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Pilot-scale binder jet 3D printing of sustained release solid dosage forms.

Mingyang Tan¹, Dehil Dharani², Xin Dong³

¹Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA; Polymer Program, Institute of Materials Science, University of Connecticut, Storrs, CT 06269, USA.

International Journal of Pharmaceutics

|December 25, 2022

Summary

3D printing enables sustained release acetaminophen (APAP) "printlets" using hydroxypropyl methylcellulose (HPMC). Increasing binder saturation restored mechanical strength, yielding robust printlets with controlled drug release.

Keywords:

3D printing Additive manufacturing Binder jetting Personalized medicine Pilot-scale Sustained release

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Area of Science:

Pharmaceutical Technology
Additive Manufacturing
Materials Science

Background:

3D printing offers versatile applications in pharmaceutical manufacturing for personalized medicine and clinical trials.
Binder Jetting (BJT) 3D printing is explored for fabricating solid dosage forms.
Acetaminophen (APAP) is a widely used analgesic model drug.

Purpose of the Study:

To develop sustained release solid dosage forms (printlets) using BJT 3D printing.
To investigate the impact of hydroxypropyl methylcellulose (HPMC) on drug release and printlet properties.
To optimize printlet mechanical strength and drug release profiles.

Main Methods:

Formulation and process development of APAP printlets using a pilot-scale BJT 3D printer.
Incorporation of HPMC as a release retardant polymer in the print powder.
Adjustment of binder saturation levels to enhance printlet mechanical strength.

Main Results:

Inclusion of HPMC significantly increased APAP drug release time from minutes to hours.
Increased HPMC content led to potential shape distortion due to swelling, requiring thicker powder layers.
Higher binder saturation levels, achieved by using more print heads, restored printlet mechanical strength.
Resultant printlets exhibited a 3.5-hour drug release time and a 12.5 kgf breaking force.

Conclusions:

BJT 3D printing can successfully produce sustained release printlets with tunable drug release profiles.
Optimizing binder saturation is crucial for achieving desired mechanical strength in HPMC-containing printlets.
3D printed dosage forms demonstrate potential for personalized medicine with comparable or superior properties to conventional tablets.