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Open AccessArticle

Influence of High, Disperse API Load on Properties along the Fused-Layer Modeling Process Chain of Solid Dosage Forms

1
Institute for Particle Technology, TU Braunschweig, Volkmaroder Str. 5, 38104 Braunschweig, Germany
2
Center of Pharmaceutical Engineering, TU Braunschweig, Franz-Liszt-Str. 35A, 38106 Braunschweig, Germany
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(4), 194; https://doi.org/10.3390/pharmaceutics11040194
Received: 15 March 2019 / Revised: 15 April 2019 / Accepted: 16 April 2019 / Published: 22 April 2019
(This article belongs to the Special Issue 3D Printing of Pharmaceuticals and Drug Delivery Devices)
In order to cope with the increasing number of multimorbid patients due to demographic changes, individualized polypill solutions must be developed. One promising tool is fused layer modeling (FLM) of dosage forms with patient-specific dose combinations and release individualization. As there are few approaches reported that systematically investigate the influence of high disperse active pharmaceutical ingredient (API) loads in filaments needed for FLM, this was the focus for the present study. Different filaments based on polyethylene oxide and hypromellose (HPMC) with different loads of theophylline as model API (up to 50 wt.%) were extruded with a twin-screw extruder and printed to dosage forms. Along the process chain, the following parameters were investigated: particle size and shape of theophylline; mechanical properties, microstructure, mass and content uniformity of filaments as well as dosage forms and the theophylline release from selected dosage forms. Especially for HPMC, increasing theophylline load enhanced the flexural strength of filaments whilst the FLM accuracy decreased inducing defects in microstructure. Theophylline load had no significant effect on the dissolution profile of HPMC-based dosage forms. Therefore, a thorough analysis of particle-induced effects is necessary to correlate mechanical properties of filaments, printability, and the dosage-and-release profile adjustment. View Full-Text
Keywords: additive manufacturing; modified release; filament extrusion; fused layer modeling; theophylline; high API load additive manufacturing; modified release; filament extrusion; fused layer modeling; theophylline; high API load
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MDPI and ACS Style

Tidau, M.; Kwade, A.; Finke, J.H. Influence of High, Disperse API Load on Properties along the Fused-Layer Modeling Process Chain of Solid Dosage Forms. Pharmaceutics 2019, 11, 194.

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