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Twin-screw granulation and high-shear granulation: The influence of mannitol grade on granule and tablet properties
09 Jun 2023 | Contributor(s):: Megarry, Andrew, Taylor, Agnes, Gholami, Aida, Wikstrom, Hakan, Tajarobi, Pirjo
Granule structure has a key influence on tablet critical quality attributes. The ability to control this structure through excipient choice is an important part of formulation development. Mannitol is a popular diluent and the choice of input grade has been shown to impact granule properties....
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The use of Rheology Combined with Differential Scanning Calorimetry to Elucidate the Granulation Mechanism of an Immiscible Formulation During Continuous Twin-Screw Melt Granulation
09 Jun 2023 | Contributor(s):: Monteyne, Tinne, Heeze, Liza, Mortier, Severine Therese F. C., Oldoerp, Klaus, Cardinaels, Ruth, Nopens, Ingmar, Vervaet, Chris, Remon, Jean-Paul, De Beer, Thomas
Twin screw hot melt granulation (TS HMG) is a valuable, but still unexplored alternative to continuous granulation of moisture sensitive drugs. However, knowledge of the material behavior during TS HMG is crucial to optimize the formulation, process and resulting granule properties. The aim of...
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The Use of PAT and Off-line Methods for Monitoring of Roller Compacted Ribbon and Granule Properties with a View to Continuous Processing
09 Jun 2023 | Contributor(s):: McAuliffe M.A.P., Omahony G.E., Blackshields C.A., Collins J.A., Egan D.P., Kiernan L., Oneill E., Lenihan S., Walker G.M., Crean A.M.
Real-time process monitoring using process analytical technology (PAT) tools can augment process understanding, enable improved process control, and hence facilitate the production of high-quality pharmaceutical products. While beneficial for batch processes, the availability of PAT tools to...
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Characteristics of multi-component formulation granules formed using distributive mixing elements in twin screw granulation
09 Jun 2023 | Contributor(s):: Pradhan, Shankali U., Sen, Maitraye, Li, Jiayu, Gabbott, Ian, Reynolds, Gavin, Litster, James D., Wassgren, Carl R.
This work examines the influence of pharmaceutical powder formulation characteristics on granule properties formed using distributive mixing elements (DMEs) in twin screw granulation. High and low drug dose formulations with three different active pharmaceutical ingredients (APIs) were...