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Abstract
With the well-known advantages of additive manufacturing methods such as three-dimensional (3D) printing in drug delivery, it is disappointing that only one product has been successful in achieving regulatory approval in the past few years. Further research and development is required in this area to introduce more 3D printed products into the market. Our study investigates the potential of fixed dose combination solid dispersion drug products generated via 3D printing. Two model drugs—fluorescein sodium (FS) and 5-aminosalicyclic acid (5-ASA)—were impregnated onto a polyvinyl alcohol (PVA) filament, and the influence of solvent choice in optimal drug loading as well as other influences such as the physicochemical and mechanical properties of the resultant filaments were investigated prior to development of the resultant drug products. Key outcomes of this work included the improvement of filament drug loading by one- to threefold due to solvent choice on the basis of its polarity and the generation of a 3D-printed product confirmed to be a solid dispersion fixed dose combination with the two model drugs exhibiting favourable in vitro dissolution characteristics.
Highlights
A fixed-dose combination (FDC) product is a single dosage form that incorporates two or more active pharmaceutical ingredients (APIs) [1,2]
The use of three-dimensional (3D) printing in drug delivery is still in its infancy compared to traditional technologies; research and development is rapidly expanding in this area due to the benefits of 3D printing to develop personalized patient-specific dosage forms with tailored release profiles [10,11,12,13]
Fused deposition modelling (FDM) 3D printing is capable of producing drug products with multiple active pharmaceutical ingredients in various compartments, which is advantageous in developing patient-centric formulations to reduce multiple daily dosing, improving patient compliance and therapeutic efficiency [26,27,28]
Summary
A fixed-dose combination (FDC) product is a single dosage form that incorporates two or more active pharmaceutical ingredients (APIs) [1,2]. The only regulatory approved (by the Food and Drug Administration (FDA)) 3D printed medicinal product is the oro-dispersible levetiracetam tablet, Spritam developed by Aprecia Pharmaceuticals in 2015 [20]. FDM 3D printing has been explored extensively in the development of medicinal products and, FDC products. FDM 3D printing is capable of producing drug products with multiple active pharmaceutical ingredients in various compartments, which is advantageous in developing patient-centric formulations to reduce multiple daily dosing, improving patient compliance and therapeutic efficiency [26,27,28]
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