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Characterization of new functionalized calcium carbonate-polycaprolactone composite material for application in geometry-constrained drug release formulation development

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The evaluation aimed to assess the performance of a novel mineral–polymer composite (FCC-PCL) in generating intricate geometries for the development of controlled-release tablet formulations. Mechanical characteristics, including compactibility, compressibility, and elastoplastic deformation, were measured for the developed material. The results, compared to other common excipients, indicate the efficient formation of complex, stable, and impermeable geometries for controlled drug release modifications under compression. The performance of the composite material was tested by compacting it into a geometrically altered tablet (Tablet-In-Cup, TIC), and the drug release was compared to a commercially available product. The TIC device exhibited a uniform surface, demonstrated high physical stability, and showed no friability. The FCC-PCL composite displayed favorable binding properties and compactibility. Additionally, it revealed an enhanced plasticity characteristic not present in the individual components. The presented FCC-PCL composite mixture holds the potential to become a valuable tool for formulating controlled-release solid dosage forms.
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