Abstract
Fused deposition modelling-based 3D printing of pharmaceutical products is facing challenges like brittleness and printability of the drug-loaded hot-melt extruded filament feedstock and stabilization of the solid-state form of the drug in the final product. The aim of this study was to investigate the influence of the drug load on printability and physical stability. The poor glass former naproxen (NAP) was hot-melt extruded with Kollidon® VA 64 at 10–30% w/w drug load. The extrudates (filaments) were characterised using differential scanning calorimetry (DSC), dynamic mechanical analysis (DMA), and thermogravimetric analysis (TGA). It was confirmed that an amorphous solid dispersion was formed. A temperature profile was developed based on the results from TGA, DSC, and DMA and temperatures used for 3D printing were selected from the profile. The 3D-printed tablets were characterised using DSC, X-ray computer microtomography (XµCT), and X-ray powder diffraction (XRPD). From the DSC and XRPD analysis, it was found that the drug in the 3D-printed tablets (20 and 30% NAP) was amorphous and remained amorphous after 23 weeks of storage (room temperature (RT), 37% relative humidity (RH)). This shows that adjusting the drug ratio can modulate the brittleness and improve printability without compromising the physical stability of the amorphous solid dispersion.
Highlights
It is becoming increasingly evident that more patient-specific medication is required owing to the uniqueness of patients
In pharmaceutical literature, fused deposition modelling (FDM) printing is combined with hot-melt extrusion (HME) to prepare the drug-loaded filament feedstock [8,9]
A major issue in FDM-based 3D printing is the brittleness of the filaments; we show in this study the possibility of improving the printability of filaments by adjusting the drug load while maintaining the physical stability of the amorphous solid dispersion (ASD)
Summary
It is becoming increasingly evident that more patient-specific medication is required owing to the uniqueness of patients. In pharmaceutical literature, fused deposition modelling (FDM) printing is combined with hot-melt extrusion (HME) to prepare the drug-loaded filament feedstock [8,9] These manufacturing methods will often produce drugs in the amorphous form [10,11], which could offer benefits such as increased apparent solubility of poorly soluble drugs, and thereby increase their bioavailability [12]. HME and FDM-based 3D printing represent controlled means of producing amorphous drugs and ASDs. Once the ASD system has been formed, there is still the probability that the drug might recrystallize, the solid-state properties of the intermediate product (filament) and the final product (3D-printed tablets) need to be characterised and controlled. The release of naproxen from the dosage form was assessed, and the storage stability with respect to the solid-state of the drug was followed for 23 weeks
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