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Fabrication of Taste-Masked Donut-Shaped Tablets Via Fused Filament Fabrication 3D Printing Paired with Hot-Melt Extrusion Techniques

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  • Theme: Pharmaceutical Thermal Processing - An Update
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Abstract

The objective of this work was to develop taste-masked donut-shaped tablet formulations utilizing fused filament fabrication three-dimensional printing paired with hot-melt extrusion techniques. Caffeine citrate was used as the model drug for its bitter taste, and a 3-point bend test was performed to assess the printability of filaments. The stiffness constant was calculated to represent the printability by fitting the breaking distances and stress data into Hooke’s law. The formulations without Eudragit E PO (F6) and with Eudragit E PO (F7) filaments exhibited the desired hardness with a “k” value of 48.30 ± 3.52 and 45.47 ± 3.51 g/mm3 (n = 10), respectively, and were successfully printed. The donut-shaped tablets were 3D printed with 10, 50, and 100% infill densities. In vitro dissolution studies were performed in simulated salivary fluid (pH 6.8, artificial saliva) to evaluate the taste-masking efficiency of the printed donuts. In the first minute, the concentrations of caffeine citrate observed in the dissolution media from all the printed donuts were less than the bitter threshold of caffeine citrate (0.25 mg/mL). Formulation F7, which contained Eudragit E PO copolymer, demonstrated better taste-masking efficiency than formulation F6. Furthermore, both formulations F6 and F7 demonstrated immediate drug release profiles in gastric medium (10% infill, > 80% release within 1 h). Taste-masked caffeine citrate formulations were successfully developed with donut shapes, which will enhance appeal in pediatric populations and increase compliance and patient acceptance of the dosage form.

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Funding

This project was also partially supported by Grant Number P30GM122733-01A1, funded by the National Institute of General Medical Sciences (NIGMS), a component of the National Institutes of Health (NIH) as one of its Centers of Biomedical Research Excellence (COBRE).

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Authors and Affiliations

  1. Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Mississippi, 38677, USA

    Honghe Wang, Nagireddy Dumpa, Suresh Bandari & Michael A. Repka

  2. Ashland Specialty Ingredients, Wilmington, Delaware, 19808, USA

    Thomas Durig

  3. Pii Center for Pharmaceutical Technology, The University of Mississippi, University, Mississippi, 38677, USA

    Michael A. Repka

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  1. Honghe Wang
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Correspondence to Michael A. Repka.

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Guest Editors: Feng Zhang, Michael Repka and Suresh Bandari

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Wang, H., Dumpa, N., Bandari, S. et al. Fabrication of Taste-Masked Donut-Shaped Tablets Via Fused Filament Fabrication 3D Printing Paired with Hot-Melt Extrusion Techniques. AAPS PharmSciTech 21, 243 (2020). https://doi.org/10.1208/s12249-020-01783-0

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