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Experimental characterization of solid-liquid mixing for a high shear wet granulation process in a twin-screw granulator (TSG) is very challenging. This is due to the opacity of the multiphase system and high-speed processing. In this study, discrete element method (DEM) based simulations are performed for a short quasi-two-dimensional simulation domain, incorporating models for liquid bridge formation, rupture, and the effect of the bridges on inter-particular forces. Based on the knowledge gained from these simulations, the kneading section of a twin-screw wet granulation process was simulated. The time evolution of particle flow and liquid distribution between particles, leading to the formation of agglomerates, was analyzed. The study showed that agglomeration is a rather delayed process that takes place once the free liquid on the particle surface is well distributed.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8308998 | PMC |
| http://dx.doi.org/10.3390/pharmaceutics13070928 | DOI Listing |
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Article Synopsis
- Previous research indicated that CR formulations using HPMC via twin-screw wet granulation resulted in uneven distribution of active pharmaceutical ingredients (APIs) within granules due to rapid hydration and swelling properties of HPMC.
- Attempts to improve uniformity by varying the liquid-to-solid ratio, modifying screw configurations, or using different fillers were unsuccessful.
- The study found that using smaller particle size fillers improved API distribution in granules compared to larger fillers, with microcrystalline cellulose (MCC) yielding the most consistent results, while other filler combinations sometimes led to underdosing issues in smaller granule fractions.
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