Fabrication of controlled-release budesonide tablets via desktop (FDM) 3D printing.
The aim of this work was to explore the feasibility of using fused deposition modelling (FDM) 3D printing (3DP) technology with hot melt extrusion (HME) and fluid bed coating to fabricate modified-release budesonide dosage forms. Budesonide was sucessfully loaded into polyvinyl alcohol filaments using HME. The filaments were engineered into capsule-shaped tablets (caplets) containing 9mg budesonide using a FDM 3D printer; the caplets were then overcoated with a layer of enteric polymer. The final printed formulation was tested in a dynamic dissolution bicarbonate buffer system, and two commercial budesonide products, Cortiment® (Uceris®) and Entocort®, were also investigated for comparison. Budesonide release from the Entocort® formulation was rapid in conditions of the upper small intestine while release from the Cortiment® product was more delayed and very slow. In contrast, the new 3D printed caplet formulation started to release in the mid-small intestine but release then continued in a sustained manner throughout the distal intestine and colon. This work has demonstrated the potential of combining FDM 3DP with established pharmaceutical processes, including HME and film coating, to fabricate modified release oral dosage forms.
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Alvaro
A
Goyanes
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Hanah
H
Chang
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Daniel
D
Sedough
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Grace B
GB
Hatton
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Jie
J
Wang
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Asma
A
Buanz
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK; FabRx Ltd., 3 Romney Road, Ashford, Kent TN24 0RW, UK.
Simon
S
Gaisford
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK; FabRx Ltd., 3 Romney Road, Ashford, Kent TN24 0RW, UK. Electronic address: a.basit@ucl.ac.uk.
Abdul W
AW
Basit
D019819:Budesonide / Q000008:administration & dosage* / Q000737:chemistry; D003692:Delayed-Action Preparations; D066330:Printing, Three-Dimensional; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*
D003692:Delayed-Action Preparations; D013607:Tablets; D019819:Budesonide
Budesonide; Colonic delivery; Fused filament fabrication; Inflammatory bowel disease; Modified release; Three dimensional printing