Scientific papers
High drug-loaded immediate-release formulations can be produced using solvent-free, continuous melt granulation with a twin-screw extruder. However, commonly used high-molecular-weight, hydrophobic melt binders can result in weak tablets and negatively affect tablet disintegration and dissolution. This study therefore investigated mannitol as a melt binder at a concentration of 30 wt.% and evaluated the effects of processing temperature and screw speed during twin-screw melt granulation on the production of high drug-loaded, immediate-release caffeine tablets with improved mechanical properties. A two-level design of experiments with three centre points was used to assess the effects of barrel temperature and screw speed on granule and tablet properties. Caffeine was used as the model drug and combined with mannitol (Parteck® M100). Twin-screw melt granulation was performed using a Pharma 11 extruder equipped with helical feed screw elements and operated without a nozzle. The processing conditions significantly affected the solid-state properties of the ingredients and the resulting granule characteristics. Under the investigated conditions, mannitol at 30 wt.% demonstrated its suitability as an effective melt binder for producing high drug-loaded, immediate-release tablets with improved mechanical properties.
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