Fabrication of Taste-Masked Donut-Shaped Tablets Via Fused Filament Fabrication 3D Printing Paired with Hot-Melt Extrusi
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Research Article Theme: Pharmaceutical Thermal Processing - An Update Guest Editors: Feng Zhang, Michael Repka and Suresh Bandari
Fabrication of Taste-Masked Donut-Shaped Tablets Via Fused Filament Fabrication 3D Printing Paired with Hot-Melt Extrusion Techniques Honghe Wang,1 Nagireddy Dumpa,1 Suresh Bandari,1 Thomas Durig,2 and Michael A. Repka1,3,4
Received 30 March 2020; accepted 10 August 2020 Abstract. The objective of this work was to develop taste-masked donut-shaped tablet formulations utilizing fused filament fabrication three-dimensional printing paired with hotmelt 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 donutshaped 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. KEY WORDS: donut-shaped design; fused filament fabrication; hot-melt extrusion; Repka-Zhang test; taste masking; three-dimensional printing.
INTRODUCTION Oral drug delivery is the most employed and convenient of all drug administration routes. A significant number of active pharmaceutical ingredients (APIs) used in oral drug delivery systems have a bitter taste (1). The bitterness of oral drug delivery systems influences compliance and patient acceptance of dosage forms (2), especially in pediatric populations. The mechanisms of commonly used tastemasking techniques can be summarized as three aspects: a physical barrier, chemical or solubility modification of active pharmaceutical ingredients, and the formation of solid
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Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Mississippi 38677, USA. 2 Ashland Specialty Ingredients, Wilmington, Delaware 19808, USA. 3 Pii Center for Pharmaceutical Technology, The University of Mississippi, University, Mississippi 38677, USA. 4 To whom corres
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