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Continuous twin screw granulation : a complex interplay between formulation properties, process settings and screw design Ghent University
Due to the numerous advantages over batch manufacturing, continuous manufacturing techniques such as twin screw wet granulation are rapidly gaining importance in pharmaceutical production. Since a large knowledge gap on the importance of formulation variables exists, this study systematically assessed the impact of different screw configurations and process settings on eight model formulations, varying in filler type, active pharmaceutical ...
Continuous twin screw granulation : impact of microcrystalline cellulose batch-to-batch variability during granulation and drying : a QbD approach Ghent University
Despite significant advances in the research domain of continuous twin screw granulation, limited information is currently available on the impact of raw material properties, especially considering batch-to-batch variability. The importance of raw material variability and subsequent mitigation of the impact of this variability on the manufacturing process and drug product was recently stressed in the Draft Guidance for Industry on Quality ...
Continuous twin screw granulation : impact of binder addition method and surfactants on granulation of a high-dosed, poorly soluble API Ghent University
Despite the recent commercialization of several drug products manufactured through continuous manufacturing techniques, knowledge on the formulation aspect of these techniques, such as twin screw wet granulation, is still rather limited. Previous research identified lactose/MCC/HPMC as a robust platform formulation for several model formulations, although granulation of the high-dosed, poorly soluble API mebendazole proved challenging. ...
Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging Ghent University
An experimental study on effect of screw configuration in twin screw wet granulation Ghent University
Native starch as in situ binder for continuous twin screw wet granulation Ghent University
The use of native starch as in situ binder in a continuous twin screw wet granulation process was studied. Gelatinization of pea starch occurred in the barrel of the granulator using a poorly soluble excipient (anhydrous dicalcium phosphate), but the degree of gelatinization depended on the liquid-to-solid ratio, the granule heating and the screw configuration. Furthermore, the degree of starch gelatinization was correlated with the granule ...
Continuous twin screw granulation : a review of recent progress and opportunities in formulation and equipment design Ghent University
Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in batch mode such as high shear granulation and fluid bed granulation, several equipment manufacturers have designed their own manufacturing setup. This ...
Continuous twin screw granulation : influence of process and formulation variables on granule quality attributes of model formulations Ghent University
In recent years, continuous manufacturing techniques, such as twin screw wet granulation, have gained significant momentum. Due to the large diversity of the (model) formulations and equipment, it is often difficult to generalize conclusions about the importance of process settings. As only limited knowledge is available on the importance of formulation variables, this study focused on the systematic quantification of both process as formulation ...
Continuous twin screw granulation : robustness of lactose/MCC-based formulations Ghent University
In recent years, significant progress has been made in the field of continuous twin screw granulation. However, only limited knowledge is currently available on the impact of active pharmaceutical ingredient (API) properties on granule quality and processability. In this study, the response behavior of four formulations containing APIs (5–10% drug load) with diverse characteristics was compared to the behavior of the corresponding placebo ...