A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets

Abstract

2 ABSTRACTPurpose. The fabrication of a ready-to-use immediate release tablets via 3D printing provides a powerful tool to on-demand individualization of dosage form. This work aims to adapt a widely used pharmaceutical grade polymer, polyvinylpyrrolidone (PVP), for instant on-demand production of immediate release tablets via FDM 3D printing.Methods. Dipyridamole or theophylline loaded filaments were produced via processing a physical mixture of API (10%) and PVP in the presence of plasticizer through hot-melt extrusion (HME). Computer software was utilized to design a capletshaped tablet. The surface morphology of the printed tablet was assessed using scanning electron microscopy (SEM). The physical form of drug and its integrity following an FDM 3D printing were assessed using x-ray powder diffractometry (XRPD), thermal analysis and HPLC. In vitro drug release studies for all 3D printed tablets were conducted in a USP II dissolution apparatus.Results. Bridging 3D printing process with HME in the presence of a thermostable filler, talc, enabled the fabrication immediate release tablets at temperatures as low as 110 o C. The integrity of two models drugs was maintained following HME and FDM 3D printing. XRPD indicated that a portion of the loaded theophylline remained crystalline in the tablet. The fabricated tablets demonstrated excellent mechanical properties, acceptable in-batch variability and an immediate in vitro release pattern. Conclusions.Combining the advantages of PVP as an impeding polymer with FDM 3D printing at low temperatures, this approach holds a potential in expanding the spectrum of drugs that could be used in FDM 3D printing for on demand manufacturing of individualised dosage forms.

Fused Deposition Modeling (FDM) 3D Printed Tablets for Intragastric Floating Delivery of Domperidone

“…Amongst the different developed 3D printing technologies, fused deposition modeling (FDM) has several significant advantages such as low-cost manufacturing, the compatibility of using the combination of pharmaceutical grade polymers with APIs through hot-melt extrusion (HME) and the ability to fabricate hollow objects 14–16 . Previous pharmaceutical researchers attempted to use FDM-based 3D printing mainly in fabricating drug delivery systems with immediate or controlled release characteristics 17–19 , hot-melt extruding filaments of pharmaceutical grade polymers 15, 20, 21 , lowering printing temperatures 22 , and preparing personalized topical drug delivery together with 3D scanning 23 . To our knowledge, there is no report on the FDM based hollow tablets for intragastric floating sustained release (FSR) of drugs.…”

3D printing of tablets using inkjet with UV photoinitiation

“…However, materials availability for inkjet printing are limited, and efforts to broaden the materials range for biotechnology applications is an active area of AM research (Begines et al, 2016;He et al, 2016;Hart et al 2016;Saunders and Derby, 2014;Gudapati et al, 2016). In addition to inkjet 3D printing, other 3D printing technologies have shown significant progress (Alhnan et al, 2016;Goyanes et al, 2015;Khaled et al, 2015aKhaled et al, , 2015bOkwuosa et al, 2016;Sadia et al, 2016). Paste based extrusion printing (Khaled et al, 2015a(Khaled et al, , 2015b and fused deposition modelling (Goyanes et al, 2015;Okwuosa et al, 2016;Sadia et al, 2016) have demonstrated the potential of fabricating immediate and extended release dosage forms, as well as printing "polypills" which contain multiple actives (Goyanes et al, 2015;Khaled et al, 2015aKhaled et al, , 2015b, starting from approved pharmaceutical grade excipients.…”

3D printing for drug manufacturing: A perspective on the future of pharmaceuticals

“…Filament can be loaded with varying concentrations of drugs for specified doses by dissolving the drug in an ethanolic solution and submerging the unprinted, solid filament in the solution [53,54] . Filament can also be loaded with drugs by melting the filament and re-solidifying it after the addition of the drugs [55] . Once the 3D printed drug product is placed in vivo, the drug itself will diffuse out of the print, while the biodegradable filament will dissolve over time.…”