continuous manufacturing processes can be predicted by evaluating the residence time distribution (RTD) of the specific unit operations. In this work, a dry granulation process was modelled and four scenarios of feeding events were simulated. We performed...
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Practical application of roller compaction process modeling
| Contributor(s):: Reynolds, Gavin, Ingale, Rohit Roberts, Ron Kothari, Sanjeev, Gururajan, Bindhu
Very limited work has been reported on comparing the performance of the roller compaction process at different scales. The majority of the approaches highlighted in the literature discuss the applicability of using confined uniaxial compaction for predicting the performance of the roller...
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Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy
| Contributor(s):: Gupta, A, Peck, GE, Miller, RW, Morris, KR
Compact strength and the particle-size distribution of milled roller compacted compacts were correlated to the slope of the best-fit line through near-infrared spectra for samples prepared under different roll speeds and feed rates. The above correlations were found to hold for compacts prepared...
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Modeling and Control of Roller Compaction for Pharmaceutical Manufacturing. Part I: Process Dynamics and Control Framework
| Contributor(s):: Hsu, Shuo-Huan, Venkatasubramanian, Venkat, Reklaitis, Gintaras V.
We derive a dynamic model for roller compaction process based on Johanson’s rolling theory, which is used to predict the stress and density profiles during the compaction and the material balance equation which describes the roll gap change. The proposed model considers the relationship between...
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Experimental determination of residence time distribution in continuous dry granulation
| Contributor(s):: Mangal, Haress, Kleinebudde, Peter
With increasing importance of continuous manufacturing, the interest in integrating dry granulation into a continuous manufacturing line is growing. Residence time distribution measurements are of importance as they provide information about duration of materials within the process. These data...
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Exploratory studies in heat-assisted continuous twin-screw dry granulation: A novel alternative technique to conventional dry granulation
| Contributor(s):: Kallakunta, Venkata Raman, Patil, Hemlata, Tiwari, Roshan, Ye, Xingyou, Upadhye, Sampada, Vladyka, Ronald S., Sarabu, Sandeep, Kim, Dong Wuk, Bandari, Suresh, Repka, Michael A.
Dry granulation is the preferred technique for solvent-sensitive products, especially drugs with stability problems such as hydrolysis. Twin-screw granulation is a continuous granulation technique, offering a potential alternative to conventional dry granulation techniques such as roller...
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Evaluating the potential for optimization of axial back-mixing in continuous pharmaceutical manufacturing
| Contributor(s):: Peterwitz, M, Schembecker, G
In continuous pharmaceutical manufacturing, the degree of back-mixing has two contrary effects on the propagation of disturbances through a process. Firstly, back-mixing results in the contamination of adjacent material by strong disturbances and additional losses. However, the available...