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Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

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The appropriateness of pharmaceutical binders for continuous twin-screw wet granulation was examined, aligning with the pharmaceutical industry's transition from batch to continuous manufacturing. A scientific approach to binder selection is crucial for efficient formulation development in twin-screw wet granulation. Consequently, this study aimed to identify binder attributes influencing binder effectiveness in the wet granulation process, focusing on a highly soluble model excipient (mannitol). In this formulation, higher binder effectiveness was associated with the rapid activation of binder properties—specifically, fast binder dissolution kinetics coupled with low viscosity attributes and favorable wetting properties. Notably, the investigation extended its scope by comparing these findings with the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate), previously explored in the research. This comprehensive comparison revealed that the critical binder attributes guiding selection vary depending on the solubility of the formulation. The identification of these critical binder attributes facilitates a rational and efficient selection process for twin-screw granulation, catering to both well-soluble and poorly soluble formulations. The addition of binders proved particularly valuable for enhancing the performance of poorly soluble formulations.
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