Formulation and characterization of the 3D-printed cap-and-body tablets of α-amylase for pancreatitis treatment

Additive manufacturing is emerging as a powerful approach for designing delayed-release dosage forms aimed at targeting the small intestine for the treatment of various disorders. Here, we report a novel cap-and-body tablet fabricated via melt extrusion (ME) for the shell and direct compression (DC) of an α-amylase-loaded core. The shell composed of Eudragit® NE 30D, PEG 600, Soluplus®, Eudragit® RS 100, and talc was printed and mechanically interlocked with the drug core formulated from polyvinylpyrrolidone, microcrystalline cellulose (PH 102), lactose, magnesium stearate, and α-amylase using a hydraulic press. This architecture enabled precise spatial and functional compartmentalization, resulting in minimal drug release under acidic conditions (SGF) and up to 88 % release within 8 h in intestinal phosphate-buffered media (SIF). Quality attributes, including friability, hardness, assay, and appearance, met USP specifications. SEM imaging revealed smooth and uniform morphology, FTIR confirmed the absence of undesirable chemical interactions, and TGA/DSC demonstrated thermal stability at printing temperatures. This cap-and-body 3D printing strategy provides a robust platform for formulating heat- and acid-labile drugs with delayed-release kinetics, offering significant potential for personalized, point-of-care manufacturing in the management of pancreatic enzyme insufficiency.