Dual extrusion-based 3D-printed core-shell tablets for colorectal delivery of Mebeverine hydrochloride.

Objective: This study aimed to fabricate a delayed-release tablet of Mebeverine hydrochloride using a novel dual extrusion-based 3D printing approach to improve the management of irritable bowel syndrome (IBS).

Significance: This study highlights a dual extrusion-based 3D printing approach that integrates a hydrogel core of Mebeverine hydrochloride with a melt-extruded polymeric shell in a single step, protecting from acidic and thermal stress while achieving controlled release. The 3D-printed tablet meets USP quality standards, demonstrating a promising strategy for IBS management and personalized therapy.

Methods: The tablet design combines a drug-loaded hydrogel core with a melted extruded polymeric shell, created simultaneously in a single printing process. While the shell formed through melt extrusion (ME) using an optimized blend Kollidon^® VA 64, PEG 4000, HPMCP, Eudragit RL100, triethyl citrate, and talc, the hydrogel core methylcellulose, sodium alginate, sodium chloride, and the drug, deposited into the internal cavity by pressure-assisted micro-syringe (PAM) extrusion.

Results: The resultant tablet limited drug release in acidic circumstances while achieving 98.6% drug release over 12 h in phosphate buffer. Weight variation, friability, hardness, assay, and content uniformity met USP specifications. SEM imaging indicated smooth and consistent surface morphology. Moreover, FTIR spectrums showed no unwanted chemical interactions, TGA and DSC analysis verified the thermal stability the drug and excipients at printing temperatures.

Conclusions: The dual extrusion based-3D printing of drug-loaded hydrogel and thermoplastic polymers provides a promising delayed-release single dosage to deliver of thermo- and acid-labile drugs for the management of IBS and associated gastrointestinal disorders.