Twin-screw melt granulation with PEG 8000: Effect of binder particle size and processing temperature on the granule and tablet properties

Sept. 1, 2024, midnight - by Zoltán Márk Horváth , Liga Petersone , Valentyn Mohylyuk

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Twin-screw melt granulation (TSMG) is a promising green technology for manufacturing solid dosage forms in pharmaceuticals and nutraceuticals. PEG 8000 is widely used as a TSMG binder. While the literature covers the effects of various low-melting PEG grades on TSMG granules' properties, there has been limited focus on their impact on the mechanical properties of tablets. This study aimed to investigate the influence of PEG 8000 particle size and TSMG temperature on the properties of granulated MCC-CaHPO4 powder and the resulting tablets. The effect of melt granulation temperature was examined using a medium PEG 8000 fraction (200–400 µm) at 115, 135, and 155 °C, while the impact of PEG 8000 particle size was assessed at 135 °C using small, medium, and large fractions (0–200, 200–400, and 400–500 µm, respectively). The granules were analyzed microscopically and characterized by flowability, angle of repose, particle size distribution, and bulk and tapped density. Tablets were produced using a compaction simulator, and their properties were analyzed through in-die Heckel plots, plastic and elastic energy profiles, tabletability, compressibility, and compactability. Microscopic methods revealed the influence of PEG 8000 particle size on granule and tablet structure, and suggested the effects of granulation temperature. These findings were used to explain the variations in the mechanical properties of tablets prepared with different PEG 8000 particle sizes and melt granulation temperatures. Despite improved powder rheology, tablets made with PEG 8000 via melt granulation exhibited higher plasticity and lower tensile strength compared to ungranulated, directly compressed MCC-CaHPO4.