Abstract

3D printing is emerging as one of the most promising methods to manufacture Pharmaceutical dosage forms as it offers multiple advantages such as personalization of dosage forms, polypill, fabrication of complex dosage forms etc. 3D printing came into existence in 1980s but its use was extended recently to pharmaceutical industry along with the approval of first 3D printed tablet Spritam by FDA in 2015. Spritam was manufactured by Aprecia pharmaceuticals using binder jetting technology. Binder jet 3D printing involves a hopper for powder discharge and printheads for ink jetting. The properties of tablets are highly dependent upon the discharge quality of powder mixture from the hopper and jetting of the ink/binder solution from the printhead nozzle. In this study, numerical models were developed using Discrete element method (DEM) to gain better understanding of the binder jet 3D printing process. The DEM modeling of hopper discharge was performed using in-house DEM code to study the effect of raw material attributes such as powder bed packing density (i.e. particle size, particle density etc) on the printing process, especially during powder bed preparation. This DEM model was further validated experimentally, and the model demonstrated good agreement with experimental results.

Highlights

  • The interest in 3D printing increased significantly after FDA approval of the first 3D printed tablet Spritam by Aprecia Pharmaceuticals, New Jersey, in 2015 [1]. 3D printing including additive manufacturing in pharmaceuticals offers multiple advantages such as personalization of medicine, risk analysis, ability to manufacture complex dosage forms and low cost of development [2]

  • A CAD image file is created and sent to the printer which is followed by powder discharge from the hopper onto a platform which is spread into a thin layer by a roller and ink/binder/Active pharmaceutical ingredient (API) solution is sprayed on top of the powder bed

  • This study aims to develop a 3D numerical model for powder discharge from the hopper installed inside the printer using Discrete element method (DEM) and experimental validation of DEM model using powder bed packing density experiments

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Summary

Introduction

The interest in 3D printing increased significantly after FDA approval of the first 3D printed tablet Spritam by Aprecia Pharmaceuticals, New Jersey, in 2015 [1]. 3D printing including additive manufacturing in pharmaceuticals offers multiple advantages such as personalization of medicine, risk analysis, ability to manufacture complex dosage forms and low cost of development [2]. A CAD image file is created and sent to the printer which is followed by powder discharge from the hopper onto a platform which is spread into a thin layer by a roller and ink/binder/Active pharmaceutical ingredient (API) solution is sprayed on top of the powder bed. The Numerical model used in this study was a soft sphere model [3] which includes forces as mentioned in equation 1

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