What is the future of Fused Deposition Modeling 3D printing in hospital pharmacies for the production of oral solid dosage forms ?

Fused deposition modeling (FDM) is a popular three-dimensional printing technology known for its precision, design flexibility, and user-friendly operation. It operates by extruding a filament through a heated nozzle, which deposits successive layers of material, solidifying onto a build plate based on a computer-generated design [1]. A manufacturing step, hot-melt extrusion (HME), is involved for the production of drug-loaded filaments. Filaments must be produced in a pharmaceutical company assuring quality attributes as mechanical/rheological properties and precise diameter. The filaments would then be distributed to pharmacies as intermediate manufacturing products prior to point-of-care (POC) printing as magistral preparation. Compared to SSE technology using paste-filled syringes, syringe filling is not required, the print quality is higher, and the process is continuous with a filament of a certain length.

We have demonstrated the feasibility of producing various drug-loaded filaments by HME, including API such as itraconazole or cannabidiol. With high precision, we have demonstrated that the dissolution rate relied on infill density and polymers composition, altering surface-to-volume ratio and component distribution, respectively. The batch printing reproducibility on 20 units meets the standards of the European Pharmacopoeia (monograph for uncoated tablets) [2] [3] [4].

3D printing in personalized medicine is a future game changer since healthcare now emphasizes patient-centered care and individualized therapies, especially for vulnerable groups like children. As an example, adrenal insufficiency treatment with hydrocortisone was selected. The few marketed oral hydrocortisone products lack suitability for various required doses and compounding capsules often fail to meet mass and content uniformity standards. Hence, high-quality oral solid dosage forms with hydrocortisone content were developed. Using the same filament but varying printed shapes dimensions, forms containing different drug doses were achieved (1-10mg). One design was created and promoted an immediate release which was a pediatric-friendly mini-waffle shape [5] We aim to perform a clinical study with a collaborative hospital soon.

FDM 3D printing technique is highly promising to develop precise and complex oral solid dosage forms thanks to the modification of printed forms shapes and sizes. This technology is ready to be implemented in hospital pharmacies to produce drug products of advanced quality providing access to individualized healthcare for patients.