期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 107, 期 1, 页码 390-401出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2017.10.021
关键词
3D printing fused deposition modeling FDM; drug-polymer miscibility rheology; amorphous solid dispersion tablets; dissolution rate
The primary aim of this study was to identify pharmaceutically acceptable amorphous polymers for producing 3D printed tablets of a model drug, haloperidol, for rapid release by fused deposition modeling. Filaments for 3D printing were prepared by hot melt extrusion at 150 degrees C with 10% and 20% w/ w of haloperidol using Kollidon (R) VA64, Kollicoat (R) IR, Affinsiol (TM) 15 cP, and HPMCAS either individually or as binary blends (Kollidon (R) VA64 thorn Affinisol (TM) 15 cP, 1: 1; Kollidon (R) VA64 thorn HPMCAS, 1: 1). Dissolution of crushed extrudates was studied at pH 2 and 6.8, and formulations demonstrating rapid dissolution rates were then analyzed for drug-polymer, polymer-polymer and drug-polymer-polymer miscibility by film casting. Polymer-polymer (1: 1) and drug-polymer-polymer (1: 5: 5 and 2: 5: 5) mixtures were found to be miscible. Tablets with 100% and 60% infill were printed using MakerBot printer at 210 degrees C, and dissolution tests of tablets were conducted at pH 2 and 6.8. Extruded filaments of Kollidon (R) VA64-Affinisol (TM) 15 cP mixtures were flexible and had optimum mechanical strength for 3D printing. Tablets containing 10% drug with 60% and 100% infill showed complete drug release at pH 2 in 45 and 120 min, respectively. Relatively high dissolution rates were also observed at pH 6.8. The 1: 1-mixture of Kollidon (R) VA64 and Affinisol T 15 cP was thus identified as a suitable polymer system for 3D printing and rapid drug release. (c) 2018 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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