Development of a 3D printed multiple unit particle system (MUPS) containing metoprolol succinate

Area of Science:

• Pharmaceutical Technology
• 3D Printing Applications
• Drug Delivery Systems

Background:

• 3D printing offers potential for personalized medicine and complex dosage forms.
• Multiple Unit Particle Systems (MUPS) provide controlled drug release advantages.

Purpose of the Study:

• To develop and characterize dual extrusion 3D printed MUPS tablets containing metoprolol succinate.
• To evaluate the feasibility of integrating drug-loaded particles within a disintegrating tablet shell.
• To assess the impact of 3D printing on drug stability and release profiles.

Main Methods:

• Fused filament fabrication using pharmaceutical-grade Eudragit® RL PO and Kollicoat® IR.
• Morphological and structural analysis via SEM, X-ray micro-computed tomography, and digital microscopy.
• Assays for mass uniformity, disintegration, API state (XRPD), degradation (HPLC), and in vitro dissolution.

Main Results:

• Uniform particle geometry and distribution confirmed; tablets met Ph. Eur. mass uniformity standards.
• Complete tablet shell disintegration within 15 min; API found in amorphous state.
• Significant API thermal degradation observed (97.8% to 65.9%); linear correlation between printed layers and drug content established.
• In vitro dissolution showed 80% API release between 105-150 min.

Conclusions:

• Dual extrusion 3D printing is feasible for producing API-MUPS tablets with pharmaceutical-grade materials.
• Critical defects like API thermal instability and particle agglomeration necessitate formulation and process optimization.
• The technology shows promise for personalized drug delivery, enabling dose individualization.