Influence of binder attributes on binder effectiveness in a continuous twin screw wet granulation process via wet and dry binder addition

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

“…Granulation experiments with DCP as poorly soluble model excipient were previously performed by Vandevivere et al [16]. These experiments were conducted at similar process conditions as for the mannitol formulation.…”

“…Binders are often included in the formulation to facilitate the granulation process (e.g., granule nucleation and growth). As the binder type affected granule quality [10,16,17], binder selection for continuous TSG should rely on a scientific approach to obtain efficient formulation development. This starts with a profound understanding of the raw material attributes influencing the granulation process because knowledge of attributes helps to predict their impact on functionality.…”

“…In order to select appropriate binders for formulation design in continuous TSG, a systematic and extensive binder characterization is needed. In previous research [16], different binder types were characterized, and their attributes were linked to binder effectiveness using a poorly soluble model excipient (dicalcium phosphate). Binder effectiveness was defined as the amount of liquid required for binder activation in order to achieve good granule friability (<30%) [16].…”

“…In previous research [16], different binder types were characterized, and their attributes were linked to binder effectiveness using a poorly soluble model excipient (dicalcium phosphate). Binder effectiveness was defined as the amount of liquid required for binder activation in order to achieve good granule friability (<30%) [16]. As the formulation solubility defines the granulation mechanism [11,29], the binder attributes affecting the granule quality of a highly soluble formulation (mannitol) were examined in the current paper.…”

“…This way, the current study promotes rational binder selection for a continuous wet granulation process. Dry binder addition was applied in this research, as it has already proven its efficiency [16]. Granule quality was determined by measuring the granule friability as an indicator of granule strength.…”