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Simplification of FDM 3D-Printing paradigm: feasibility of 1-step Direct Powder Printing for Immediate Release dosage forms production

Fanous, Marina and Gold, Sarah and Muller, Silvain and Hirsch, Stefan and Ogorka, Joerg and Imanidis, Georgios (2020) Simplification of FDM 3D-Printing paradigm: feasibility of 1-step Direct Powder Printing for Immediate Release dosage forms production. International journal of pharmaceutics. ISSN 1873-3476; 0378-5173

Abstract

Three-dimensional (3D)-printing of tablets via fused deposition modelling (FDM) is gaining attention for the production of flexible and personalized dosage forms. FDM presents advantages for decentralized on-site manufacturing in hospitals and pharmacies as no powder or solvents are involved in the printing process and post-processing can be avoided. However, the current FDM paradigm for dosage forms development is complex, and involves a hot-melt extrusion step and 3D printable drug-loaded filaments as intermediate products for tablet manufacturing.
In this study, simplification of the current FDM set-up for rapid release dosage forms manufacturing was explored. Several powder blends were directly loaded into a cartridge-like head and were successfully printed directly with honeycomb design following heating of the extrusion cartridge. This served as a proof of concept for 1-step direct powder printing (DPP) with incorporation of in-built porosity allowing higher surface area.
A heat processable, water soluble polymer, Hydroxypropylcellulose (HPC) SSL was chosen as rapid release matrix former and caffeine (10%) as thermally stable model drug. The effect of incorporation of a plasticizer/pore former (PEG4000) and a rapidly dissolving polymer (Kollidon VA64) on DPP processability and dissolution profiles was investigated. Formulations were directly 3D-printed into solid dosage forms with high (80%) and low (30%) infill density, and critical quality attributes analyzed (e.g. dissolution profiles, chemical stability and physical form).
The obtained directly 3D-printed tablets demonstrated good weight and content uniformity. Low infill density tablets showed rapid release dissolution profiles independently of the formulation, whereas for high infill density tablets a combination of pore-former PEG4000 and rapidly-dissolving polymer Kollidon VA64 was required to achieve rapid release. Caffeine was found in crystalline state and in the desired polymorph in directly 3D-printed tablets.
Direct Powder 3D-printing feasibility for immediate release dosage forms manufacturing was demonstrated. This technique might create an opportunity to skip the hot-melt extrusion step, allowing 3D-printing independent of mechanical properties of a filament. This might potentially prolong formulation shelf life as thermal stress is applied only once, shortly before the tablets production and dispensing. Moreover, this powder-in-a-cartridge technique might create a future opportunity for decentralized production: loading powder formulation in a cartridge at the industrial facility, and 3D-printing on clinical site potentially using in the same 3D-printer for implants, tablets and even tissues and organs.

Item Type: Article
Date Deposited: 20 Feb 2020 00:45
Last Modified: 20 Feb 2020 00:45
URI: https://oak.novartis.com/id/eprint/40738

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