title: Fused-filament 3D printing of drug products: Microstructure analysis and drug release characteristics of PVA-based caplets.
abstract: Fused deposition modeling (FDM) 3-Dimensional (3D) printing is becoming an increasingly important technology in the pharmaceutical sciences, since it allows the manufacture of personalized oral dosage forms by deposition of thin layers of material. Here, a filament extruder was used to obtain filaments of polyvinyl alcohol (PVA) containing paracetamol or caffeine appropriate for 3D printing. The filaments were used to manufacture caplets for oral administration by FDM 3D printing, with the aim of evaluating the effect of the internal structure (micropore volume), drug loading and composition on drug dissolution behaviour. Micropore volume of the caplets was primarily determined by the presence of large pores due to gaps in the printed layers/net while printing, and the porosity of the caplets was 10 fold higher than the porosity of the extruded filament. Dynamic dissolution drug release tests on the caplets in biorelevant bicarbonate media revealed distinctive release profiles, which were dependent on drug solubility and drug loading. Porosity of the caplets did not help to predict the different drug release profiles. This study confirms the potential of 3D printing to fabricate caplets and helps to elucidate which factors influence drug release from this type of new dosage form.
authors.affiliation: UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK; Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Santiago de Compostela, Santiago de Compostela, Spain.
authors.forename: Alvaro
authors.initials: A
authors.lastname: Goyanes
authors.affiliation: UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK; Pharmaceutical Research and Technology Labs., Astellas Pharma Inc., 180 Ozumi, Yaizu-shi, Shizuoka 425-0072, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Kobayashi
authors.affiliation: Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Santiago de Compostela, Santiago de Compostela, Spain.
authors.forename: Ramón
authors.initials: R
authors.lastname: Martínez-Pacheco
authors.affiliation: 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.
authors.forename: Simon
authors.initials: S
authors.lastname: Gaisford
authors.affiliation: 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.
authors.forename: Abdul W
authors.initials: AW
authors.lastname: Basit
mesh_terms: D000082:Acetaminophen / Q000737:chemistry; D001639:Bicarbonates / Q000737:chemistry; D002110:Caffeine / Q000737:chemistry; D065546:Drug Liberation; D011142:Polyvinyl Alcohol / Q000737:chemistry*; D016062:Porosity; D066330:Printing, Three-Dimensional; D012995:Solubility; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D001639:Bicarbonates; D013607:Tablets; D000082:Acetaminophen; D002110:Caffeine; D011142:Polyvinyl Alcohol
keywords: Acetaminophen; Additive manufacturing; Bicarbonate buffers; Fused deposition modeling; Hot melt extrusion; Rapid prototyping; Three dimensional printing