Opensource semi-solid 3D printer designed for oral drug production in hospital pharmacies

Area of Science:

• Pharmaceutical Technology
• Additive Manufacturing
• Drug Delivery Systems

Background:

• Three-dimensional (3D) printing, particularly semi-solid extrusion (SSE), shows promise for pharmaceutical manufacturing.
• Limited accessibility to specialized SSE 3D printers hinders widespread adoption.
• The need for customizable and cost-effective drug production solutions is growing.

Purpose of the Study:

• To develop and validate an accessible, semi-solid extrusion (SSE) 3D printer with an integrated in-process weighing system.
• To demonstrate the printer's capability in producing pharmaceutical printlets with accuracy and reproducibility.
• To assess the potential of the developed system for personalized medicine in hospital settings.

Main Methods:

• Development of a novel SSE 3D printer featuring an in-process weighing system and local network capability.
• Utilization of vaseline and low acyl gellan gum with levetiracetam (LVT) as model materials for validation.
• Heating of 20 mL syringe contents to target temperatures within 20 minutes.
• Continuous weighing of printlets during the 3D printing process.
• Evaluation of printlet mass-volume proportionality, repeatability, and content uniformity according to European Pharmacopeia standards.

Main Results:

• The developed SSE 3D printer successfully heated materials within 20 minutes.
• The integrated weighing system demonstrated high accuracy, with deviations of 0.3-0.5% compared to an external balance.
• Vaseline printlets exhibited excellent mass-volume proportionality (R² 0.9954) and repeatability over 3 days (RSD 1.5%).
• Levetiracetam (LVT) printlets (n=30) met European Pharmacopeia content uniformity requirements, with an average content of 143.9 mg (RSD 1.2%) and an acceptance value of 5.7.

Conclusions:

• The developed SSE 3D printer is customizable, affordable, and equipped with a precise in-process weighing system.
• The printer's performance validates its potential for producing accurate and reproducible pharmaceutical dosage forms.
• This technology offers a promising pathway for the democratization of personalized medicine within hospital pharmacies.