Isomalt as polyvinylpyrrolidone replacement in high-shear wet granulation and tablet preparation

Second-level professional higher education study programme "Industrial pharmacy"

This research investigates isomalt as an alternative binding agent to polyvinylpyrrolidone in high-shear wet granulation processes. While isomalt has established applications in food production as a sweetener and bulking agent, its binding properties are of interest in pharmaceutical formulations development.
The experimental work comprised systematic evaluation of granulation processes and resulting product characteristics through controlled high-shear wet granulation experiments. Analysis focused on critical parameters including particle size distribution, flow properties, moisture content, tablet hardness, friability, and disintegration time.

Results demonstrated that the granulation process with isomalt solution was less sensitive to the change in isomalt concentration, suggesting a higher reproducibility of the granulation process with isomalt compared to the PVP. The isomalt functions as an effective binding agent, producing granules and tablets with distinct physical properties, notably faster disintegration times compared to polyvinylpyrrolidone. While meeting basic requirements, isomalt-containing formulations exhibited different mechanical strength characteristics, suggesting specific applications in formulations where rapid disintegration is advantageous.