Oral drug delivery systems using core–shell structure additive manufacturing technologies: a proof-of-concept study
The aim of this study was to couple fused deposition modelling 3D printing with melt extrusion technology to produce core–shell-structured controlled-release tablets with dual-mechanism drug-release performance in a simulated intestinal fluid medium. Coupling abovementioned technologies for personalized drug delivery can improve access to complex dosage formulations at a reasonable cost. Compared with traditional pharmaceutical manufacturing, this should facilitate the following: (1) the ability to manipulate drug release by adjusting structures, (2) enhanced solubility and bioavailability of poorly water-soluble drugs and (3) on-demand production of more complex structured dosages for personalized treatment.
Methods
Acetaminophen was the model drug and the extrusion process was evaluated by a series of physicochemical characterizations. The geometries, morphologies, and in vitro drug-release performances were compared between directly compressed and 3D-printed tablets.
Key findings
Initially, 3D-printed tablets released acetaminophen more rapidly than directly compressed tablets. Drug release became constant and steady after a pre-determined time. Thus, rapid effectiveness was ensured by an initially fast acetaminophen release and an extended therapeutic effect was achieved by stabilizing drug release.
Conclusions
The favourable drug-release profiles of 3D-printed tablets demonstrated the advantage of coupling HME with 3D printing technology to produce personalized dosage formulations.
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Keywords: 3D-printed tablets, acetaminophen, drug delivery systems, oral delivery improvement, hot melt extrusion, patient-focused dosages
Materials: Acetaminophen (APAP) (Lot: 004819C016., purity: >94.88%, Mallinckrodt, MO, USA), with a melting point of 170–172°C, was selected as the model API.[26] Benecel hydroxypropylmethylcellulose (HPMC) E5 (donated by Ashland Inc., Covington, KY, USA) was used as the shell matrix, while AquaSolve HPMC acetate succinate (HPMCAS) HG (donated by Ashland Inc.) was selected as the core matrix.