As the pharmaceutical industry moves away from mass production towards a more personalised model, 3D printing of drugs have the potential to revolutionise the market. The main benefit of using 3D printing technology for personalised pharmaceuticals is the ability to produce small batches with carefully tailored dosages, shapes, sizes, and release characteristics. It also allows flavours to be incorporated into a pill without the need of a film coating, entirely masking the taste of chemical compounds. 3D printers can be installed in pharmacies, hospitals, clinics, and remote locations, enabling on-demand production of drugs, particularly those with poor stability or that have cold chain storage requirements. For pharmaceutical companies, 3D printing can significantly reduce costs, waste, and environmental burden as printers only deposit the exact amount of raw materials required.
Aprecia Pharmaceuticals’ Spritam (levetiracetam), an anti-epileptic drug, is the first and only 3D-printed pharmaceutical. It received the Food and Drug Administration (FDA) approval in 2015 and is made using Aprecia’s proprietary ZipDose technology. The orodispersible tablet achieves full disintegration within seconds when in contact with liquid. Additionally, very high doses are achievable (up to 1,000mg), which are not typically possible through conventional methods. ZipDose technology uses a drop-on-solid printing technique where droplets of a liquid binding agent are deposited by a print nozzle onto a free pharmaceutical powder bed, unifying the free-form powder where it lands. The bed is then lowered to allow for another layer of free-form powder to be added. Further droplets are introduced, adding height to the nascent pill, while the surrounding, unbound powder particles act as a support structure to prevent the collapse of the highly porous pill structure.
In April 2020, UK-based FabRx launched the first commercially available 3D printer for personalised drug manufacturing. M3DIMAKER is an extrusion-based printer that allows the print nozzle to be changed to accommodate different dosage requirements. Alongside the established extrusion-based fusion deposition modelling printing, whereby the printer melts the pharmaceutical mixture and excipients through a nozzle onto the build plate, the M3DIMAKER also uses a different extrusion-based method developed by FabRx: direct powder extrusion (DPE). Similar to Aprecia’s ZipDose technology, DPE deposits a powdered pharmaceutical agent onto a print bed through a nozzle aided by a single extruder. Both methods enable the manufacture of multiple-drug combination pills and sustained or delayed-release tablets.
To date, large biopharmaceutical companies have shown minimal activity in this area. In February 2020, Merck KGaA announced a collaboration with AMCM for the development and production of 3D printed pharmaceuticals for clinical trials and, later, for clinical manufacturing. The stated goal of the partnership is to develop drugs using powder bed fusion, whereby a laser melts and fuses powder together layer by layer. Merck and AMCM expect this to make the manufacturing of tablets both faster and cheaper due to the avoidance of reformulations. GlaxoSmithKline has also shown interest in 3D printing of drugs, partnering with the University of Nottingham on a study that used nozzle printing and ultraviolet curing to produce 3D printed ropinirole tablets to treat Parkinson’s disease.
The traditional one-size-fits-all model of drug development is inefficient and costly. Pharma companies need to adopt new technologies such as 3D printing to make more personalised treatments, improve R&D efficiencies, reduce costs, and minimise waste. This will not only lead to more streamlined and cost-effective supply chains, it will also improve sustainability, which has been touted as one of the most important trends across industries for 2021 and beyond.