Abstract

In this work, modified-release solid dosage forms were fabricated by adjusting geometrical properties of solid dosage forms through hot-melt 3D extrusion (3D HME). Using a 3D printer with air pressure driving HME system, solid dosage forms containing ibuprofen (IBF), polyvinyl pyrrolidone (PVP), and polyethylene glycol (PEG) were printed by simultaneous HME and 3D deposition. Printed solid dosage forms were evaluated for their physicochemical properties, dissolution rates, and floatable behavior. Results revealed that IBF content in the solid dosage form could be individualized by adjusting the volume of solid dosage form. IBF was dispersed as amorphous state with enhanced solubility and dissolution rate in a polymer solid dosage form matrix. Due to absence of a disintegrant, sustained release of IBF from printed solid dosage forms was observed in phosphate buffer at pH 6.8. The dissolution rate of IBF was dependent on geometric properties of the solid dosage form. The dissolution rate of IBF could be modified by merging two different geometries into one solid dosage form. In this study, the 3D HME process showed high reproducibility and accuracy for preparing dosage forms. API dosage and release profile were found to be customizable by modifying or combining 3D modeling.

Highlights

  • Personalized medication has received attention from the medical society because of different drug effects caused by genetic background [1]

  • By using hot-melt 3D extrusion, solid dispersion of active pharmaceutical ingredients (APIs) can be deposited in an on-demand process without requiring a filament preparation step

  • It was found that doses and release profiles of API can be customized by changing or combining 3D modeling

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Summary

Introduction

Personalized medication has received attention from the medical society because of different drug effects caused by genetic background [1]. Current pharmaceutical manufacturing is based on mass production which produces pharmaceutical dosage forms with small variations in doses and API release profiles [2] Because of such low flexibility, there are few options to adjust doses for individualized pharmacotherapy such as dosing liquid and dividing dosage forms into small units. These options are usually not suitable for controlled-release dosage forms and can lead high inaccuracy of dose uniformity [3]. Three-dimensional (3D) printing technology has received attention as a novel candidate for future pharmaceutical manufacturing because of its advantages such as on-demand manufacturing, ability to fabricate complex structure, high accuracy, reproducibility, and cost effectiveness [4]

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