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Suitability of sugar alcohols (polyols) as binders in twin-screw melt granulation for preparation of high-drug-loaded immediate-release tablets with superior mechanical properties

Project/agreement No.
RSU-PAG-2024/1-0004
Project funding
199 198.00 EUR, The project No. 5.2.1.1.i.0/2/24/I/CFLA/005, "RSU internal and RSU with LASE external consolidation", is financed by the investment of the European Union's Recovery and Resilience Mechanism and the state budget.
Project manager
Project realization
01.04.2024. - 31.03.2026.

Aim

The main aim of the research project is to investigate the applicability of alternative binders for twin-screw melt granulation (specifically, polyols) to achieve immediate release from tablets with superior mechanical properties.

Description

Twin-screw melt granulation (TSMG) is one of the promising green technological approaches for manufacturing solid dosage forms of pharmaceuticals and nutraceuticals (but even household chemicals). Having a lot of advantages compared to other methods, such as continuous processing (easily automated, better quality control, small footprint) and sustainability (solvent-less, less waste, energetically efficient), at the current state of formulation science development, this process has some disadvantages. These disadvantages are limitations in achieving fast or immediate release and the relatively low mechanical properties of tablets. These disadvantages are connected to the historically established usage of specific low-melting binders. The main aim of the research project is to investigate the applicability of alternative binders for TSMG (specifically, polyols) to achieve immediate release from tablets with superior mechanical properties. While high-drug-loaded immediate-release tablets were chosen as a worst-case scenario to illustrate the applicability of alternative binders.